Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Note: Other protocol defined Inclusion/Exclusion Criteria apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
REGN3500
  • Drug: REGN3500
    Administered subcutaneous (SC) every 2 weeks (q2w)
Experimental
Dupilumab
  • Drug: Dupilumab
    Administered SC q2w
    Other names:
    • REGN668
    • Dupixent
Experimental
Combo
  • Drug: REGN3500 + Dupilumab Combo
    Administered SC q2w
    Other names:
    • REGN668
    • Dupixent
Experimental
Placebo
  • Drug: REGN3500
    Administered subcutaneous (SC) every 2 weeks (q2w)
  • Drug: Dupilumab
    Administered SC q2w
    Other names:
    • REGN668
    • Dupixent
  • Drug: Placebo
    Administered SC q2w

Recruiting Locations

Regeneron Research Site
Phoenix, Arizona 85259

Regeneron Research Site
Fountain Valley, California 92708

Regeneron Research Site
Long Beach, California 90808

Regeneron Research Site
Los Angeles, California 90025

Regeneron Research Site
Los Angeles, California 90033

Regeneron Research Site
Sacramento, California 95815

Regeneron Research Site
Davie, Florida 33328

Regeneron Research Site
Sandy Springs, Georgia 30328

Regeneron Research Site
Rockville, Maryland 20850

Regeneron Research Site
Bay City, Michigan 48706

Regeneron Research Site
Saint Joseph, Michigan 49085

Regeneron Research Site
Troy, Michigan 48084

Regeneron Research Site
Bronx, New York 10467

Regeneron Research Site
Forest Hills, New York 11375

Regeneron Research Site
New York, New York 10022

Regeneron Research Site
New York, New York 10029

Regeneron Research Site
High Point, North Carolina 27262

Regeneron Research Site
Norman, Oklahoma 73071

Regeneron Research Site
Portland, Oregon 97239

Regeneron Research Site
Pittsburgh, Pennsylvania 15213

Regeneron Research Site
Arlington, Texas 76014

Regeneron Research Site
Richmond, Virginia 23220

More Details

NCT ID
NCT03736967
Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administration
844-734-6643
clinicaltrials@regeneron.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.