Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (SOLO 1)

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

NCT02277743

R668-AD-1334

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: 671 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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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671 participants in 3 patient groups

Placebo

Experimental 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 once weekly (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

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