Atopic Dermatitis, Skin Diseases
Conditions
Keywords
Atopic Dermatitis, Orismilast
Brief summary
This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe atopic dermatitis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe atopic dermatitis and assess the safety aspects of these 3 different doses. The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.
Interventions
Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: * UNI50001 * LEO32731
DRUGPlacebo
Placebo matching tablets
Sponsors
UNION therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Tablets will be packaged in the same type of blister and the active and placebo tablets will have the same appearance (in terms of size, form, weight, and color).
Intervention model description
Participants will be assigned randomly in a 1:1:1:1 ratio to receive 1 of the 3 orismilast modified release doses (20 mg, 30 mg, or 40 mg) or placebo twice daily (BID)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Capable of giving signed informed consent. 2. Male and female patients ≥18 years of age 3. Body weight of \>40 kg 4. Diagnosis of AD for a minimum of 1 year (before the Screening visit) using the Hanifin and Rajka criteria 5. Moderate to severe AD (affected BSA at least 10%, IGA-AD grade of at least 3, and EASI score of at least 16) at the screening and baseline visits 6. Candidate for systemic treatment or phototherapy for AD
Exclusion criteria
1. Therapy-resistant atopic dermatitis 2. Unstable AD with acute deterioration, requiring rescue therapy for AD within 4 weeks of the Screening visit or expected to require rescue therapy within 2 weeks after randomization 3. History of allergy or hypersensitivity to any component of the study treatment 4. Active infection (eg, bacterial, viral, fungal) requiring treatment with systemic antibiotics within 4 weeks of the Screening visit 5. Malignancy or history of malignancy except for treated (ie, cured) basal cell skin carcinoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16 | Baseline and Week 16 | The EASI is a tool to measure the severity of clinical signs and the percentage of affected body surface area (BSA) in patients with atopic dermatitis (AD). The EASI is a composite scoring system to evaluate the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/papulation, excoriation, and lichenification are scored on a scale of 0 (absent) to 3 (severe) for each body region: head and neck, upper limbs (including the external axillae and hands), trunk (including the internal axillae and groin), and lower limbs (including the buttocks and feet). The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16 | Baseline and Week 16 | Laboratory parameters including chemistry was evaluated at baseline and at Week 16. |
| Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response at Week 16 | At Week 16 | The EASI is a tool to measure the severity of clinical signs and the percentage of affected BSA in patients with AD. The EASI is a composite scoring system to evaluate the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/papulation, excoriation, and lichenification are scored on a scale of 0 (absent) to 3 (severe) for each body region: head and neck, upper limbs (including the external axillae and hands), trunk (including the internal axillae and groin), and lower limbs (including the buttocks and feet). The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). |
| Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for AD (IGA-AD) at Week 16 | At Week 16 | The IGA-AD is a measure used by physicians to determine a patient's overall severity of disease. The static version was used for measurement at a single point in time. The Investigator rated the severity of the patient's AD on a 5-point scale ranging from 0 (clear) to 4 (severe). |
| Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | At Weeks 2, 4, 8, 12, and 20 | The IGA-AD is a measure used by physicians to determine a patient's overall severity of disease. The static version was used for measurement at a single point in time. The Investigator rated the severity of the patient's AD on a 5-point scale ranging from 0 (clear) to 4 (severe). |
| Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | At Weeks 2, 4, 8, 12, and 20 | The EASI is an investigator-assessed instrument measuring the severity of clinical signs and the percentage of affected BSA in patients with AD. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). |
| Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | At Weeks 2, 4, 8, 12, 16, and 20 | The EASI is an investigator-assessed instrument measuring the severity of clinical signs and the percentage of affected BSA in patients with AD. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). |
| Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | At Weeks 2, 4, 8, 12, 16, and 20 | The EASI is an investigator-assessed instrument measuring the severity of clinical signs and the percentage of affected BSA in patients with AD. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). |
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Baseline and Weeks 2, 4, 8, 12, and 20 | The EASI is a tool to measure the severity of clinical signs and the percentage of affected BSA in patients with AD. The EASI is a composite scoring system to evaluate the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/papulation, excoriation, and lichenification are scored on a scale of 0 (absent) to 3 (severe) for each body region: head and neck, upper limbs (including the external axillae and hands), trunk (including the internal axillae and groin), and lower limbs (including the buttocks and feet). The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). |
| Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Baseline, Weeks 1, 2, 4, 8, 12, 16, and 20 | The severity of itch (pruritus) due to AD was assessed using a horizontal 11-point NRS. Patients were asked to assess their worst itching due to AD over the past 24 hours on an NRS anchored by the terms no itching (0) and worst possible itching (10). |
| Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | At Weeks 1, 2, 4, 8, 12, 16 and 20 | The severity of itch (pruritus) due to AD was assessed using a horizontal 11-point NRS. Patients were asked to assess their worst itching due to AD over the past 24 hours on an NRS anchored by the terms no itching (0) and worst possible itching (10). |
| Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Baseline and Weeks 2, 4, 8, 12, 16, and 20 | The BSA assessment estimated the extent of disease or skin affected by AD and was expressed as a percentage of total BSA. BSA was determined by the Investigator or designee using the participant's hand (palm + fingers) = 1% BSA rule. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20 | Baseline and Weeks 8, 16, and 20 | The DLQI is a 10-item validated questionnaire completed by the patient and used to assess the effect of skin disease on the patient's quality of life during the previous week. The 10 questions cover the following topics: symptoms; embarrassment; interference with shopping and home care, clothing choices, social and leisure activities, sports participation, work or study, close relationships, and sex; and treatment. Each question is scored from 0 to 3 (not at all, a little, a lot, and very much, respectively), giving a total score ranging from 0 to 30. A high score is indicative of a poor quality of life. |
| Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Baseline and Weeks 2, 4, 8, 12, 16, and 20 | The POEM is a 7-item, validated questionnaire completed by the patient to assess disease symptoms. Patients were asked to respond to questions on frequency of sleep loss and skin dryness, itching, flaking, cracking, bleeding, and weeping over the past week. All answers carry equal weight, with a total possible score ranging from 0 to 28. A high score is indicative of a poor quality of life. |
| Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Baseline and Weeks 2, 4, 8, 12, 16, and 20 | The PGIC scale measures change in clinical status of AD. The PGIC is based on a 7-point scale, and the patient will rate the change from the start of treatment as 1 very much improved, 2 much improved, 3 minimally improved, 4 no change, 5 minimally worse, 6 much worse, and 7 very much worse. |
| Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Baseline and Weeks 1, 2, 4, 8, 12, 16, and 20 | The sleep disturbance NRS is a scale used by the patients to report their degree of sleep loss related to AD. Patients were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being no sleep loss related to signs/symptoms of AD and 10 being I cannot sleep at all because of the signs/symptoms of AD. Higher scores indicate worse outcomes. |
| Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Baseline and Weeks 1, 2, 4, 8, 12, 16, and 20 | The skin pain NRS is a patient-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing no pain and 10 representing worst pain imaginable. Overall severity of a participant's skin pain is indicated by selecting the number that best describes the worst level of skin pain in the past 24 hours. |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | From Baseline through Week 20 | An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at screening, worsens during the study, regardless of the suspected cause of the event. |
| Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | At Week 16 | A complete physical examination (a check of the head, eyes, ears, nose, and throat; heart; lungs; abdomen; skin; cervical and axillary lymph nodes; and neurological and musculoskeletal systems) was performed at screening (Visit 1) and Weeks 16. |
| Change From Baseline in Body Temperature at Weeks 16 and 20 | Baseline and Weeks 16 and 20 | A complete physical examination that included body temperature measurement was performed at screening (Visit 1) and Weeks 16 and 20. |
| Change From Baseline in Respiration Rate at Weeks 16 and 20 | Baseline and Weeks 16 and 20 | A complete physical examination that included respiration rate measurement was performed at screening (Visit 1) and Weeks 16 and 20. |
| Change From Baseline in Heart Rate at Weeks 16 and 20 | Baseline and Weeks 16 and 20 | A complete physical examination that included heart rate measurement was performed at screening (Visit 1) and Weeks 16 and 20. |
| Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 | Baseline and Weeks 16 and 20 | A complete physical examination that included systolic and diastolic blood pressure measurements was performed at screening (Visit 1) and Weeks 16 and 20. |
| Change From Baseline in Body Mass Index (BMI) at Weeks 16 and 20 | Baseline and Weeks 16 and 20 | A complete physical examination that included BMI measurements was performed at screening (Visit 1) and Weeks 16 and 20. |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | At Week 16 | Electrocardiograms were assessed by the investigators based on automatically generated parameters. |
| Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration at Week 16 | Baseline and Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. |
| Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin at Week 16 | Baseline and Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. |
| Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume at Week 16 | Baseline and Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. |
| Change From Baseline in Hematology Parameter: Hematocrit at Week 16 | Baseline and Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. |
| Change From Baseline in Hematology Parameter: Hemoglobin at Week 16 | Baseline and Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. |
| Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Baseline and Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. |
| Change From Baseline in Hematology Parameter: Platelets at Week 16 | Baseline and Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. |
| Change From Baseline in Hematology Parameter: Reticulocytes at Week 16 | Baseline and Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. |
| Change From Baseline in Hematology Parameter: Basophils/Leukocytes at Week 16 | Baseline and Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. |
| Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes at Week 16 | Baseline and Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. |
| Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes at Week 16 | Baseline and Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. |
| Change From Baseline in Hematology Parameter: Monocytes/Leukocytes at Week 16 | Baseline and Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. |
| Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes at Week 16 | Baseline and Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. |
| Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Baseline and Week 16 | Laboratory parameters including chemistry was evaluated at baseline and at Week 16. |
| Change From Baseline in Chemistry Parameter: Albumin at Week 16 | Baseline and Week 16 | Laboratory parameters including chemistry was evaluated at baseline and at Week 16. |
| Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Baseline and Weeks 2, 4, 8, 12, 16, and 20 | The PGIS scale is a single question asking the patient how he or she would rate his or her overall AD symptoms over the past 24 hours. The 5 categories of responses are (0) no symptoms, (1) very mild, (2) mild, (3) moderate, and (4) severe. |
| Change From Baseline in Chemistry Parameter: Phosphate at Week 16 | Baseline and Week 16 | Laboratory parameters including chemistry was evaluated at baseline and at Week 16. |
| Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | At Week 16 | Laboratory parameters including chemistry was evaluated at baseline and at Week 16. |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Baseline and Weeks 2, 4, 8, 12, 16, and 20 | The HADS is a patient reported outcome, comprises of 7 questions for anxiety and 7 questions for depression, with each answer graded from 0 to 3 with a higher score indicating a worse condition. For each group of questions, scores of 7 or less indicate cases without anxiety or depression, whereas scores of 8 to 10, 11 to 14, and 15 to 21 indicate mild, moderate, and severe cases, respectively. |
| Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | At Weeks 2, 4, 8, 12, 16, and 20 | The C-SSRS, Investigator-administered version, was designed to provide a prospective, standardized measure of suicidality. C-SSRS is administered in the form of a clinical interview. The C-SSRS categories have been re-ordered from the actual scale to facilitate the definitions of the endpoints, and to enable clarity in the presentation of the results: Category 1 - Wish to be Dead, Category 2 - Non-specific Active Suicidal Thoughts, Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Category 5 - Active Suicidal Ideation with Specific Plan and Intent, Category 6 - Preparatory Acts or Behavior, Category 7 - Aborted Attempt, Category 8 - Interrupted Attempt, Category 9 - Actual Attempt (non-fatal), Category 10 - Completed Suicide. |
| Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Baseline and Week 16 | Laboratory parameters including chemistry was evaluated at baseline and at Week 16. |
Countries
Germany, Hungary, Poland, United States
Participant flow
Recruitment details
The study was conducted in Germany (9 sites), Poland (17 sites), Hungary (4 sites), and the United States (27 sites).
