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

NCT03736967

TerminatedPhase 2

Sponsor: Regeneron Pharmaceuticals

Conditions: Atopic Dermatitis

Interventions: REGN3500, Dupilumab, REGN3500 + Dupilumab Combo, Placebo

Countries: United States, Belgium, Czechia, Germany, Poland, South Korea, Spain

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

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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. ≥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
Locations (66)
  • Phoenix, Arizona, United States
  • Fountain Valley, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Sacramento, California, United States
  • Davie, Florida, United States
  • Sandy Springs, Georgia, United States
  • Rockville, Maryland, United States
  • Bay City, Michigan, United States
  • Saint Joseph, Michigan, United States
  • Troy, Michigan, United States
  • Forest Hills, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • The Bronx, New York, United States
  • High Point, North Carolina, United States
  • Norman, Oklahoma, United States
  • Portland, Oregon, United States
  • Pittsburgh, Pennsylvania, United States
  • Arlington, Texas, United States
  • Richmond, Virginia, United States
  • Anderlecht, Belgium
  • Antwerp, Belgium
  • Brussels, Belgium
  • Brussels, Belgium
  • Liège, Belgium
  • Loverval, Belgium
  • Brno, Czechia
  • Pardubice, Czechia
  • + 36 more on CT.gov