Rocatinlimab for Eczema

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Amgen

No Placebo Group

Trial Summary

What is the purpose of this trial?The primary objective of the study is to evaluate the pharmacokinetics (PK) of multiple cytochrome P450 (CYP450) substrates alone and in combination with rocatinlimab in participants with moderate to severe atopic dermatitis (AD).

Eligibility Criteria

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.

Inclusion Criteria

Investigator's Global Assessment (IGA) score ≥3 at screening and Check-in

Provide signed informed consent

Skin treatments haven't worked for me in the past 6 months.

+4 more

Exclusion Criteria

Consumption of specific food items and/or beverages within 1 week prior to Check-in

Presence of specific lab abnormalities at screening or Check-in

Positive hepatitis B or hepatitis C panel and/or positive human immunodeficiency virus test at screening

+16 more

Participant Groups

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.

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.