Participants by arm
| Arm | Count |
|---|---|
| Orismilast Modified Release Tablets 20 mg BID Oral, twice daily morning and evening
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.
Other Names:
* UNI50001
* LEO32731 | 58 |
| Orismilast Modified Release Tablets 30 mg BID Oral, twice daily morning and evening
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.
Other Names:
* UNI50001
* LEO32731 | 61 |
| Orismilast Modified Release Tablets 40 mg BID Oral, twice daily morning and evening
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.
Other Names:
* UNI50001
* LEO32731 | 59 |
| Placebo Tablets BID Oral, twice daily morning and evening
Placebo: Placebo matching tablets | 55 |
| Total | 233 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 8 | 14 | 13 | 2 |
| Overall Study | Lack of Efficacy | 4 | 1 | 2 | 2 |
| Overall Study | Lost to Follow-up | 2 | 5 | 3 | 3 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 7 | 4 | 5 |
Baseline characteristics
| Characteristic | Orismilast Modified Release Tablets 20 mg BID | Total | Placebo Tablets BID | Orismilast Modified Release Tablets 40 mg BID | Orismilast Modified Release Tablets 30 mg BID |
|---|---|---|---|---|---|
| Age, Continuous | 40.2 years STANDARD_DEVIATION 14.34 | 40.6 years STANDARD_DEVIATION 15.02 | 40.9 years STANDARD_DEVIATION 16.87 | 42.5 years STANDARD_DEVIATION 15.69 | 39.1 years STANDARD_DEVIATION 13.3 |
| Asthma Diagnosis No | 45 Participants | 185 Participants | 45 Participants | 49 Participants | 46 Participants |
| Asthma Diagnosis Yes | 13 Participants | 48 Participants | 10 Participants | 10 Participants | 15 Participants |
| Body Mass Index (BMI) | 28.550 kg/m^2 STANDARD_DEVIATION 5.7815 | 28.457 kg/m^2 STANDARD_DEVIATION 6.7782 | 28.178 kg/m^2 STANDARD_DEVIATION 6.4475 | 29.485 kg/m^2 STANDARD_DEVIATION 8.3062 | 27.632 kg/m^2 STANDARD_DEVIATION 6.3312 |
| Child-bearing potential Missing | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants |
| Child-bearing potential No | 10 Participants | 37 Participants | 9 Participants | 10 Participants | 8 Participants |
| Child-bearing potential Yes | 26 Participants | 80 Participants | 17 Participants | 18 Participants | 19 Participants |
| Disease Duration | 19.6 years STANDARD_DEVIATION 12.83 | 19.4 years STANDARD_DEVIATION 14.06 | 17.6 years STANDARD_DEVIATION 14.16 | 20.4 years STANDARD_DEVIATION 14.4 | 19.9 years STANDARD_DEVIATION 14.91 |
| Disease Duration >2 years No | 3 Participants | 15 Participants | 5 Participants | 5 Participants | 2 Participants |
| Disease Duration >2 years Yes | 55 Participants | 218 Participants | 50 Participants | 54 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 78 Participants | 23 Participants | 16 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 154 Participants | 32 Participants | 42 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Height | 168.02 cm STANDARD_DEVIATION 10.955 | 169.98 cm STANDARD_DEVIATION 10.867 | 169.25 cm STANDARD_DEVIATION 10.422 | 172.13 cm STANDARD_DEVIATION 11.659 | 170.45 cm STANDARD_DEVIATION 10.236 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 13 Participants | 2 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 44 Participants | 9 Participants | 15 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 5 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 8 Participants | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 43 Participants | 163 Participants | 41 Participants | 37 Participants | 42 Participants |
| Sex: Female, Male Female | 37 Participants | 119 Participants | 27 Participants | 28 Participants | 27 Participants |
| Sex: Female, Male Male | 21 Participants | 114 Participants | 28 Participants | 31 Participants | 34 Participants |
| Weight | 80.52 kg STANDARD_DEVIATION 17.123 | 82.19 kg STANDARD_DEVIATION 20.45 | 80.89 kg STANDARD_DEVIATION 21.25 | 86.57 kg STANDARD_DEVIATION 23.368 | 80.73 kg STANDARD_DEVIATION 19.469 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 61 | 0 / 59 | 0 / 55 |
| other Total, other adverse events | 44 / 58 | 48 / 61 | 51 / 59 | 35 / 55 |
| serious Total, serious adverse events | 1 / 58 | 0 / 61 | 1 / 59 | 0 / 55 |
Outcome results
Primary
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
The EASI is a tool to measure the severity of clinical signs and the percentage of affected body surface area (BSA) in patients with atopic dermatitis (AD). The EASI is a composite scoring system to evaluate the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/papulation, excoriation, and lichenification are scored on a scale of 0 (absent) to 3 (severe) for each body region: head and neck, upper limbs (including the external axillae and hands), trunk (including the internal axillae and groin), and lower limbs (including the buttocks and feet). The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).
Time frame: Baseline and Week 16
Population: The Intent-To-treat (ITT) Population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16 | -55.1 percent change | Standard Error 4.89 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16 | -52.2 percent change | Standard Error 5.39 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16 | -61.4 percent change | Standard Error 5.02 |
| Placebo Tablets BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16 | -50.4 percent change | Standard Error 4.98 |
p-value: 0.50595% CI: [-18.2, 9]ANCOVA
p-value: 0.81295% CI: [-15.8, 12.3]ANCOVA
p-value: 0.11895% CI: [-24.6, 2.8]ANCOVA
Secondary
Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20
The BSA assessment estimated the extent of disease or skin affected by AD and was expressed as a percentage of total BSA. BSA was determined by the Investigator or designee using the participant's hand (palm + fingers) = 1% BSA rule.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, and 20
Population: The ITT Population included all randomized participants who received at least 1 dose of study drug. n represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | -2.7 percentage of total body surface | Standard Error 1.39 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | -7.0 percentage of total body surface | Standard Error 1.43 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | -9.4 percentage of total body surface | Standard Error 1.46 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | -13.7 percentage of total body surface | Standard Error 1.56 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | -14.5 percentage of total body surface | Standard Error 1.61 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | -13.9 percentage of total body surface | Standard Error 1.57 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | -5.1 percentage of total body surface | Standard Error 1.33 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | -11.1 percentage of total body surface | Standard Error 1.55 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | -7.8 percentage of total body surface | Standard Error 1.51 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | -12.4 percentage of total body surface | Standard Error 1.61 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | -7.3 percentage of total body surface | Standard Error 1.39 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | -14.7 percentage of total body surface | Standard Error 1.61 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | -8.6 percentage of total body surface | Standard Error 1.4 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | -16.4 percentage of total body surface | Standard Error 1.6 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | -12.3 percentage of total body surface | Standard Error 1.49 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | -14.7 percentage of total body surface | Standard Error 1.53 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | -17.4 percentage of total body surface | Standard Error 1.57 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | -4.4 percentage of total body surface | Standard Error 1.38 |
| Placebo Tablets BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | -11.4 percentage of total body surface | Standard Error 1.51 |
| Placebo Tablets BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | -15.4 percentage of total body surface | Standard Error 1.54 |
| Placebo Tablets BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | -5.0 percentage of total body surface | Standard Error 1.44 |
| Placebo Tablets BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | -2.8 percentage of total body surface | Standard Error 1.41 |
| Placebo Tablets BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | -7.8 percentage of total body surface | Standard Error 1.5 |
| Placebo Tablets BID | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | -13.8 percentage of total body surface | Standard Error 1.53 |
Secondary
Change From Baseline in Body Mass Index (BMI) at Weeks 16 and 20
A complete physical examination that included BMI measurements was performed at screening (Visit 1) and Weeks 16 and 20.
Time frame: Baseline and Weeks 16 and 20
Population: The safety population included all randomized participants who received at least 1 dose of study drug. n represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Body Mass Index (BMI) at Weeks 16 and 20 | Week 16 | -0.28 kg/m^2 | Standard Deviation 1.081 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Body Mass Index (BMI) at Weeks 16 and 20 | Week 20 | -0.11 kg/m^2 | Standard Deviation 0.845 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Body Mass Index (BMI) at Weeks 16 and 20 | Week 20 | -0.15 kg/m^2 | Standard Deviation 0.72 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Body Mass Index (BMI) at Weeks 16 and 20 | Week 16 | -0.13 kg/m^2 | Standard Deviation 0.758 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Body Mass Index (BMI) at Weeks 16 and 20 | Week 16 | -0.34 kg/m^2 | Standard Deviation 1.252 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Body Mass Index (BMI) at Weeks 16 and 20 | Week 20 | -0.37 kg/m^2 | Standard Deviation 1.339 |
| Placebo Tablets BID | Change From Baseline in Body Mass Index (BMI) at Weeks 16 and 20 | Week 16 | 0.16 kg/m^2 | Standard Deviation 0.773 |
| Placebo Tablets BID | Change From Baseline in Body Mass Index (BMI) at Weeks 16 and 20 | Week 20 | 0.18 kg/m^2 | Standard Deviation 0.911 |
Secondary
Change From Baseline in Body Temperature at Weeks 16 and 20
A complete physical examination that included body temperature measurement was performed at screening (Visit 1) and Weeks 16 and 20.
