Prurigo Nodularis
Conditions
Keywords
Prurigo, Neurodermatitis, Pruritus, Skin diseases
Brief summary
The primary objective was to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (\>=) 18 years of age with prurigo nodularis (PN) after a 16-week treatment period.
Interventions
DRUGNemolizumab
Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.
DRUGPlacebo
Participants received matching placebo as SC injection.
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of PN for at least 6 months with: Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs, at least 20 nodules on the entire body with a bilateral distribution and Investigator Global Assessment (IGA) score more than equal to (\>=) 3 (based on the IGA scale ranging from 0 to 4, in which 3 was moderate and 4 is severe) at both the screening and baseline visits * Severe pruritus was defined as follows on the PP NRS: 1. At the screening visit (Visit 1): PP NRS score was \>= 7.0 for the 24-hour period immediately preceding the screening visit. 2. At the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS score was \>= 7.0 over the previous week * Female participants of childbearing potential (that is \[i.e,\], fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use at least 1 adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection
Exclusion criteria
* Body weight less than \< 30 kg * Chronic pruritus resulting from another active condition other than PN, such as but not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis, contact dermatitis, acne, folliculitis, lichen planus, habitual picking/excoriation disorder, sporotrichosis, bullous autoimmune disease, end-stage renal disease, or cholestatic liver disease (example \[eg\] primary biliary cirrhosis) or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care * Unilateral lesions of prurigo (eg, only one arm affected) * History of or current confounding skin condition (eg, Netherton syndrome, cutaneous T-cell lymphoma \[mycosis fungoides or Sezary syndrome\], chronic actinic dermatitis, dermatitis herpetiformis) * Participants with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis * Neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis * Requiring rescue therapy for PN during the screening period or expected to require rescue therapy within 4 weeks following the baseline visit * Positive serology results (hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\], hepatitis C (HCV) antibody with positive confirmatory test for HCV (eg, polymerase chain reaction \[PCR\]), or human immunodeficiency virus antibody) at the screening visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16 | Baseline, Week 16 | The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to both timepoints, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. |
| Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16 | Baseline, Week 16 | IGA success is defined as clear (0) or almost clear (1), and a reduction from baseline of greater than or equal to 2 points at week 16. Full scale is scored from 0-4, higher score indicates more severe symptoms. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16 | Baseline, Week 16 | The SD NRS is a scale to be used by the participants to report the degree of their sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to 10) during the 7 days up to the treatment start (including until treatment start time) (rounding to nearest whole number is not permitted). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (prurigo nodularis)' and 10 being 'I did not sleep at all due to the symptoms of prurigo nodularis'. Higher scores indicate worse outcome. Analysis window extension was applied to both timepoints, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. |
| Number of Participants With an Improvement of >=4 From Baseline in SD NRS at Week 4 | Baseline, Week 4 | The SD NRS is a scale to be used by the participants to report the degree of their sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to10) during the 7 days up to the treatment start (including until treatment start time) (rounding to nearest whole number is not permitted). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (prurigo nodularis)' and 10 being 'I did not sleep at all due to the symptoms of prurigo nodularis'. Higher scores indicate worse outcome. Analysis window extension was applied to baseline, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. |
| Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4 | Baseline, Week 4 | The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to baseline, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. |
| Number of Participants With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) | From baseline up to end of treatment period (16 Weeks) | AE defined as any untoward medical occurrence in clinical study participant administered a medicinal product which does not necessarily have causal relationship with this treatment. TEAEs defined as AEs occurring after first administration of study drug until the last study visit. SAE was any untoward medical occurrence, in view of either Investigator or Sponsor, that resulted in death, was life-threatening, resulted in inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was important medical event. AESI was noteworthy TEAE for study drug that was to be monitored closely and reported promptly. Relatedness to study drug was based on Investigator's discretion. Analysis was performed on safety population which included all randomised participants who received at least 1 administration of study drug. |
| Number of Participants With PP NRS < 2 at Week 4 | Week 4 | The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. |
| Number of Participants With PP NRS < 2 at Week 16 | Week 16 | The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to week 16, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. |
Countries
Belgium, Canada, France, Netherlands, Poland, South Korea, Spain, Switzerland, United States
Participant flow
Recruitment details
The study was conducted at 55 sites in 9 countries.
Pre-assignment details
A total of 274 participants were randomized and treated (183 participants in Nemolizumab and 91 participants in Placebo group) received treatment in this study.
Participants by arm
| Arm | Count |
|---|---|
| Nemolizumab Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks.
Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection. | 183 |
| Placebo Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks.
Placebo: Participants received matching placebo as SC injection. | 91 |
| Total | 274 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 2 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Nemolizumab | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 53.7 Years STANDARD_DEVIATION 14.41 | 52.7 Years STANDARD_DEVIATION 14.64 | 50.8 Years STANDARD_DEVIATION 15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 12 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 173 Participants | 252 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 10 Participants | 5 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 23 Participants | 37 Participants | 14 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 12 Participants | 7 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Others | 5 Participants | 7 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 147 Participants | 215 Participants | 68 Participants |
| Region of Enrollment Europe | 122 Participants | 183 Participants | 61 Participants |
| Region of Enrollment North America | 47 Participants | 69 Participants | 22 Participants |
| Region of Enrollment Pacifica | 14 Participants | 22 Participants | 8 Participants |
| Sex: Female, Male Female | 113 Participants | 168 Participants | 55 Participants |
| Sex: Female, Male Male | 70 Participants | 106 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 183 | 0 / 91 |
| other Total, other adverse events | 29 / 183 | 13 / 91 |
| serious Total, serious adverse events | 4 / 183 | 5 / 91 |
Outcome results
Primary
Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16
The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to both timepoints, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders.
