Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Regeneron Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: REGN3500-Matching Placebo; Drug: REGN3500

Study type: Interventional

Funder types: Industry

Identifiers

NCT03738423

R3500-AD-1805

2018-001544-64 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the study is to assess the efficacy of REGN3500 monotherapy in Atopic dermatitis (AD), as well as understand the dose-response relationship, compared with placebo treatment, in adult patients with moderate-to-severe AD.

Secondary objectives are to:

• Assess the safety and tolerability of subcutaneous (SC) doses of REGN3500 monotherapy in adult patients with moderate-to-severe AD
• Assess the Pharmacokinetics (PK) of REGN3500 in adult patients with moderate-to-severe AD
• Assess the immunogenicity of REGN3500 in adult patients with moderate-to-severe AD

Enrollment: 129 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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. IGA score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at screening and baseline visits
4. ≥10% Body surface area (BSA) of AD involvement at the screening and baseline visits
5. 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. Participation in a prior anti-Interleukin (IL)-33 medication clinical study

2. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit

3. Having used any of the following treatments within 4 weeks before the baseline visit or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:

   1. Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, Interferon-gamma (IFN-γ), Janus kinase inhibitors, azathioprine, methotrexate, etc)
   2. Phototherapy for AD

4. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit

5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit

6. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit

7. Known or suspected history of immunosuppression

8. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening

9. Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCV Ab) at the screening visit

10. 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

129 participants in 5 patient groups

Treatment 1

Experimental group

Treatment:

Drug: REGN3500-Matching Placebo

Drug: REGN3500

Treatment 2

Experimental group

Treatment:

Drug: REGN3500-Matching Placebo

Drug: REGN3500

Treatment 3

Experimental group

Treatment:

Drug: REGN3500-Matching Placebo

Drug: REGN3500

Treatment 4

Experimental group

Treatment:

Drug: REGN3500-Matching Placebo

Drug: REGN3500

Treatment 5

Experimental group

Description:

Matching placebo

Treatment:

Drug: REGN3500-Matching Placebo