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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 5 years
Awards & highlights
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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
Caffeine
2014
Completed Phase 3
~2980
Metoprolol
2006
Completed Phase 4
~3730
Midazolam
2018
Completed Phase 4
~1910
Warfarin
2017
Completed Phase 4
~248220
Vitamin K
2016
Completed Phase 4
~570
Omeprazole
2006
Completed Phase 4
~940
Rocatinlimab
2024
Completed Phase 3
~750
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Who is running the clinical trial?
AmgenLead Sponsor
1,420 Previous Clinical Trials
1,382,929 Total Patients Enrolled
MDStudy DirectorAmgen
961 Previous Clinical Trials
928,844 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My body processes some medications slowly due to my genetics.I haven't taken steroids or immune system drugs in the last 4 weeks.Skin treatments haven't worked for me in the past 6 months.I am between 18 and 65 years old.I am not currently on antibiotics or antivirals for an infection.I haven't used strong skin creams, certain skin medications, or light therapy in the last week.I have not been in a study or taken any experimental drugs recently.My partner is pregnant or plans to become pregnant during the study and up to 18 weeks after it ends.I have not had cancer or blood disorders in the last 5 years.I have been diagnosed with Alzheimer's disease for at least 6 months.Over 7% of my skin is affected by atopic dermatitis.I was diagnosed with a worm infection in the last 6 months that wasn't cured by standard treatments.I cannot take certain medications due to health risks.I am not pregnant, breastfeeding, nor planning to during and up to 18 weeks after the study.I have had a skin infection within the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Rocatinlimab and CYP450 Substrates
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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