A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab

Galderma

Status and phase: Completed; Phase 2

Conditions: Dermatitis, Atopic

Treatments: Drug: Placebo; Drug: Nemolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04365387

RD.06.SPR.118380

Details and patient eligibility

About

The purpose of this study is to assess the effect of nemolizumab (CD14152) on humoral immune responses to tetanus and meningococcal vaccination in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD).

Full description

This is a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent participants (≥ 12 to 54 years) with moderate-to-severe AD. Eligible participants must have a documented history of inadequate response to topical AD medication(s). Approximately 200 participants were randomized 1:1 to receive either 30 mg nemolizumab (with a 60 mg loading dose) or placebo, stratified by baseline disease severity Investigator Global Assessment (IGA) (IGA = 3, moderate; IGA = 4, severe). The study consisted of a 2- to 4-week screening period, a 16-week treatment period, and an 8-week follow-up period (12 weeks after the last study drug injection).

Enrollment: 242 patients

Sex: All

Ages: 12 to 54 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic AD for at least 2 years
• EASI score >= 16
• IGA score >= 3
• AD involvement >= 10% of BSA
• Peak (maximum) pruritus NRS score of at least 4.0

Exclusion criteria

• Body weight < 30 kilogram (kg)
• History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) or to any of the study drug excipients
• History of severe allergic reaction to either vaccine or to vaccine components including alum, thimerosal, phenol
• Participants for whom administration of the meningococcal vaccine provided in this study is contraindicated or medically inadvisable
• Participants for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this study is contraindicated or medically inadvisable
• Receipt of any vaccine (except inactivated influenza vaccine) within 12 weeks prior to screening, any meningococcal vaccine within 1 year prior to screening, or any tetanus-, diphtheria-, or pertussis-containing vaccine within 5 years prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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242 participants in 2 patient groups, including a placebo group

Nemolizumab

Experimental group

Description:

Participants received a loading dose of nemolizumab (60 milligram \[mg\]) via 2 subcutaneous (SC) injections at baseline. Nemolizumab (30 mg) was administered via a single subcutaneous injection every 4 weeks (Q4W) at Weeks 4, 8, and 12.

Treatment:

Drug: Nemolizumab

Placebo

Placebo Comparator group

Description:

Participants received a placebo via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12.

Treatment:

Drug: Placebo