Trial results for nemolizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis were posted on ClinicalTrials.gov on 2025-06-05. The study assessed immunization responses, showing participants treated with nemolizumab had a 13.3% higher positive serum bactericidal antibody (SBA) response to Meningococcal Serogroup C (MenC) polysaccharide compared to placebo.
Background
The study aimed to assess the effect of nemolizumab on humoral immune responses to tetanus and meningococcal vaccination in adult and adolescent participants with moderate-to-severe atopic dermatitis.
Trial design
The study (NCT04365387) was a Phase 2, completed trial that enrolled 242 participants. It investigated nemolizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis. Participants received either nemolizumab or placebo.
Key results
The trial assessed humoral immune responses to tetanus and meningococcal vaccination at Week 16 (4 weeks post-vaccination).
For tetanus toxoid vaccination, immune responses were largely comparable between the nemolizumab and placebo groups across several measures:
- The percentage of participants with a positive serum IgG response (>= 4-Fold Increase or >= 0.2 IU/mL) was 67.5% for nemolizumab and 65.4% for placebo (difference: 2.1; 90.0% CI: -10.3 to 14.5).
- For a >=2-Fold Increase or >= 0.2 IU/mL response, 78.8% in the nemolizumab group responded compared to 83.3% in the placebo group (difference: -4.6; 90.0% CI: -14.9 to 5.7).
- Regarding protective antibody levels, 100% of participants in both groups achieved serum anti-tetanus IgG concentrations of >= 0.1 IU/mL, and 97.5% (nemolizumab) vs 96.2% (placebo) achieved >= 1.0 IU/mL. The Cochran-Mantel-Haenszel difference for these thresholds was 1.4 (90.0% CI: -3.2 to 5.9).
For Meningococcal Serogroup C (MenC) polysaccharide vaccination, a notable difference was observed:
- The percentage of participants with a positive serum bactericidal antibody (SBA) response was 77.0% for nemolizumab and 63.6% for placebo. The Cochran-Mantel-Haenszel difference was 13.3 (90.0% CI: 0.1 to 26.4).
- For a positive SBA response defined as reciprocal titer >=8, 83.3% in the nemolizumab group responded compared to 81.9% in the placebo group (difference: 1.3; 90.0% CI: -9.3 to 11.9).
What this means
The results indicate that nemolizumab did not negatively impact the humoral immune response to tetanus vaccination in adult and adolescent participants with moderate-to-severe atopic dermatitis. Furthermore, the data suggest a potentially enhanced positive serum bactericidal antibody response to Meningococcal Serogroup C polysaccharide in the nemolizumab group compared to placebo. These findings are important for understanding the safety profile of nemolizumab regarding vaccine efficacy in this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04365387, titled "A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab," were posted on 2025-06-05 on clinicaltrials.gov.