Time frame: Baseline and Weeks 16 and 20
Population: The safety population included all randomized participants who received at least 1 dose of study drug. n represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Body Temperature at Weeks 16 and 20 | Week 16 | -0.07 Degree Celsius | Standard Deviation 0.3 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Body Temperature at Weeks 16 and 20 | Week 20 | -0.08 Degree Celsius | Standard Deviation 0.357 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Body Temperature at Weeks 16 and 20 | Week 20 | -0.05 Degree Celsius | Standard Deviation 0.32 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Body Temperature at Weeks 16 and 20 | Week 16 | 0.05 Degree Celsius | Standard Deviation 0.239 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Body Temperature at Weeks 16 and 20 | Week 20 | -0.11 Degree Celsius | Standard Deviation 0.362 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Body Temperature at Weeks 16 and 20 | Week 16 | -0.01 Degree Celsius | Standard Deviation 0.35 |
| Placebo Tablets BID | Change From Baseline in Body Temperature at Weeks 16 and 20 | Week 20 | 0.03 Degree Celsius | Standard Deviation 0.264 |
| Placebo Tablets BID | Change From Baseline in Body Temperature at Weeks 16 and 20 | Week 16 | 0.00 Degree Celsius | Standard Deviation 0.324 |
Secondary
Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16
Laboratory parameters including chemistry was evaluated at baseline and at Week 16.
Time frame: Baseline and Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Gamma Glutamyl Transferase | -6.8 Units per liter | Standard Deviation 62.55 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Alkaline Phosphatase | -4.8 Units per liter | Standard Deviation 25.88 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Lactate Dehydrogenase | -15.8 Units per liter | Standard Deviation 41.47 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Aspartate Aminotransferase | -1.6 Units per liter | Standard Deviation 13.08 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Alanine Aminotransferase | -1.5 Units per liter | Standard Deviation 17.16 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Aspartate Aminotransferase | 0.6 Units per liter | Standard Deviation 9.75 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Gamma Glutamyl Transferase | -0.8 Units per liter | Standard Deviation 9.11 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Lactate Dehydrogenase | -12.9 Units per liter | Standard Deviation 58.24 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Alkaline Phosphatase | 2.1 Units per liter | Standard Deviation 11.55 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Alanine Aminotransferase | -0.7 Units per liter | Standard Deviation 10.06 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Aspartate Aminotransferase | -0.4 Units per liter | Standard Deviation 11.35 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Alanine Aminotransferase | 1.0 Units per liter | Standard Deviation 10.87 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Alkaline Phosphatase | 1.5 Units per liter | Standard Deviation 11.32 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Gamma Glutamyl Transferase | 3.3 Units per liter | Standard Deviation 23.98 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Lactate Dehydrogenase | -12.9 Units per liter | Standard Deviation 50.15 |
| Placebo Tablets BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Gamma Glutamyl Transferase | -1.7 Units per liter | Standard Deviation 6.75 |
| Placebo Tablets BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Alkaline Phosphatase | -1.7 Units per liter | Standard Deviation 11.11 |
| Placebo Tablets BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Alanine Aminotransferase | -0.6 Units per liter | Standard Deviation 13.13 |
| Placebo Tablets BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Aspartate Aminotransferase | -1.4 Units per liter | Standard Deviation 11.5 |
| Placebo Tablets BID | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Lactate Dehydrogenase | -7.9 Units per liter | Standard Deviation 36.44 |
Secondary
Change From Baseline in Chemistry Parameter: Albumin at Week 16
Laboratory parameters including chemistry was evaluated at baseline and at Week 16.
Time frame: Baseline and Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Chemistry Parameter: Albumin at Week 16 | -0.4 Grams per liter | Standard Deviation 2.67 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Chemistry Parameter: Albumin at Week 16 | 0.0 Grams per liter | Standard Deviation 2.8 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Chemistry Parameter: Albumin at Week 16 | 0.0 Grams per liter | Standard Deviation 2.57 |
| Placebo Tablets BID | Change From Baseline in Chemistry Parameter: Albumin at Week 16 | 0.1 Grams per liter | Standard Deviation 2.36 |
Secondary
Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16
Laboratory parameters including chemistry was evaluated at baseline and at Week 16.
Time frame: Baseline and Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16 | Bilirubin | 0.29 Micromoles per liter | Standard Deviation 2.487 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16 | Direct Bilirubin | 0.03 Micromoles per liter | Standard Deviation 0.205 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16 | Creatinine | 2.9 Micromoles per liter | Standard Deviation 13.41 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16 | Bilirubin | 0.13 Micromoles per liter | Standard Deviation 2.948 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16 | Direct Bilirubin | -0.13 Micromoles per liter | Standard Deviation 0.552 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16 | Creatinine | 2.3 Micromoles per liter | Standard Deviation 12.07 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16 | Creatinine | 2.3 Micromoles per liter | Standard Deviation 12.59 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16 | Bilirubin | 0.32 Micromoles per liter | Standard Deviation 2.361 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16 | Direct Bilirubin | 0.01 Micromoles per liter | Standard Deviation 0.084 |
| Placebo Tablets BID | Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16 | Bilirubin | 0.68 Micromoles per liter | Standard Deviation 3.234 |
| Placebo Tablets BID | Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16 | Direct Bilirubin | 0.17 Micromoles per liter | Standard Deviation 0.739 |
| Placebo Tablets BID | Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16 | Creatinine | -1.0 Micromoles per liter | Standard Deviation 7.58 |
Secondary
Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16
Laboratory parameters including chemistry was evaluated at baseline and at Week 16.
Time frame: Baseline and Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Chloride | -0.2 Millimoles per liter | Standard Deviation 3.29 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Calcium | -0.021 Millimoles per liter | Standard Deviation 0.143 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Urea Nitrogen | -0.207 Millimoles per liter | Standard Deviation 1.1653 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Sodium | -0.1 Millimoles per liter | Standard Deviation 2.89 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Potassium | -0.01 Millimoles per liter | Standard Deviation 0.498 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Sodium | 0.6 Millimoles per liter | Standard Deviation 3.47 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Urea Nitrogen | -0.315 Millimoles per liter | Standard Deviation 1.2731 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Calcium | 0.013 Millimoles per liter | Standard Deviation 0.1085 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Chloride | 0.0 Millimoles per liter | Standard Deviation 3.08 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Potassium | -0.01 Millimoles per liter | Standard Deviation 0.393 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Sodium | 1.4 Millimoles per liter | Standard Deviation 2.75 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Potassium | -0.18 Millimoles per liter | Standard Deviation 0.449 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Chloride | 0.2 Millimoles per liter | Standard Deviation 3.05 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Calcium | 0.006 Millimoles per liter | Standard Deviation 0.126 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Urea Nitrogen | 0.104 Millimoles per liter | Standard Deviation 1.3782 |
| Placebo Tablets BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Calcium | -0.015 Millimoles per liter | Standard Deviation 0.13 |
| Placebo Tablets BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Sodium | 0.5 Millimoles per liter | Standard Deviation 2.66 |
| Placebo Tablets BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Chloride | 0.1 Millimoles per liter | Standard Deviation 3.07 |
| Placebo Tablets BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Potassium | -0.06 Millimoles per liter | Standard Deviation 0.372 |
| Placebo Tablets BID | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Urea Nitrogen | -0.041 Millimoles per liter | Standard Deviation 1.5732 |
Secondary
Change From Baseline in Chemistry Parameter: Phosphate at Week 16
Laboratory parameters including chemistry was evaluated at baseline and at Week 16.
Time frame: Baseline and Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Chemistry Parameter: Phosphate at Week 16 | 0.003 Millimoles per liter | Standard Deviation 0.1986 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Chemistry Parameter: Phosphate at Week 16 | 0.045 Millimoles per liter | Standard Deviation 0.201 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Chemistry Parameter: Phosphate at Week 16 | 0.043 Millimoles per liter | Standard Deviation 0.2661 |
| Placebo Tablets BID | Change From Baseline in Chemistry Parameter: Phosphate at Week 16 | -0.009 Millimoles per liter | Standard Deviation 0.1579 |
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20
The DLQI is a 10-item validated questionnaire completed by the patient and used to assess the effect of skin disease on the patient's quality of life during the previous week. The 10 questions cover the following topics: symptoms; embarrassment; interference with shopping and home care, clothing choices, social and leisure activities, sports participation, work or study, close relationships, and sex; and treatment. Each question is scored from 0 to 3 (not at all, a little, a lot, and very much, respectively), giving a total score ranging from 0 to 30. A high score is indicative of a poor quality of life.
Time frame: Baseline and Weeks 8, 16, and 20
Population: The ITT Population included all randomized participants who received at least 1 dose of study drug. n represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20 | Week 8 | -5.8 score on a scale | Standard Error 0.8 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20 | Week 16 | -7.5 score on a scale | Standard Error 0.87 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20 | Week 20 | -8.3 score on a scale | Standard Error 0.9 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20 | Week 20 | -8.9 score on a scale | Standard Error 0.89 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20 | Week 8 | -7.2 score on a scale | Standard Error 0.83 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20 | Week 16 | -8.2 score on a scale | Standard Error 0.89 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20 | Week 8 | -6.5 score on a scale | Standard Error 0.82 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20 | Week 20 | -8.6 score on a scale | Standard Error 0.86 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20 | Week 16 | -9.0 score on a scale | Standard Error 0.86 |
| Placebo Tablets BID | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20 | Week 8 | -5.7 score on a scale | Standard Error 0.82 |
| Placebo Tablets BID | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20 | Week 16 | -7.5 score on a scale | Standard Error 0.83 |
| Placebo Tablets BID | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20 | Week 20 | -7.8 score on a scale | Standard Error 0.84 |
Secondary
Change From Baseline in Heart Rate at Weeks 16 and 20
A complete physical examination that included heart rate measurement was performed at screening (Visit 1) and Weeks 16 and 20.
