Atopic Dermatitis
Conditions
Keywords
Moderate, Severe
Brief summary
The primary objective of the study is to assess the efficacy of REGN3500 monotherapy in Atopic dermatitis (AD), as well as understand the dose-response relationship, compared with placebo treatment, in adult patients with moderate-to-severe AD. Secondary objectives are to: * Assess the safety and tolerability of subcutaneous (SC) doses of REGN3500 monotherapy in adult patients with moderate-to-severe AD * Assess the Pharmacokinetics (PK) of REGN3500 in adult patients with moderate-to-severe AD * Assess the immunogenicity of REGN3500 in adult patients with moderate-to-severe AD
Interventions
DRUGREGN3500
Administered subcutaneous (SC)
DRUGREGN3500-Matching Placebo
Administered subcutaneous (SC)
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Chronic AD, according to American Academy of Dermatology Consensus Criteria (Eichenfield, 2014), that has been present for at least 3 years before the screening visit 2. Eczema Area and Severity Index (EASI) score ≥16 at the screening and baseline visits 3. IGA score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at screening and baseline visits 4. ≥10% Body surface area (BSA) of AD involvement at the screening and baseline visits 5. Documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments are medically inadvisable Key
Exclusion criteria
1. Participation in a prior anti-Interleukin (IL)-33 medication clinical study 2. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit 3. Having used any of the following treatments within 4 weeks before the baseline visit or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment: 1. Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, Interferon-gamma (IFN-γ), Janus kinase inhibitors, azathioprine, methotrexate, etc) 2. Phototherapy for AD 4. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit 5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit 6. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit 7. Known or suspected history of immunosuppression 8. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening 9. Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCV Ab) at the screening visit 10. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | Week 16 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percent change from baseline in EASI score at Week 16 was reported. Values after first rescue treatment were set to missing. |
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percent change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders. |
| Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported. |
| Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders. |
| Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported. |
| Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Absolute change from baseline in EASI score at Week 16 based on observed values set to missing after rescue treatment was reported. |
| Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Absolute change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported. |
| Percentage of Participants With Both Investigator Global Assessment (IGA) Score 0 or 1 (on 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | Week 16 | IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5 point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with both IGA score of 0 or 1 and a reduction from baseline of ≥2 points at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing IGA score at Week 16 were counted as non-responders. |
| Percentage of Participants With Both IGA Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on All Observed Values Regardless of Rescue Treatment at Week 16 | Week 16 | IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5 point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with both IGA score of 0 or 1 and a reduction from baseline of ≥2 points at Week 16 based on all observed values regardless of rescue treatment were reported. |
| Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | Week 16 | Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Absolute change from baseline in weekly average of daily Peak Pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported. |
| Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | Week 16 | Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 |
| Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50 Percent [%] Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-50 (≥50% Improvement from baseline) at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders. |
| Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | Week 16 | Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on all observed values regardless of rescue treatment was reported. |
| Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Peak Daily Pruritus NRS Score ≥4 Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | Week 16 | Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Percentage of participants with improvement of weekly average of daily peak pruritus NRS score ≥4 from baseline to Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing NRS score at Week 16 were counted as non-responders. |
| Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Daily Peak Pruritus NRS Score ≥4 Based on All Observed Values Regardless of Rescue Treatment at Week 16 | Week 16 | Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Percentage of participants with improvement of weekly average of daily peak pruritus NRS score ≥4 from baseline to Week 16 based on all observed values regardless of rescue treatment were reported. |
| Time to Onset of Effect on Pruritus (≥4-point Reduction of Weekly Average of Daily Peak Pruritus NRS From Baseline) | Week 16 | Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours? |
| Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16 | Week 16 | The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis (AD). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). |
| Absolute Change From Baseline in Percent Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement at Week 16 | Week 16 | BSA affected by AD will be assessed for each section of the body using the rule of nines (the possible highest score for each region is: head and neck \[9%\], anterior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], and genitals \[1%\]) and will be reported as a percentage of all major body sections combined. The proportion assigned to different body regions is different in younger children as compared to older children (head and neck area is assigned a higher proportion in younger children as compared to older children). |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16 | Up to week 16 | Adverse Event (AE): any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. Serious AE (SAE): any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE: AEs starting/worsening after first intake of study drug. TEAEs included: serious TEAEs and Non-serious TEAEs. AESI included: Anaphylactic or acute allergic reactions; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; severe infections; any clinical endoparasitosis; Conjunctivitis, keratitis, or blepharitis; significant Alanine aminotransferase (ALT) elevation. Number of participants with TEAEs, Serious TEAES and AESIs from baseline up to Week 16 were reported. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36 | Up to week 36 | AE: any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. SAE: any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE: AEs starting/worsening after first intake of study drug. TEAEs included both Serious TEAEs and Non-serious TEAEs. AESI included: Anaphylactic or acute allergic reactions; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; severe infections; any clinical endoparasitosis; Conjunctivitis, keratitis, or blepharitis; significant Alanine aminotransferase (ALT) elevation. Number of participants with TEAEs, Serious TEAES and AESIs from baseline up to Week 36 were reported. |
