Phase 3 N=666 Randomized Quadruple-blind Treatment

A Study To Evaluate The Effects And Safety Of Treatment, Treatment Withdrawal, Followed By Re-Treatment With CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT01186744 ↗

Enrolled (actual)

666

Serious AEs

4.1%

Results posted

Jun 2014

Primary outcome: Primary: Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B) — 90.3; 63.4; 91.1; 61.4 percentage of participants — p=0.0008

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: CP-690,550 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B)	90.3; 63.4; 91.1; 61.4; 70.3; 36.2	0.0008 sig
PRIMARY Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B)	80.6; 57.3; 80.0; 52.3; 67.7; 34.4	0.0027 sig
PRIMARY Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B)	50.00; 0.00; 0.00; 0.00; 100.00; 13.16	—
PRIMARY Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B)	23.08; 5.17; 6.67; 7.14; 23.08; 25.86	—
SECONDARY Median Time to PASI75 Response During Initial CP-690,550 Treatment (Period A)	24.3; 8.7	—
SECONDARY Median Time to PGA Response of Clear or Almost Clear During Initial CP-690,550 Treatment (Period A)	24.1; 8.1	—
SECONDARY Percentage of Participants Achieving Both a PASI50-75 Response and Dermatology Life Quality Index (DLQI) ≤5 Response During Initial CP-690,550 Treatment (Period A)	12.69; 21.19; 18.73; 19.40; 18.13; 13.13	—
SECONDARY Percentage of Participant Maintaining an Adequate Response During the Double-Blind Treatment Withdrawal (Period B)	100.0; 90.0; 100.0; 85.9; 96.7; 72.0	—
SECONDARY Median Time to Loss of Adequate Response During the Double-Blind Treatment Withdrawal (Period B)	NA; 16.4; NA; 16.1	—
SECONDARY Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Period Between Week 24 and Week 32 (Period B)	0.00; 0.00; 0.00; 0.00; 0.00; 0.00	—
SECONDARY Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Double-Blind Treatment Withdrawal (Period B)	0.00; 0.00; 0.00; 0.00; 0.00; 0.00	—
SECONDARY Percentage of Participants Maintaining Adequate PASI Response and Maintaining PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)	100.00; 90.0; 100.0; 85.9; 96.7; 72.0	—
SECONDARY Median Time to Loss of >50% of the Visit A4/Week 24 PASI Response and Loss of PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)	NA; 16.4; NA; 16.1	—
SECONDARY Percentage of Participants Regaining PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C	14.3; 7.7; 14.3; 37.0; 28.6; 32.3	—
SECONDARY Median Time to Regain PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C	16.4; 16.4; NA; 12.4	—
SECONDARY Percentage of Participants Regaining PASI75 and PGA Response (PGA of Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Who Had Lost Both PASI75 Response and PGA Response at the Beginning of Period C	0.00; 0.00; 0.00; 0.00; 14.29; 7.69	—
SECONDARY Median Time to PASI75 Response During CP-690,550 Re-Treatment (Period C) For Those Who Had a >50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B)	4.5; 16.4; NA; 8.1	—
SECONDARY Median Time to PGA Response of Clear or Almost Clear During CP-690,550 Re-Treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe at the Beginning of Period C	16.3; 16.1; 13.1; 8.1	—
SECONDARY Percentage of Participants With a PASI75 Response During the Initial CP-690,550 Treatment (Period A)	7.85; 22.39; 23.87; 50.45; 38.07; 60.60	—
SECONDARY Percentage of Participants With a PASI75 Response During Double-Blind Withdrawal Treatment (Period B)	87.10; 63.41; 86.67; 59.40; 70.97; 34.15	—
SECONDARY Percentage of Participants With a PASI75 Response During the CP-690,550 Re-Treatment (Period C)	70.37; 34.67; 73.81; 60.83; 62.96; 48.00	—
SECONDARY Percentage of Participants With PGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)	14.20; 37.91; 30.51; 54.03; 37.16; 58.81	—
SECONDARY Percentage of Participants With PGA Response of Clear or Almost Clear During Double-Blind Withdrawal Treatment (Period B)	77.42; 57.32; 77.78; 48.12; 74.19; 32.93	—
SECONDARY Percentage of Participants With PGA Response of Clear or Almost Clear During the CP-690,550 Re-Treatment (Period C)	62.96; 40.00; 61.90; 59.17; 62.96; 49.33	—
SECONDARY Mean Total Percent of Psoriatic Body Surface Area (BSA) During Initial CP-690,550 Treatment (Period A)	27.5; 27.2; 22.3; 18.1; 17.2; 12.1	—
SECONDARY Mean Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)	1.9; 3.8; 2.0; 2.7; 1.9; 6.1	—
SECONDARY Mean Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)	2.3; 11.4; 3.0; 12.0; 2.1; 10.6	—
SECONDARY Mean Change From Baseline in Total Percent of Psoriatic BSA During Initial CP-690,550 Treatment (Period A)	-5.3; -9.0; -10.4; -14.5; -14.4; -18.5	—
SECONDARY Mean Change From Baseline in Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)	0.0; 2.3; -0.3; 4.1; 0.3; 4.1	—
SECONDARY Mean Change From Baseline in Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)	-0.2; -1.0; 0.1; -4.9; 0.1; -2.3	—
SECONDARY Mean Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)	28.7; 25.9; 20.5; 14.3; 14.8; 9.7	—
SECONDARY Mean Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)	4.2; 3.3; 0.9; 2.8; 4.1; 11.3	—
SECONDARY Mean Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)	4.0; 18.6; 2.0; 18.3; 3.6; 12.5	—
SECONDARY Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)	-7.9; -11.7; -13.8; -16.0; -15.4; -17.9	—
SECONDARY Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)	-0.3; 8.0; 0.7; 9.3; 0.4; 10.0	—
SECONDARY Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)	-0.3; -6.4; 0.9; -10.8; 0.0; -8.6	—
SECONDARY Mean PASI Score During Initial CP-690,550 Treatment (Period A)	21.1; 20.9; 13.5; 10.4; 10.1; 6.5	—
SECONDARY Mean PASI Score During Double-Blind Treatment Withdrawal (Period B)	1.6; 1.8; 1.7; 1.5; 2.0; 5.0	—
SECONDARY Mean PASI Score During the CP-690,550 Re-Treatment (Period C)	2.7; 9.9; 3.4; 9.8; 2.5; 7.8	—
SECONDARY Mean Change From Baseline-A in PASI Score During Initial CP-690,550 Treatment (Period A)	-7.6; -10.5; -11.1; -14.2; -13.1; -15.8	—
SECONDARY Mean Change From Baseline-B in PASI Score During Double-Blind Treatment Withdrawal (Period B)	0.4; 3.3; 0.2; 3.8; 0.9; 4.9	—
SECONDARY Mean Change From Baseline-C in PASI Score During the CP-690,550 Re-Treatment (Period C)	-0.2; -2.3; -0.1; -4.8; 0.0; -3.8	—
SECONDARY Mean PASI Component Scores During Initial CP-690,550 Treatment (Period A)	2.2; 2.2; 1.4; 1.1; 1.1; 0.7	—
SECONDARY Mean PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)	0.5; 0.4; 0.3; 0.3; 0.6; 1.1	—
SECONDARY Mean PASI Component Scores During the CP-690,550 Re-Treatment (Period C)	0.7; 1.5; 0.5; 1.6; 0.6; 1.1	—
SECONDARY Mean Change From Baseline in PASI Component Scores During Initial CP-690,550 Treatment (Period A)	-0.8; -1.2; -1.1; -1.5; -1.2; -1.6	—
SECONDARY Mean Change From Baseline in PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)	0.1; 0.8; 0.2; 0.8; 0.2; 0.9	—
SECONDARY Mean Change From Baseline in PASI Component Scores During the CP-690,550 Re-Treatment (Period C)	-0.1; -0.4; 0.1; -0.9; 0.1; -0.7	—
SECONDARY Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During Period A	28.70; 54.63; 55.29; 75.52; 65.26; 79.40	—
SECONDARY Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During Period A	1.21; 6.27; 8.76; 24.78; 18.73; 36.72	—
SECONDARY Percentage of Participants Achieving at Least a 100% Reduction in PASI Relative to Baseline-A (PASI100) During Period A	0.91; 2.09; 2.72; 7.46; 7.25; 15.82	—
SECONDARY Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During the CP-690,550 Re-Treatment (Period C)	96.30; 42.67; 92.86; 49.17; 100.00; 69.33	—
SECONDARY Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During the CP-690,550 Re-Treatment (Period C)	48.15; 12.00; 45.24; 15.83; 48.15; 17.33	—
SECONDARY Percentage of Participants Achieving 100% Reduction in PASI Relative to Baseline-A (PASI100) During the CP-690,550 Re-Treatment (Period C)	18.52; 5.33; 23.81; 5.00; 18.52; 9.33	—
SECONDARY Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Initial CP-690,550 Treatment (Period A)	0.92; 0.60; 0.62; 0.62; 0.96; 0.98	—
SECONDARY Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Double-Blind Treatment Withdrawal (Period B)	0.00; 0.00; 0.00; 0.00; 0.00; 0.00	—
SECONDARY Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During the CP-690,550 Re-Treatment (Period C)	0.00; 0.00; 0.00; 0.00; 0.00; 0.00	—
SECONDARY Mean Itch Severity Item (ISI) Score During the Initial CP-690,550 Treatment (Period A)	6.7; 6.9; 3.2; 2.2; 2.8; 1.6	—
SECONDARY Mean ISI Score During the Double-Blind Treatment Withdrawal (Period B)	1.5; 1.2; 0.6; 0.8; 1.7; 3.6	—
SECONDARY Mean ISI Score During the CP-690,550 Re-Treatment (Period C)	2.3; 4.9; 1.7; 5.2; 2.6; 2.6	—
SECONDARY Mean Change From Baseline-A in ISI Score During the Initial CP-690,550 Treatment (Period A)	-3.6; -4.6; -3.9; -5.3; -3.8; -5.2	—
SECONDARY Mean Change From Baseline-B in ISI Score During the Double-Blind Treatment Withdrawal (Period B)	0.2; 2.4; 0.1; 3.3; -0.0; 2.9	—
SECONDARY Mean Change From Baseline-C in ISI Score During the CP-690,550 Re-Treatment (Period C)	0.3; -2.3; 0.0; -3.1; 0.1; -2.6	—
SECONDARY Percentage of Participants With ISI Score of 0 During the Initial CP-690,550 Treatment (Period A)	12.92; 25.69; 16.92; 41.28; 20.00; 37.92	—
SECONDARY Percentage of Participants With ISI Score of 0 During CP-690,550 Re-Treatment (Period C)	0.00; 0.00; 0.00; 0.00; 0.00; 11.27	—
SECONDARY Percentage of Participants Achieving ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)	27.62; 46.03; 34.29; 60.00; 34.92; 60.00	—
SECONDARY Percentage of Participants Achieving an ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C)	0.00; 0.00; 0.00; 0.00; 14.29; 22.58	—
SECONDARY Percentage of Participants Achieving ISI ≥2-Point Reduction During the Initial CP-690,550 Treatment (Period A)	81.59; 88.89; 80.32; 87.94; 73.97; 84.76	—
SECONDARY Percentage of Participants Achieving ISI ≥2-Point Reduction During the CP-690,550 Re-Treatment (Period C)	28.57; 61.29; 14.29; 80.00; 28.57; 64.52	—
SECONDARY ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response	27.8; 47.2; 41.2; 67.8; 52.4; 78.6	—
SECONDARY Median Time to ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)	16.4; 8.0	—
SECONDARY ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C) - Percentage of Participants With a Response	14.3; 22.8; 14.3; 41.3; 28.6; 37.9	—
SECONDARY Median Time to ISI Score of ≤1 During the CP-690,550 Re-Treatment (Period C)	NA; 16.1; NA; 8.3	—
SECONDARY ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response	82.2; 90.3; 89.5; 96.5; 93.6; 97.8	—
SECONDARY Median Time to ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A)	4.1; 4.1	—
SECONDARY ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C) - Percentage of Participant With a Response	28.6; 61.8; 14.3; 80.0; 35.7; 75.1	—
SECONDARY Median Time to ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C)	16.6; 4.9; NA; 4.3	—
SECONDARY Mean Dermatology Life Quality Index (DLQI) Score During the Initial CP-690,550 Treatment (Period A)	12.6; 12.6; 6.8; 4.8; 5.4; 3.4	—
SECONDARY Mean DLQI Score During the CP-690,550 Re-Treatment (Period C)	3.6; 7.0; 2.2; 8.8; 3.4; 4.3	—