Time frame: Baseline and Weeks 16 and 20
Population: The safety population included all randomized participants who received at least 1 dose of study drug. n represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Heart Rate at Weeks 16 and 20 | Week 16 | 3.3 Beats per minute | Standard Deviation 9.59 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Heart Rate at Weeks 16 and 20 | Week 20 | 1.4 Beats per minute | Standard Deviation 7.7 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Heart Rate at Weeks 16 and 20 | Week 20 | -1.0 Beats per minute | Standard Deviation 11.11 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Heart Rate at Weeks 16 and 20 | Week 16 | 1.1 Beats per minute | Standard Deviation 9.99 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Heart Rate at Weeks 16 and 20 | Week 16 | 4.4 Beats per minute | Standard Deviation 9.01 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Heart Rate at Weeks 16 and 20 | Week 20 | 4.8 Beats per minute | Standard Deviation 7.79 |
| Placebo Tablets BID | Change From Baseline in Heart Rate at Weeks 16 and 20 | Week 16 | -2.5 Beats per minute | Standard Deviation 11.07 |
| Placebo Tablets BID | Change From Baseline in Heart Rate at Weeks 16 and 20 | Week 20 | -2.4 Beats per minute | Standard Deviation 10.36 |
Secondary
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16
Laboratory parameters including hematology was evaluated at baseline and at Week 16.
Time frame: Baseline and Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Leukocytes | 0.357 cells*10^9 per liter | Standard Deviation 2.5643 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Basophils | 0.002 cells*10^9 per liter | Standard Deviation 0.0131 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Eosinophils | -0.048 cells*10^9 per liter | Standard Deviation 0.2048 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Lymphocytes | 0.031 cells*10^9 per liter | Standard Deviation 0.5119 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Monocytes | 0.031 cells*10^9 per liter | Standard Deviation 0.1884 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Neutrophils | 0.339 cells*10^9 per liter | Standard Deviation 2.207 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Neutrophils | 0.040 cells*10^9 per liter | Standard Deviation 1.3733 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Lymphocytes | 0.009 cells*10^9 per liter | Standard Deviation 0.4377 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Leukocytes | -0.061 cells*10^9 per liter | Standard Deviation 1.8343 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Eosinophils | -0.131 cells*10^9 per liter | Standard Deviation 0.6653 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Basophils | 0.007 cells*10^9 per liter | Standard Deviation 0.0187 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Monocytes | 0.017 cells*10^9 per liter | Standard Deviation 0.1336 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Basophils | -0.002 cells*10^9 per liter | Standard Deviation 0.0133 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Eosinophils | -0.055 cells*10^9 per liter | Standard Deviation 0.3146 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Lymphocytes | -0.065 cells*10^9 per liter | Standard Deviation 0.3665 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Neutrophils | -0.233 cells*10^9 per liter | Standard Deviation 1.5109 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Monocytes | -0.008 cells*10^9 per liter | Standard Deviation 0.107 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Leukocytes | -0.372 cells*10^9 per liter | Standard Deviation 1.6455 |
| Placebo Tablets BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Monocytes | 0.021 cells*10^9 per liter | Standard Deviation 0.1205 |
| Placebo Tablets BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Neutrophils | -0.170 cells*10^9 per liter | Standard Deviation 1.398 |
| Placebo Tablets BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Basophils | -0.002 cells*10^9 per liter | Standard Deviation 0.0206 |
| Placebo Tablets BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Lymphocytes | 0.020 cells*10^9 per liter | Standard Deviation 0.4073 |
| Placebo Tablets BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Leukocytes | -0.153 cells*10^9 per liter | Standard Deviation 1.3115 |
| Placebo Tablets BID | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Eosinophils | -0.020 cells*10^9 per liter | Standard Deviation 0.1309 |
Secondary
Change From Baseline in Hematology Parameter: Basophils/Leukocytes at Week 16
Laboratory parameters including hematology was evaluated at baseline and at Week 16.
Time frame: Baseline and Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hematology Parameter: Basophils/Leukocytes at Week 16 | 0.02 percentage of basophils in leukocytes | Standard Deviation 0.216 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hematology Parameter: Basophils/Leukocytes at Week 16 | 0.10 percentage of basophils in leukocytes | Standard Deviation 0.269 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hematology Parameter: Basophils/Leukocytes at Week 16 | 0.01 percentage of basophils in leukocytes | Standard Deviation 0.225 |
| Placebo Tablets BID | Change From Baseline in Hematology Parameter: Basophils/Leukocytes at Week 16 | -0.03 percentage of basophils in leukocytes | Standard Deviation 0.359 |
Secondary
Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes at Week 16
Laboratory parameters including hematology was evaluated at baseline and at Week 16.
Time frame: Baseline and Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes at Week 16 | -0.42 percentage of eosinophils in leukocytes | Standard Deviation 2.353 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes at Week 16 | -0.96 percentage of eosinophils in leukocytes | Standard Deviation 4.705 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes at Week 16 | -0.35 percentage of eosinophils in leukocytes | Standard Deviation 3.323 |
| Placebo Tablets BID | Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes at Week 16 | -0.28 percentage of eosinophils in leukocytes | Standard Deviation 2.268 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin at Week 16
Laboratory parameters including hematology was evaluated at baseline and at Week 16.
Time frame: Baseline and Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin at Week 16 | -0.24 picogram | Standard Deviation 1.057 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin at Week 16 | -0.27 picogram | Standard Deviation 0.69 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin at Week 16 | -0.25 picogram | Standard Deviation 0.816 |
| Placebo Tablets BID | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin at Week 16 | -0.14 picogram | Standard Deviation 0.71 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration at Week 16
Laboratory parameters including hematology was evaluated at baseline and at Week 16.
Time frame: Baseline and Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration at Week 16 | 5.2 Grams per liter | Standard Deviation 16.86 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration at Week 16 | 5.8 Grams per liter | Standard Deviation 20.08 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration at Week 16 | 2.0 Grams per liter | Standard Deviation 17.65 |
| Placebo Tablets BID | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration at Week 16 | 3.0 Grams per liter | Standard Deviation 18.07 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume at Week 16
Laboratory parameters including hematology was evaluated at baseline and at Week 16.
Time frame: Baseline and Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume at Week 16 | -2.34 Femtoliters | Standard Deviation 4.833 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume at Week 16 | -2.80 Femtoliters | Standard Deviation 6.069 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume at Week 16 | -1.52 Femtoliters | Standard Deviation 6.262 |
| Placebo Tablets BID | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume at Week 16 | -1.52 Femtoliters | Standard Deviation 6.535 |
Secondary
Change From Baseline in Hematology Parameter: Hematocrit at Week 16
Laboratory parameters including hematology was evaluated at baseline and at Week 16.
Time frame: Baseline and Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hematology Parameter: Hematocrit at Week 16 | -0.0125 Liter per liter | Standard Deviation 0.03242 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hematology Parameter: Hematocrit at Week 16 | -0.0100 Liter per liter | Standard Deviation 0.03359 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hematology Parameter: Hematocrit at Week 16 | -0.0061 Liter per liter | Standard Deviation 0.0342 |
| Placebo Tablets BID | Change From Baseline in Hematology Parameter: Hematocrit at Week 16 | -0.0045 Liter per liter | Standard Deviation 0.03509 |
Secondary
Change From Baseline in Hematology Parameter: Hemoglobin at Week 16
Laboratory parameters including hematology was evaluated at baseline and at Week 16.
Time frame: Baseline and Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hematology Parameter: Hemoglobin at Week 16 | -1.5 Grams per liter | Standard Deviation 6.7 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hematology Parameter: Hemoglobin at Week 16 | -0.2 Grams per liter | Standard Deviation 6.89 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hematology Parameter: Hemoglobin at Week 16 | -1.0 Grams per liter | Standard Deviation 8.12 |
| Placebo Tablets BID | Change From Baseline in Hematology Parameter: Hemoglobin at Week 16 | 0.2 Grams per liter | Standard Deviation 8.33 |
Secondary
Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes at Week 16
Laboratory parameters including hematology was evaluated at baseline and at Week 16.
Time frame: Baseline and Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes at Week 16 | -0.48 percentage of lymphocytes in leukocytes | Standard Deviation 7.737 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes at Week 16 | 0.46 percentage of lymphocytes in leukocytes | Standard Deviation 6.139 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes at Week 16 | 1.05 percentage of lymphocytes in leukocytes | Standard Deviation 7.232 |
| Placebo Tablets BID | Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes at Week 16 | 0.94 percentage of lymphocytes in leukocytes | Standard Deviation 6.922 |
Secondary
Change From Baseline in Hematology Parameter: Monocytes/Leukocytes at Week 16
Laboratory parameters including hematology was evaluated at baseline and at Week 16.
Time frame: Baseline and Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hematology Parameter: Monocytes/Leukocytes at Week 16 | 0.18 percentage of monocytes in leukocytes | Standard Deviation 2.468 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hematology Parameter: Monocytes/Leukocytes at Week 16 | 0.31 percentage of monocytes in leukocytes | Standard Deviation 1.487 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hematology Parameter: Monocytes/Leukocytes at Week 16 | 0.09 percentage of monocytes in leukocytes | Standard Deviation 1.679 |
| Placebo Tablets BID | Change From Baseline in Hematology Parameter: Monocytes/Leukocytes at Week 16 | 0.29 percentage of monocytes in leukocytes | Standard Deviation 2.13 |
Secondary
Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes at Week 16
Laboratory parameters including hematology was evaluated at baseline and at Week 16.
Time frame: Baseline and Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes at Week 16 | 0.72 percentage of neutrophils in leukocytes | Standard Deviation 9.487 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes at Week 16 | 0.13 percentage of neutrophils in leukocytes | Standard Deviation 8.508 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes at Week 16 | -0.67 percentage of neutrophils in leukocytes | Standard Deviation 9.06 |
| Placebo Tablets BID | Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes at Week 16 | -0.90 percentage of neutrophils in leukocytes | Standard Deviation 9.247 |
Secondary
Change From Baseline in Hematology Parameter: Platelets at Week 16
Laboratory parameters including hematology was evaluated at baseline and at Week 16.
Time frame: Baseline and Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hematology Parameter: Platelets at Week 16 | 22.5 cells*10^9 per liter | Standard Deviation 51.03 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hematology Parameter: Platelets at Week 16 | 11.7 cells*10^9 per liter | Standard Deviation 55.24 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hematology Parameter: Platelets at Week 16 | -1.8 cells*10^9 per liter | Standard Deviation 61.72 |
| Placebo Tablets BID | Change From Baseline in Hematology Parameter: Platelets at Week 16 | -3.0 cells*10^9 per liter | Standard Deviation 37.53 |
Secondary
Change From Baseline in Hematology Parameter: Reticulocytes at Week 16
Laboratory parameters including hematology was evaluated at baseline and at Week 16.
Time frame: Baseline and Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hematology Parameter: Reticulocytes at Week 16 | 0.008 percentage | Standard Deviation 0.4376 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hematology Parameter: Reticulocytes at Week 16 | 0.025 percentage | Standard Deviation 0.3758 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hematology Parameter: Reticulocytes at Week 16 | -0.137 percentage | Standard Deviation 0.4313 |
| Placebo Tablets BID | Change From Baseline in Hematology Parameter: Reticulocytes at Week 16 | -0.024 percentage | Standard Deviation 0.3411 |
Secondary
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20
The HADS is a patient reported outcome, comprises of 7 questions for anxiety and 7 questions for depression, with each answer graded from 0 to 3 with a higher score indicating a worse condition. For each group of questions, scores of 7 or less indicate cases without anxiety or depression, whereas scores of 8 to 10, 11 to 14, and 15 to 21 indicate mild, moderate, and severe cases, respectively.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, and 20
Population: The safety population included all randomized participants who received at least 1 dose of study drug. n represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | -1.7 score on a scale | Standard Deviation 3.05 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | -2.3 score on a scale | Standard Deviation 3.08 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | -2.2 score on a scale | Standard Deviation 3.11 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | -2.5 score on a scale | Standard Deviation 3.27 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | -1.5 score on a scale | Standard Deviation 2.9 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | -2.0 score on a scale | Standard Deviation 3.41 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | -0.9 score on a scale | Standard Deviation 2.69 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | -2.4 score on a scale | Standard Deviation 3.13 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | -1.0 score on a scale | Standard Deviation 2.84 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | -1.7 score on a scale | Standard Deviation 3.22 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | -1.9 score on a scale | Standard Deviation 2.95 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | -0.5 score on a scale | Standard Deviation 2.54 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | -1.1 score on a scale | Standard Deviation 4.07 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | -1.5 score on a scale | Standard Deviation 4.25 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | -2.2 score on a scale | Standard Deviation 4.09 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | -1.2 score on a scale | Standard Deviation 4.23 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | -1.2 score on a scale | Standard Deviation 3.12 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | -1.5 score on a scale | Standard Deviation 4.31 |
| Placebo Tablets BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | -0.3 score on a scale | Standard Deviation 3.01 |
| Placebo Tablets BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | -1.2 score on a scale | Standard Deviation 2.88 |
| Placebo Tablets BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | -1.5 score on a scale | Standard Deviation 2.91 |
| Placebo Tablets BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | -1.2 score on a scale | Standard Deviation 3.61 |
| Placebo Tablets BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | -1.4 score on a scale | Standard Deviation 2.9 |
| Placebo Tablets BID | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | -1.4 score on a scale | Standard Deviation 3.21 |
Secondary
Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20
The PGIC scale measures change in clinical status of AD. The PGIC is based on a 7-point scale, and the patient will rate the change from the start of treatment as 1 very much improved, 2 much improved, 3 minimally improved, 4 no change, 5 minimally worse, 6 much worse, and 7 very much worse.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, and 20
Population: The ITT Population included all randomized participants who received at least 1 dose of study drug. n represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | 3.0 score on a scale | Standard Error 0.15 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | 2.6 score on a scale | Standard Error 0.25 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | 2.9 score on a scale | Standard Error 0.16 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | 2.2 score on a scale | Standard Error 0.2 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | 2.5 score on a scale | Standard Error 0.18 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | 2.6 score on a scale | Standard Error 0.18 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | 2.3 score on a scale | Standard Error 0.21 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | 2.5 score on a scale | Standard Error 0.18 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | 2.4 score on a scale | Standard Error 0.18 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | 3.0 score on a scale | Standard Error 0.15 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | 2.5 score on a scale | Standard Error 0.25 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | 2.9 score on a scale | Standard Error 0.16 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | 2.9 score on a scale | Standard Error 0.18 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | 3.1 score on a scale | Standard Error 0.15 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | 2.9 score on a scale | Standard Error 0.16 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | 2.7 score on a scale | Standard Error 0.17 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | 2.3 score on a scale | Standard Error 0.2 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | 2.6 score on a scale | Standard Error 0.24 |
| Placebo Tablets BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | 2.7 score on a scale | Standard Error 0.23 |
| Placebo Tablets BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | 2.9 score on a scale | Standard Error 0.19 |
| Placebo Tablets BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | 3.6 score on a scale | Standard Error 0.16 |
| Placebo Tablets BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | 3.3 score on a scale | Standard Error 0.18 |
| Placebo Tablets BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | 3.1 score on a scale | Standard Error 0.17 |
| Placebo Tablets BID | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | 3.4 score on a scale | Standard Error 0.16 |
Secondary
Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20
The PGIS scale is a single question asking the patient how he or she would rate his or her overall AD symptoms over the past 24 hours. The 5 categories of responses are (0) no symptoms, (1) very mild, (2) mild, (3) moderate, and (4) severe.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, and 20
Population: The ITT Population included all randomized participants who received at least 1 dose of study drug. n represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | -1.0 score on a scale | Standard Error 0.15 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | -0.9 score on a scale | Standard Error 0.14 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | -1.5 score on a scale | Standard Error 0.17 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | -1.4 score on a scale | Standard Error 0.16 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | -1.5 score on a scale | Standard Error 0.17 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | -0.9 score on a scale | Standard Error 0.15 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | -1.4 score on a scale | Standard Error 0.17 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | -1.5 score on a scale | Standard Error 0.16 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | -1.0 score on a scale | Standard Error 0.15 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | -1.0 score on a scale | Standard Error 0.14 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | -0.8 score on a scale | Standard Error 0.13 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | -1.4 score on a scale | Standard Error 0.17 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | -1.0 score on a scale | Standard Error 0.15 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | -1.1 score on a scale | Standard Error 0.16 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | -1.5 score on a scale | Standard Error 0.16 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | -0.7 score on a scale | Standard Error 0.14 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | -0.9 score on a scale | Standard Error 0.14 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | -1.5 score on a scale | Standard Error 0.16 |
| Placebo Tablets BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | -1.2 score on a scale | Standard Error 0.16 |
| Placebo Tablets BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | -1.1 score on a scale | Standard Error 0.16 |
| Placebo Tablets BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | -0.4 score on a scale | Standard Error 0.14 |
| Placebo Tablets BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | -0.4 score on a scale | Standard Error 0.15 |
| Placebo Tablets BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | -0.7 score on a scale | Standard Error 0.15 |
| Placebo Tablets BID | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | -1.0 score on a scale | Standard Error 0.15 |
Secondary
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20
The POEM is a 7-item, validated questionnaire completed by the patient to assess disease symptoms. Patients were asked to respond to questions on frequency of sleep loss and skin dryness, itching, flaking, cracking, bleeding, and weeping over the past week. All answers carry equal weight, with a total possible score ranging from 0 to 28. A high score is indicative of a poor quality of life.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, and 20
Population: The ITT Population included all randomized participants who received at least 1 dose of study drug. n represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | -4.6 score on a scale | Standard Error 0.84 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | -6.4 score on a scale | Standard Error 0.87 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | -7.3 score on a scale | Standard Error 0.89 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | -9.4 score on a scale | Standard Error 0.95 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | -9.8 score on a scale | Standard Error 0.97 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | -8.7 score on a scale | Standard Error 1 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | -9.1 score on a scale | Standard Error 0.98 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | -9.8 score on a scale | Standard Error 0.94 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | -5.6 score on a scale | Standard Error 0.8 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | -8.3 score on a scale | Standard Error 0.92 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | -6.5 score on a scale | Standard Error 0.85 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | -9.1 score on a scale | Standard Error 0.98 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | -7.6 score on a scale | Standard Error 0.85 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | -8.1 score on a scale | Standard Error 0.9 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | -8.4 score on a scale | Standard Error 0.93 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | -9.5 score on a scale | Standard Error 0.96 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | -10.1 score on a scale | Standard Error 0.95 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | -7.3 score on a scale | Standard Error 0.83 |
| Placebo Tablets BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 16 | -7.5 score on a scale | Standard Error 0.93 |
| Placebo Tablets BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 20 | -8.1 score on a scale | Standard Error 0.94 |
| Placebo Tablets BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 4 | -3.8 score on a scale | Standard Error 0.88 |
| Placebo Tablets BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 12 | -6.6 score on a scale | Standard Error 0.91 |
| Placebo Tablets BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 2 | -2.9 score on a scale | Standard Error 0.86 |
| Placebo Tablets BID | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | Week 8 | -7.0 score on a scale | Standard Error 0.91 |
Secondary
Change From Baseline in Respiration Rate at Weeks 16 and 20
A complete physical examination that included respiration rate measurement was performed at screening (Visit 1) and Weeks 16 and 20.
Time frame: Baseline and Weeks 16 and 20
Population: The safety population included all randomized participants who received at least 1 dose of study drug. n represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Respiration Rate at Weeks 16 and 20 | Week 16 | 0.1 Breaths per minute | Standard Deviation 1.51 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Respiration Rate at Weeks 16 and 20 | Week 20 | 0.1 Breaths per minute | Standard Deviation 1.38 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Respiration Rate at Weeks 16 and 20 | Week 20 | -0.1 Breaths per minute | Standard Deviation 1.3 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Respiration Rate at Weeks 16 and 20 | Week 16 | 0.2 Breaths per minute | Standard Deviation 1.37 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Respiration Rate at Weeks 16 and 20 | Week 16 | 0.1 Breaths per minute | Standard Deviation 1.26 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Respiration Rate at Weeks 16 and 20 | Week 20 | 0.0 Breaths per minute | Standard Deviation 1 |
| Placebo Tablets BID | Change From Baseline in Respiration Rate at Weeks 16 and 20 | Week 16 | 0.3 Breaths per minute | Standard Deviation 1.72 |
| Placebo Tablets BID | Change From Baseline in Respiration Rate at Weeks 16 and 20 | Week 20 | 0.2 Breaths per minute | Standard Deviation 1.59 |
Secondary
Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20
The skin pain NRS is a patient-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing no pain and 10 representing worst pain imaginable. Overall severity of a participant's skin pain is indicated by selecting the number that best describes the worst level of skin pain in the past 24 hours.
Time frame: Baseline and Weeks 1, 2, 4, 8, 12, 16, and 20
Population: The ITT Population included all randomized participants who received at least 1 dose of study drug. n represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1 | -2.0 score on a scale | Standard Error 0.34 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16 | -3.5 score on a scale | Standard Error 0.39 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12 | -3.4 score on a scale | Standard Error 0.38 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2 | -1.9 score on a scale | Standard Error 0.34 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20 | -3.8 score on a scale | Standard Error 0.4 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4 | -2.3 score on a scale | Standard Error 0.35 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8 | -2.7 score on a scale | Standard Error 0.36 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16 | -3.7 score on a scale | Standard Error 0.39 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8 | -2.9 score on a scale | Standard Error 0.37 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4 | -2.3 score on a scale | Standard Error 0.34 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12 | -3.3 score on a scale | Standard Error 0.38 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20 | -3.1 score on a scale | Standard Error 0.39 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2 | -2.2 score on a scale | Standard Error 0.33 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1 | -1.8 score on a scale | Standard Error 0.33 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8 | -2.6 score on a scale | Standard Error 0.37 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1 | -1.9 score on a scale | Standard Error 0.34 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2 | -1.7 score on a scale | Standard Error 0.34 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4 | -2.3 score on a scale | Standard Error 0.34 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12 | -2.7 score on a scale | Standard Error 0.37 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16 | -3.6 score on a scale | Standard Error 0.38 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20 | -3.3 score on a scale | Standard Error 0.39 |
| Placebo Tablets BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4 | -1.4 score on a scale | Standard Error 0.36 |
| Placebo Tablets BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20 | -2.8 score on a scale | Standard Error 0.38 |
| Placebo Tablets BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16 | -2.9 score on a scale | Standard Error 0.38 |
| Placebo Tablets BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2 | -0.9 score on a scale | Standard Error 0.35 |
| Placebo Tablets BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1 | -0.7 score on a scale | Standard Error 0.35 |
| Placebo Tablets BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12 | -2.4 score on a scale | Standard Error 0.37 |
| Placebo Tablets BID | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8 | -2.6 score on a scale | Standard Error 0.37 |
Secondary
Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20
The sleep disturbance NRS is a scale used by the patients to report their degree of sleep loss related to AD. Patients were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being no sleep loss related to signs/symptoms of AD and 10 being I cannot sleep at all because of the signs/symptoms of AD. Higher scores indicate worse outcomes.
Time frame: Baseline and Weeks 1, 2, 4, 8, 12, 16, and 20
Population: The ITT Population included all randomized participants who received at least 1 dose of study drug. n represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20 | -2.8 score on a scale | Standard Error 0.43 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2 | -2.0 score on a scale | Standard Error 0.35 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16 | -3.4 score on a scale | Standard Error 0.41 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8 | -2.6 score on a scale | Standard Error 0.38 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12 | -3.2 score on a scale | Standard Error 0.4 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1 | -1.1 score on a scale | Standard Error 0.35 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4 | -2.4 score on a scale | Standard Error 0.36 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2 | -1.7 score on a scale | Standard Error 0.34 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1 | -1.5 score on a scale | Standard Error 0.35 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16 | -3.7 score on a scale | Standard Error 0.42 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4 | -2.3 score on a scale | Standard Error 0.36 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8 | -2.8 score on a scale | Standard Error 0.39 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20 | -2.2 score on a scale | Standard Error 0.42 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12 | -3.4 score on a scale | Standard Error 0.4 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1 | -1.5 score on a scale | Standard Error 0.35 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2 | -1.6 score on a scale | Standard Error 0.35 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4 | -2.4 score on a scale | Standard Error 0.36 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20 | -3.3 score on a scale | Standard Error 0.41 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8 | -2.6 score on a scale | Standard Error 0.38 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12 | -3.4 score on a scale | Standard Error 0.39 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16 | -2.9 score on a scale | Standard Error 0.4 |
| Placebo Tablets BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16 | -2.5 score on a scale | Standard Error 0.39 |
| Placebo Tablets BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12 | -2.7 score on a scale | Standard Error 0.38 |
| Placebo Tablets BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4 | -1.7 score on a scale | Standard Error 0.37 |
| Placebo Tablets BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2 | -0.9 score on a scale | Standard Error 0.36 |
| Placebo Tablets BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1 | -0.5 score on a scale | Standard Error 0.37 |
| Placebo Tablets BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8 | -2.2 score on a scale | Standard Error 0.38 |
| Placebo Tablets BID | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20 | -2.4 score on a scale | Standard Error 0.4 |
Secondary
Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20
A complete physical examination that included systolic and diastolic blood pressure measurements was performed at screening (Visit 1) and Weeks 16 and 20.
Time frame: Baseline and Weeks 16 and 20
Population: The safety population included all randomized participants who received at least 1 dose of study drug. n represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 | Systolic Blood Pressure Week 20 | 2.7 mmHg | Standard Deviation 10.18 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 | Diastolic Blood Pressure Week 16 | -0.5 mmHg | Standard Deviation 8.46 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 | Diastolic Blood Pressure Week 20 | -0.6 mmHg | Standard Deviation 8.21 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 | Systolic Blood Pressure Week 16 | 0.3 mmHg | Standard Deviation 11.62 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 | Diastolic Blood Pressure Week 20 | -1.2 mmHg | Standard Deviation 9.76 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 | Diastolic Blood Pressure Week 16 | -0.6 mmHg | Standard Deviation 8.33 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 | Systolic Blood Pressure Week 16 | 1.0 mmHg | Standard Deviation 12.04 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 | Systolic Blood Pressure Week 20 | -0.6 mmHg | Standard Deviation 12.02 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 | Systolic Blood Pressure Week 20 | -0.2 mmHg | Standard Deviation 13.19 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 | Systolic Blood Pressure Week 16 | -1.4 mmHg | Standard Deviation 12.66 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 | Diastolic Blood Pressure Week 16 | -2.1 mmHg | Standard Deviation 6.93 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 | Diastolic Blood Pressure Week 20 | -1.9 mmHg | Standard Deviation 8.48 |
| Placebo Tablets BID | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 | Diastolic Blood Pressure Week 16 | -1.8 mmHg | Standard Deviation 8.23 |
| Placebo Tablets BID | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 | Diastolic Blood Pressure Week 20 | -1.1 mmHg | Standard Deviation 7.19 |
| Placebo Tablets BID | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 | Systolic Blood Pressure Week 16 | -0.1 mmHg | Standard Deviation 9.76 |
| Placebo Tablets BID | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 | Systolic Blood Pressure Week 20 | 0.7 mmHg | Standard Deviation 10.29 |
Secondary
Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20
The severity of itch (pruritus) due to AD was assessed using a horizontal 11-point NRS. Patients were asked to assess their worst itching due to AD over the past 24 hours on an NRS anchored by the terms no itching (0) and worst possible itching (10).
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, and 20
Population: The ITT Population included all randomized participants who received at least 1 dose of study drug. n represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1 | -1.9 units on a scale | Standard Error 0.33 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12 | -3.4 units on a scale | Standard Error 0.37 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8 | -3.1 units on a scale | Standard Error 0.35 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20 | -3.8 units on a scale | Standard Error 0.4 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2 | -2.4 units on a scale | Standard Error 0.33 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4 | -2.5 units on a scale | Standard Error 0.34 |
| Orismilast Modified Release Tablets 20 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16 | -3.8 units on a scale | Standard Error 0.38 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12 | -3.9 units on a scale | Standard Error 0.37 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1 | -2.0 units on a scale | Standard Error 0.32 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2 | -2.8 units on a scale | Standard Error 0.32 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8 | -3.1 units on a scale | Standard Error 0.36 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16 | -4.2 units on a scale | Standard Error 0.39 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20 | -3.9 units on a scale | Standard Error 0.39 |
| Orismilast Modified Release Tablets 30 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4 | -2.8 units on a scale | Standard Error 0.33 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2 | -2.6 units on a scale | Standard Error 0.33 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4 | -2.6 units on a scale | Standard Error 0.33 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20 | -3.9 units on a scale | Standard Error 0.38 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1 | -2.4 units on a scale | Standard Error 0.33 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8 | -3.1 units on a scale | Standard Error 0.36 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16 | -4.2 units on a scale | Standard Error 0.38 |
| Orismilast Modified Release Tablets 40 mg BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12 | -3.5 units on a scale | Standard Error 0.37 |
| Placebo Tablets BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4 | -1.9 units on a scale | Standard Error 0.35 |
| Placebo Tablets BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12 | -2.7 units on a scale | Standard Error 0.36 |
| Placebo Tablets BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16 | -3.2 units on a scale | Standard Error 0.37 |
| Placebo Tablets BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1 | -1.1 units on a scale | Standard Error 0.34 |
| Placebo Tablets BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20 | -3.4 units on a scale | Standard Error 0.38 |
| Placebo Tablets BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8 | -2.6 units on a scale | Standard Error 0.36 |
| Placebo Tablets BID | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2 | -1.2 units on a scale | Standard Error 0.33 |
Secondary
Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20
The EASI is an investigator-assessed instrument measuring the severity of clinical signs and the percentage of affected BSA in patients with AD. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).
Time frame: At Weeks 2, 4, 8, 12, 16, and 20
Population: The ITT Population included all randomized participants who received at least 1 dose of study drug. n represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20, Yes | 29 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8, No | 27 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20, No | 7 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2, No | 50 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4, No | 36 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12, No | 17 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8, Yes | 20 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16, Yes | 25 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12, Yes | 22 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16, No | 14 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4, Yes | 14 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2, Yes | 5 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16, No | 14 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8, Yes | 14 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12, Yes | 18 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20, No | 13 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2, No | 49 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8, No | 28 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4, Yes | 14 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2, Yes | 11 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12, No | 21 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16, Yes | 21 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4, No | 39 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20, Yes | 22 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20, Yes | 26 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2, Yes | 11 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2, No | 44 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4, Yes | 15 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16, Yes | 30 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16, No | 8 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4, No | 38 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8, Yes | 20 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8, No | 24 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12, Yes | 28 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12, No | 13 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20, No | 10 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20, No | 16 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8, No | 32 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16, Yes | 27 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12, No | 23 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2, No | 47 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12, Yes | 22 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2, Yes | 6 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4, No | 39 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4, Yes | 11 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8, Yes | 14 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20, Yes | 26 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16, No | 16 Number of participants |
Secondary
Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20
The EASI is an investigator-assessed instrument measuring the severity of clinical signs and the percentage of affected BSA in patients with AD. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).