| Serum Concentration of Functional REGN3500 | Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32 and 36 | Serum Concentration of Functional REGN3500 was reported. |
| Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA) | Up to week 36 | Treatment-Emergent (TE) ADA was defined as any positive post baseline assay response when baseline results were negative or missing. Treatment-Emergent ADA responses were further classified as: - persistent (treatment-emergent positive ADA response detected in at least 2 consecutive post baseline samples separated by at least a 16-week post baseline period \[based on nominal sampling time\], with no ADA-negative samples in-between, regardless of any missing samples or a positive response at the last ADA sampling time point),- indeterminate (a positive assay response at the last collection time point only, regardless of any missing samples), - transient (not persistent/indeterminate, regardless of any missing samples). Number of participants with positive treatment-emergent anti-REGN3500 antibodies (ADA) were reported. Here, Number of Participants Analyzed signifies those participants who were evaluable for this endpoint. |
| Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | Week 16 | Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported. Values after first rescue treatment were set to missing and participants with missing NRS score at Week 16 were counted as non-responders. |
| Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-50 (≥50% Improvement from baseline) at Week 16 were based on all observed values regardless of rescue treatment were reported. |
Countries
Australia, Canada, Czechia, Germany, Hungary, Japan, Poland, South Korea, Spain, United Kingdom, United States
Participant flow
Recruitment details
A total of 238 participants were screened at centers in North America (United States of America and Canada), Europe (Czech Republic, Germany, Hungary, Spain, and Poland), and Asia Pacific (Republic of Korea, Japan, and Australia). Out of which, 129 participants were randomized in this study.
Pre-assignment details
Participants were randomized in 1:1:1:1:1 ratio to 1 of the 5 treatment groups: Placebo every 2 weeks (Q2W); REGN3500 30 milligrams (mg) every 8 weeks (Q8W); REGN3500 100 mg every 4 weeks (Q4W); REGN3500 300 mg Q4W and REGN3500 300 mg Q2W.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Q2W Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14. | 25 |
| REGN3500 30 mg Q8W Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14. | 26 |
| REGN3500 100 mg Q4W Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. | 27 |
| REGN3500 300 mg Q4W Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. | 25 |
| REGN3500 300 mg Q2W Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. | 26 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 3 | 1 | 1 | 1 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 | 1 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 1 |
| Overall Study | Randomized but never treated | 0 | 0 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 9 | 12 | 9 | 12 | 10 |
Baseline characteristics
| Characteristic | Placebo Q2W | REGN3500 30 mg Q8W | REGN3500 100 mg Q4W | REGN3500 300 mg Q4W | REGN3500 300 mg Q2W | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 36.6 Years STANDARD_DEVIATION 14.22 | 36.0 Years STANDARD_DEVIATION 16.41 | 37.0 Years STANDARD_DEVIATION 14.48 | 35.6 Years STANDARD_DEVIATION 12.56 | 38.8 Years STANDARD_DEVIATION 15.44 | 36.8 Years STANDARD_DEVIATION 14.51 |
| Eczema Area and Severity Index (EASI) Score | 30.3 Scores on a scale STANDARD_DEVIATION 11.88 | 29.8 Scores on a scale STANDARD_DEVIATION 12 | 33.6 Scores on a scale STANDARD_DEVIATION 11.01 | 27.7 Scores on a scale STANDARD_DEVIATION 10.68 | 32.7 Scores on a scale STANDARD_DEVIATION 15.13 | 30.9 Scores on a scale STANDARD_DEVIATION 12.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 4 Participants | 0 Participants | 0 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 24 Participants | 22 Participants | 25 Participants | 23 Participants | 118 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 8 Participants | 5 Participants | 11 Participants | 10 Participants | 43 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 2 Participants | 3 Participants | 2 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 14 Participants | 20 Participants | 11 Participants | 14 Participants | 72 Participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 12 Participants | 14 Participants | 15 Participants | 68 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 15 Participants | 11 Participants | 11 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 26 | 0 / 26 | 0 / 24 | 1 / 26 |
| other Total, other adverse events | 7 / 25 | 11 / 26 | 9 / 26 | 8 / 24 | 10 / 26 |
| serious Total, serious adverse events | 0 / 25 | 0 / 26 | 0 / 26 | 1 / 24 | 2 / 26 |
Outcome results
Primary
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16
The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percent change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported.
Time frame: Week 16
Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.~Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -18.9 Percentage of change | Standard Deviation 52.01 |
| REGN3500 30 mg Q8W | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -46.0 Percentage of change | Standard Deviation 45.35 |
| REGN3500 100 mg Q4W | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -48.7 Percentage of change | Standard Deviation 44.66 |
| REGN3500 300 mg Q4W | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -67.0 Percentage of change | Standard Deviation 28.74 |
| REGN3500 300 mg Q2W | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -56.1 Percentage of change | Standard Deviation 35.32 |
Primary
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percent change from baseline in EASI score at Week 16 was reported. Values after first rescue treatment were set to missing.
