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
NCT ID: NCT05891119
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
21 participants
INTERVENTIONAL
2023-06-03
2025-02-12
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Rocatinlimab and CYP450 Substrates
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.
Caffeine
Oral liquid
Metoprolol
Oral tablet
Midazolam
Oral liquid
Warfarin
Oral tablet
Vitamin K
Oral tablet
Omeprazole
Oral capsule
Rocatinlimab
Subcutaneous injection
Interventions
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Caffeine
Oral liquid
Metoprolol
Oral tablet
Midazolam
Oral liquid
Warfarin
Oral tablet
Vitamin K
Oral tablet
Omeprazole
Oral capsule
Rocatinlimab
Subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20210147
Identifier Type: -
Identifier Source: org_study_id