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

Primary Purpose

Atopic Dermatitis

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

REGN3500

Dupilumab

REGN3500 + Dupilumab Combo

Placebo

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Moderate, Severe

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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
Eczema Area and Severity Index (EASI) score ≥16 at the screening and baseline visits
≥10% Body surface area (BSA) of AD involvement at the screening and baseline visits
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:

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
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
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
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCV Ab) at the screening visit
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Note: Other protocol defined Inclusion/Exclusion Criteria apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

REGN3500

Dupilumab

Combo

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

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

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.

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

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

Serum Concentration of Functional Dupilumab

Serum Concentration of Functional Dupilumab was reported.

Full Information

NCT ID

NCT03736967

First Posted

November 7, 2018

Last Updated

October 1, 2021

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT03736967

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Terminated

Why Stopped

Lack of efficacy

Study Start Date

November 12, 2018 (Actual)

Primary Completion Date

March 13, 2020 (Actual)

Study Completion Date

July 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

Moderate, Severe

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

206 (Actual)

8. Arms, Groups, and Interventions

Arm Title

REGN3500

Arm Type

Experimental

Arm Title

Dupilumab

Arm Type

Experimental

Arm Title

Combo

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

REGN3500

Intervention Description

Administered subcutaneous (SC) every 2 weeks (q2w)

Intervention Type

Drug

Intervention Name(s)

Dupilumab

Other Intervention Name(s)

REGN668, Dupixent

Intervention Description

Administered SC q2w

Intervention Type

Drug

Intervention Name(s)

REGN3500 + Dupilumab Combo

Other Intervention Name(s)

REGN668, Dupixent

Intervention Description

Administered SC q2w

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC q2w

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Week 16

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16

Description

Time Frame

Week 16

Title

Description

Time Frame

Week 16

Title

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

Description

Time Frame

Week 16

Title

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

Description

Time Frame

Week 16

Title

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

Description

Time Frame

Week 16

Title

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

Description

Time Frame

Week 16

Title

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

Description

Time Frame

Week 16

Title

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

Description

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.

Time Frame

Week 16

Title

Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16

Description

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

Title

Description

Time Frame

Week 16

Title

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

Description

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

Title

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

Description

Time Frame

Week 16

Title

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

Description

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.

Time Frame

Week 16

Title

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

Description

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

Title

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

Description

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

Title

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

Description

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.

Time Frame

Week 16

Title

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

Description

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.

Time Frame

Week 16

Title

Time to Onset of Effect on Pruritus (≥4-point Reduction of Weekly Average of Daily Peak Pruritus NRS From Baseline)

Description

Time Frame

Week 16

Title

Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16

Description

Time Frame

Week 16

Title

Absolute Change From Baseline in Percent Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement at Week 16

Description

Time Frame

Week 16

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) From Baseline up to Week 16

Description

Time Frame

Baseline up to Week 16

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) From Baseline up to Week 36

Description

Time Frame

Baseline up to Week 36

Title

Number of Participants With Positive Treatment-Emergent Anti-drug Antibodies (ADA) to REGN3500 and Dupilumab

Description

Time Frame

Baseline up to Week 36

Title

Serum Concentration of Functional REGN3500

Description

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

Time Frame

Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, and 36

Title

Serum Concentration of Functional Dupilumab

Description

Serum Concentration of Functional Dupilumab was reported.

Time Frame

Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, and 36

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: 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 Eczema Area and Severity Index (EASI) score ≥16 at the screening and baseline visits ≥10% Body surface area (BSA) of AD involvement at the screening and baseline visits 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: 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 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 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 History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCV Ab) at the screening visit Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study Note: Other protocol defined Inclusion/Exclusion Criteria apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Management

Organizational Affiliation

Regeneron Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Regeneron Research Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

Facility Name

Regeneron Research Site

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Regeneron Research Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90808

Country

United States

Facility Name

Regeneron Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Regeneron Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Regeneron Research Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95815

