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Atopic DermatitisEarly Phase 1NCT05891119

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

A Early Phase 1 study testing Caffeine, Metoprolol and Midazolam in people with Atopic Dermatitis, run by Amgen at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Caffeine, Metoprolol and Midazolam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
7 sitesUnited States
Study dates
3 Jun 2023to 12 Feb 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Have previously completed or withdrawn from this study or any other study investigating rocatinlimab or have previously received a dose of an investigational drug within the past 90 days or 5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
Show all 35Show fewer
  • 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
  • Active, chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals at screening or Check-in
  • Superficial skin infections, including tinea infections, within 2 weeks prior to Check-in
  • History of acquired, common variable, primary or secondary immunodeficiency
  • Positive hepatitis B or hepatitis C panel and/or positive human immunodeficiency virus test, at screening as per Center for Disease Control interpretation. Participants whose hepatitis B and C results are compatible with prior immunity (resulting from inoculation) may be included. Participants with positive hepatitis B core antibody will be excluded.
  • Active malignancy, multiple myeloma, myeloproliferative or lymphoproliferative disorder, or a history of any of these conditions within 5 years prior to informed consent (except curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma)
  • Diagnosis of a helminth parasitic infection within 6 months prior to screening that had not been treated with or failed to respond to standard of care therapy.
  • History of suicidal ideation (thoughts), suicide-related behaviors, suicide attempt(s), depression or major psychiatric illness within 6 months prior to signing the informed consent
  • Female participants who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study through 18 weeks after the end of study visit
  • Unwilling to adhere to contraceptive requirements through 18 weeks after the end of study visit
  • Male participant with a pregnant partner or partner planning to become pregnant while the participant is on study through 18 weeks after the end of study visit

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • DermDox Dermatology Centers, PC - Camp Hill

    Camp Hill, Pennsylvania, 17011

  • Accel Research Sites (ACR)

    DeLand, Florida, 32720-3134

  • Axis Clinicals, LCC

    Dilworth, Minnesota, 56529

  • Direct Helpers Research Center (DHRC)

    Hialeah, Florida, 33012-3618

  • DermDox Dermatology Centers, PC - Sugarloaf

    Nashville, Tennessee, 37203-1632

  • Velocity Clinical Research, North Hollywood

    North Hollywood, California, 91606-1570

  • Velocity Clinical Research -Spartanburg

    Spartanburg, South Carolina, 29303-4225

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Drug-Drug Interaction Study to Investigate the Effect of Rocatinlimab (AMG 451) on the Pharmacokinetics of Multiple CYP450 Substrates in Patients With Moderate to Severe Atopic Dermatitis

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).

Being tested
Caffeine, Metoprolol, Midazolam, Warfarin, Vitamin K
Keywords
Moderate to Severe Atopic Dermatitis, Rocatinlimab, AMG 451, Cytochrome P450 (CYP450) Substrates
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CaffeineDietary supplement

    Also called Caffeine Citrate

    Oral liquid

  • MetoprololDrug

    Also called Metoprolol Tartrate

    Oral tablet

  • MidazolamDrug

    Also called Midazolam Hydrochloride

    Oral liquid

  • WarfarinDrug

    Also called Warfarin Sodium

    Oral tablet

  • Vitamin KDietary supplement

    Oral tablet

  • OmeprazoleDrug

    Also called Omeprazole magnesium

    Oral capsule

  • RocatinlimabDrug

    Also called AMG 451

    Subcutaneous injection

Study groups in NCT05891119
Study groupRoleWhat they receive
Rocatinlimab and CYP450 SubstratesExperimentalA 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.
Receives: Dietary Supplement: Caffeine; Drug: Metoprolol; Drug: Midazolam; Drug: Warfarin; Dietary Supplement: Vitamin K; Drug: Omeprazole; Drug: Rocatinlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Serum Concentration (Cmax) of CYP450 Substrate

    Measured: Day 1

  2. Cmax of CYP450 Substrate

    Measured: Day 120

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

    Measured: Day 1

  4. AUClast of CYP450 Substrate

    Measured: Day 120

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

    Measured: Day 1

  6. AUCinf of CYP450 Substrate

    Measured: Day 120

Secondary outcomes (3)

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

    Measured: Up to Day 238

  2. Number of Participants with Serious Adverse Events (SAEs)

    Measured: Up to Day 238

  3. Number of Participants with Anti-rocatinlimab Antibody Formation

    Measured: Up to Day 238

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2023
  2. Study start3 Jun 2023
  3. Primary completion28 Aug 2024
  4. Study completion12 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05891119
Sponsor's protocol ID
20210147
Status last verified
Dec 2025
First submitted
26 May 2023
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Caffeine, Metoprolol and Midazolam in people with Atopic Dermatitis, run by Amgen at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Serum Concentration (Cmax) of CYP450 Substrate (time frame: Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05891119.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

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