A Study Evaluating The Efficacy And Safety Of CP-690,550 In Asian Subjects With Moderate To Severe Plaque Psoriasis

NCT01815424 | Completed Phase 3 Results DMC

• 1 other identifier: A3921174
• Study Type: interventional
• Target: 266
• Locations: 3 countries
• Sites: 24

Brief Summary

The primary objective of this study is to compare the efficacy of CP-690,550 (5 mg BID and 10 mg BID) versus placebo for the reduction in severity of plaque psoriasis after 16 weeks of treatment in Asian subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Conditions

Psoriasis

Keywords

Tofacitinib; CP-690; 550; Xeljanz; Jak-Inhibitor; Oral Treatment; Psoriasis vulgaris; Pruritus; Itch; DLQI; moderate; severe; chronic; plaque psoriasis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at 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 to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).

  Week 16

• Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at 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 \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75% reduction in PASI relative to Baseline.

  Week 16

Secondary Outcomes (41)

• Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16

  Baseline to Week 16

• Percentage of Participants Achieving at Least a 90% Reduction in PASI (PASI90) at Week 16

  Week 16

• Change From Baseline in DLQI Total Score at Week 16

  Baseline to Week 16

• Percentage of Participants With PGA Score of "Clear" or "Almost Clear" at Week 4

  Week 4

• Percentage of Participants Achieving PASI75 Response at Week 4

  Week 4

Other Outcomes (10)

• Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16

  Baseline to Week 16

• Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52

  Baseline to Week 52

• Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16

  Baseline to Week 16

Study Arms (3)

Placebo BID

PLACEBO COMPARATOR

Drug: placebo

5mg BID CP-690,550

EXPERIMENTAL

Drug: CP-690,550

10mg BID CP-690,550

EXPERIMENTAL

Drug: CP-690,550

Interventions

placebo DRUG

placebo BID for 16 weeks and then re-randomized into active groups

Placebo BID

CP-690,550 DRUG

CP-690,550 5mg BID for 52 weeks

5mg BID CP-690,550

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have had a diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at least 12 months prior to the first screening procedure.
• Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline (Day 1).
• Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment).

You may not qualify if:

• Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed.
• 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.
• Subjects who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA) for the study are excluded.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (24)

Dept. Of dermatology &STD, Beijing Friendship Hospital, Capital Medical University

Xicheng District, Beijing Municipality, 100050, China

Location

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Hospital of Skin Diseases, Chinese Academy of Medical Sciences

Nanjing, Jiangsu, 210042, China

Location

Department of Dermatology, The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116027, China

Location

Huashan Hospital, Fudan University/Dermatology Department

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai Changhai Hospital, Dermatology Department

Shanghai, Shanghai Municipality, 200433, China

Location

Dermatology Department, The First Affiliated Hospital, The Fourth Military Medical University

Xi’an, Shanxi, 710032, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610031, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

The First Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology and STD Dept

Hangzhou, Zhejiang, 310003, China

Location

The Second Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Peking University First Hospital / The Department of Dermatology

Beijing, 100034, China

Location

Peking University People's Hospital/Dermatology Department

Beijing, 100044, China

Location

Beijing Hospital of the Ministry of Health/Department of Dermatology

Beijing, 100730, China

Location

Peking Union Medical College Hospital/Department of Dermatology

Beijing, 100730, China

Location

Tianjin Medical University General Hospital, Dermatological Department

Tianjin, 300052, China

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Department of Dermatology,Severance Hospital, Yonsei University Health System

Seoul, 120-452, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

• Zhang J, Tsai TF, Lee MG, Zheng M, Wang G, Jin H, Gu J, Li R, Liu Q, Chen J, Tu C, Qi C, Zhu H, Ports WC, Crook T. The efficacy and safety of tofacitinib in Asian patients with moderate to severe chronic plaque psoriasis: A Phase 3, randomized, double-blind, placebo-controlled study. J Dermatol Sci. 2017 Oct;88(1):36-45. doi: 10.1016/j.jdermsci.2017.05.004. Epub 2017 May 16.

  PMID: 28558978 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Psoriasis; Pruritus; Lymphoma, Follicular; Bronchiolitis Obliterans Syndrome

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 21, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 16, 2019
• Results First Posted: March 5, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (3); TW (3); CN (18)