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

NCT ID: NCT01979016

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-01-31

Brief Summary

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).

Conditions

Atopic Dermatitis (AD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo qw

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.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Matching placebo

Background treatment

Intervention Type: OTHER

Participants were required to apply stable doses of a topical emollient (moisturizer) twice daily for at least 7 days before the baseline visit and at least 7 days after the baseline visit (day -7 to day 8).

Dupilumab 200 mg qw

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.

Group Type: EXPERIMENTAL

Dupilumab

Intervention Type: DRUG

Background treatment

Intervention Type: OTHER

Participants were required to apply stable doses of a topical emollient (moisturizer) twice daily for at least 7 days before the baseline visit and at least 7 days after the baseline visit (day -7 to day 8).

Interventions

Dupilumab

Intervention Type: DRUG

Placebo

Matching placebo

Intervention Type: DRUG

Background treatment

Participants were required to apply stable doses of a topical emollient (moisturizer) twice daily for at least 7 days before the baseline visit and at least 7 days after the baseline visit (day -7 to day 8).

Intervention Type: OTHER

Other Intervention Names

REGN668; SAR231893; Dupixent; Topical emollient

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Chicago, Illinois, United States

New York, New York, United States

Dallas, Texas, United States

Montreal, Quebec, Canada

Countries

United States; Canada

References

Callewaert C, Nakatsuji T, Knight R, Kosciolek T, Vrbanac A, Kotol P, Ardeleanu M, Hultsch T, Guttman-Yassky E, Bissonnette R, Silverberg JI, Krueger J, Menter A, Graham NMH, Pirozzi G, Hamilton JD, Gallo RL. IL-4Ralpha Blockade by Dupilumab Decreases Staphylococcus aureus Colonization and Increases Microbial Diversity in Atopic Dermatitis. J Invest Dermatol. 2020 Jan;140(1):191-202.e7. doi: 10.1016/j.jid.2019.05.024. Epub 2019 Jun 25.

Reference Type: DERIVED

PMID: 31252032 (View on PubMed)

Guttman-Yassky E, Bissonnette R, Ungar B, Suarez-Farinas M, Ardeleanu M, Esaki H, Suprun M, Estrada Y, Xu H, Peng X, Silverberg JI, Menter A, Krueger JG, Zhang R, Chaudhry U, Swanson B, Graham NMH, Pirozzi G, Yancopoulos GD, D Hamilton JD. Dupilumab progressively improves systemic and cutaneous abnormalities in patients with atopic dermatitis. J Allergy Clin Immunol. 2019 Jan;143(1):155-172. doi: 10.1016/j.jaci.2018.08.022. Epub 2018 Sep 5.

Reference Type: DERIVED

PMID: 30194992 (View on PubMed)

Other Identifiers

R668-AD-1307

Identifier Type: -

Identifier Source: org_study_id