Country

United States

Facility Name

Regeneron Research Site

City

Davie

State/Province

Florida

ZIP/Postal Code

33328

Country

United States

Facility Name

Regeneron Research Site

City

Sandy Springs

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Regeneron Research Site

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Regeneron Research Site

City

Bay City

State/Province

Michigan

ZIP/Postal Code

48706

Country

United States

Facility Name

Regeneron Research Site

City

Saint Joseph

State/Province

Michigan

ZIP/Postal Code

49085

Country

United States

Facility Name

Regeneron Research Site

City

Troy

State/Province

Michigan

ZIP/Postal Code

48084

Country

United States

Facility Name

Regeneron Research Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

Regeneron Research Site

City

Forest Hills

State/Province

New York

ZIP/Postal Code

11375

Country

United States

Facility Name

Regeneron Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10022

Country

United States

Facility Name

Regeneron Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Regeneron Research Site

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Regeneron Research Site

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73071

Country

United States

Facility Name

Regeneron Research Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Regeneron Research Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Regeneron Research Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76014

Country

United States

Facility Name

Regeneron Research Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23220

Country

United States

Facility Name

Regeneron Research Site

City

Anderlecht

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Regeneron Research Site

City

Antwerp

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Regeneron Research Site

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Regeneron Research Site

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Regeneron Research Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Regeneron Research Site

City

Loverval

ZIP/Postal Code

6280

Country

Belgium

Facility Name

Regeneron Research Site

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Regeneron Research Site

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

Regeneron Research Site

City

Praha 1

ZIP/Postal Code

110 00

Country

Czechia

Facility Name

Regeneron Research Site

City

Praha

ZIP/Postal Code

130 00

Country

Czechia

Facility Name

Regeneron Research Site

City

Bad Bentheim

ZIP/Postal Code

48455

Country

Germany

Facility Name

Regeneron Research Site

City

Berlin

ZIP/Postal Code

12459

Country

Germany

Facility Name

Regeneron Research Site

City

Halle/Saale

ZIP/Postal Code

06120

Country

Germany

Facility Name

Regeneron Research Site

City

Hamburg

ZIP/Postal Code

20537

Country

Germany

Facility Name

Regeneron Research Site

City

Hamburg

ZIP/Postal Code

22391

Country

Germany

Facility Name

Regeneron Research Site

City

Hanau

ZIP/Postal Code

63450

Country

Germany

Facility Name

Regeneron Research Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Regeneron Research Site

City

Lubeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Regeneron Research Site

City

Mahlow

ZIP/Postal Code

15831

Country

Germany

Facility Name

Regeneron Research Site

City

Munchen

ZIP/Postal Code

80337

Country

Germany

Facility Name

Regeneron Research Site

City

Munster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Regeneron Research Site

City

Quedlinburg

ZIP/Postal Code

06484

Country

Germany

Facility Name

Regeneron Research Site

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Regeneron Research Site

City

Witten

ZIP/Postal Code

58453

Country

Germany

Facility Name

Regeneron Research Site

City

Gyeonggi-do

ZIP/Postal Code

13496

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Gyeonggi-do

ZIP/Postal Code

14584

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Gyeonggi-do

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Gyeonggi-do

ZIP/Postal Code

18450

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Incheon

ZIP/Postal Code

21431

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Incheon

ZIP/Postal Code

21565

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Incheon

ZIP/Postal Code

22332

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Seoul

ZIP/Postal Code

07441

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Bydgoszcz

ZIP/Postal Code

85-065

Country

Poland

Facility Name

Regeneron Research Site

City

Bydgoszcz

ZIP/Postal Code

85-796

Country

Poland

Facility Name

Regeneron Research Site

City

Iwonicz Zdroj

ZIP/Postal Code

38-440

Country

Poland

Facility Name

Regeneron Research Site

City

Krakow

ZIP/Postal Code

30-033

Country

Poland

Facility Name

Regeneron Research Site

City

Lodz

ZIP/Postal Code

90-436

Country

Poland

Facility Name

Regeneron Research Site

City

Wroclaw

ZIP/Postal Code

51-685

Country

Poland

Facility Name

Regeneron Research Site

City

Barakaldo

ZIP/Postal Code

48903

Country

Spain

Facility Name

Regeneron Research Site

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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

Atopic Dermatitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial