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NCT05891119
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
EARLY_PHASE1 trial testing Caffeine in Atopic Dermatitis in 21 participants. Completed in 12 February 2025.
28 August 2024
Quick facts
| Lead sponsor | Amgen |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 21 |
| Start date | 3 June 2023 |
| Primary completion | 28 August 2024 |
| Estimated completion | 12 February 2025 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- Caffeine (caffeine) — full drug profile →
- Metoprolol (metoprolol) — full drug profile →
- Midazolam (midazolam) — full drug profile →
- Warfarin (warfarin) — full drug profile →
- Vitamin K
- Omeprazole (omeprazole) — full drug profile →
- Rocatinlimab
Conditions studied
- Atopic Dermatitis — all drugs for Atopic Dermatitis →
Sponsor
Amgen — full company profile →
Who can join
Adults 18 to 65, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05891119
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Atopic Dermatitis
Currently open trials in the same condition.
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- NCT07488065 — A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants · Phase 1 · recruiting
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Other Amgen trials
Trials by the same sponsor.
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- NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05891119 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Amgen
- Last refreshed: 23 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05891119.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing