A Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Participants With Moderate-to-Severe Atopic Dermatitis

Part of paid clinical trials in North Hollywood, California.

Sponsor
Galderma R&D
Study ID
NCT04562116
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nemolizumab — DRUG
    Nemolizumab 30 mg will be administered as SC injections.
  • CYP 450 Substrates — DRUG
    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.

Study Details

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).

Key Dates

Start date
Dec 8, 2021
Status verified
Nov 2024
Primary completion
Jun 7, 2023
Completion
Jun 7, 2023

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: CYP 450 Substrates plus Nemolizumab
    Participants will receive 1 single oral dose of selected, commercially available, cytochrome P450 substrates (CYP450-S) on Day 1 and after a 1-week washout period, participants will receive a 60 milligram (mg) loading dose of nemolizumab via 2 consecutive subcutaneous (SC) 30-mg injections at the Week 1 visit, followed by a single 30-mg injection once in every 4 weeks (Q4W) at Week 5 and Week 9. Participants will receive a second oral dosing of CYP450-S at Week 10.

Primary Outcome Measure

Change in Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment [ Time Frame: Baseline (before nemolizumab injection, at Week 0) and Week 10 (after nemolizumab injection): Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose ]

Locations (5)

FacilityCityStateZIPSite coordinators
8894 Galderma Investigational SiteNorth HollywoodCalifornia91606-
9954 Galderma Investigational SiteHallandaleFlorida33009-
9923 Galderma Investigational SiteMiamiFlorida33147-
8030 Galderma Investigational SiteRaleighNorth Carolina27612-
8076 Galderma Investigational SiteAustinTexas78759-

Find similar trials in North Hollywood, CA

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
8894 Galderma Investigational Site· North Hollywood, CA9954 Galderma Investigational Site· Hallandale, FL9923 Galderma Investigational Site· Miami, FL8030 Galderma Investigational Site· Raleigh, NC8076 Galderma Investigational Site· Austin, TX

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