Time frame: Week 16
Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.~Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -33.5 Percentage of change | Standard Deviation 41.81 |
| REGN3500 30 mg Q8W | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -57.9 Percentage of change | Standard Deviation 31.65 |
| REGN3500 100 mg Q4W | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -52.7 Percentage of change | Standard Deviation 46.64 |
| REGN3500 300 mg Q4W | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -80.0 Percentage of change | Standard Deviation 10.54 |
| REGN3500 300 mg Q2W | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -54.0 Percentage of change | Standard Deviation 36.8 |
Secondary
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16
The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Absolute change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported.
Time frame: Week 16
Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.~Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -4.10 Score on a scale | Standard Deviation 13.079 |
| REGN3500 30 mg Q8W | Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -12.07 Score on a scale | Standard Deviation 11.764 |
| REGN3500 100 mg Q4W | Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -13.83 Score on a scale | Standard Deviation 12 |
| REGN3500 300 mg Q4W | Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -15.15 Score on a scale | Standard Deviation 8.299 |
| REGN3500 300 mg Q2W | Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -14.68 Score on a scale | Standard Deviation 9.41 |
Secondary
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16
The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Absolute change from baseline in EASI score at Week 16 based on observed values set to missing after rescue treatment was reported.
Time frame: Week 16
Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.~Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -7.8 Score on a scale | Standard Deviation 10.225 |
| REGN3500 30 mg Q8W | Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -14.64 Score on a scale | Standard Deviation 8.489 |
| REGN3500 100 mg Q4W | Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -14.81 Score on a scale | Standard Deviation 12.614 |
| REGN3500 300 mg Q4W | Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -18.19 Score on a scale | Standard Deviation 6.298 |
| REGN3500 300 mg Q2W | Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -13.79 Score on a scale | Standard Deviation 9.534 |
Secondary
Absolute Change From Baseline in Percent Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement at Week 16
BSA affected by AD will be assessed for each section of the body using the rule of nines (the possible highest score for each region is: head and neck \[9%\], anterior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], and genitals \[1%\]) and will be reported as a percentage of all major body sections combined. The proportion assigned to different body regions is different in younger children as compared to older children (head and neck area is assigned a higher proportion in younger children as compared to older children).
Time frame: Week 16
Population: FAS; All observed values regardless of rescue treatment use; Here 'n' = number of evaluable participants at the specific timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Absolute Change From Baseline in Percent Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement at Week 16 | -2.74 Percentage of change | Standard Deviation 17.854 |
| REGN3500 30 mg Q8W | Absolute Change From Baseline in Percent Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement at Week 16 | -15.19 Percentage of change | Standard Deviation 16.509 |
| REGN3500 100 mg Q4W | Absolute Change From Baseline in Percent Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement at Week 16 | -11.43 Percentage of change | Standard Deviation 22.022 |
| REGN3500 300 mg Q4W | Absolute Change From Baseline in Percent Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement at Week 16 | -22.16 Percentage of change | Standard Deviation 15.783 |
| REGN3500 300 mg Q2W | Absolute Change From Baseline in Percent Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement at Week 16 | -20.99 Percentage of change | Standard Deviation 16.161 |
Secondary
Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16
Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16
Time frame: Week 16
Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.~Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -0.51 Score on a scale | Standard Deviation 1.43 |
| REGN3500 30 mg Q8W | Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -2.56 Score on a scale | Standard Deviation 3.563 |
| REGN3500 100 mg Q4W | Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -4.19 Score on a scale | Standard Deviation 2.198 |
| REGN3500 300 mg Q4W | Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -2.69 Score on a scale | Standard Deviation 2.799 |
| REGN3500 300 mg Q2W | Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -3.12 Score on a scale | Standard Deviation 3.896 |
Secondary
Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16
Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Absolute change from baseline in weekly average of daily Peak Pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported.
Time frame: Week 16
Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.~Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -0.53 Score on a scale | Standard Deviation 1.583 |
| REGN3500 30 mg Q8W | Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -2.95 Score on a scale | Standard Deviation 3.791 |
| REGN3500 100 mg Q4W | Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -4.22 Score on a scale | Standard Deviation 2.372 |
| REGN3500 300 mg Q4W | Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -3.34 Score on a scale | Standard Deviation 2.628 |
| REGN3500 300 mg Q2W | Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -3.12 Score on a scale | Standard Deviation 3.896 |
Secondary
Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA)
Treatment-Emergent (TE) ADA was defined as any positive post baseline assay response when baseline results were negative or missing. Treatment-Emergent ADA responses were further classified as: - persistent (treatment-emergent positive ADA response detected in at least 2 consecutive post baseline samples separated by at least a 16-week post baseline period \[based on nominal sampling time\], with no ADA-negative samples in-between, regardless of any missing samples or a positive response at the last ADA sampling time point),- indeterminate (a positive assay response at the last collection time point only, regardless of any missing samples), - transient (not persistent/indeterminate, regardless of any missing samples). Number of participants with positive treatment-emergent anti-REGN3500 antibodies (ADA) were reported. Here, Number of Participants Analyzed signifies those participants who were evaluable for this endpoint.
Time frame: Up to week 36
Population: The Anti-drug Antibodies (ADA) analysis set included all treated participants who received any amount of study drug (active or placebo \[safety analysis set\]) and had at least one non-missing anti-REGN3500 result following the first dose of study drug or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Q2W | Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA) | TE Persistent | 0 Participants |
| Placebo Q2W | Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA) | TE Indeterminate | 0 Participants |
| Placebo Q2W | Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA) | TE Transient | 0 Participants |
| REGN3500 30 mg Q8W | Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA) | TE Transient | 0 Participants |
| REGN3500 30 mg Q8W | Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA) | TE Persistent | 0 Participants |
| REGN3500 30 mg Q8W | Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA) | TE Indeterminate | 0 Participants |
| REGN3500 100 mg Q4W | Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA) | TE Transient | 0 Participants |
| REGN3500 100 mg Q4W | Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA) | TE Persistent | 0 Participants |
| REGN3500 100 mg Q4W | Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA) | TE Indeterminate | 0 Participants |
| REGN3500 300 mg Q4W | Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA) | TE Persistent | 0 Participants |
| REGN3500 300 mg Q4W | Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA) | TE Indeterminate | 0 Participants |
| REGN3500 300 mg Q4W | Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA) | TE Transient | 0 Participants |
| REGN3500 300 mg Q2W | Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA) | TE Transient | 0 Participants |
| REGN3500 300 mg Q2W | Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA) | TE Persistent | 0 Participants |
| REGN3500 300 mg Q2W | Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA) | TE Indeterminate | 0 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16
Adverse Event (AE): any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. Serious AE (SAE): any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE: AEs starting/worsening after first intake of study drug. TEAEs included: serious TEAEs and Non-serious TEAEs. AESI included: Anaphylactic or acute allergic reactions; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; severe infections; any clinical endoparasitosis; Conjunctivitis, keratitis, or blepharitis; significant Alanine aminotransferase (ALT) elevation. Number of participants with TEAEs, Serious TEAES and AESIs from baseline up to Week 16 were reported.
Time frame: Up to week 16
Population: The safety analysis set (SAF) included all randomized participants who received any study drug and was based on the treatment received (as treated).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Q2W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16 | Participants with Serious TEAEs | 0 Participants |
| Placebo Q2W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16 | Participants with TEAEs | 9 Participants |
| Placebo Q2W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16 | Participants with AESIs | 0 Participants |
| REGN3500 30 mg Q8W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16 | Participants with Serious TEAEs | 0 Participants |
| REGN3500 30 mg Q8W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16 | Participants with TEAEs | 13 Participants |
| REGN3500 30 mg Q8W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16 | Participants with AESIs | 0 Participants |
| REGN3500 100 mg Q4W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16 | Participants with AESIs | 1 Participants |
| REGN3500 100 mg Q4W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16 | Participants with TEAEs | 12 Participants |
| REGN3500 100 mg Q4W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16 | Participants with Serious TEAEs | 0 Participants |
| REGN3500 300 mg Q4W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16 | Participants with Serious TEAEs | 0 Participants |
| REGN3500 300 mg Q4W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16 | Participants with TEAEs | 9 Participants |
| REGN3500 300 mg Q4W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16 | Participants with AESIs | 0 Participants |
| REGN3500 300 mg Q2W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16 | Participants with AESIs | 0 Participants |
| REGN3500 300 mg Q2W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16 | Participants with Serious TEAEs | 2 Participants |
| REGN3500 300 mg Q2W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16 | Participants with TEAEs | 15 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36
AE: any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. SAE: any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE: AEs starting/worsening after first intake of study drug. TEAEs included both Serious TEAEs and Non-serious TEAEs. AESI included: Anaphylactic or acute allergic reactions; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; severe infections; any clinical endoparasitosis; Conjunctivitis, keratitis, or blepharitis; significant Alanine aminotransferase (ALT) elevation. Number of participants with TEAEs, Serious TEAES and AESIs from baseline up to Week 36 were reported.
Time frame: Up to week 36
Population: SAF included all randomized participants who received any study drug and was based on the treatment received (as treated).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Q2W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36 | Participants with Serious TEAEs | 0 Participants |
| Placebo Q2W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36 | Participants with TEAEs | 11 Participants |
| Placebo Q2W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36 | Participants with AESIs | 0 Participants |
| REGN3500 30 mg Q8W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36 | Participants with TEAEs | 14 Participants |
| REGN3500 30 mg Q8W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36 | Participants with AESIs | 0 Participants |
| REGN3500 30 mg Q8W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36 | Participants with Serious TEAEs | 0 Participants |
| REGN3500 100 mg Q4W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36 | Participants with TEAEs | 14 Participants |
| REGN3500 100 mg Q4W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36 | Participants with Serious TEAEs | 0 Participants |
| REGN3500 100 mg Q4W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36 | Participants with AESIs | 1 Participants |
| REGN3500 300 mg Q4W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36 | Participants with AESIs | 0 Participants |
| REGN3500 300 mg Q4W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36 | Participants with TEAEs | 13 Participants |
| REGN3500 300 mg Q4W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36 | Participants with Serious TEAEs | 1 Participants |
| REGN3500 300 mg Q2W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36 | Participants with Serious TEAEs | 2 Participants |
| REGN3500 300 mg Q2W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36 | Participants with TEAEs | 15 Participants |
| REGN3500 300 mg Q2W | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36 | Participants with AESIs | 0 Participants |
Secondary
Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-50 (≥50% Improvement from baseline) at Week 16 were based on all observed values regardless of rescue treatment were reported.
Time frame: Week 16
Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.~Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 25.0 Percentage of participants |
| REGN3500 30 mg Q8W | Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 60.0 Percentage of participants |
| REGN3500 100 mg Q4W | Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 62.5 Percentage of participants |
| REGN3500 300 mg Q4W | Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 77.8 Percentage of participants |
| REGN3500 300 mg Q2W | Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 60.0 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50 Percent [%] Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-50 (≥50% Improvement from baseline) at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.
Time frame: Week 16
Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.~Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50 Percent [%] Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 30.0 Percentage of participants |
| REGN3500 30 mg Q8W | Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50 Percent [%] Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 71.4 Percentage of participants |
| REGN3500 100 mg Q4W | Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50 Percent [%] Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 71.4 Percentage of participants |
| REGN3500 300 mg Q4W | Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50 Percent [%] Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 100 Percentage of participants |
| REGN3500 300 mg Q2W | Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50 Percent [%] Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 55.6 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported.
Time frame: Week 16
Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.~Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 16.7 Percentage of participants |
| REGN3500 30 mg Q8W | Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 30.0 Percentage of participants |
| REGN3500 100 mg Q4W | Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 25.0 Percentage of participants |
| REGN3500 300 mg Q4W | Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 55.6 Percentage of participants |
| REGN3500 300 mg Q2W | Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 40.0 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.
Time frame: Week 16
Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.~Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 20.0 Percentage of participants |
| REGN3500 30 mg Q8W | Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 28.6 Percentage of participants |
| REGN3500 100 mg Q4W | Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 28.6 Percentage of participants |
| REGN3500 300 mg Q4W | Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 71.4 Percentage of participants |
| REGN3500 300 mg Q2W | Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 44.4 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported.
Time frame: Week 16
Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.~Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 8.3 Percentage of participants |
| REGN3500 30 mg Q8W | Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 20.0 Percentage of participants |
| REGN3500 100 mg Q4W | Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 25.0 Percentage of participants |
| REGN3500 300 mg Q4W | Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 22.2 Percentage of participants |
| REGN3500 300 mg Q2W | Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 30.0 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.
Time frame: Week 16
Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.~Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 10.0 Percentage of participants |
| REGN3500 30 mg Q8W | Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 14.3 Percentage of participants |
| REGN3500 100 mg Q4W | Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 28.6 Percentage of participants |
| REGN3500 300 mg Q4W | Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 28.6 Percentage of participants |
| REGN3500 300 mg Q2W | Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 33.3 Percentage of participants |
Secondary
Percentage of Participants With Both IGA Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on All Observed Values Regardless of Rescue Treatment at Week 16
IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5 point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with both IGA score of 0 or 1 and a reduction from baseline of ≥2 points at Week 16 based on all observed values regardless of rescue treatment were reported.
Time frame: Week 16
Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.~Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants With Both IGA Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 8.3 Percentage of participants |
| REGN3500 30 mg Q8W | Percentage of Participants With Both IGA Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 0.0 Percentage of participants |
| REGN3500 100 mg Q4W | Percentage of Participants With Both IGA Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 25.0 Percentage of participants |
| REGN3500 300 mg Q4W | Percentage of Participants With Both IGA Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 33.3 Percentage of participants |
| REGN3500 300 mg Q2W | Percentage of Participants With Both IGA Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 30.0 Percentage of participants |
Secondary
Percentage of Participants With Both Investigator Global Assessment (IGA) Score 0 or 1 (on 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on Observed Values Set to Missing After Rescue Treatment at Week 16
IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5 point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with both IGA score of 0 or 1 and a reduction from baseline of ≥2 points at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing IGA score at Week 16 were counted as non-responders.
Time frame: Week 16
Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.~Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants With Both Investigator Global Assessment (IGA) Score 0 or 1 (on 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 10.0 Percentage of participants |
| REGN3500 30 mg Q8W | Percentage of Participants With Both Investigator Global Assessment (IGA) Score 0 or 1 (on 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 0.0 Percentage of participants |
| REGN3500 100 mg Q4W | Percentage of Participants With Both Investigator Global Assessment (IGA) Score 0 or 1 (on 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 28.6 Percentage of participants |
| REGN3500 300 mg Q4W | Percentage of Participants With Both Investigator Global Assessment (IGA) Score 0 or 1 (on 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 42.9 Percentage of participants |
| REGN3500 300 mg Q2W | Percentage of Participants With Both Investigator Global Assessment (IGA) Score 0 or 1 (on 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 33.3 Percentage of participants |
Secondary
Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Daily Peak Pruritus NRS Score ≥4 Based on All Observed Values Regardless of Rescue Treatment at Week 16
Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Percentage of participants with improvement of weekly average of daily peak pruritus NRS score ≥4 from baseline to Week 16 based on all observed values regardless of rescue treatment were reported.
Time frame: Week 16
Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.~Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Daily Peak Pruritus NRS Score ≥4 Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 0.0 Percentage of participants |
| REGN3500 30 mg Q8W | Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Daily Peak Pruritus NRS Score ≥4 Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 40.0 Percentage of participants |
| REGN3500 100 mg Q4W | Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Daily Peak Pruritus NRS Score ≥4 Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 62.5 Percentage of participants |
| REGN3500 300 mg Q4W | Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Daily Peak Pruritus NRS Score ≥4 Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 22.2 Percentage of participants |
| REGN3500 300 mg Q2W | Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Daily Peak Pruritus NRS Score ≥4 Based on All Observed Values Regardless of Rescue Treatment at Week 16 | 50.0 Percentage of participants |
Secondary
Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Peak Daily Pruritus NRS Score ≥4 Based on Observed Values Set to Missing After Rescue Treatment at Week 16
Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Percentage of participants with improvement of weekly average of daily peak pruritus NRS score ≥4 from baseline to Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing NRS score at Week 16 were counted as non-responders.
Time frame: Week 16
Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.~Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Peak Daily Pruritus NRS Score ≥4 Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 0.0 Percentage of participants |
| REGN3500 30 mg Q8W | Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Peak Daily Pruritus NRS Score ≥4 Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 42.9 Percentage of participants |
| REGN3500 100 mg Q4W | Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Peak Daily Pruritus NRS Score ≥4 Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 57.1 Percentage of participants |
| REGN3500 300 mg Q4W | Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Peak Daily Pruritus NRS Score ≥4 Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 28.6 Percentage of participants |
| REGN3500 300 mg Q2W | Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Peak Daily Pruritus NRS Score ≥4 Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | 50.0 Percentage of participants |
Secondary
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16
The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis (AD). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Time frame: Week 16
Population: FAS; All observed values, regardless of rescue treatment use; Here 'n' = number of evaluable participants at the specific timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16 | -12.7 Percentage of change | Standard Deviation 25.41 |
| REGN3500 30 mg Q8W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16 | -31.4 Percentage of change | Standard Deviation 22.67 |
| REGN3500 100 mg Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16 | -39.2 Percentage of change | Standard Deviation 38.39 |
| REGN3500 300 mg Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16 | -42.40 Percentage of change | Standard Deviation 20 |
| REGN3500 300 mg Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16 | -40.5 Percentage of change | Standard Deviation 29 |
Secondary
Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16
Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on all observed values regardless of rescue treatment was reported.
Time frame: Week 16
Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.~Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -5.9 Percentage of change | Standard Deviation 18.62 |
| REGN3500 30 mg Q8W | Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -27.5 Percentage of change | Standard Deviation 39.24 |
| REGN3500 100 mg Q4W | Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -52.8 Percentage of change | Standard Deviation 27.47 |
| REGN3500 300 mg Q4W | Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -33.9 Percentage of change | Standard Deviation 38.71 |
| REGN3500 300 mg Q2W | Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | -32.2 Percentage of change | Standard Deviation 47.46 |
Secondary
Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16
Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported. Values after first rescue treatment were set to missing and participants with missing NRS score at Week 16 were counted as non-responders.
Time frame: Week 16
Population: FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.~Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -6.1 Percentage of change | Standard Deviation 20.65 |
| REGN3500 30 mg Q8W | Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -31.6 Percentage of change | Standard Deviation 39.01 |
| REGN3500 100 mg Q4W | Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -53.1 Percentage of change | Standard Deviation 29.65 |
| REGN3500 300 mg Q4W | Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -43.1 Percentage of change | Standard Deviation 36.42 |
| REGN3500 300 mg Q2W | Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | -32.2 Percentage of change | Standard Deviation 47.46 |
Secondary
Serum Concentration of Functional REGN3500
Serum Concentration of Functional REGN3500 was reported.
