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

NCT05891119 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 20210147
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 7

Brief Summary

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).

Conditions

Atopic Dermatitis

Keywords

Moderate to Severe Atopic Dermatitis; Rocatinlimab; AMG 451; Cytochrome P450 (CYP450) Substrates

Outcome Measures

Primary Outcomes (6)

• Maximum Observed Serum Concentration (Cmax) of CYP450 Substrate

  Day 1

• Cmax of CYP450 Substrate

  Day 120

• Area Under the Serum Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of CYP450 Substrate

  Day 1

• AUClast of CYP450 Substrate

  Day 120

• Area Under the Serum Concentration-Time Curve from Time Zero to Infinity (AUCinf) of CYP450 Substrate

  Day 1

• AUCinf of CYP450 Substrate

  Day 120

Secondary Outcomes (3)

• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  Up to Day 238

• Number of Participants with Serious Adverse Events (SAEs)

  Up to Day 238

• Number of Participants with Anti-rocatinlimab Antibody Formation

  Up to Day 238

Study Arms (1)

Rocatinlimab and CYP450 Substrates

EXPERIMENTAL

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.

Dietary Supplement: Caffeine; Drug: Metoprolol; Drug: Midazolam; Drug: Warfarin; Dietary Supplement: Vitamin K; Drug: Omeprazole; Drug: Rocatinlimab

Interventions

Caffeine DIETARY_SUPPLEMENT

Oral liquid

Also known as: Caffeine Citrate

Rocatinlimab and CYP450 Substrates

Metoprolol DRUG

Oral tablet

Also known as: Metoprolol Tartrate

Rocatinlimab and CYP450 Substrates

Midazolam DRUG

Oral liquid

Also known as: Midazolam Hydrochloride

Rocatinlimab and CYP450 Substrates

Warfarin DRUG

Oral tablet

Also known as: Warfarin Sodium

Rocatinlimab and CYP450 Substrates

Vitamin K DIETARY_SUPPLEMENT

Oral tablet

Rocatinlimab and CYP450 Substrates

Omeprazole DRUG

Oral capsule

Also known as: Omeprazole magnesium

Rocatinlimab and CYP450 Substrates

Rocatinlimab DRUG

Subcutaneous injection

Also known as: AMG 451

Rocatinlimab and CYP450 Substrates

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Amgen: lead

Study Sites (7)

Velocity Clinical Research, North Hollywood

North Hollywood, California, 91606-1570, United States

Location

Accel Research Sites (ACR)

DeLand, Florida, 32720-3134, United States

Location

Direct Helpers Research Center (DHRC)

Hialeah, Florida, 33012-3618, United States

Location

Axis Clinicals, LCC

Dilworth, Minnesota, 56529, United States

Location

DermDox Dermatology Centers, PC - Camp Hill

Camp Hill, Pennsylvania, 17011, United States

Location

Velocity Clinical Research -Spartanburg

Spartanburg, South Carolina, 29303-4225, United States

Location

DermDox Dermatology Centers, PC - Sugarloaf

Nashville, Tennessee, 37203-1632, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Caffeine; caffeine citrate; Metoprolol; Midazolam; Warfarin; Vitamin K; Omeprazole

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzodiazepines; Benzazepines; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phytol; Diterpenes; Terpenes; Polycyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Benzimidazoles

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 6, 2023
• Study Start: June 3, 2023
• Primary Completion: August 28, 2024
• Study Completion: February 12, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (7)