Study to Investigate the Effect of Rocatinlimab (AMG 451) on the Pharmacokinetics of Multiple Cytochrome P450 (CYP450) Substrates in Participants With Moderate to Severe Atopic Dermatitis

Completed · Early Phase 1

Conditions studied: Atopic Dermatitis

In brief

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).

Key facts

Study ID

NCT05891119

Run by

Amgen

People needed

21

Starts

2023-06-03

Expected to finish

2025-02-12

Last updated by the study team

2025-12-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participant, aged 18 to 65 years
• Diagnosis of AD, defined as diagnosis of AD for at least 6 months before signing of informed consent
• Eczema Area Severity Index score ≥8 at the screening and Check-in
• Investigator's Global Assessment (IGA) score ≥3 (on the 0 to 4 IGA scale) at screening and Check-in
• ≥7% Body Surface Area of AD involvement at initial screening
• History of inadequate response to topical corticosteroid therapy (TCS) of medium to higher potency within 6 months (with or without topical calcineurin inhibitors [TCI]) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
• Provide signed informed consent

You may not qualify if…

• Have previously completed or withdrawn from this study or any other study investigating rocatinlimab or have previously received a dose of an investigational drug within the past 90 days or 5 half-lives, whichever is longer, prior to Check-in
• The use of any of the following treatments within 4 weeks before Check-in:
• Systemic corticosteroids
• Immunosuppressive/immunomodulating drugs
• The use of any of the following treatments within one week before Check-in:
• Topical corticosteroids of any super-high potency
• Topical phosphodiesterase 4 (PDE4) inhibitors
• Phototherapy
• Administration, within 14 days before baseline or within a period of 5 times the elimination half-life of the medication before baseline, whichever is longer, of any medication that is a known inducer or inhibitor of either one or more of the following cytochrome P450 (CYP) enzymes: CYP3A4, CYP2C19, CYP2C9, CYP2D6, and CYP1A2. Participants who are on any of these medications at the time of screening and cannot be safely taken off these medications will be excluded from the study.
• Any contraindication to one or more of the following drugs, according to the applicable labeling:
• Midazolam
• Omeprazole
• Warfarin (and Vitamin K)
• Caffeine
• Metoprolol
• Consumption of any 1 or more of the following food items and/or beverages within 1 week prior to Check-in:
• Grapefruit or grapefruit juice, apple or apple juice, orange or orange juice, lemons or lemon juice, limes or lime juice
• Vegetables from the mustard green family (eg, broccoli)
• Charbroiled meats
• Caffeinated beverages, foods or drugs containing caffeine
• History of alcoholism or drug/chemical abuse within 1 year prior to Check-in or regular alcohol consumption (>14 units per week for males and >7 units for females)
• Smoke more than 10 cigarettes or use the equivalent (as determined by site staff) tobacco- or nicotine-containing products per day and unwilling to adhere to smoking restrictions.
• Poor metabolizers for CYP2C9, CYP2C19, or CYP2D6 based on genotyping
• Presence of any one or more of the following lab abnormalities at screening or Check-in:
• Platelet count <100k /µL, international normalized ratio (INR)>1.2, prothrombin time (PT)>13.5 sec or partial thromboplastin time (PTT)>35 sec

Where it is running

• Velocity Clinical Research, North Hollywood — North Hollywood, California, United States
• Accel Research Sites (ACR) — DeLand, Florida, United States
• Direct Helpers Research Center (DHRC) — Hialeah, Florida, United States
• Axis Clinicals, LCC — Dilworth, Minnesota, United States
• DermDox Dermatology Centers, PC - Camp Hill — Camp Hill, Pennsylvania, United States
• Velocity Clinical Research -Spartanburg — Spartanburg, South Carolina, United States
• DermDox Dermatology Centers, PC - Sugarloaf — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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