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

Galderma R&D242 enrolled

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

242

Conditions

Dermatitis, Atopic

Interventions

NemolizumabDRUG

Nemolizumab was administered by 2 SC injections as 60-mg loading dose at baseline and a single 30-mg dose at Weeks 4, 8, and 12.

PlaceboDRUG

Placebo was administered by 2 SC injections at baseline and a single dose at Weeks 4, 8, and 12.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 54 Years

Medical Language ↔ Plain English

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

Locations (64)

Outcomes

Primary Outcomes

Percentage of Participants With a Positive Serum Immunoglobulin G (IgG) Response (>= 4-Fold Increase or >= 0.2 IU/mL in Anti-Tetanus IgG Concentrations) to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination)

Percentage of participants with a positive serum IgG response to tetanus toxoid, defined as greater than or equal to (\>=) 4-fold increase in anti-tetanus IgG concentrations from baseline in participants with pre-vaccination anti-tetanus IgG concentrations \>= 0.1 international unit per milliliter (IU/mL); or \>= 0.2 IU/mL anti-tetanus IgG concentrations in participants with pre-vaccination antitetanus IgG concentrations less than (\<) 0.1 IU/mL, at Week 16 (4 weeks post-vaccination) were reported.

Time frame: At Week 16 (4 weeks post-vaccination)

Secondary Outcomes

Percentage of Participants With a Positive Serum IgG Response (>=2-Fold Increase or >= 0.2 IU/mL in Anti-tetanus IgG Concentrations) to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination)

Percentage of participants with a positive serum IgG response to tetanus toxoid, defined as \>= 2-fold increase in anti-tetanus IgG concentrations from baseline in participants with pre-vaccination anti-tetanus IgG concentrations \>= 0.1 IU/mL; or \>= 0.2 IU/mL anti-tetanus IgG concentrations in participants with pre-vaccination Anti tetanus IgG concentrations \< 0.1 IU/mL, at Week 16 (4 weeks post-vaccination) were reported.

Time frame: At Week 16 (4 weeks post-vaccination)

Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 0.1 IU/mL at Week 16

Percentage of participants with serum anti-tetanus IgG concentrations of \>= 0.1 IU/mL at Week 16 were reported. The detection and characterization of antibodies to tetanus toxoid was performed using a validated immunoassay.

Time frame: At Week 16

Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 1.0 IU/mL at Week 16

Percentage of participants with serum anti-tetanus IgG concentrations of \>= 1.0 IU/mL at Week 16 were reported. The detection and characterization of antibodies to tetanus toxoid was performed using a validated immunoassay.

Data from ClinicalTrials.gov

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...and 54 more locations