Phase 3 N=1,101 Randomized Quadruple-blind Treatment

A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT01241591 ↗

Enrolled (actual)

1,101

Serious AEs

1.9%

Results posted

May 2014

Primary outcome: Primary: Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 — 47.11; 68.18; 66.27; 14.95 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: CP 690,550 5 mg (Drug); CP 690,550 10 mg (Drug); Etanercept 50 mg (Biological); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12	47.11; 68.18; 66.27; 14.95	—
PRIMARY Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12	39.51; 63.64; 58.81; 5.61	—
SECONDARY Percentage of Participants With a PGA Response of "Clear" or "Almost Clear" During the 12-Week Double-Blind Treatment	6.77; 10.74; 7.85; 1.87; 21.25; 35.91	—
SECONDARY Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
SECONDARY Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment	1.53; 2.75; 0.91; 0.00; 10.34; 19.81	—
SECONDARY Mean PASI Score During the 12-Week Double-Blind Treatment	23.13; 23.29; 22.73; 22.78; 18.16; 16.81	—
SECONDARY Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment	-5.03; -6.47; -5.48; -1.58; -8.83; -11.30	—
SECONDARY Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment	2.28; 2.36; 2.32; 2.40; 1.82; 1.65	—
SECONDARY Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment	-0.46; -0.72; -0.56; -0.15; -0.80; -1.19	—
SECONDARY Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment	32.15; 31.74; 30.63; 31.88; 29.53; 28.12	—
SECONDARY Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment	-7.54; -11.71; -7.54; 0.23; -19.90; -29.17	—
SECONDARY Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment	10.74; 18.35; 11.18; 0.94; 33.23; 50.46	—
SECONDARY Median Time to PASI50 Response During the 12-Week Double-Blind Treatment	8.1; 5.0; 7.9; NA	—
SECONDARY Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment	0.00; 0.61; 0.30; 0.00; 1.57; 4.64	—
SECONDARY Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment	12.6; 8.6; 12.1; NA	—
SECONDARY Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment	0.92; 0.61; 0.30; 4.72; 2.19; 0.93	—
SECONDARY Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment	5.19; 5.26; 5.23; 5.15; 3.47; 2.87	—
SECONDARY Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment	-1.73; -2.39; -1.22; -0.26; -2.24; -3.43	—
SECONDARY Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment	10.42; 13.88; 10.54; 1.02; 15.66; 34.28	—
SECONDARY Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment	12.98; 13.32; 12.73; 12.27; 7.82; 5.95	—
SECONDARY Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment	-5.28; -7.43; -5.80; -1.64; -7.33; -9.72	—
SECONDARY Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment	3.44; 3.49; 3.47; 3.46; 2.11; 1.63	—
SECONDARY Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment	-1.34; -1.87; -1.53; -0.53; -1.81; -2.41	—
SECONDARY Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment	60.93; 71.38; 61.35; 36.59; 71.54; 85.28	—
SECONDARY Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment	13.07; 21.79; 15.51; 7.37; 33.22; 51.36	—
SECONDARY Median Time to DLQI Response	—	—
SECONDARY Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12	47.4; 48.3; 47.5; 46.8; 51.7; 53.6	—
SECONDARY Mean SF-36 Domain Scores at Baseline and Week 12	48.3; 49.0; 48.6; 46.7; 51.9; 53.1	—
SECONDARY Mean Change From Baseline in SF-36 MCS and PCS Scores	4.1; 5.0; 5.2; 0.8; 5.0; 7.6	—
SECONDARY Mean Change From Baseline in SF-36 Domain Scores	3.5; 3.7; 3.7; 1.1; 5.1; 6.3	—
SECONDARY Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment	0.0; 0.0; 0.0; 0.0; 0.0; 0.3	—
SECONDARY Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment	1.54; 4.35; 1.51; 0.94; 7.21; 17.65	—
SECONDARY Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment	44.0; 68.5; 62.4; 15.8; 27.0; 17.4	—
SECONDARY Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12	71.01; 85.90; 85.95; 31.58	—
SECONDARY Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment	0.7; 0.7; 0.7; 0.6; 0.8; 0.9	—
SECONDARY Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind Treatment	0.14; 0.21; 0.19; 0.03	—
SECONDARY Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment	63.3; 63.3; 64.2; 60.5; 75.3; 81.1	—
SECONDARY Mean Change From Baseline in EQ-5D VAS at Week 12	11.6; 16.6; 15.7; 3.0	—
SECONDARY Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment	1.3; 1.3; 1.3; 1.3; 1.2; 1.1	—
SECONDARY Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12	-0.1; -0.1; -0.1; -0.0; -0.1; -0.1	—
SECONDARY Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment	0.8; 0.9; 1.3; 2.5; 6.9; 4.5	—
SECONDARY Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind Treatment	10.43; 9.78; 10.08; 8.45	—
SECONDARY Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work	67.8; 71.2; 72.3; 71.4; 18.3; 21.0	—
SECONDARY Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind Treatment	37.97; 30.49; 34.15; 56.25	—
SECONDARY Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment	75.4; 77.0; 75.7; 74.9; 40.0; 29.2	—
SECONDARY Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind Treatment	-35.2; -47.9; -44.3; -9.6	—

Summary

To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.

Eligibility Criteria

Inclusion Criteria

Have had a diagnosis of plaque type psoriasis (psoriasis vulgaris);
Have plaque-type psoriasis covering at least 10% of total body surface area
Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis

Exclusion Criteria

Non-plaque or drug induced forms of psoriasis
Cannot discontinue current systemic and/or topical therapies for the treatment of psoriasis
Cannot discontinue phototherapy
Any uncontrolled significant medical condition

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01241591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.