A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis

NCT01276639 | Completed Phase 3 Results DMC

• 1 other identifier: A3921078
• Study Type: interventional
• Target: 901
• Locations: 11 countries
• Sites: 74

Brief Summary

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.

Conditions

Psoriasis

Keywords

Xeljanz; tofacitinib; chronic; Pruritus; Itch; DLQI; severe; moderate; treatment; safety; efficacy; CP-690,550; Plaque Psoriasis; Psoriasis Vulgaris; Jax-inhibitor; Oral Treatment

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis 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 With a Psoriasis Area and Severity Index 75 (PASI 75) Response 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. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.

  Week 16

Secondary Outcomes (51)

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

  Baseline, Week 16

• Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16

  Week 16

• Dermatology Life Quality Index (DLQI) Total Score

  Baseline

• Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16

  Week 4, 16

• Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4

  Week 4

Study Arms (3)

Active Treatment 10 mg BID

EXPERIMENTAL

Drug: CP-690,550

ActiveTreatment 5 mg BID

EXPERIMENTAL

Drug: CP-690,550

Placebo Treatment

PLACEBO COMPARATOR

Drug: Placebo/CP-690,550

Interventions

CP-690,550 DRUG

10 mg oral BID, Continuous treatment for 52 Weeks

Active Treatment 10 mg BID

Placebo/CP-690,550 DRUG

0 mg oral BID, Continuous treatment for 16 Weeks; 10 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)

Placebo Treatment

Eligibility Criteria

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

You may qualify if:

• Are 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering as least 10%of body surface area
• a Psoriasis Area and Severity Index (PASI) score of 12 and are considered to be candidates for systemic or light therapy
• No evidence of active or latent tuberculosis

You may not qualify if:

• Non-plaque or drug induced forms of psoriasis
• cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB)
• any uncontrolled significant medical condition

Sponsors & Collaborators

• Pfizer: lead

Study Sites (74)

Radiant Research, Inc.

Birmingham, Alabama, 35209, United States

Location

University of California, Irvine - Dermatology Research

Irvine, California, 92697, United States

Location

Skin Surgery Medical Group, Inc.

San Diego, California, 92117, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Cherry Creek Research, Inc.

Denver, Colorado, 80209, United States

Location

The Savin Center, P.C.

New Haven, Connecticut, 06511, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Academic Alliance in Dermatology

Tampa, Florida, 33609, United States

Location

Atlanta Dermatology, Vein & Research Center, P.C.

Alpharetta, Georgia, 30022, United States

Location

Peachtree Dermatology Associates Research Center

Atlanta, Georgia, 30327, United States

Location

MedaPhase Inc.

Newnan, Georgia, 30263, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital - Clinical Unit for Research Trials and Outcomes in Skin

Boston, Massachusetts, 02114, United States

Location

Skin Specialists, P.C.

Omaha, Nebraska, 68144, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Skin Search of Rochester, Inc.

Rochester, New York, 14623, United States

Location

Raleigh Radiology Blue Ridge

Raleigh, North Carolina, 27612, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

Baker Allergy, Asthma and Dermatology Research Center, LLC

Lake Oswego, Oregon, 97035, United States

Location

University of Pittsburgh Medical Center - Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

Dermatology Associates of Knoxville, PC

Knoxville, Tennessee, 37917, United States

Location

Modern Research Associates, PLLC

Dallas, Texas, 75231, United States

Location

Menter Dermatology Research Institute

Dallas, Texas, 75246, United States

Location

Center for Clinical Studies

Houston, Texas, 77030, United States

Location

Rockwood Dermatology Center

Spokane, Washington, 99202, United States

Location

Rockwood Research Center

Spokane, Washington, 99202, United States

Location

Wenatchee Valley Medical Center - Clinical Research Department

Wenatchee, Washington, 98801, United States

Location

Madison Skin and Research, Inc.

Madison, Wisconsin, 53719, United States

Location

Dermadvances Research

Winnipeg, Manitoba, R3C 1R4, Canada

Location

Dr. Zohair Tomi PMC Inc.

St. John's, Newfoundland and Labrador, A1B 4S8, Canada

Location

Eastern Canada Cutaneous Research Associates Ltd.

Halifax, Nova Scotia, B3H 1Z4, Canada

Location

Ultranova Skincare

Barrie, Ontario, L4M 6L2, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1A8, Canada

Location

North Bay Dermatology Centre

North Bay, Ontario, P1B 3Z7, Canada

Location

Oakville Dermatology Laser Centre

Oakville, Ontario, L6J 7W5, Canada

Location

Office of Dr. Michael Robern

Ottawa, Ontario, K2G 6E2, Canada

Location

K.Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1C4, Canada

Location

CRCMRGilbert Inc., Centre de Dermatologie Maizerets

Québec, Quebec, G1J 1X7, Canada

Location

Centro de Reumatologia y Ortopedia

Barranquilla, Atlántico, 0000, Colombia

Location

Riesgo de Fractura S.A

Bogot, Cundinamarca, 0000, Colombia

Location

Charite - Universitaetsmedizin Berlin

Berlin, 10117, Germany

Location

Aerztehaus "Rudolf Virchow"

