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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Regeneron Pharmaceuticals

Status and phase

Terminated
Phase 2

Conditions

Atopic Dermatitis

Treatments

Drug: Dupilumab
Drug: REGN3500 + Dupilumab Combo
Drug: Placebo
Drug: REGN3500

Study type

Interventional

Funder types

Industry

Identifiers

NCT03736967
R3500-AD-1798
2018-001543-30 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

206 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

206 participants in 4 patient groups

REGN3500
Experimental group
Treatment:
Drug: REGN3500
Dupilumab
Experimental group
Treatment:
Drug: Dupilumab
Combo
Experimental group
Treatment:
Drug: REGN3500 + Dupilumab Combo
Placebo
Experimental group
Treatment:
Drug: REGN3500
Drug: Placebo
Drug: Dupilumab

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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