MedDataX Logo

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

NCT ID: NCT03736967

Last Updated: 2021-11-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-12

Study Completion Date

2020-07-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Moderate Severe

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

REGN3500

Group Type EXPERIMENTAL

REGN3500

Intervention Type DRUG

Administered subcutaneous (SC) every 2 weeks (q2w)

Dupilumab

Group Type EXPERIMENTAL

Dupilumab

Intervention Type DRUG

Administered SC q2w

Combo

Group Type EXPERIMENTAL

REGN3500 + Dupilumab Combo

Intervention Type DRUG

Administered SC q2w

Placebo

Group Type EXPERIMENTAL

REGN3500

Intervention Type DRUG

Administered subcutaneous (SC) every 2 weeks (q2w)

Dupilumab

Intervention Type DRUG

Administered SC q2w

Placebo

Intervention Type DRUG

Administered SC q2w

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

REGN3500

Administered subcutaneous (SC) every 2 weeks (q2w)

Intervention Type DRUG

Dupilumab

Administered SC q2w

Intervention Type DRUG

REGN3500 + Dupilumab Combo

Administered SC q2w

Intervention Type DRUG

Placebo

Administered SC q2w

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

REGN668 Dupixent REGN668 Dupixent

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanofi

INDUSTRY

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Regeneron Research Site

Phoenix, Arizona, United States

Site Status

Regeneron Research Site

Fountain Valley, California, United States

Site Status

Regeneron Research Site

Long Beach, California, United States

Site Status

Regeneron Research Site

Los Angeles, California, United States

Site Status

Regeneron Research Site

Los Angeles, California, United States

Site Status

Regeneron Research Site

Sacramento, California, United States

Site Status

Regeneron Research Site

Davie, Florida, United States

Site Status

Regeneron Research Site

Sandy Springs, Georgia, United States

Site Status

Regeneron Research Site

Rockville, Maryland, United States

Site Status

Regeneron Research Site

Bay City, Michigan, United States

Site Status

Regeneron Research Site

Saint Joseph, Michigan, United States

Site Status

Regeneron Research Site

Troy, Michigan, United States

Site Status

Regeneron Research Site

Forest Hills, New York, United States

Site Status

Regeneron Research Site

New York, New York, United States

Site Status

Regeneron Research Site

New York, New York, United States

Site Status

Regeneron Research Site

The Bronx, New York, United States

Site Status

Regeneron Research Site

High Point, North Carolina, United States

Site Status

Regeneron Research Site

Norman, Oklahoma, United States

Site Status

Regeneron Research Site

Portland, Oregon, United States

Site Status

Regeneron Research Site

Pittsburgh, Pennsylvania, United States

Site Status

Regeneron Research Site

Arlington, Texas, United States

Site Status

Regeneron Research Site

Richmond, Virginia, United States

Site Status

Regeneron Research Site

Anderlecht, , Belgium

Site Status

Regeneron Research Site

Antwerp, , Belgium

Site Status

Regeneron Research Site

Brussels, , Belgium

Site Status

Regeneron Research Site

Brussels, , Belgium

Site Status

Regeneron Research Site

Liège, , Belgium

Site Status

Regeneron Research Site

Loverval, , Belgium

Site Status

Regeneron Research Site

Brno, , Czechia

Site Status

Regeneron Research Site

Pardubice, , Czechia

Site Status

Regeneron Research Site

Prague, , Czechia

Site Status

Regeneron Research Site

Prague, , Czechia

Site Status

Regeneron Research Site

Bad Bentheim, , Germany

Site Status

Regeneron Research Site

Berlin, , Germany

Site Status

Regeneron Research Site

Halle, , Germany

Site Status

Regeneron Research Site

Hamburg, , Germany

Site Status

Regeneron Research Site

Hamburg, , Germany

Site Status

Regeneron Research Site

Hanau, , Germany

Site Status

Regeneron Research Site

Leipzig, , Germany

Site Status

Regeneron Research Site

Lübeck, , Germany

Site Status

Regeneron Research Site

Mahlow, , Germany

Site Status

Regeneron Research Site

München, , Germany

Site Status

Regeneron Research Site

Münster, , Germany

Site Status

Regeneron Research Site

Quedlinburg, , Germany

Site Status

Regeneron Research Site

Tübingen, , Germany

Site Status

Regeneron Research Site

Witten, , Germany

Site Status

Regeneron Research Site

Bydgoszcz, , Poland

Site Status

Regeneron Research Site

Bydgoszcz, , Poland

Site Status

Regeneron Research Site

Iwonicz-Zdrój, , Poland

Site Status

Regeneron Research Site

Krakow, , Poland

Site Status

Regeneron Research Site

Lodz, , Poland

Site Status

Regeneron Research Site

Wroclaw, , Poland

Site Status

Regeneron Research Site

Gyeonggi-do, , South Korea

Site Status

Regeneron Research Site

Gyeonggi-do, , South Korea

Site Status

Regeneron Research Site

Gyeonggi-do, , South Korea

Site Status

Regeneron Research Site

Gyeonggi-do, , South Korea

Site Status

Regeneron Research Site

Gyeonggi-do, , South Korea

Site Status

Regeneron Research Site

Incheon, , South Korea

Site Status

Regeneron Research Site

Incheon, , South Korea

Site Status

Regeneron Research Site

Incheon, , South Korea

Site Status

Regeneron Research Site

Seoul, , South Korea

Site Status

Regeneron Research Site

Seoul, , South Korea

Site Status

Regeneron Research Site

Seoul, , South Korea

Site Status

Regeneron Research Site

Seoul, , South Korea

Site Status

Regeneron Research Site

Barakaldo, , Spain

Site Status

Regeneron Research Site

Santiago de Compostela, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Belgium Czechia Germany Poland South Korea Spain

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-001543-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R3500-AD-1798

Identifier Type: -

Identifier Source: org_study_id