Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis

A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis

The primary objective of the study is to evaluate the efficacy of REGN3500 monotherapy compared with placebo treatment in adult patients with moderate-to-severe Atopic dermatitis (AD).

Secondary Objectives are to:

• Evaluate the efficacy of REGN3500 in combination with dupilumab compared with placebo treatment in adult patients with moderate-to-severe AD
• Assess the safety, tolerability, and immunogenicity of subcutaneous (SC) doses of REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with moderate-to-severe AD
• Evaluate the Pharmacokinetic (PK) of REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with moderate-to-severe AD

Study Overview

• Status: Terminated
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: REGN3500; Drug: Dupilumab; Drug: REGN3500 + Dupilumab Combo; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Anderlecht, Belgium, 1070
    • Regeneron Research Site
  • Antwerp, Belgium, 2650
    • Regeneron Research Site
  • Brussels, Belgium, 1090
    • Regeneron Research Site
  • Brussels, Belgium, 1200
    • Regeneron Research Site
  • Liege, Belgium, 4000
    • Regeneron Research Site
  • Loverval, Belgium, 6280
    • Regeneron Research Site
• Czechia
  • Brno, Czechia, 602 00
    • Regeneron Research Site
  • Pardubice, Czechia, 530 02
    • Regeneron Research Site
  • Praha, Czechia, 130 00
    • Regeneron Research Site
  • Praha 1, Czechia, 110 00
    • Regeneron Research Site
• Germany
  • Bad Bentheim, Germany, 48455
    • Regeneron Research Site
  • Berlin, Germany, 12459
    • Regeneron Research Site
  • Halle/Saale, Germany, 06120
    • Regeneron Research Site
  • Hamburg, Germany, 20537
    • Regeneron Research Site
  • Hamburg, Germany, 22391
    • Regeneron Research Site
  • Hanau, Germany, 63450
    • Regeneron Research Site
  • Leipzig, Germany, 04103
    • Regeneron Research Site
  • Lubeck, Germany, 23538
    • Regeneron Research Site
  • Mahlow, Germany, 15831
    • Regeneron Research Site
  • Munchen, Germany, 80337
    • Regeneron Research Site
  • Munster, Germany, 48149
    • Regeneron Research Site
  • Quedlinburg, Germany, 06484
    • Regeneron Research Site
  • Tuebingen, Germany, 72076
    • Regeneron Research Site
  • Witten, Germany, 58453
    • Regeneron Research Site
• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 13496
    • Regeneron Research Site
  • Gyeonggi-do, Korea, Republic of, 13620
    • Regeneron Research Site
  • Gyeonggi-do, Korea, Republic of, 14584
    • Regeneron Research Site
  • Gyeonggi-do, Korea, Republic of, 16499
    • Regeneron Research Site
  • Gyeonggi-do, Korea, Republic of, 18450
    • Regeneron Research Site
  • Incheon, Korea, Republic of, 22332
    • Regeneron Research Site
  • Incheon, Korea, Republic of, 21565
    • Regeneron Research Site
  • Incheon, Korea, Republic of, 21431
    • Regeneron Research Site
  • Seoul, Korea, Republic of, 03722
    • Regeneron Research Site
  • Seoul, Korea, Republic of, 06591
    • Regeneron Research Site
  • Seoul, Korea, Republic of, 03080
    • Regeneron Research Site
  • Seoul, Korea, Republic of, 07441
    • Regeneron Research Site
• Poland
  • Bydgoszcz, Poland, 85-065
    • Regeneron Research Site
  • Bydgoszcz, Poland, 85-796
    • Regeneron Research Site
  • Iwonicz Zdroj, Poland, 38-440
    • Regeneron Research Site
  • Krakow, Poland, 30-033
    • Regeneron Research Site
  • Lodz, Poland, 90-436
    • Regeneron Research Site
  • Wroclaw, Poland, 51-685
    • Regeneron Research Site
• Spain
  • Barakaldo, Spain, 48903
    • Regeneron Research Site
  • Santiago de Compostela, Spain, 15706
    • Regeneron Research Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85259
      • Regeneron Research Site
  • California
    • Fountain Valley, California, United States, 92708
      • Regeneron Research Site
    • Long Beach, California, United States, 90808
      • Regeneron Research Site
    • Los Angeles, California, United States, 90033
      • Regeneron Research Site
    • Los Angeles, California, United States, 90025
      • Regeneron Research Site
    • Sacramento, California, United States, 95815
      • Regeneron Research Site
  • Florida
    • Davie, Florida, United States, 33328
      • Regeneron Research Site
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Regeneron Research Site
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Regeneron Research Site
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Regeneron Research Site
    • Saint Joseph, Michigan, United States, 49085
      • Regeneron Research Site
    • Troy, Michigan, United States, 48084
      • Regeneron Research Site
  • New York
    • Bronx, New York, United States, 10467
      • Regeneron Research Site
    • Forest Hills, New York, United States, 11375
      • Regeneron Research Site
    • New York, New York, United States, 10029
      • Regeneron Research Site
    • New York, New York, United States, 10022
      • Regeneron Research Site
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Regeneron Research Site
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Regeneron Research Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • Regeneron Research Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Regeneron Research Site
  • Texas
    • Arlington, Texas, United States, 76014
      • Regeneron Research Site
  • Virginia
    • Richmond, Virginia, United States, 23220
      • Regeneron Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. ≥10% Body surface area (BSA) of AD involvement at the screening and baseline visits
4. 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. Prior participation in an anti-Interleukin (IL)-33 class antibody (including but not limited to REGN3500) or anti-IL-4Rα class antibody (including but not limited to dupilumab) clinical study; past treatment with or current treatment with dupilumab or another anti-IL-4Rα treatment
2. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit
3. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis (TB), histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment
4. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
5. Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCV Ab) at the screening visit
6. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Note: Other protocol defined Inclusion/Exclusion Criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo	Drug: REGN3500; Administered subcutaneous (SC) every 2 weeks (q2w); Drug: Dupilumab; Administered SC q2w; Other Names: Dupixent; REGN668; Drug: Placebo; Administered SC q2w
Experimental: REGN3500	Drug: REGN3500; Administered subcutaneous (SC) every 2 weeks (q2w)
Experimental: Dupilumab	Drug: Dupilumab; Administered SC q2w; Other Names: Dupixent; REGN668
Experimental: Combo	Drug: REGN3500 + Dupilumab Combo; Administered SC q2w; Other Names: Dupixent; REGN668

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 EASI score at Week 16 were counted as non-responders.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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 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.	Week 16
Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (≥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.	Week 16
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. 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.	Week 16
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.	Week 16
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.	Week 16
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.	Week 16
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 was reported.	Week 16
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.	Week 16
Percentage of Participants With Both Investigator Global Assessment (IGA) Score 0 or 1 (on the 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.	Week 16
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.	Week 16
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.	Week 16
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 at Week 16 based on all observed values regardless of rescue treatment was reported.	Week 16
Percent Change From Baseline in 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.	Week 16
Percent Change From Baseline in 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.	Week 16
Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Peak Daily Pruritus NRS ≥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 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 at Week 16 were counted as non-responders.	Week 16
Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Peak Daily Pruritus NRS ≥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 from baseline to Week 16 based on all observed values regardless of rescue treatment were reported.	Week 16
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?" Due to study discontinuation, not all planned participants were enrolled. For those already enrolled, the study drug was discontinued and participants were transitioned to post-treatment follow-up period. A large amount of data remained uncollected as not all enrolled participants completed all planned study visits and procedures for assessments for some endpoints. Therefore, this endpoint was removed and no data was collected for this outcome measure.	Week 16
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). Due to study discontinuation, not all planned participants were enrolled. For those already enrolled, the study drug was discontinued and participants were transitioned to post-treatment follow-up period. A large amount of data remained uncollected as not all enrolled participants completed all planned study visits and procedures for assessments for some endpoints. Therefore, this endpoint was removed and no data was collected for this outcome measure.	Week 16
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). Due to study discontinuation, not all planned participants were enrolled. For those already enrolled, the study drug was discontinued and participants were transitioned to post-treatment follow-up period. A large amount of data remained uncollected as not all enrolled participants completed all planned study visits and procedures for assessments for some endpoints. Therefore, this endpoint was removed and no data was collected for this outcome measure.	Week 16
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) From Baseline 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: SAEs and Non-SAEs. AESI included: Anaphylactic reactions; Systemic/severe hypersensitivity reactions; Malignancy; Helminthic infections; Suicide-related events; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; any clinical endoparasitosis; Conjunctivitis and significant Alanine aminotransferase (ALT) elevation. Number of participants with TEAEs, Serious TEAES and AESIs from baseline up to Week 16 were reported.	Baseline up to Week 16
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) From Baseline 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 SAEs and Non-SAEs. AESI included: Anaphylactic reactions; Systemic/severe hypersensitivity reactions; Malignancy; Helminthic infections; Suicide-related events; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; any clinical endoparasitosis; Conjunctivitis and significant ALT elevation. Number of participants with TEAEs, Serious TEAES and AESIs from baseline up to Week 36 were reported.	Baseline up to Week 36
Number of Participants With Positive Treatment-Emergent Anti-drug Antibodies (ADA) to REGN3500 and Dupilumab	Treatment-Emergent (TE) ADA: any positive post baseline assay response when baseline results were negative/missing. TE 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). Here, "Number of Participants Analysed" signifies those participants who were evaluable for this endpoint.	Baseline up to Week 36
Serum Concentration of Functional REGN3500	Serum Concentration of Functional REGN3500 was reported. Data was reported for REGN3500 300 mg Q2W and REGN3500 300 mg + Dupilumab 300 mg Q2W arms only	Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, and 36
Serum Concentration of Functional Dupilumab	Serum Concentration of Functional Dupilumab was reported.	Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, and 36

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Actual): March 13, 2020
• Study Completion (Actual): July 28, 2020

Study Registration Dates

• First Submitted: November 7, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Severe; Moderate
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: R3500-AD-1798; 2018-001543-30 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No