A study to see if multiple doses of REGN668 given by injections under the skin is safe to use in adult patients with moderate-to-severe atopic dermatitis when given at the same time as topical corticosteroids

A randomized, double-blind, parallel-group, placebo-controlled study to assess the safety of REGN668 administered concomitantly with topical corticosteroids to patients with moderate-to-severe Atopic dermatitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000946-37-HU

Enrollment

Registered

2012-04-23

Start date

2012-06-13

Completion date

Unknown

Last updated

2013-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis MedDRA version: 14.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Product Name: REGN668/SAR231893 Product Code: REGN668/SAR231893 Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: REGN668/SAR231893 Other descr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female patients aged 18 years or older 2. Chronic Atopic Dermatitis for at least 2 years 3. Patients must be applying an additive-free, basic bland emollient twice daily for at least 7 days before the baseline visit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 27 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion criteria

Exclusion criteria: 1. Prior treatment with REGN668 2. Hypersensitivity to corticosteroids or to any other ingredients contained by the TCS product used in the study 3. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit 4. Known history of human immunodeficiency virus (HIV) infection 5. History of clinical parasite infection 6. Pregnant or breast-feeding women 7. History of alcohol or drug abuse within 2 years of the screening visit 8. Treatment with an investigational drug within 8 weeks or within 5 half-lives, if known (whichever is longer), before the baseline visit 9. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to assess the safety of repeated subcutaneous (SC) doses of REGN668 administered concomitantly with topical corticosteroids (TCS) in adult patients with moderate-to-severe atopic dermatitis (AD).;Secondary Objective: No secondary objectives have been identified for the study;Primary end point(s): The primary endpoint is the incidence and severity of adverse events (AEs).;Timepoint(s) of evaluation of this end point: Throughout the duration of the study	—

Measure

Time frame

Main Objective: The primary objective of the study is to assess the safety of repeated subcutaneous (SC) doses of REGN668 administered concomitantly with topical corticosteroids (TCS) in adult patients with moderate-to-severe atopic dermatitis (AD).;Secondary Objective: No secondary objectives have been identified for the study;Primary end point(s): The primary endpoint is the incidence and severity of adverse events (AEs).;Timepoint(s) of evaluation of this end point: Throughout the duration of the study

—

Secondary

Measure	Time frame
Secondary end point(s): No secondary end points have been identified for the study;Timepoint(s) of evaluation of this end point: No secondary end points have been identified for the study	—

Countries

Germany, Hungary

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026