Time frame: Baseline, Week 16
Population: ITT population consisted of all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nemolizumab | Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16 | 103 Participants |
| Placebo | Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16 | 19 Participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.p-value: <0.000195% CI: [26.3, 48.5]Cochran-Mantel-Haenszel
Primary
Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16
IGA success is defined as clear (0) or almost clear (1), and a reduction from baseline of greater than or equal to 2 points at week 16. Full scale is scored from 0-4, higher score indicates more severe symptoms. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders.
Time frame: Baseline, Week 16
Population: ITT population consisted of all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nemolizumab | Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16 | 69 Participants |
| Placebo | Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16 | 10 Participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.p-value: <0.000195% CI: [18.8, 38.2]Cochran-Mantel-Haenszel
Secondary
Number of Participants With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)
AE defined as any untoward medical occurrence in clinical study participant administered a medicinal product which does not necessarily have causal relationship with this treatment. TEAEs defined as AEs occurring after first administration of study drug until the last study visit. SAE was any untoward medical occurrence, in view of either Investigator or Sponsor, that resulted in death, was life-threatening, resulted in inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was important medical event. AESI was noteworthy TEAE for study drug that was to be monitored closely and reported promptly. Relatedness to study drug was based on Investigator's discretion. Analysis was performed on safety population which included all randomised participants who received at least 1 administration of study drug.
Time frame: From baseline up to end of treatment period (16 Weeks)
Population: Safety population included all randomized participants who received at least 1 administration of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nemolizumab | Number of Participants With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) | Adverse Events of Special Interest (AESIs) | 21 Participants |
| Nemolizumab | Number of Participants With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) | Treatment Emergent Adverse Events (TEAEs) | 112 Participants |
| Nemolizumab | Number of Participants With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) | Serious Adverse Events (SAEs) | 4 Participants |
| Placebo | Number of Participants With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) | Adverse Events of Special Interest (AESIs) | 9 Participants |
| Placebo | Number of Participants With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) | Treatment Emergent Adverse Events (TEAEs) | 48 Participants |
| Placebo | Number of Participants With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) | Serious Adverse Events (SAEs) | 5 Participants |
Secondary
Number of Participants With an Improvement of >=4 From Baseline in SD NRS at Week 4
The SD NRS is a scale to be used by the participants to report the degree of their sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to10) during the 7 days up to the treatment start (including until treatment start time) (rounding to nearest whole number is not permitted). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (prurigo nodularis)' and 10 being 'I did not sleep at all due to the symptoms of prurigo nodularis'. Higher scores indicate worse outcome. Analysis window extension was applied to baseline, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders.
Time frame: Baseline, Week 4
Population: ITT population consisted of all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nemolizumab | Number of Participants With an Improvement of >=4 From Baseline in SD NRS at Week 4 | 68 Participants |
| Placebo | Number of Participants With an Improvement of >=4 From Baseline in SD NRS at Week 4 | 9 Participants |
p-value: <0.000195% CI: [18.4, 37.5]Cochran-Mantel-Haenszel
Secondary
Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16
The SD NRS is a scale to be used by the participants to report the degree of their sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to 10) during the 7 days up to the treatment start (including until treatment start time) (rounding to nearest whole number is not permitted). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (prurigo nodularis)' and 10 being 'I did not sleep at all due to the symptoms of prurigo nodularis'. Higher scores indicate worse outcome. Analysis window extension was applied to both timepoints, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders.
Time frame: Baseline, Week 16
Population: ITT population consisted all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nemolizumab | Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16 | 95 Participants |
| Placebo | Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16 | 19 Participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.p-value: <0.000195% CI: [20.7, 43.2]Cochran-Mantel-Haenszel
Secondary
Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4
The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to baseline, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders.
Time frame: Baseline, Week 4
Population: ITT population consisted of all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nemolizumab | Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4 | 75 Participants |
| Placebo | Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4 | 7 Participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.p-value: <0.000195% CI: [24.3, 42.4]Cochran-Mantel-Haenszel
Secondary
Number of Participants With PP NRS < 2 at Week 16
The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to week 16, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders.
Time frame: Week 16
Population: ITT population consisted all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nemolizumab | Number of Participants With PP NRS < 2 at Week 16 | 64 Participants |
| Placebo | Number of Participants With PP NRS < 2 at Week 16 | 7 Participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.p-value: <0.000195% CI: [21.3, 38.6]Cochran-Mantel-Haenszel
Secondary
Number of Participants With PP NRS < 2 at Week 4
The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders.
Time frame: Week 4
Population: ITT population consisted all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nemolizumab | Number of Participants With PP NRS < 2 at Week 4 | 36 Participants |
| Placebo | Number of Participants With PP NRS < 2 at Week 4 | 2 Participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.p-value: <0.000195% CI: [12, 25.7]Cochran-Mantel-Haenszel