Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

NCT ID: NCT02277769

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 708 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-01-31

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: PLACEBO_COMPARATOR

Placebo (for 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.

Dupilumab 300 mg 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.

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

DUPIXENT®; REGN668; SAR231893

Eligibility Criteria

Inclusion Criteria

1. Chronic AD that has been present for at least 3 years before the screening visit;

2. ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits;

3. 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 (eg, 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 is 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, is likely to require such treatment(s) during the first 4 weeks of study treatment:

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

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

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

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

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

8. Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit;

9. Known or suspected history of immunosuppression;

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

11. 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

Anniston, Alabama, United States

Birmingham, Alabama, United States

Phoenix, Arizona, United States

Bakersfield, California, United States

Costa Mesa, California, United States

Fremont, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Orange, California, United States

Roseville, California, United States

Temecula, California, United States

Trumbull, Connecticut, United States

Miami, Florida, United States

Oviedo, Florida, United States

Tampa, Florida, United States

West Palm Beach, Florida, United States

Alpharetta, Georgia, United States

Atlanta, Georgia, United States

Columbus, Georgia, United States

Buffalo Grove, Illinois, United States

Plainfield, Indiana, United States

West Des Moines, Iowa, United States

Overland Park, Kansas, United States

Rockville, Maryland, United States

Washington Park, Maryland, United States

Boston, Massachusetts, United States

Farmington Hills, Michigan, United States

Minneapolis, Minnesota, United States

Plymouth, Minnesota, United States

Saint Joseph, Missouri, United States

St Louis, Missouri, United States

Billings, Montana, United States

Bozeman, Montana, United States

Las Vegas, Nevada, United States

Verona, New Jersey, United States

Forest Hills, New York, United States

New York, New York, United States

Smithtown, New York, United States

Chapel Hill, North Carolina, United States

Raleigh, North Carolina, United States

Wilmington, North Carolina, United States

Winston-Salem, North Carolina, United States

Tulsa, Oklahoma, United States

Portland, Oregon, United States

Jenkintown, Pennsylvania, United States

Greer, South Carolina, United States

Arlington, Texas, United States

Austin, Texas, United States

Bellaire, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Richmond, Virginia, United States

Seattle, Washington, United States

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Surrey, British Columbia, Canada

St. John's, Newfoundland and Labrador, Canada

Ajax, Ontario, Canada

Mississauga, Ontario, Canada

Oakville, Ontario, Canada

Ottawa, Ontario, Canada

Peterborough, Ontario, Canada

Richmond Hill, Ontario, Canada

Montreal, Quebec, Canada

Lille, , France

Marseille, , France

Nantes, , France

Berlin, , Germany

Bochum, , Germany

Darmstadt, , Germany

Friedrichshafen, , Germany

Hamburg, , Germany

Kiel, , Germany

Hong Kong, , Hong Kong

Lucca, , Italy

Pisa, , Italy

Roma, , Italy

Kaunas, , Lithuania

Klaipėda, , Lithuania

Vilnius, , Lithuania

Elblag, , Poland

Gdansk, , Poland

Katowice, , Poland

Poznan, , Poland

Torun, , Poland

Warsaw, , Poland

Busan, , South Korea

Gyeonggi-do, , South Korea

Incheon, , South Korea

Seoul, , South Korea

Stockholm, , Sweden

London, , United Kingdom

Plymouth, , United Kingdom

Countries

United States; Canada; France; Germany; Hong Kong; Italy; Lithuania; Poland; South Korea; Sweden; United Kingdom

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Other Identifiers

R668-AD-1416

Identifier Type: -

Identifier Source: org_study_id