Time frame: At Weeks 2, 4, 8, 12, and 20
Population: The ITT Population included all randomized participants who received at least 1 dose of study drug. n represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 4, No | 43 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 20, No | 20 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 8, Yes | 11 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 4, Yes | 7 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 12, No | 25 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 2, Yes | 1 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 12, Yes | 14 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 2, No | 54 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 20, Yes | 16 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 8, No | 36 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 8, No | 35 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 20, Yes | 15 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 12, Yes | 7 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 12, No | 32 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 2, No | 56 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 20, No | 20 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 8, Yes | 7 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 2, Yes | 4 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 4, Yes | 6 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 4, No | 47 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 2, No | 53 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 20, No | 20 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 12, Yes | 13 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 4, Yes | 9 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 8, No | 31 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 4, No | 44 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 12, No | 28 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 20, Yes | 16 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 8, Yes | 13 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 2, Yes | 2 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 12, No | 34 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 4, Yes | 4 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 8, Yes | 8 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 20, Yes | 14 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 20, No | 28 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 2, Yes | 1 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 2, No | 52 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 4, No | 46 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 8, No | 38 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | Week 12, Yes | 11 Number of participants |
Secondary
Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20
The EASI is an investigator-assessed instrument measuring the severity of clinical signs and the percentage of affected BSA in patients with AD. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).
Time frame: At Weeks 2, 4, 8, 12, 16, and 20
Population: The ITT Population included all randomized participants who received at least 1 dose of study drug. n represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16, Yes | 7 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16, No | 32 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20, Yes | 10 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2, Yes | 1 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20, No | 26 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2, No | 54 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8, Yes | 4 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8, No | 43 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4, Yes | 1 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12, Yes | 5 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12, No | 34 Number of participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4, No | 49 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2, Yes | 2 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12, No | 34 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20, No | 26 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12, Yes | 5 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2, No | 58 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8, Yes | 4 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4, Yes | 3 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16, Yes | 7 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4, No | 50 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8, No | 38 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16, No | 28 Number of participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20, Yes | 9 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16, No | 28 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4, No | 51 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16, Yes | 10 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20, No | 28 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8, No | 38 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4, Yes | 2 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12, No | 33 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2, No | 55 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12, Yes | 8 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20, Yes | 8 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8, Yes | 6 Number of participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2, Yes | 0 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20, No | 33 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2, Yes | 0 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 2, No | 53 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 20, Yes | 9 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4, Yes | 1 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 4, No | 49 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8, Yes | 3 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 8, No | 43 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12, Yes | 4 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 12, No | 41 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16, Yes | 7 Number of participants |
| Placebo Tablets BID | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | Week 16, No | 36 Number of participants |
Secondary
Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16
A complete physical examination (a check of the head, eyes, ears, nose, and throat; heart; lungs; abdomen; skin; cervical and axillary lymph nodes; and neurological and musculoskeletal systems) was performed at screening (Visit 1) and Weeks 16.
Time frame: At Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Skin, Week 16 | 4 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Physical Examination, Other, Week 16 | 1 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Abdomen, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Musculoskeletal System, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Cervical Lymph Nodes, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Lungs, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Heart, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Neurological System, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Axillary Lymph Nodes, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Head, Eyes, Ears, Nose and Throat, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Axillary Lymph Nodes, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Abdomen, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Heart, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Skin, Week 16 | 8 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Head, Eyes, Ears, Nose and Throat, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Lungs, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Physical Examination, Other, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Musculoskeletal System, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Cervical Lymph Nodes, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Neurological System, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Axillary Lymph Nodes, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Head, Eyes, Ears, Nose and Throat, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Heart, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Lungs, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Cervical Lymph Nodes, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Abdomen, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Skin, Week 16 | 3 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Neurological System, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Musculoskeletal System, Week 16 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Physical Examination, Other, Week 16 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Head, Eyes, Ears, Nose and Throat, Week 16 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Neurological System, Week 16 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Skin, Week 16 | 6 Participants |
| Placebo Tablets BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Lungs, Week 16 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Physical Examination, Other, Week 16 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Musculoskeletal System, Week 16 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Heart, Week 16 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Axillary Lymph Nodes, Week 16 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Abdomen, Week 16 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | Cervical Lymph Nodes, Week 16 | 0 Participants |
Secondary
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16
Electrocardiograms were assessed by the investigators based on automatically generated parameters.
Time frame: At Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QTc interval > 450 msec | 1 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QT interval > 450 msec | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QTc interval > 500 msec | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QT interval > 480 msec | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QTc interval > 480 msec | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QT interval > 500 msec | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QTc interval > 450 msec | 4 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QT interval > 480 msec | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QTc interval > 480 msec | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QT interval > 500 msec | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QTc interval > 500 msec | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QT interval > 450 msec | 1 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QTc interval > 500 msec | 1 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QT interval > 450 msec | 1 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QTc interval > 450 msec | 2 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QT interval > 500 msec | 1 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QTc interval > 480 msec | 1 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QT interval > 480 msec | 1 Participants |
| Placebo Tablets BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QTc interval > 500 msec | 0 Participants |
| Placebo Tablets BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QTc interval > 450 msec | 2 Participants |
| Placebo Tablets BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QT interval > 450 msec | 2 Participants |
| Placebo Tablets BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QT interval > 480 msec | 1 Participants |
| Placebo Tablets BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QT interval > 500 msec | 0 Participants |
| Placebo Tablets BID | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | QTc interval > 480 msec | 1 Participants |
Secondary
Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS, Investigator-administered version, was designed to provide a prospective, standardized measure of suicidality. C-SSRS is administered in the form of a clinical interview. The C-SSRS categories have been re-ordered from the actual scale to facilitate the definitions of the endpoints, and to enable clarity in the presentation of the results: Category 1 - Wish to be Dead, Category 2 - Non-specific Active Suicidal Thoughts, Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Category 5 - Active Suicidal Ideation with Specific Plan and Intent, Category 6 - Preparatory Acts or Behavior, Category 7 - Aborted Attempt, Category 8 - Interrupted Attempt, Category 9 - Actual Attempt (non-fatal), Category 10 - Completed Suicide.
Time frame: At Weeks 2, 4, 8, 12, 16, and 20
Population: The safety population included all randomized participants who received at least 1 dose of study drug. n represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Behavior, Week 2, 4, 8, 12, 16, and 20 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Self-injurious behavior without suicidal intent, Week 2, 4, 8, 12, 16, and 20 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation at Weeks 2, 4, 8, 12, 16, and 20 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Self-injurious behavior without suicidal intent, Week 2, 4, 8, 12, 16, and 20 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Behavior, Week 2, 4, 8, 12, 16, and 20 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation at Weeks 2, 4, 8, 12, 16, and 20 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Self-injurious behavior without suicidal intent, Week 2, 4, 8, 12, 16, and 20 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation at Weeks 2, 4, 8, 12, 16, and 20 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Behavior, Week 2, 4, 8, 12, 16, and 20 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation at Weeks 2, 4, 8, 12, 16, and 20 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Behavior, Week 2, 4, 8, 12, 16, and 20 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Self-injurious behavior without suicidal intent, Week 2, 4, 8, 12, 16, and 20 | 0 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAE)
An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at screening, worsens during the study, regardless of the suspected cause of the event.
Time frame: From Baseline through Week 20
Population: The safety population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Any TEAEs | 44 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Any Treatment Emergent Serious Adverse Events (TESAEs) | 1 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, possibly | 16 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, definitely | 18 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, probably | 17 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Death | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Any related TEAEs | 37 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by toxicity grade, Grade 2 | 19 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Treatment Emergent Adverse Event of Special Interest | 3 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs leading to study drug discontinuation | 8 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TESAEs leading to study drug discontinuation | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by toxicity grade, Grade 1 | 37 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, unrelated | 18 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by toxicity grade, Grade 3 | 4 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, unlikely | 6 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, unrelated | 17 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, unlikely | 7 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TESAEs leading to study drug discontinuation | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, definitely | 17 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Treatment Emergent Adverse Event of Special Interest | 10 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, possibly | 19 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Any Treatment Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Any related TEAEs | 39 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by toxicity grade, Grade 1 | 41 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, probably | 20 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by toxicity grade, Grade 3 | 6 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by toxicity grade, Grade 2 | 26 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Any TEAEs | 48 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Death | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs leading to study drug discontinuation | 16 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs leading to study drug discontinuation | 14 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Any TEAEs | 51 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Any related TEAEs | 42 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Any Treatment Emergent Serious Adverse Events (TESAEs) | 1 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Death | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Treatment Emergent Adverse Event of Special Interest | 9 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TESAEs leading to study drug discontinuation | 1 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, unrelated | 22 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, unlikely | 8 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, possibly | 22 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, probably | 15 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, definitely | 15 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by toxicity grade, Grade 1 | 44 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by toxicity grade, Grade 2 | 20 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by toxicity grade, Grade 3 | 2 Participants |
| Placebo Tablets BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, unrelated | 21 Participants |
| Placebo Tablets BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs leading to study drug discontinuation | 2 Participants |
| Placebo Tablets BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by toxicity grade, Grade 2 | 9 Participants |
| Placebo Tablets BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, definitely | 3 Participants |
| Placebo Tablets BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TESAEs leading to study drug discontinuation | 0 Participants |
| Placebo Tablets BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Treatment Emergent Adverse Event of Special Interest | 1 Participants |
| Placebo Tablets BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Any related TEAEs | 14 Participants |
| Placebo Tablets BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by toxicity grade, Grade 1 | 30 Participants |
| Placebo Tablets BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Death | 0 Participants |
| Placebo Tablets BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Any Treatment Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| Placebo Tablets BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Any TEAEs | 35 Participants |
| Placebo Tablets BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, probably | 4 Participants |
| Placebo Tablets BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, possibly | 8 Participants |
| Placebo Tablets BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by relationship, unlikely | 5 Participants |
| Placebo Tablets BID | Number of Participants With Treatment Emergent Adverse Events (TEAE) | TEAEs by toxicity grade, Grade 3 | 0 Participants |
Secondary
Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16
Laboratory parameters including chemistry was evaluated at baseline and at Week 16.
