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NCT04562116 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Participants With Moderate-to-Severe Atopic Dermatitis
A Phase 2 study, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT04562116: Completed Phase 2 study, sponsored by Galderma R&D.
NCT04562116 is a Phase 2 study that has completed, run by Galderma R&D. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04562116, a Phase 2 study, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of nemolizumab (CD14152) on the pharmacokinetics (PK) of a drug "cocktail" representative of CYP450 (CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4/5 sensitive index substrates) in adult participants with moderate to- severe atopic dermatitis (AD).
Primary Outcome
AUC (0-infinity) was defined as AUC from time 0 to infinity, calculated as the sum of AUC (0-last) and C(last)/lambda(z); where C(last) was the last observed measurable (non-BQL) concentration; and lambda(z) was apparent terminal elimination rate constant. Probe drugs included Caffeine, Metoprolol Tartrate, Midazolam, Omeprazole and Warfarin Sodium. Change in AUC(0-infinity) of each of the 5 probe drugs before (Baseline) and after 9-week nemolizumab treatment is reported.
Interventions
- DRUG Nemolizumab
- DRUG CYP 450 Substrates
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2021-12-08 |
| Est. Completion | 2023-06-07 |
| Phase | Phase 2 |
What the finished NCT04562116 record still lists
NCT04562116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Nemolizumab is the first listed.
NCT04562116 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04562116 about?
NCT04562116 is a clinical study titled "A Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Participants With Moderate-to-Severe Atopic Dermatitis". The purpose of this study is to evaluate the effect of nemolizumab (CD14152) on the pharmacokinetics (PK) of a drug "cocktail" representative of CYP450 (CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4/5 sensitive index substrates) in adult participants with moderate to- severe atopic dermatitis (AD).
What is the current status of trial NCT04562116?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2021-12-08. Estimated completion is 2023-06-07.
What interventions are being tested in trial NCT04562116?
The interventions under investigation include: Nemolizumab (DRUG), CYP 450 Substrates (DRUG).
Who is sponsoring clinical trial NCT04562116?
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 NCT04562116's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 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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