Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (SOLO 2)

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Dermatitis, Atopic

Treatments: Drug: Dupilumab; Drug: Placebo (for Dupilumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02277769

R668-AD-1416

Details and patient eligibility

About

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).

Enrollment: 708 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Note: The information listed above is not intended to contain all considerations relevant to a participant's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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708 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo (for Dupilumab)

Dupilumab 300 mg every 2 weeks (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 placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.

Treatment:

Drug: Placebo (for Dupilumab)

Drug: Dupilumab

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 of Dupilumab qw from Week 1 to Week 15.

Treatment:

Drug: Dupilumab