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NCT01096862
A Study to Explore Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Psoriasis
Phase 2 trial testing peficitinib in Psoriasis in 124 participants. Completed in 27 July 2011.
27 July 2011
Quick facts
| Lead sponsor | Astellas Pharma Inc |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 124 |
| Start date | 23 March 2010 |
| Primary completion | 27 July 2011 |
| Estimated completion | 27 July 2011 |
| Sites | 11 locations across United States |
Drugs / interventions tested
- peficitinib — full drug profile →
- Placebo
Conditions studied
- Psoriasis — all drugs for Psoriasis →
Sponsor
Astellas Pharma Inc — full company profile →
Who can join
18 and older, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to explore the efficacy and safety of multiple, escalating doses of ASP015K when compared to placebo in subjects with moderate to severe plaque psoriasis.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Janus kinase-targeting therapies in rheumatology: a mechanisms-based approach.
Tanaka Y, Luo Y, O'Shea JJ, Nakayamada S. · · 2022 · cited 329× · PMID 34987201 · DOI 10.1038/s41584-021-00726-8 -
Emerging Topical and Systemic JAK Inhibitors in Dermatology.
Solimani F, Meier K, Ghoreschi K. · · 2019 · cited 199× · PMID 31849996 · DOI 10.3389/fimmu.2019.02847 -
Targeting the Janus Kinase Family in Autoimmune Skin Diseases.
Howell MD, Kuo FI, Smith PA. · · 2019 · cited 180× · PMID 31649667 · DOI 10.3389/fimmu.2019.02342 -
Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis.
Mease PJ, Armstrong AW. · · 2014 · cited 167× · PMID 24566842 · DOI 10.1007/s40265-014-0191-y -
Selective JAKinibs: Prospects in Inflammatory and Autoimmune Diseases.
T Virtanen A, Haikarainen T, Raivola J, Silvennoinen O. · · 2019 · cited 164× · PMID 30701418 · DOI 10.1007/s40259-019-00333-w -
JAK inhibitors: treatment efficacy and safety profile in patients with psoriasis.
Hsu L, Armstrong AW. · · 2014 · cited 88× · PMID 24883332 · DOI 10.1155/2014/283617 -
Systemic Treatment of Psoriasis with JAK Inhibitors: A Review.
Kvist-Hansen A, Hansen PR, Skov L. · · 2020 · cited 84× · PMID 31893355 · DOI 10.1007/s13555-019-00347-w -
The Role of Janus Kinase Signaling in Graft-Versus-Host Disease and Graft Versus Leukemia.
Schroeder MA, Choi J, Staser K, DiPersio JF. · · 2018 · cited 82× · PMID 29289756 · DOI 10.1016/j.bbmt.2017.12.797
Verify or expand the search:
- PubMed search for NCT01096862
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of peficitinib
Trials testing the same drug.
- NCT04143477 — A Study to Evaluate the Pharmacokinetics and Safety of ASP015K in Healthy Chinese Subjects · Phase 1 · completed
- NCT02760342 — A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Metformin · Phase 1 · completed
- NCT02531191 — Bioequivalence Evaluation of a New and Current Tablet of ASP015K · Phase 1 · completed
- NCT01711814 — A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rh · Phase 2 · completed
- NCT01554696 — A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had · Phase 2 · completed
Other recruiting trials for Psoriasis
Currently open trials in the same condition.
- NCT07471048 — A Study to Evaluate the Impact of a Magnolia Officinalis Dietary Supplement on Immune Biomarkers in Subjects With Psoria · NA · recruiting
- NCT07449234 — A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis · recruiting
- NCT07234838 — Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO) · recruiting
- NCT07194200 — Safety and Efficacy of Lactobacillus Plantarum for Psoriasis: A Randomized Double-Blind Placebo-Controlled Trial · Phase 2 · recruiting
- NCT07250997 — PALLAS Laser for Skin Diseases · NA · recruiting
Other Astellas Pharma Inc trials
Trials by the same sponsor.
- NCT07318714 — A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke · Phase 1, PHASE2 · recruiting
- NCT07094204 — A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors · Phase 1 · recruiting
- NCT06970665 — A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Ma · Phase 4 · recruiting
- NCT06364696 — A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors · Phase 1 · active not recruiting
- NCT06206421 — A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause · Phase 3 · completed
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 NCT01096862 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma Inc
- Last refreshed: 21 October 2024
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/NCT01096862.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing