← Back to Search

Monoclonal Antibodies

Rocatinlimab for Eczema

Phase < 1
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 238
Awards & highlights

Study Summary

This trial tests how different drugs interact with rocatinib to treat moderate to severe eczema.

Who is the study for?
Adults aged 18-65 with moderate to severe atopic dermatitis (AD) who haven't responded well to topical corticosteroids can join. They must have a significant area of skin affected and certain severity scores. Excluded are those with immune deficiencies, recent drug abuse, specific dietary habits before check-in, or use of conflicting medications.Check my eligibility
What is being tested?
The trial is testing how the body processes common drugs when taken alone versus alongside Rocatinlimab in people with AD. It's looking at Warfarin (a blood thinner), Metoprolol (for high blood pressure), Caffeine, Midazolam (a sedative), Omeprazole (for acid reflux), and Vitamin K.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to Rocatinlimab, as well as typical side effects from the other study drugs like bleeding risks from Warfarin or drowsiness from Midazolam.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 238
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 238 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUCinf of CYP450 Substrate
AUClast of CYP450 Substrate
Area Under the Serum Concentration-Time Curve from Time Zero to Infinity (AUCinf) of CYP450 Substrate
+3 more
Secondary outcome measures
Number of Participants with Anti-rocatinlimab Antibody Formation
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Rocatinlimab and CYP450 SubstratesExperimental Treatment7 Interventions
A single oral dose of a CYP450 substrates cocktail which will include caffeine, metoprolol, midazolam, warfarin (with vitamin K), and omeprazole will be administered on Day 1. A single dose of rocatinlimab will then be administered on Days 8, 22, 36, 64, and 92. A single oral dose of CYP450 substrates cocktail in combination with a single dose of rocatinlimab will then be administered on Day 120.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midazolam
2018
Completed Phase 4
~1910
Warfarin
2017
Completed Phase 4
~248220
Caffeine
2014
Completed Phase 3
~2980
Metoprolol
2006
Completed Phase 4
~3730
Omeprazole
2006
Completed Phase 4
~940
Vitamin K
2016
Completed Phase 4
~570

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,382 Previous Clinical Trials
1,379,662 Total Patients Enrolled
MDStudy DirectorAmgen
928 Previous Clinical Trials
926,709 Total Patients Enrolled

Media Library

Rocatinlimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05891119 — Phase < 1
Atopic Dermatitis Research Study Groups: Rocatinlimab and CYP450 Substrates
Atopic Dermatitis Clinical Trial 2023: Rocatinlimab Highlights & Side Effects. Trial Name: NCT05891119 — Phase < 1
Rocatinlimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05891119 — Phase < 1
~3 spots leftby Aug 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top