Time frame: At Week 16
Population: The safety population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed in each treatment arm at the given time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Transitional Epithelial Cells, Occasional | 2 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 6-9 | 1 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 6-9 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 10-15 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 16-29 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, >75 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, 1-2 | 9 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 1-5 | 8 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, None | 6 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, Occasional | 4 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Yeast Cells, Present | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Hyaline Casts, None | 20 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Hyaline Casts, 1-5 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, None | 5 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, 3-5 | 1 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Bacteria, Increase to 2+ | 2 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, 6-9 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, 16-29 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 16-29 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 30-49 | 1 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, 10-15 | 2 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 50-75 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Bacteria, Increase to 1+ | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, None | 5 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Uric Acid Crystals, None | 20 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, 6-9 | 1 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, Occasional | 6 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 30-49 | 1 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, 1-5 | 10 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Uric Acid Crystals, >75 | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Bacteria, Increase to 4+ | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Bacteria, Increase to 3+ | 0 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, Occasional | 2 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Mucous Threads, Present | 4 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, None | 16 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Amorphous Crystals, Present | 1 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 1-5 | 2 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, 10-15 | 1 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Transitional Epithelial Cells, Occasional | 1 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 6-9 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Amorphous Crystals, Present | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 30-49 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Uric Acid Crystals, None | 11 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 10-15 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, None | 5 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 1-5 | 6 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 30-49 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 16-29 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Bacteria, Increase to 3+ | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, >75 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 50-75 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, None | 11 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, 6-9 | 1 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, None | 4 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, 1-2 | 2 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Hyaline Casts, None | 12 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Uric Acid Crystals, >75 | 1 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, Occasional | 4 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, None | 1 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Bacteria, Increase to 1+ | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Mucous Threads, Present | 4 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Hyaline Casts, 1-5 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 1-5 | 1 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, Occasional | 3 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, 3-5 | 1 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, Occasional | 2 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, 16-29 | 1 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Bacteria, Increase to 4+ | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, 6-9 | 1 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Bacteria, Increase to 2+ | 1 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, 1-5 | 2 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 6-9 | 2 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 16-29 | 0 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Yeast Cells, Present | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 6-9 | 1 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Amorphous Crystals, Present | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Bacteria, Increase to 1+ | 2 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Bacteria, Increase to 2+ | 1 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 16-29 | 1 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 30-49 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, None | 20 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, 1-2 | 6 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, 3-5 | 4 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, 6-9 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 16-29 | 1 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 30-49 | 1 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 50-75 | 1 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, None | 2 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, Occasional | 4 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Transitional Epithelial Cells, Occasional | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Uric Acid Crystals, >75 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Bacteria, Increase to 3+ | 1 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Bacteria, Increase to 4+ | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 1-5 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 6-9 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 10-15 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, >75 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, None | 7 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, Occasional | 4 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Hyaline Casts, 1-5 | 0 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Hyaline Casts, None | 21 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 1-5 | 8 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, Occasional | 7 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Mucous Threads, Present | 5 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, 1-5 | 8 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, 6-9 | 1 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, 10-15 | 2 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, 16-29 | 1 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, None | 5 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Uric Acid Crystals, None | 21 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Yeast Cells, Present | 0 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Bacteria, Increase to 4+ | 1 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 6-9 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 30-49 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, Occasional | 8 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Bacteria, Increase to 3+ | 0 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Uric Acid Crystals, >75 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 16-29 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Mucous Threads, Present | 5 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Transitional Epithelial Cells, Occasional | 1 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, Occasional | 4 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Bacteria, Increase to 2+ | 0 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, 1-5 | 6 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, None | 5 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 50-75 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Yeast Cells, Present | 1 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, 6-9 | 2 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 30-49 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 16-29 | 1 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Uric Acid Crystals, None | 23 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, 10-15 | 1 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, 6-9 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, 3-5 | 3 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Bacteria, Increase to 1+ | 4 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, 16-29 | 1 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, 1-2 | 11 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, None | 22 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Hyaline Casts, 1-5 | 1 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, Occasional | 4 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, None | 4 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Amorphous Crystals, Present | 0 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Hyaline Casts, None | 22 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Erythrocytes, >75 | 1 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 10-15 | 1 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Squamous Epithelial Cells, None | 9 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Leukocytes, 1-5 | 9 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 6-9 | 0 Participants |
| Placebo Tablets BID | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Calcium Oxalate Crystals, 1-5 | 0 Participants |
Secondary
Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response at Week 16
The EASI is a tool to measure the severity of clinical signs and the percentage of affected BSA in patients with AD. The EASI is a composite scoring system to evaluate the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/papulation, excoriation, and lichenification are scored on a scale of 0 (absent) to 3 (severe) for each body region: head and neck, upper limbs (including the external axillae and hands), trunk (including the internal axillae and groin), and lower limbs (including the buttocks and feet). The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).
Time frame: At Week 16
Population: The ITT Population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response at Week 16 | No | 69.6 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response at Week 16 | Yes | 30.4 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response at Week 16 | Yes | 25.9 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response at Week 16 | No | 74.1 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response at Week 16 | Yes | 36.4 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response at Week 16 | No | 63.6 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response at Week 16 | No | 63.9 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response at Week 16 | Yes | 36.1 percentage of participants |
Secondary
Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for AD (IGA-AD) at Week 16
The IGA-AD is a measure used by physicians to determine a patient's overall severity of disease. The static version was used for measurement at a single point in time. The Investigator rated the severity of the patient's AD on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time frame: At Week 16
Population: The ITT Population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for AD (IGA-AD) at Week 16 | Yes | 26.3 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for AD (IGA-AD) at Week 16 | No | 73.7 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for AD (IGA-AD) at Week 16 | No | 75.7 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for AD (IGA-AD) at Week 16 | Yes | 24.3 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for AD (IGA-AD) at Week 16 | Yes | 30.9 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for AD (IGA-AD) at Week 16 | No | 69.1 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for AD (IGA-AD) at Week 16 | Yes | 9.5 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for AD (IGA-AD) at Week 16 | No | 90.5 percentage of participants |
Secondary
Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20
The IGA-AD is a measure used by physicians to determine a patient's overall severity of disease. The static version was used for measurement at a single point in time. The Investigator rated the severity of the patient's AD on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time frame: At Weeks 2, 4, 8, 12, and 20
Population: The ITT Population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 4, Yes | 4.7 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 4, No | 95.3 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 12, Yes | 20.9 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 12, No | 79.1 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 20, Yes | 28.0 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 2, No | 98.2 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 2, Yes | 1.8 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 20, No | 72.0 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 8, Yes | 19.2 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 8, No | 80.8 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 20, No | 71.8 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 8, No | 87.0 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 20, Yes | 28.2 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 4, Yes | 5.3 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 8, Yes | 13.0 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 12, Yes | 17.5 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 2, Yes | 3.3 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 4, No | 94.7 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 2, No | 96.7 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 12, No | 82.5 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 4, Yes | 5.6 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 4, No | 94.4 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 20, Yes | 26.4 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 20, No | 73.6 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 2, Yes | 3.4 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 2, No | 96.6 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 12, No | 81.3 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 8, Yes | 11.6 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 8, No | 88.4 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 12, Yes | 18.7 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 20, No | 83.4 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 4, Yes | 1.9 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 2, Yes | 0.0 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 4, No | 98.1 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 8, Yes | 6.2 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 8, No | 93.8 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 12, Yes | 7.2 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 12, No | 92.8 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 20, Yes | 16.6 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | Week 2, No | 100 percentage of participants |
Secondary
Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20
The severity of itch (pruritus) due to AD was assessed using a horizontal 11-point NRS. Patients were asked to assess their worst itching due to AD over the past 24 hours on an NRS anchored by the terms no itching (0) and worst possible itching (10).
Time frame: At Weeks 1, 2, 4, 8, 12, 16 and 20
Population: The ITT Population included all randomized participants who received at least 1 dose of study drug. Here Overall Number of Participants Analyzed represents the number of participants analyzed at each time point in each treatment arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8, No | 60.5 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1, Yes | 21.4 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20, No | 48.8 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16, No | 43.0 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12, Yes | 49.5 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4, No | 66.4 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12, No | 50.5 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20, Yes | 51.2 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16, Yes | 57.0 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4, Yes | 33.6 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8, Yes | 39.5 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1, No | 78.6 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2, No | 69.6 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2, Yes | 30.4 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20, Yes | 45.0 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1, Yes | 24.7 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1, No | 75.3 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4, No | 64.1 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8, Yes | 39.3 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8, No | 60.7 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12, Yes | 49.7 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12, No | 50.3 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16, No | 49.6 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20, No | 55.0 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2, Yes | 32.5 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2, No | 67.5 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4, Yes | 35.9 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16, Yes | 50.4 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20, No | 52.6 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8, Yes | 46.1 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1, Yes | 31.5 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2, No | 65.9 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16, No | 40.4 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1, No | 68.5 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8, No | 53.9 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20, Yes | 47.4 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12, Yes | 52.2 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4, Yes | 30.2 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12, No | 47.8 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16, Yes | 59.6 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4, No | 69.8 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2, Yes | 34.1 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8, No | 62.8 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16, No | 58.3 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20, Yes | 52.1 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12, No | 54.8 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 20, No | 47.9 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1, No | 92.0 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 8, Yes | 37.2 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2, Yes | 10.3 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 2, No | 89.7 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4, No | 71.6 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 1, Yes | 8.0 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 12, Yes | 45.2 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 16, Yes | 41.7 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | Week 4, Yes | 28.4 percentage of participants |
Secondary
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20
The EASI is a tool to measure the severity of clinical signs and the percentage of affected BSA in patients with AD. The EASI is a composite scoring system to evaluate the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/papulation, excoriation, and lichenification are scored on a scale of 0 (absent) to 3 (severe) for each body region: head and neck, upper limbs (including the external axillae and hands), trunk (including the internal axillae and groin), and lower limbs (including the buttocks and feet). The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).
Time frame: Baseline and Weeks 2, 4, 8, 12, and 20
Population: The ITT Population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 20 | -56.6 percent change | Standard Error 5.27 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 12 | -53.9 percent change | Standard Error 4.56 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 2 | -19.4 percent change | Standard Error 3.5 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 4 | -35.3 percent change | Standard Error 3.98 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 8 | -42.2 percent change | Standard Error 4.61 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 8 | -40.3 percent change | Standard Error 4.64 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 4 | -32.6 percent change | Standard Error 3.85 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 20 | -55.7 percent change | Standard Error 5.59 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 2 | -21.6 percent change | Standard Error 3.39 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 12 | -45.3 percent change | Standard Error 4.53 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 4 | -33.7 percent change | Standard Error 3.98 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 12 | -56.7 percent change | Standard Error 4.81 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 20 | -58.7 percent change | Standard Error 5.33 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 2 | -21.3 percent change | Standard Error 3.51 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 8 | -49.6 percent change | Standard Error 4.67 |
| Placebo Tablets BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 12 | -44.5 percent change | Standard Error 4.63 |
| Placebo Tablets BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 20 | -50.5 percent change | Standard Error 5.15 |
| Placebo Tablets BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 8 | -36.0 percent change | Standard Error 4.77 |
| Placebo Tablets BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 4 | -25.7 percent change | Standard Error 4.05 |
| Placebo Tablets BID | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | Week 2 | -10.8 percent change | Standard Error 3.61 |