Safety and Tolerability of Dupilumab in Participants With Moderate to Severe Atopic Dermatitis

NCT ID: NCT01385657

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-03-31

Brief Summary

The purpose of this study is to assess the safety and tolerability of repeated subcutaneous (SC) doses of Dupilumab in participants with moderate-to-severe atopic dermatitis (AD).

Conditions

Atopic Dermatitis

Study Design

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

Study Groups

Placebo

Placebo (for Dupilumab) as a single subcutaneous (SC) injection on Day 1, 8, 15, and 22

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

A total of 4 doses were administered.

Background treatment

Intervention Type: OTHER

Participants were required to apply stable doses of an additive-free, basic bland emollient on the affected areas of the skin twice daily throughout the study.

Dupilumab 150 mg

Dupilumab 150 mg as a single SC injection on Day 1, 8, 15, and 22

Group Type: EXPERIMENTAL

Dupilumab

Intervention Type: DRUG

A total of 4 doses were administered.

Background treatment

Intervention Type: OTHER

Participants were required to apply stable doses of an additive-free, basic bland emollient on the affected areas of the skin twice daily throughout the study.

Dupilumab 300 mg

Dupilumab 300 mg as a single SC injection on Day 1, 8, 15, and 22

Group Type: EXPERIMENTAL

Dupilumab

Intervention Type: DRUG

A total of 4 doses were administered.

Background treatment

Intervention Type: OTHER

Participants were required to apply stable doses of an additive-free, basic bland emollient on the affected areas of the skin twice daily throughout the study.

Interventions

Placebo

A total of 4 doses were administered.

Intervention Type: DRUG

Dupilumab

A total of 4 doses were administered.

Intervention Type: DRUG

Background treatment

Participants were required to apply stable doses of an additive-free, basic bland emollient on the affected areas of the skin twice daily throughout the study.

Intervention Type: OTHER

Other Intervention Names

REGN668; SAR231893; Dupixent

Eligibility Criteria

Inclusion Criteria

1. Male or female, 18 years or older;

2. Chronic AD diagnosed by the Eichenfield revised criteria of Hannifin and Rajka that had been present for at least 3 years before the screening visit;

3. Eczema Area and Severity Index (EASI) score ≥ 12 at the screening and baseline visits;

4. Investigator's Global Assessment (IGA) score ≥ 3 at the screening and baseline visits;

5. ≥ 10% body surface area (BSA) of AD involvement at the screening and baseline visits;

6. History of inadequate response to a stable (≥ 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit.

Exclusion Criteria

1. Positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit;

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

3. Treatment with leukotriene inhibitors within 4 weeks before the baseline visit;

4. Treatment with systemic corticosteroids within 4 weeks before the baseline visit;

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

6. Systemic treatment for AD with an immunosuppressive/immunomodulating substance within 4 weeks before the baseline visit;

7. Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, or antifungals within 4 weeks before the screening visit or superficial skin infections within 1 week before the screening visit;

8. Known history of human immunodeficiency virus (HIV) infection;

9. History of clinical parasite infection, other than treated trichomoniasis;

10. History of malignancy within 5 years before the baseline visit, with the following exceptions: participants with a history of completely treated carcinoma in-situ of cervix, and non-metastatic squamous or basal cell carcinoma of the skin were allowed;

11. Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the participant at risk, interfere with participation in the study, or interfere with the interpretation of study results;

12. Pregnant or breast-feeding women;

13. Unwilling to use adequate birth control, if of reproductive potential and sexually active.

• 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

Kogarah, New South Wales, Australia

Woolloongabba, Queensland, Australia

Carlton, Victoria, Australia

Nedlands, Western Australia, Australia

Hanover, Lower Saxony, Germany

Bonn, North Rhine-Westphalia, Germany

Berlin, , Germany

Berlin, , Germany

Gera, , Germany

Münster, , Germany

Sydenham, Christchurch, New Zealand

Caversham, Dunedin, New Zealand

Auckland, , New Zealand

Countries

Australia; Germany; New Zealand

References

Hamilton JD, Suarez-Farinas M, Dhingra N, Cardinale I, Li X, Kostic A, Ming JE, Radin AR, Krueger JG, Graham N, Yancopoulos GD, Pirozzi G, Guttman-Yassky E. Dupilumab improves the molecular signature in skin of patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol. 2014 Dec;134(6):1293-1300. doi: 10.1016/j.jaci.2014.10.013.

Reference Type: RESULT

PMID: 25482871 (View on PubMed)

Beck LA, Thaci D, Hamilton JD, Graham NM, Bieber T, Rocklin R, Ming JE, Ren H, Kao R, Simpson E, Ardeleanu M, Weinstein SP, Pirozzi G, Guttman-Yassky E, Suarez-Farinas M, Hager MD, Stahl N, Yancopoulos GD, Radin AR. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014 Jul 10;371(2):130-9. doi: 10.1056/NEJMoa1314768.

Reference Type: RESULT

PMID: 25006719 (View on PubMed)

Other Identifiers

R668-AD-1026

Identifier Type: -

Identifier Source: org_study_id