Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis (AD)

Treatments: Drug: Placebo; Drug: Dupilumab; Other: Background treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT01979016

R668-AD-1307

Details and patient eligibility

About

The primary objective of the study was to assess the efficacy of Dupilumab, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, 18 years or older;
2. Chronic AD that had been present for at least 3 years before the screening visit;
3. Patients with documented recent history (within 6 months before the screening visit) of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable;
4. Willing and able to comply with all clinic visits and study-related procedures.

Exclusion criteria

1. Prior participation in a Dupilumab clinical trial;

2. Treatment with an investigational drug within 8 weeks or within 5 half-lives before the baseline visit;

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

   • Systemic corticosteroids;
   • Immunosuppressive/immunomodulating drugs;
   • Phototherapy for AD;

4. Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit;

5. Treatment with certain biologics;

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

7. Planned major surgical procedure during the participant's participation in this study;

8. Participant was a member of the investigational team or his/her immediate family;

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

10. Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study;

Note: The information listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial therefore not all inclusion/exclusion criteria are listed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups

Placebo qw

Experimental group

Description:

Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection once weekly (qw) from Week 1 to Week 15.

Treatment:

Other: Background treatment

Drug: Placebo

Dupilumab 200 mg qw

Experimental group

Description:

Two subcutaneous injections of Dupilumab 200 milligram (mg) (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.

Treatment:

Other: Background treatment

Drug: Dupilumab