Phase 2
Completed N=242
A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab
Dermatitis, Atopic
Source: ClinicalTrials.gov NCT04365387 ↗
Enrolled (actual)
242
Serious AEs
0.4%
Results posted
Jun 2025
Primary outcomePrimary: 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) — 67.5; 65.4 Percentage of Participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
67.5; 65.4 | — |
| SECONDARY 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) |
78.8; 83.3 | — |
| SECONDARY Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 0.1 IU/mL at Week 16 |
100; 100 | — |
| SECONDARY Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 1.0 IU/mL at Week 16 |
97.5; 96.2 | — |
| SECONDARY Percentage of Participants With a Positive Serum Bactericidal Antibody (SBA) Response to Meningococcal Serogroup C (MenC) Polysaccharide at Week 16 |
77.0; 63.6 | — |
| SECONDARY Percentage of Participants With a Positive SBA Response (Defined as SBA Reciprocal Titer ≥8) to MenC Polysaccharide at Week 16 |
83.3; 81.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04365387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.