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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Dupilumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01859988

R668-AD-1021

Details and patient eligibility

About

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

Enrollment: 380 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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380 participants in 6 patient groups

Placebo qw

Experimental group

Description:

Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection every week (qw) from Week 1 to Week 15.

Treatment:

Drug: Placebo

Dupilumab 300 mg qw

Experimental group

Description:

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 qw from Week 1 to Week 15.

Treatment:

Drug: Dupilumab

Dupilumab 300 mg q2w

Experimental group

Description:

Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 15.

Treatment:

Drug: Dupilumab

Drug: Placebo

Dupilumab 200 mg q2w

Experimental group

Description:

Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.

Treatment:

Drug: Dupilumab

Drug: Placebo

Dupilumab 300 mg q4w

Experimental group

Description:

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 every 4 weeks (q4w) and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.

Treatment:

Drug: Dupilumab

Drug: Placebo

Dupilumab 100 mg q4w

Experimental group

Description:

Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.

Treatment:

Drug: Dupilumab

Drug: Placebo