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NCT01276639
Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Phase 3 trial testing CP-690,550 in Psoriasis in 901 participants. Completed in 1 April 2013.
1 April 2013
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 901 |
| Start date | 1 March 2011 |
| Primary completion | 1 April 2013 |
| Estimated completion | 1 April 2013 |
| Sites | 74 locations across United States, Canada, Colombia, Germany, Hungary, Japan, Mexico, Poland |
Drugs / interventions tested
- CP-690,550 — full drug profile →
- CP-690,550 — full drug profile →
- Placebo/CP-690,550 — full drug profile →
- Placebo/CP-690,550 — full drug profile →
Conditions studied
- Psoriasis — all drugs for Psoriasis →
Sponsor
Pfizer — full company profile →
Who can join
18 and older, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16
Time frame: Week 16
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded -
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16
Time frame: Week 16
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttock
Sponsor's own description
The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: results from two randomized, placebo-controlled, phase III trials.
Papp KA, Menter MA, Abe M, Elewski B, et al · · 2015 · cited 231× · PMID 26149717 · DOI 10.1111/bjd.14018 -
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 -
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
Sbidian E, Chaimani A, Garcia-Doval I, Do G, et al · · 2017 · cited 106× · PMID 29271481 · DOI 10.1002/14651858.cd011535.pub2 -
Tyrosine Kinases in Autoimmune and Inflammatory Skin Diseases.
Szilveszter KP, Németh T, Mócsai A. · · 2019 · cited 102× · PMID 31447854 · DOI 10.3389/fimmu.2019.01862 -
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 -
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
Sbidian E, Chaimani A, Afach S, Doney L, et al · · 2020 · cited 78× · PMID 31917873 · DOI 10.1002/14651858.cd011535.pub3 -
The arrival of JAK inhibitors: advancing the treatment of immune and hematologic disorders.
Furumoto Y, Gadina M. · · 2013 · cited 73× · PMID 23743669 · DOI 10.1007/s40259-013-0040-7
Verify or expand the search:
- PubMed search for NCT01276639
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CP-690,550
Trials testing the same drug.
- NCT02831855 — Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis · Phase 4 · completed
- NCT01470612 — Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis · Phase 3 · completed
- NCT01458574 — A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis · Phase 3 · completed
- NCT00678561 — Topical CP-690,550 For Chronic Plaque Psoriasis · Phase 2 · completed
- NCT01743677 — CP-690,550 Thorough QTc Study · Phase 1 · 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 Pfizer trials
Trials by the same sponsor.
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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 NCT01276639 (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 Pfizer
- Last refreshed: 18 September 2014
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/NCT01276639.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing