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

Purpose

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.

Condition	Intervention	Phase
Psoriasis	Drug: CP-690,550 Drug: Placebo/CP-690,550	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Physician Global Assessment (PGA) response, ie, the proportion of participants achieving a PGA of "clear" or "almost clear" at week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Psoriasis Area and Severity Index 75 (PASI75) response, ie, the proportion of participants achieving at least a 75% reduction in Psoriasis Area and Severity Index relative to baseline at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in Body Surface Area (BSA) at Week 16 [ Time Frame: baseline, Week 16 ] [ Designated as safety issue: No ]
Psoriasis Area and Severity Index 90 (PASI90) response [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 [ Time Frame: baseline, Week 16 ] [ Designated as safety issue: No ]
Physician Global Assessment (PGA) response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Psoriasis Area and Severity Index 75 (PASI75) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Change from baseline in Dermatology Life Quality Index (DLQI) total score at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
Percent change from baseline in Nail Psoriasis Severity Index (NAPSI) at week 16 in participants with nail psoriasis at baseline [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
Proportion of participants maintaining Physicians Global (PGA) response at week 52 among participants achieving PGA response at Week 16 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Proportion of participants maintaining Psoriasis Area Severity Index 75 (PASI75) response at Week 52 among participants achieving PASI75 response at week 16 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Proportion of participants maintaining Psoriasis Area Index 90 (PASI90) response at week 52 among participants achieving PASI90 response at week 16 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Time to Physicians Global Assessment (PGA) response [ Time Frame: Weeks 2,4,8,12,16 ] [ Designated as safety issue: No ]
Time to Psoriasis Area and Severity Index 75(PASI75) response [ Time Frame: Weeks 2,4,8,12,16 ] [ Designated as safety issue: No ]
Time to Psoriasis Area and Severity Index 50 (PASI50) response [ Time Frame: Weeks 2,4,8,12,16 ] [ Designated as safety issue: No ]
Physicians Global Assessment (PGA)response [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
Proportion of participants in each Physicians Global Assessment (PGA) category [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
Psoriasis Aera and Severity Index 75 (PASI75) response [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
Actual and change from baseline in Psoriasis Area and Severity Index (PASI) and component scores [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
Percent change from baseline in Physicians Area and Severity Index (PASI) [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
Actual and percent change from baseline in Body Surface Area (BSA) [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
Proportion of participants achieving at least a 50% and 90% reduction in PASI relative to baseline (PASI50 and PASI90, respectively) [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
Proportion of participants with a PASI score > or equal to 125% of the baseline PASI score at any time point through Week 52 [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
Actual and change from baseline Nail Psoriasis Severity Index (NAPSI) and number of affected nails in participants with nail psoriasis at baseline [ Time Frame: Baseline, Weeks 8,16,20,28,40,52 ] [ Designated as safety issue: No ]
Percent change from baseline in Nail Psoriasis Severity Index (NAPSI) in participants with nail psoriasis at baseline [ Time Frame: Weeks 8,16,20,28,40,52 ] [ Designated as safety issue: No ]
Proportion of participants achieving at least 75% and 100% reduction in Nail Psoriasis Severity Index (NAPSI) relative to baseline (NAPSI75 and NAPSI100, respectively) in subjects with nail psoriasis at baseline [ Time Frame: Weeks 8,16,20,28,40,52 ] [ Designated as safety issue: No ]
Actual and change from baseline in Itch Severity Item (ISI) score [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
Actual and change from baseline in the Dermatology Life Quality Index (DLQI) score [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Weeks 4,16,28,52 ] [ Designated as safety issue: No ]
Short Form 36 Health Survey (SF 36) - Version 2, Acute [ Time Frame: Weeks 16,28,52 ] [ Designated as safety issue: No ]
Work Limitation Questionnaire (WLQ) [ Time Frame: Weeks 4,16,28,52 ] [ Designated as safety issue: No ]
Patient Global Assessment (PtGA) [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
Patient Satisfaction with Study Medication (PSSM) [ Time Frame: Weeks 16,28,52 ] [ Designated as safety issue: No ]
Joint Pain Assessment (JPA) [ Time Frame: Weeks 4,16,28,52 ] [ Designated as safety issue: No ]
Euro Qol 5 Dimensions (EQ-5D) [ Time Frame: Weeks 16,28,40,52 ] [ Designated as safety issue: No ]
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) [ Time Frame: Weeks 16,28,40,52 ] [ Designated as safety issue: No ]
Family Dermatology Life Quality Index (FDLQI) [ Time Frame: Weeks 16,52 ] [ Designated as safety issue: No ]

Enrollment:	920
Study Start Date:	March 2011
Study Completion Date:	March 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Active Treatment 10 mg BID	Drug: CP-690,550 10 mg oral BID, Continuous treatment for 52 Weeks
Experimental: ActiveTreatment 5 mg BID	Drug: CP-690,550 5 mg oral BID, Continuous treatment for 52 Weeks
Placebo Comparator: Placebo Treatment	Drug: Placebo/CP-690,550 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) Drug: Placebo/CP-690,550 0 mg oral BID, Continuous treatment for 16 Weeks; 5 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276639

Show 74 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01276639 History of Changes
Other Study ID Numbers:	A3921078
Study First Received:	January 12, 2011
Last Updated:	May 13, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

chronic
severe
moderate
treatment
safety

efficacy
CP-690
550
Plaque Psoriasis
Psoriasis Vulgaris

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013