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NCT04365387 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab
A Phase 2 study, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 2
- Development phase
- 242
- Enrollment target
NCT04365387: Completed Phase 2 study, sponsored by Galderma R&D.
NCT04365387 is a Phase 2 study that has completed, run by Galderma R&D. The registered enrollment target is 242 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04365387, a Phase 2 study, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 242 participants
- Enrollment target
Study 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).
Primary Outcome
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 report
Interventions
- DRUG Placebo
- DRUG Nemolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2020-03-05 |
| Est. Completion | 2023-07-07 |
| Phase | Phase 2 |
What the finished NCT04365387 record still lists
NCT04365387 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04365387 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04365387 about?
NCT04365387 is a clinical study titled "A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab". 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).
What is the current status of trial NCT04365387?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 242 participants. The study started on 2020-03-05. Estimated completion is 2023-07-07.
What interventions are being tested in trial NCT04365387?
The interventions under investigation include: Placebo (DRUG), Nemolizumab (DRUG).
Who is sponsoring clinical trial NCT04365387?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04365387's enrollment target sits among peer trials
242 237th of 2000 higher than 1,762 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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