Time frame: Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32 and 36
Population: The Pharmacokinetic (PK) analysis set included all randomized participants who received any study drug and who had at least 1 non-missing study drug concentration result following the first dose of study drug. Here, Number Analyzed signifies those participants who were evaluable at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGN3500 30 mg Q8W | Serum Concentration of Functional REGN3500 | Week 20 | 0.523 Milligrams per Liter (mg/L) | Standard Deviation 0.441 |
| REGN3500 30 mg Q8W | Serum Concentration of Functional REGN3500 | Week 16 | 1.05 Milligrams per Liter (mg/L) | Standard Deviation 0.733 |
| REGN3500 30 mg Q8W | Serum Concentration of Functional REGN3500 | Week 8 | 1.41 Milligrams per Liter (mg/L) | Standard Deviation 1.99 |
| REGN3500 30 mg Q8W | Serum Concentration of Functional REGN3500 | Week 32 | 0.0171 Milligrams per Liter (mg/L) | Standard Deviation 0.0484 |
| REGN3500 30 mg Q8W | Serum Concentration of Functional REGN3500 | Week 12 | 2.63 Milligrams per Liter (mg/L) | Standard Deviation 2.2 |
| REGN3500 30 mg Q8W | Serum Concentration of Functional REGN3500 | Week 2 | 3.29 Milligrams per Liter (mg/L) | Standard Deviation 2.7 |
| REGN3500 30 mg Q8W | Serum Concentration of Functional REGN3500 | Baseline (Week 0) | NA Milligrams per Liter (mg/L) | — |
| REGN3500 30 mg Q8W | Serum Concentration of Functional REGN3500 | Week 28 | 0.0838 Milligrams per Liter (mg/L) | Standard Deviation 0.109 |
| REGN3500 30 mg Q8W | Serum Concentration of Functional REGN3500 | Week 24 | 0.170 Milligrams per Liter (mg/L) | Standard Deviation 0.157 |
| REGN3500 30 mg Q8W | Serum Concentration of Functional REGN3500 | Week 4 | 2.33 Milligrams per Liter (mg/L) | Standard Deviation 1.82 |
| REGN3500 30 mg Q8W | Serum Concentration of Functional REGN3500 | Week 36 | NA Milligrams per Liter (mg/L) | — |
| REGN3500 100 mg Q4W | Serum Concentration of Functional REGN3500 | Week 4 | 5.14 Milligrams per Liter (mg/L) | Standard Deviation 3.73 |
| REGN3500 100 mg Q4W | Serum Concentration of Functional REGN3500 | Baseline (Week 0) | 0.157 Milligrams per Liter (mg/L) | Standard Deviation 0.8 |
| REGN3500 100 mg Q4W | Serum Concentration of Functional REGN3500 | Week 2 | 7.35 Milligrams per Liter (mg/L) | Standard Deviation 5.65 |
| REGN3500 100 mg Q4W | Serum Concentration of Functional REGN3500 | Week 32 | 0.625 Milligrams per Liter (mg/L) | Standard Deviation 0.56 |
| REGN3500 100 mg Q4W | Serum Concentration of Functional REGN3500 | Week 8 | 9.27 Milligrams per Liter (mg/L) | Standard Deviation 5.33 |
| REGN3500 100 mg Q4W | Serum Concentration of Functional REGN3500 | Week 12 | 8.74 Milligrams per Liter (mg/L) | Standard Deviation 6.37 |
| REGN3500 100 mg Q4W | Serum Concentration of Functional REGN3500 | Week 16 | 10.6 Milligrams per Liter (mg/L) | Standard Deviation 4.91 |
| REGN3500 100 mg Q4W | Serum Concentration of Functional REGN3500 | Week 20 | 5.03 Milligrams per Liter (mg/L) | Standard Deviation 3.93 |
| REGN3500 100 mg Q4W | Serum Concentration of Functional REGN3500 | Week 24 | 2.23 Milligrams per Liter (mg/L) | Standard Deviation 1.24 |
| REGN3500 100 mg Q4W | Serum Concentration of Functional REGN3500 | Week 28 | 1.08 Milligrams per Liter (mg/L) | Standard Deviation 0.813 |
| REGN3500 100 mg Q4W | Serum Concentration of Functional REGN3500 | Week 36 | 0.299 Milligrams per Liter (mg/L) | Standard Deviation 0.25 |
| REGN3500 300 mg Q4W | Serum Concentration of Functional REGN3500 | Week 2 | 21.4 Milligrams per Liter (mg/L) | Standard Deviation 9.83 |
| REGN3500 300 mg Q4W | Serum Concentration of Functional REGN3500 | Week 36 | 0.960 Milligrams per Liter (mg/L) | Standard Deviation 0.741 |
| REGN3500 300 mg Q4W | Serum Concentration of Functional REGN3500 | Week 28 | 3.49 Milligrams per Liter (mg/L) | Standard Deviation 2.76 |
| REGN3500 300 mg Q4W | Serum Concentration of Functional REGN3500 | Week 16 | 35.2 Milligrams per Liter (mg/L) | Standard Deviation 17.3 |
| REGN3500 300 mg Q4W | Serum Concentration of Functional REGN3500 | Week 4 | 14.3 Milligrams per Liter (mg/L) | Standard Deviation 7.05 |
| REGN3500 300 mg Q4W | Serum Concentration of Functional REGN3500 | Baseline (Week 0) | NA Milligrams per Liter (mg/L) | — |
| REGN3500 300 mg Q4W | Serum Concentration of Functional REGN3500 | Week 8 | 23.3 Milligrams per Liter (mg/L) | Standard Deviation 10.4 |
| REGN3500 300 mg Q4W | Serum Concentration of Functional REGN3500 | Week 32 | 1.93 Milligrams per Liter (mg/L) | Standard Deviation 1.37 |
| REGN3500 300 mg Q4W | Serum Concentration of Functional REGN3500 | Week 12 | 30.3 Milligrams per Liter (mg/L) | Standard Deviation 12 |
| REGN3500 300 mg Q4W | Serum Concentration of Functional REGN3500 | Week 24 | 7.14 Milligrams per Liter (mg/L) | Standard Deviation 5.22 |
| REGN3500 300 mg Q4W | Serum Concentration of Functional REGN3500 | Week 20 | 12.4 Milligrams per Liter (mg/L) | Standard Deviation 6.58 |
| REGN3500 300 mg Q2W | Serum Concentration of Functional REGN3500 | Week 4 | 37.9 Milligrams per Liter (mg/L) | Standard Deviation 15.2 |
| REGN3500 300 mg Q2W | Serum Concentration of Functional REGN3500 | Week 16 | 60.8 Milligrams per Liter (mg/L) | Standard Deviation 33.3 |
| REGN3500 300 mg Q2W | Serum Concentration of Functional REGN3500 | Week 20 | 29.8 Milligrams per Liter (mg/L) | Standard Deviation 23.5 |
| REGN3500 300 mg Q2W | Serum Concentration of Functional REGN3500 | Week 2 | 22.0 Milligrams per Liter (mg/L) | Standard Deviation 11 |
| REGN3500 300 mg Q2W | Serum Concentration of Functional REGN3500 | Week 36 | 1.02 Milligrams per Liter (mg/L) | Standard Deviation 1.31 |
| REGN3500 300 mg Q2W | Serum Concentration of Functional REGN3500 | Week 24 | 12.1 Milligrams per Liter (mg/L) | Standard Deviation 14.4 |
| REGN3500 300 mg Q2W | Serum Concentration of Functional REGN3500 | Week 28 | 6.70 Milligrams per Liter (mg/L) | Standard Deviation 7.64 |
| REGN3500 300 mg Q2W | Serum Concentration of Functional REGN3500 | Baseline (Week 0) | NA Milligrams per Liter (mg/L) | — |
| REGN3500 300 mg Q2W | Serum Concentration of Functional REGN3500 | Week 8 | 51.4 Milligrams per Liter (mg/L) | Standard Deviation 20.7 |
| REGN3500 300 mg Q2W | Serum Concentration of Functional REGN3500 | Week 12 | 57.7 Milligrams per Liter (mg/L) | Standard Deviation 26.3 |
| REGN3500 300 mg Q2W | Serum Concentration of Functional REGN3500 | Week 32 | 3.73 Milligrams per Liter (mg/L) | Standard Deviation 5.41 |
Secondary
Time to Onset of Effect on Pruritus (≥4-point Reduction of Weekly Average of Daily Peak Pruritus NRS From Baseline)
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?
Time frame: Week 16
Population: Time to event analysis performed for participants in FAS with baseline weekly peak NRS score ≥4 and at least one post-baseline weekly peak NRS score reduced ≥4 points from baseline. Time to event was calculated in weeks as the (date of first event - the date of first dose)/7. The event of NRS reduction ≥4 was based on observed data regardless of rescue use. Here 'n' = number of evaluable participants analyzed at specified time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Time to Onset of Effect on Pruritus (≥4-point Reduction of Weekly Average of Daily Peak Pruritus NRS From Baseline) | 6.6 Weeks | Standard Deviation 3.71 |
| REGN3500 30 mg Q8W | Time to Onset of Effect on Pruritus (≥4-point Reduction of Weekly Average of Daily Peak Pruritus NRS From Baseline) | 7.1 Weeks | Standard Deviation 4.74 |
| REGN3500 100 mg Q4W | Time to Onset of Effect on Pruritus (≥4-point Reduction of Weekly Average of Daily Peak Pruritus NRS From Baseline) | 7.1 Weeks | Standard Deviation 5.02 |
| REGN3500 300 mg Q4W | Time to Onset of Effect on Pruritus (≥4-point Reduction of Weekly Average of Daily Peak Pruritus NRS From Baseline) | 6.0 Weeks | Standard Deviation 4.29 |
| REGN3500 300 mg Q2W | Time to Onset of Effect on Pruritus (≥4-point Reduction of Weekly Average of Daily Peak Pruritus NRS From Baseline) | 5.8 Weeks | Standard Deviation 3.5 |