Clinical trial · Interventional
Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis
A Phase 2, Randomized, Double-blind, Placebo-controlled Study To Evaluate Safety And Efficacy Of Pf-04965842 In Subjects With Moderate To Severe Psoriasis
NCT02201524CI-TRIAL-00024160terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated 26 June 2015 due to changes in the drug development portfolio. This study was not terminated for reasons of safety and/or efficacy
Summary
Brief summary (as posted)
Study B7451005 is a Phase 2 study which will assess the efficacy and safety of PF-04965842 in patients with moderate to severe psoriasis. The study will include three PF-04965842 groups (200 mg daily, 400 mg daily and 200 mg twice daily) and a placebo group. The treatment period will be 4 weeks in duration and will be followed up by a 4 week follow up period.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Plaque Psoriasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-04965842 | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- 200mg of PF-04965842 twice daily
- interventionNames
- Drug: PF-04965842
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- 400mg of PF-04965842 once daily
- interventionNames
- Drug: PF-04965842
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
- 200mg of PF-04965842 once daily
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose. 2. Have plaque type psoriasis covering at least 15% of total BSA at Day 1 (at the time of the first study dose). 3. Have a PASI score of 12 or greater at Day 1 (at the time of the first study dose). 4. Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment). Exclusion Criteria: 1. Currently have non plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis. 2. 3\. Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium. 3. Have received any of the following treatment regimens specified in the timeframes outlined below: Within 9 months of first dose of study drug: • Ustekinumab (Stelara). Within 12 weeks of first dose of study drug: • Any experimental therapy for psoriasis or rheumatoid arthritis. Within 4 8 weeks of first dose of study drug: * Biologic therapies for psoriasis have discontinuation periods determined from approximately 5x half life of the respective biologic: * 4 weeks: etanercept (Enbrel). * 8 weeks: infliximab (Remicade), adalimumab (Humira). Within 4 weeks of first dose of study drug: * Systemic treatments other than biologics that could affect psoriasis (eg, oral or injectable corticosteroids, retinoids, methotrexate, cyclosporine, fumaric acid derivatives, sulfasalazine, hydroxycarbamide (hydroxyurea), azathioprine). * Phototherapy and psoralen plus ultraviolet A therapy (PUVA). * Other - intramuscular gold, immunization with any live virus vaccination (eg, FluMist), herbal medications. Within 2 weeks of first dose of study drug: * Topical treatments that could affect psoriasis (eg, corticosteroids, tars, keratolytics, anthralin, vitamin D analogs, and retinoids). * Phototherapy with ultraviolet B (UVB) (narrowband or broadband).
References
Publications (3)
- DERIVEDArmstrong AW, Alexis AF, Blauvelt A, Silverberg JI, Feeney C, Levenberg M, Chan G, Zhang F, Fostvedt L. Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1849-1861. doi: 10.1007/s13555-024-01183-3. Epub 2024 Jun 19. PMID 38896380
- DERIVEDWojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population pharmacokinetic-pharmacodynamic modelling of platelet time-courses following administration of abrocitinib. Br J Clin Pharmacol. 2022 Aug;88(8):3856-3871. doi: 10.1111/bcp.15334. Epub 2022 Apr 11. PMID 35342978
- DERIVEDWojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21. PMID 35061234