The primary objectives of the study are 1) to compare the efficacy of CP-690,550 (5 mg BID and 10 mg BID) versus etanercept (50 mg BIW) for the reduction in severity of plaque psoriasis after 12 weeks of treatment, and 2) to evaluate the safety and…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Physician*s Global Assessment (PGA) response ie, the proportion of subjects
achieving a PGA of *clear* or *almost clear*, at Week 12;
Psoriasis Area and Severity Index 75 (PASI75) response ie, the proportion of
subjects achieving at least a 75% reduction in Psoriasis Area and Severity
Index relative to baseline, at Week 12.
Secondary outcome
PGA response at Week 2, 4, and 8;
Proportion of subjects in each PGA category at various timepoints through Week
12;
PASI75 response at Week 2, 4, and 8;
Actual and change from baseline in PASI and PASI component scores at various
timepoints through Week 12;
Proportion of subjects achieving at least a 50% and 90% reduction in PASI
relative to baseline (PASI50 and PASI90, respectively) at various timepoints
through Week 12;
Time to PASI50 and PASI75 responses;
Proportion of subjects with a PASI score >=125% of the baseline PASI score at
various timepoints through Week 12;
Actual and change from baseline in the Itch Severity Item (ISI) score at
various timepoints through Week 12;
Actual and change from baseline on the Dermatology Life Quality Index (DLQI)
score at various timepoints through Week 12.
Other patient reported outcome (PRO) measures to be assessed at various
timepoints through Week 12, including:
Short Form-36 (Version 2, Acute) (SF-36);
Patient Global Assessment of Psoriasis (PtGA);
Patient Satisfaction with Study Medication (PSSM);
EuroQol 5 Dimensions (EQ-5D);
Psoriasis Health Care Resource Utilization Questionnaire (Ps-HCRU);
Psoriasis Quality of Life-12 (PQOL-12).
Background summary
CP-690,550 is being developed for oral treatment of adult patients with
moderate to severe chronic plaque psoriasis who are candidates for systemic
therapy or phototherapy. CP-690,550 is a potent inhibitor of the Janus Kinase
(JAK) family of kinases. While CP-690,550 shows nanomolar inhibitory potency
against all JAK family kinases in enzyme studies, it shows functional
specificity for JAK1 and JAK1/3 over JAK2 in cell assays. The broad effects of
JAK1/3 inhibition on multiple cytokine pathways provides the rationale for
developing CP-690,550 as treatment for psoriasis, a disease in which lymphocyte
activation/proliferation plays a pathogenic role. Efficacy of oral dosing with
CP-690,550 in psoriasis patients has been demonstrated in 2 studies, a 14-day
and a 12-week treatment study, providing clinical support for JAK inhibition as
a novel approach to treat plaque psoriasis. This study is a 12-week active
comparator study, designed 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.
Study objective
The primary objectives of the study are 1) to compare the efficacy of
CP-690,550 (5 mg BID and 10 mg BID) versus etanercept (50 mg BIW) for the
reduction in severity of plaque psoriasis after 12 weeks of treatment, and 2)
to 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.
Study design
Phase 3, multi-site, randomized, double-blind, double-dummy,
placebo-controlled, parallel-group, 12-week study of the efficacy and safety of
two oral doses of CP-690,550 (5 mg BID and 10 mg BID) and one subcutaneous dose
of etanercept (50 mg BIW) in subjects with moderate to severe chronic plaque
psoriasis who are candidates for systemic therapy or phototherapy.
Intervention
Subjects will be randomized in a 3:3:3:1 ratio to one of four parallel
treatment groups.
Group A: CP 690,550 5 mg BID oral + Placebo BIW subcutaneous injection
Group B: CP 690,550 10 mg BID oral + Placebo BIW subcutaneous injection
Group C: placebo BID oral + Etanercept 50 mg BIW subcutaneous injection
Group D: placebo BID oral + Placebo BIW subcutaneous injection
Study burden and risks
During a 12 week study period subjects undergo complete and targeted physical
examinations, Tb testing, ECG, Chest radiographs, blood and urine collection.
Patient reported outcomes are collected using questionnaires.
East 42nd Street 235
New York NY 10017
US
East 42nd Street 235
New York NY 10017
US
Listed location countries
Age
Inclusion criteria
1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Be at least 18 years of age at time of informed consent.
4. Have had a diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at least 12 months prior to first dose of study drug.
5. Have a PASI score of 12 or greater AND a PGA score of 3 (*moderate*) or 4 (*severe*) at Baseline/Day 1 (prior to first dose of study drug).
6. Have plaque-type psoriasis covering at least 10% of total body surface area (BSA) at Baseline/Day 1.
7. Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment).
8. Considered by dermatologist investigator to have failed to respond to, or who have a contraindication to, or are intolerant to at least one conventional systemic therapy for the treatment of plaque psoriasis (including cyclosporine, methotrexate, or psoralen plus ultraviolet A light [PUVA]).
9. Sexually active women of childbearing potential are required to use adequate contraceptive methods during participation in this study. 10. No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
10. Are candidates for etanercept according to the approved local product labeling
Exclusion criteria
1. Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed.
2. Have evidence of skin conditions (eg, eczema) at the time of the screening or baseline visit that would interfere with evaluation of psoriasis.
3. 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.
4. If planned initiation of, or changes to, concomitant medication that could affect psoriasis are to occur within 2 weeks prior to randomization and/or during the study.
5. Cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA).
6. Are taking or require oral or injectable (eg, intraarticular, intramuscular, or intravenous) corticosteroids for any condition.
7. Women who are pregnant or lactating, or planning pregnancy while enrolled in the
study.
8. Have previously been treated with efalizumab (Raptiva).
9. Have previously been treated with etanercept (Enbrel) for any reason.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-020004-30-NL |
| ClinicalTrials.gov | NCT01241591 |
| CCMO | NL34169.078.10 |