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

Conditions

• Dermatitis, Atopic

Eligibility Criteria

Sex

ALL

Age

12 Years - 54 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date

Mar 5, 2020

Status verified

May 2025

Primary completion

Jul 7, 2023

Completion

Jul 7, 2023

Study Design

Enrollment

242 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Nemolizumab
  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.
• Placebo Comparator: Placebo
  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.

Primary Outcome Measure

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) [ Time Frame: At Week 16 (4 weeks post-vaccination) ]

Locations (64)

Related coverage on Hipa.ai

• Nemolizumab Maintains Vaccine Response in Atopic Dermatitis, Shows Enhanced…
  Nemolizumab · Jun 5, 2025 · ClinicalTrials.gov

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