Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

Galderma

Status and phase: Completed; Phase 3

Conditions: Moderate-to-Severe Atopic Dermatitis

Treatments: Drug: Placebo; Drug: Nemolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03989349

RD.06.SPR.118169

Details and patient eligibility

About

The main purpose of the study was to assess the efficacy and safety of nemolizumab after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical treatments.

Full description

This was a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent subjects of age 12 years and above with moderate-to-severe AD. Eligible subjects had documented history of inadequate response to topical AD medication(s). Approximately 750 subjects were randomized in 2:1 to receive either nemolizumab or placebo, stratified by baseline disease severity (Investigator's Global Assessment (IGA) = 3, moderate; IGA = 4, severe) and peak pruritus numeric rating scale (PP NRS) severity (PP NRS >= 7; PP NRS < 7). A minimum of 250 subjects were randomized in each PP NRS strata. All nemolizumab-treated subjects who were clinical responders at Week 16 (i.e., the end of initial treatment [Initial Treatment Period]/beginning of Maintenance Period) were re-randomized (1:1:1) to different treatment regimens (nemolizumab injections Q4W or every 8 weeks (Q8W) [with placebo injections at Weeks 20, 28, 36, and 44 to maintain the blind] or placebo Q4W). A clinical responder was defined as a subject at Week 16 with an IGA of 0 (clear) or 1 (almost clear) or a >=75% improvement in EASI from baseline (EASI-75). All placebo-treated subjects who responded to placebo during the Initial Treatment Period continued to receive placebo Q4W in the Maintenance Period.

Enrollment: 787 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or female subjects aged greater than and equal to (>=) 12 years at the screening visit.
• Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for at least 2 years before the screening visit.
• Eczema Area and Severity Index (EASI) score >=16 at the screening and baseline visits.
• Investigator Global Assessment (IGA) score >= 3 (scale of 0 to 4) at the screening and baseline visits.
• AD involvement >= 10 percent (%) of body surface area (BSA) at screening and baseline visits.
• Peak Pruritus Numerical Rating Scale (PPNRS) score of at least 4.0 at the screening and baseline visits.
• Documented recent history of inadequate response to topical medications (topical corticosteroids [TCS] with or without Topical calcineurin inhibitors [TCI]).
• Female subjects of childbearing potential (that is, fertile, following menarche and until becoming postmenopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.

Key Exclusion Criteria:

• Body weight (<) 30 kilograms (kg)
• Exacerbation of asthma requiring hospitalization in the preceding 12 months. Uncontrolled asthma in the preceding 3 months.
• Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit.
• Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study.

Note: Subjects with chronic,stable use of prophylactic treatment for recurrent herpes viral infection can be included in this clinical study.

• History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, e.g., monoclonal antibody) or to any of the study drug excipients.
• Any clinically significant issue, based on investigator judgement.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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787 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo administered via subcutaneous injection

Treatment:

Drug: Placebo

Nemolizumab

Experimental group

Description:

Nemolizumab administered via subcutaneous injection

Treatment:

Drug: Nemolizumab