Overview

Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Status:
Completed

Trial end date:
2014-09-01

Target enrollment:
0

Participant gender:
All

Summary

To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult participants with moderate-to-severe atopic dermatitis (AD).

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Regeneron Pharmaceuticals

Collaborator:

Sanofi

Criteria

The inclusion criteria included, but were not limited to, the following:

1. Chronic Atopic Dermatitis that had been present for at least 3 years

2. History of inadequate response to out-patient treatment with topical medications, or
for whom topical treatments were otherwise inadvisable (e.g, because of important side
effects or safety risks)

3. Willing and able to comply with all clinic visits and study-related procedures

The exclusion criteria included, but were not limited to, the following:

1. Prior treatment with dupilumab (REGN668/SAR231893)

2. Presence of certain laboratory abnormalities at the screening visit

3. Treatment with an investigational drug within 8 weeks of baseline visit

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

5. Certain other treatments and medical procedures undertaken within a particular time
frame prior to the baseline visit

6. Known history of human immunodeficiency virus (HIV) infection

7. History of malignancy within 5 years before the baseline visit (with certain
exceptions)

8. Planned surgical procedure during the length of the study

9. High risk of parasite infection

10. Any other medical or psychological condition that in the opinion of the investigator
or the sponsor's medical monitor, would place the participants at risk, interfere with
participation in the study or interfere with interpretation of study results

11. Pregnant or breast-feeding women