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Eczema drug interaction study: will rocatinlimab change how other meds work?

NCT ID NCT05891119

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-phase study looked at how rocatinlimab, an experimental drug for eczema, affects the way the body processes several common medications (caffeine, metoprolol, midazolam, warfarin, omeprazole). 21 adults with moderate to severe eczema took these drugs with and without rocatinlimab to measure any changes. The goal was to gather safety and interaction data, not to treat the eczema itself.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rocatinlimab (AMG 451)
What this could lead to
If successful, this study could help doctors understand how rocatinlimab interacts with other medications, guiding safer use in future eczema treatments.
What could go wrong
This is a very early, small study (21 people) focused on drug interactions, not on treating eczema. It may not lead to any new treatment or change in care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

21 people

The number who actually took part.

Started

Jun 2023

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female participant, aged 18 to 65 years 2. Diagnosis of AD, defined as diagnosis of AD for at least 6 months before signing of informed consent 3. Eczema Area Severity Index score ≥8 at the screening and Check-in 4. Investigator's Global Assessment (IGA) score ≥3 (on the 0 to 4 IGA scale) at screening and Check-in 5. ≥7% Body Surface Area of AD involvement at initial screening 6. 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). 7. Provide signed informed consent Exclusion Criteria: 1. 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 2. The use of any of the following treatments within 4 weeks before Check-in: * Systemic corticosteroids * Immunosuppressive/immunomodulating drugs 3. The use of any of the following treatments within one week before Check-in: 1. Topical corticosteroids of any super-high potency 2. Topical phosphodiesterase 4 (PDE4) inhibitors 3. Phototherapy 4. 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. 5. Any contraindication to one or more of the following drugs, according to the applicable labeling: * Midazolam * Omeprazole * Warfarin (and Vitamin K) * Caffeine * Metoprolol 6. 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 7. 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) 8. 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. 9. Poor metabolizers for CYP2C9, CYP2C19, or CYP2D6 based on genotyping 10. 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 11. Active, chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals at screening or Check-in 12. Superficial skin infections, including tinea infections, within 2 weeks prior to Check-in 13. History of acquired, common variable, primary or secondary immunodeficiency 14. 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. 15. 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) 16. 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. 17. 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 18. 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 19. Unwilling to adhere to contraceptive requirements through 18 weeks after the end of study visit 20. 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Accel Research Sites (ACR)

    DeLand, Florida, 32720-3134, United States

  • Axis Clinicals, LCC

    Dilworth, Minnesota, 56529, United States

  • DermDox Dermatology Centers, PC - Camp Hill

    Camp Hill, Pennsylvania, 17011, United States

  • DermDox Dermatology Centers, PC - Sugarloaf

    Nashville, Tennessee, 37203-1632, United States

  • Direct Helpers Research Center (DHRC)

    Hialeah, Florida, 33012-3618, United States

  • Velocity Clinical Research -Spartanburg

    Spartanburg, South Carolina, 29303-4225, United States

  • Velocity Clinical Research, North Hollywood

    North Hollywood, California, 91606-1570, United States

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