SECONDARY Mean DLQI Score During the Double-Blind Treatment Withdrawal (Period B)	2.6; 1.8; 1.2; 1.2; 3.4; 4.7	—
SECONDARY Mean Change From Baseline-A in DLQI Score During the Initial CP-690,550 Treatment (Period A)	-5.8; -7.6; -7.1; -9.1; -7.6; -9.4	—
SECONDARY Mean Change From Baseline-B in DLQI Score During the Double-Blind Treatment Withdrawal (Period B)	0.8; 3.0; 0.1; 4.6; 0.5; 4.1	—
SECONDARY Mean Change From Baseline-C in DLQI Score During the CP-690,550 Re-Treatment (Period C)	-0.2; -2.9; 0.0; -4.9; 0.2; -3.4	—
SECONDARY Mean DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)	2.7; 2.7; 1.5; 1.1; 1.2; 0.8	—
SECONDARY Mean DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)	0.5; 0.3; 0.2; 0.3; 0.8; 0.8	—
SECONDARY Mean DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)	0.7; 1.5; 0.4; 1.8; 0.6; 0.9	—
SECONDARY Mean Change From Baseline-A in DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)	-1.2; -1.6; -1.5; -1.9; -1.7; -2.0	—
SECONDARY Mean Change From Baseline-B in DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)	0.3; 0.5; 0.1; 0.9; 0.1; 0.8	—
SECONDARY Mean Change From Baseline-C in DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)	0.0; -0.7; 0.1; -1.0; 0.2; -0.7	—
SECONDARY Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)	59.86; 75.44; 70.42; 80.78; 70.77; 79.00	—
SECONDARY Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-B Response During Double-Blind Treatment Withdrawal (Period B)	0.00; 16.67; 33.33; 0.00; 0.00; 0.00	—
SECONDARY Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-C Response During CP-690,550 Re-Treatment (Period C)	0.00; 47.50; 0.00; 65.79; 12.50; 55.00	—
SECONDARY Percentage of Participants Achieving DLQI ≤1 Response During the Initial CP-690,550 Treatment (Period A)	13.44; 26.88; 25.94; 41.88; 30.94; 53.13	—
SECONDARY Percentage of Participants Achieving DLQI ≤1 Response During Double-Blind Treatment Withdrawal (Period B)	0.00; 0.00; 0.00; 0.00; 7.69; 4.00	—
SECONDARY Percentage of Participants Achieving DLQI ≤1 Response During CP-690,550 Re-Treatment (Period C)	0.00; 0.00; 0.00; 0.00; 16.67; 24.59	—
SECONDARY Percentage of Participants by DLQI Severity Category During the Initial CP-690,550 Treatment (Period A)	3.0; 3.9; 15.2; 17.1; 27.0; 21.3	—
SECONDARY Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)	60.1; 76.6; 77.4; 88.7; 85.7; 94.9	—
SECONDARY Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)	4.4; 4.1	—
SECONDARY Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)	0.0; 47.5; 0.0; 65.8; 12.5; 72.5	—
SECONDARY Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)	NA; 8.1; NA; 4.4	—
SECONDARY Mean Short-Form 36 (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores During the Initial CP-690,550 Treatment (Period A)	48.1; 47.8; 50.5; 52.9; 45.2; 46.1	—
SECONDARY Mean SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)	51.8; 49.9; 53.8; 49.7; 52.9; 52.7	—
SECONDARY Mean Change From Baseline-A in SF-36 PCS and MCS Scores During the Initial CP-690,550 Treatment (Period A)	1.9; 5.2; 3.2; 4.9	—
SECONDARY Mean Change From Baseline-C in SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)	-0.9; 2.7; -1.0; 1.8; -1.6; 0.1	—
SECONDARY Mean SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)	48.3; 48.0; 50.7; 52.7; 47.2; 47.6	—
SECONDARY Mean SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)	50.7; 51.3; 52.7; 51.1; 51.7; 52.4	—
SECONDARY Mean Change From Baseline-A in SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)	1.8; 4.6; 2.6; 5.6; 4.5; 9.0	—
SECONDARY Mean Change From Baseline-C in SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)	-0.4; 1.2; -0.5; 0.7; -0.7; 1.2	—
SECONDARY Percentage of Participants in Each Patient Global Assessment (PtGA) of Psoriasis Category During the Initial CP-690,550 Treatment (Period A)	0.0; 0.0; 0.0; 0.3; 3.6; 1.2	—
SECONDARY Percentage of Participants in Each PtGA of Psoriasis Category During Double-Blind Treatment Withdrawal (Period B)	16.1; 19.5; 24.4; 35.3; 45.2; 61.0	—
SECONDARY Percentage of Participants in Each PtGA of Psoriasis Category During CP-690,550 Re-Treatment (Period C)	22.2; 2.7; 19.0; 5.0; 33.3; 18.7	—
SECONDARY Percentage of Participants With PtGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)	11.78; 21.19; 22.36; 45.37; 30.51; 54.63	—
SECONDARY Percentage of Participants With PtGA Response of Clear or Almost Clear During CP-690,550 Re-Treatment (Period C) Among Participants Who Had a PtGA of Mild, Moderate or Severe During CP-690,550 Treatment Withdrawal (Period B)	14.29; 6.35; 23.53; 8.00; 21.43; 19.05	—
SECONDARY Percentage of Participants Maintaining PtGA Response of Clear or Almost Clear During the Double-Blind Treatment Withdrawal (Period B) Among Participants Who Had a Response of Clear or Almost Clear at Beginning of Period B	94.7; 50.7; 82.0; 55.5; 89.2; 32.8	—
SECONDARY Mean EuroQol 5 Dimensions (EQ-5D) Health State Profile Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)	0.7; 0.7; 0.8; 0.9; 69.9; 70.6	—
SECONDARY Mean EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)	0.8; 0.8; 0.9; 0.8; 0.9; 0.9	—
SECONDARY Mean Change From Baseline-A in EQ-5D Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)	0.1; 0.2; 5.3; 9.3	—
SECONDARY Mean Change From Baseline-C in EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)	0.0; 0.1; -0.0; 0.1; -1.0; 4.2	—
SECONDARY Mean EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)	1.3; 1.3; 1.2; 1.2; 1.1; 1.1	—
SECONDARY Mean EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)	1.2; 1.2; 1.1; 1.2; 1.2; 1.1	—
SECONDARY Mean Change From Baseline-A in EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)	-0.1; -0.1; 0.0; -0.1; -0.1; -0.2	—
SECONDARY Mean Change From Baseline-C in EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)	0.0; -0.0; 0.0; -0.0; 0.0; -0.1	—
SECONDARY Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During the Initial CP-690,550 Treatment (Period A)	0.0; 0.6; 0.0; 0.0; 0.0; 0.3	—
SECONDARY Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During Double-Blind Treatment Withdrawal (Period B)	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
SECONDARY Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During CP-690,550 Re-Treatment (Period C)	0.0; 0.0; 0.0; 0.0	—

Summary

The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and subsequent withdrawal of active treatment at various timepoints during the 16 week double blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) following 4 -16 weeks of CP 690,550 treatment withdrawal and subsequent re treatment; and 3) evaluate the safety and tolerability of CP 690,550 (5 mg BID and 10 mg BID) in subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Eligibility Criteria

Inclusion Criteria

18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at least 12 months prior to first dose of study drug;
Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND Physician's Global Assessment (PGA) score of 3 (moderate) or 4 (severe); Psoriasis covering at least 10% of body surface area;
No evidence of active or latent or inadequately treated infection with Tuberculosis or other serious infections.

Exclusion Criteria

Non-plaque or drug induced forms of psoriasis;
Cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot discontinue phototherapy (Psoralen Ultraviolet A; Ultraviolet B).
Any uncontrolled significant medical condition.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01186744). 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.