Berlin, 13055, Germany

Location

Klinik und Poliklinik fuer Dermatologie und Allergologie der Universitaet Bonn

Bonn, 53105, Germany

Location

Universitaetsklinik Carl Gustav Carus

Dresden, 01307, Germany

Location

Klinische Forschung Hamburg GmbH

Hamburg, 20253, Germany

Location

Universitaetsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, 19055, Germany

Location

Praxisklinik fuer Dermatologie, Allergologie und Venenheilkunde

Vechta, 49377, Germany

Location

Facharzt fuer Dermatologie und Venerologie, Allergologie

Wuppertal, 42275, Germany

Location

Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza

Kecskemét, 6000, Hungary

Location

Josa Andras Oktatokorhaz, Borgyogyaszat

Nyíregyháza, 4400, Hungary

Location

Pecsi Tudomanyegyetem/Bor-, Nemikortani es Onkodermatologiai Klinika

Pécs, 7624, Hungary

Location

Gunma University Hospital

Maebashi, Gunma, Japan

Location

JR Sapporo hospital

Sapporo, Hokkaido, Japan

Location

Kobe University Hospital

Chūōku, Kobe, Japan

Location

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Location

Social Insurance Chuo General Hospital

Shinjyuku-ku, Tokyo, Japan

Location

Centro de Dermatologia de Monterrey

Monterrey, Nuevo León, 64460, Mexico

Location

Poznanski Osrodek Medyczny

Poznan, 60-773, Poland

Location

Katedra i Klinika Chorob Skornych i Wenerycznych, Pomorski Uniwersytet Medyczny

Szczecin, 70-111, Poland

Location

Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu

Wroclaw, 50-368, Poland

Location

Oddzial Dermatologiczny

Wroclaw, 51-124, Poland

Location

Clinical Hospital Center Zvezdara

Belgrade, 11000, Serbia

Location

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 110, Taiwan

Location

Dept of Dermatology and Venerology of SI "Crimean State Medical University n.a. S.I. Georgiyevskyj"

Simferopol, Autonomous Republic of Crimea, 95006, Ukraine

Location

Dept of Dermatology, Infectious and Parasitic Skin Diseases

Kharkiv, Ukraine, 61057, Ukraine

Location

Ternopil Regional Clinical Dermatovenerologic Dispensary

Ternopil, Ukraine, 46006, Ukraine

Location

Dept of Dermatology and Venereology of National Medical University n.a. O.O. Bogomolets

Kyiv, 01032, Ukraine

Location

Related Publications (5)

• Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.

  PMID: 32816215 DERIVED

• Wolk R, Armstrong EJ, Hansen PR, Thiers B, Lan S, Tallman AM, Kaur M, Tatulych S. Effect of tofacitinib on lipid levels and lipid-related parameters in patients with moderate to severe psoriasis. J Clin Lipidol. 2017 Sep-Oct;11(5):1243-1256. doi: 10.1016/j.jacl.2017.06.012. Epub 2017 Jun 24.

  PMID: 28751001 DERIVED

• Merola JF, Elewski B, Tatulych S, Lan S, Tallman A, Kaur M. Efficacy of tofacitinib for the treatment of nail psoriasis: Two 52-week, randomized, controlled phase 3 studies in patients with moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2017 Jul;77(1):79-87.e1. doi: 10.1016/j.jaad.2017.01.053. Epub 2017 Apr 7.

  PMID: 28396102 DERIVED

• Tan H, Valdez H, Griffins CE, Mrowietz U, Tallman A, Wolk R, Gordon K. Early clinical response to tofacitinib treatment as a predictor of subsequent efficacy: Results from two phase 3 studies of patients with moderate-to-severe plaque psoriasis. J Dermatolog Treat. 2017 Feb;28(1):3-7. doi: 10.1080/09546634.2016.1214671. Epub 2016 Aug 18.

  PMID: 27538247 DERIVED

• Papp KA, Menter MA, Abe M, Elewski B, Feldman SR, Gottlieb AB, Langley R, Luger T, Thaci D, Buonanno M, Gupta P, Proulx J, Lan S, Wolk R; OPT Pivotal 1 and OPT Pivotal 2 investigators. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: results from two randomized, placebo-controlled, phase III trials. Br J Dermatol. 2015 Oct;173(4):949-61. doi: 10.1111/bjd.14018.

  PMID: 26149717 DERIVED

Related Links

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

MeSH Terms

Conditions

Psoriasis; Bronchiolitis Obliterans Syndrome; Pruritus; Lymphoma, Follicular

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System 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

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: January 12, 2011
• First Posted: January 13, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: September 19, 2014
• Results First Posted: September 19, 2014

Record last verified: 2014-09

Locations

CO (2); DE (10); HU (3); TW (2); JP (5); UA (4); PL (4); ME (1); SE (1); US (32); CA (10)