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

NCT ID: NCT02277743

Last Updated: 2017-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 671 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-02-29

Brief Summary

This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).

Conditions

Dermatitis, Atopic

Study Design

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

Study Groups

Placebo

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 (for Dupilumab)

Intervention Type: DRUG

Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms

Dupilumab 300 mg once weekly (qw)

Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.

Group Type: EXPERIMENTAL

Dupilumab

Intervention Type: DRUG

Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms

Dupilumab 300 mg every 2 weeks (q2w)

Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.

Group Type: EXPERIMENTAL

Dupilumab

Intervention Type: DRUG

Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms

Placebo (for Dupilumab)

Intervention Type: DRUG

Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms

Interventions

Dupilumab

Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms

Intervention Type: DRUG

Placebo (for Dupilumab)

Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms

Intervention Type: DRUG

Other Intervention Names

REGN668; SAR231893; DUPIXENT®

Eligibility Criteria

Inclusion Criteria

1. Male or female, 18 years or older

2. Chronic AD (according to American Academy of Dermatology Consensus Criteria Eichenfield 2014) that has been present for at least 3 years before the screening visit;

3. Eczema Area and Severity Index (EASI) Score ≥16 at the screening and baseline visits;

4. Investigator's Global Assessment (IGA) Score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at the screening and baseline visits;

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

6. Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (e.g, because of important side effects or safety risks).

Exclusion Criteria

1. Participation in a prior Dupilumab clinical study;

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

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

• Immunosuppressive/ immunomodulating drugs (e.g, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.);
• Phototherapy for AD

4. Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit;

5. Treatment with biologics as follows:

• Any cell-depleting agents including but not limited to rituximab: within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever was longer
• Other biologics: within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever was longer

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

7. Planned or anticipated use of any prohibited medications and procedures during study treatment;

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

9. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. NOTE: Participants might be rescreened after infection resolves;

10. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g, tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment;

11. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;

12. Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit;

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

14. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study;

15. Women 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

Birmingham, Alabama, United States

Fort Smith, Arkansas, United States

Rogers, Arkansas, United States

Clovis, California, United States

Lomita, California, United States

Los Angeles, California, United States

Oceanside, California, United States

Palmdale, California, United States

Rolling Hills Estates, California, United States

San Diego, California, United States

Santa Monica, California, United States

Stockton, California, United States

Boca Raton, Florida, United States

Clearwater, Florida, United States

Fort Lauderdale, Florida, United States

Miami, Florida, United States

Miami Lakes, Florida, United States

Pensacola, Florida, United States

Tampa, Florida, United States

Newnan, Georgia, United States

Chicago, Illinois, United States

Normal, Illinois, United States

Evansville, Indiana, United States

Indianapolis, Indiana, United States

Louisville, Kentucky, United States

Boston, Massachusetts, United States

Troy, Michigan, United States

St Louis, Missouri, United States

Newington, New Hampshire, United States

East Windsor, New Jersey, United States

Buffalo, New York, United States

Corning, New York, United States

New Hyde Park, New York, United States

Rochester, New York, United States

High Point, North Carolina, United States

Bethlehem, Pennsylvania, United States

Upland, Pennsylvania, United States

Chattanooga, Tennessee, United States

Knoxville, Tennessee, United States

San Antonio, Texas, United States

Waco, Texas, United States

Ogden, Utah, United States

Newport News, Virginia, United States

Norfolk, Virginia, United States

Spokane, Washington, United States

Dupnitsa, , Bulgaria

Plovdiv, , Bulgaria

Sofia, , Bulgaria

Winnepeg, Manitoba, Canada

Bathurst, New Brunswick, Canada

Hamilton, Ontario, Canada

Mississauga, Ontario, Canada

Newmarket, Ontario, Canada

Ottawa, Ontario, Canada

Richmond Hill, Ontario, Canada

Toronto, Ontario, Canada

Copenhagen, , Denmark

Hellerup, , Denmark

Tallinn, , Estonia

Tartu, , Estonia

Helsinki, , Finland

Tampere, , Finland

Turku, , Finland

Berlin, , Germany

Bielefed, , Germany

Blaubeuren Abbey, , Germany

Erlangen, , Germany

Halle, , Germany

Hamburg, , Germany

Hanover, , Germany

München, , Germany

Münster, , Germany

Osnabrück, , Germany

Schwerin, , Germany

Stuttgart, , Germany

Kurume, Fukuoka, Japan

Fukuyama, Hiroshima, Japan

Inashiki, Ibaraki, Japan

Yokohama, Kanagawa, Japan

Habikino, Osaka, Japan

Neyagawa, Osaka, Japan

Sakai, Osaka, Japan

Takatsuki, Osaka, Japan

Hamamatsu, Shizuoka, Japan

Bunkyo-ku, Tokyo, Japan

Chuo-ku, Tokyo, Japan

Nerima-ku, Tokyo, Japan

Shinagawa, Tokyo, Japan

Shinjuku, Tokyo, Japan

Kofu, Yamanashi, Japan

Gifu, , Japan

Hiroshima, , Japan

Kyoto, , Japan

Osaka, , Japan

Singapore, , Singapore

Alcañiz, , Spain

Alicante, , Spain

Barcelona, , Spain

Madrid, , Spain

Seville, , Spain

Valencia, , Spain

Countries

United States; Bulgaria; Canada; Denmark; Estonia; Finland; Germany; Japan; Singapore; Spain

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Other Identifiers

R668-AD-1334

Identifier Type: -

Identifier Source: org_study_id