CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
Nemolizumab +1 moredrug
Likely dose
Nemolizumab 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04562116
NCT04562116Phase 2Completed
CompareCT.gov

An Open-label Drug-Drug Interaction Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Subjects With Moderate-to-Severe Atopic Dermatitis

Galderma R&D·interventional·Posted Sep 24, 2020·Updated Dec 5, 2024

In Brief

A Phase 2 clinical trial evaluating Nemolizumab and CYP 450 Substrates for Atopic Dermatitis. Completed, enrolled 17 participants across 6 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesBulgaria, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedSep 24, 2020
Enrollment StartDec 8, 2021
Primary CompletionJun 7, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.8 years ago

Interventions

Nemolizumabdrug

Nemolizumab 30 mg will be administered as SC injections.

CYP 450 Substratesdrug

CYP substrates (Caffeine, Warfarin Sodium, Midazolam, Omeprazole, and Metoprolol Tartrate) will administered orally at Week 0 (Day 1) and Week 10 as per the commercially available prescribing information.