Evaluation of Dupilumab in Chinese Adult Patients With Moderate to Severe Atopic Dermatitis

Sanofi

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: Emollient (moisturizer); Drug: Dupilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03912259

U1111-1190-7728 (Other Identifier)

EFC15116

Details and patient eligibility

About

Primary Objective:

To evaluate the efficacy of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe atopic dermatitis (AD).

Secondary Objectives:

• To evaluate the safety of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe AD.
• To evaluate the effect of dupilumab on improving patient reported outcomes (PROs).
• To evaluate dupilumab immunogenicity.

Full description

The maximum study duration was 33 weeks per participants, including a screening period of up to 5 weeks, a 16-week randomized treatment period, and a 12-week follow-up period.

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, 18 years or older.
• AD (according to American Academy of Dermatology Consensus Criteria, 2014) that had been present for at least 3 years before the screening visit.
• Eczema Area and Severity Index (EASI) score greater than or equal to (>=) 16 at the screening and baseline visits.
• Investigator's Global Assessment (IGA) score >=3 (on the 0 to 4 IGA scale, in which 3 was moderate and 4 was severe) at the screening and baseline visits.
• Participants with >=10 percent (%) body surface area (BSA) of AD involvement at the screening and baseline visits.
• Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity >=4.
• Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments were otherwise medically inadvisable (e.g., because of important side effects or safety risks).

Exclusion criteria

• Had 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, interferon-gamma [IFN-γ], Janus kinase inhibitors, azathioprine, methotrexate);
  • Phototherapy for AD.

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

• Treatment with systemic Traditional Chinese Medicine (TCM) within 4 weeks before the baseline visit or treatment with topical TCM within 1 week before the baseline visit.

• 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 is longer;
  • Other biologics: within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever was longer.

• Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (participants may continue using stable doses of such moisturizers if initiated before the screening visit).

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

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

• 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 may be rescreened after infection resolves.

• 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.

• Active TB, latent untreated TB or a history of incompletely treated TB or non-tuberculous mycobacterial infection were excluded from the study unless that was well documented by a specialist that the participants had adequately treated and could then start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. TB testing would be performed according to local guidelines if required by regulatory authorities or ethics committees.

The above information was not intended to contain all considerations relevant to a participants potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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165 participants in 2 patient groups, including a placebo group

Placebo Q2W

Placebo Comparator group

Description:

Placebo matched to dupilumab 600 milligrams (mg) (loading dose), subcutaneously (SC) on Day 1 followed by placebo matched to dupilumab 300 mg once every 2 weeks (Q2W) for 16 weeks.

Treatment:

Drug: Placebo

Drug: Emollient (moisturizer)

Dupilumab 300 mg Q2W

Experimental group

Description:

Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.

Treatment:

Drug: Dupilumab

Drug: Emollient (moisturizer)