Primary Objective- To evaluate the long term safety and tolerability of treatment with CP-690,550 (10 mg BID or variable dose 5 and 10 mg BID) in adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This protocol uses independent endpoint adjudication committees to
determine whether certain investigator-reported events meet the
definition of disease-related efficacy endpoints, using pre-defined
endpoint criteria.
- Incidence and severity of adverse events during treatment.
- Incidence of clinical laboratory abnormalities and change from baseline (in
this and/or prior study) in clinical laboratory values during treatment.
- Incidence of investigator-reported clinically significant changes in physical
examination from baseline (in this and/or prior study) during treatment.
- Incidence of vital sign (blood pressure and heart rate) abnormalities and
change from baseline (in this and/or prior study) in vital sign measures during
treatment.
- Incidence of electrocardiogram (ECG) abnormalities and change from baseline
(in this and/or prior study) in ECG measurements during treatment using data
obtained until the implementation of Protocol Amendment 17.
- Summary of adjudicated cardiovascular endpoints.
- Summary of malignancies confirmed by central laboratory pathologist over-read
of biopsies.
Secondary outcome
-Physician*s Global Assessment (PGA) response ie, the proportion of subjects
achieving a PGA of *clear* or *almost clear* at various time points.
- Psoriasis Area and Severity Index 75 (PASI75) response ie, the proportion of
subjects achieving at least a 75% reduction in PASI relative to baseline (in
this and/or prior study) at various time points.
- The actual and change from baseline (in this and/or prior study) in PASI and
PASI component scores at various time points.
- The proportion of subjects achieving at least a 50% and 90% reduction in PASI
relative to baseline (in this and/or prior study) (ie, PASI50 and PASI90,
respectively) at various time points.
- Proportion of subjects with a PASI score >=125% of the baseline PASI score (in
this and/or prior study) at any time point.
- The actual and change from baseline (in this and/or prior study) in the Itch
Severity Item (ISI) score at various time points.
- The actual and change from baseline (in this and/or prior study) on the
Dermatology Life Quality Index (DLQI) score at various time points.
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 is an open-label study to
evaluate the long-term safety and tolerability of CP-690,550 as treatment of
moderate to severe chronic plaque psoriasis in patients previously treated with
CP-690,550.
Study objective
Primary Objective
- To evaluate the long term safety and tolerability of treatment with
CP-690,550 (10 mg BID or variable dose 5 and 10 mg BID) in adult subjects with
moderate to severe chronic plaque psoriasis who are candidates for systemic
therapy or phototherapy.
Secondary Objectives
- To evaluate the durability of efficacy of CP-690,550 (10 mg BID or variable 5
and 10 mg BID) in adult subjects with moderate to severe chronic plaque
psoriasis who are candidates for systemic therapy or phototherapy.
- To evaluate effects on patient reported outcome (PRO) measures during
treatment with CP-690,550 (10 mg BID or variable 5 and 10 mg BID) at various
time points in adult subjects with moderate to severe chronic plaque psoriasis
who are candidates for systemic therapy or phototherapy.
Study design
A PHASE 3, MULTI-SITE, OPEN-LABEL STUDY.
Intervention
At the baseline visit, all subjects begin taking 10 mg BID CP-690,550. After
the first 3 months of treatment, the investigator has the option to decrease
the dose to 5 mg BID, based on efficacy response or based on manageable safety
findings (eg, lab safety abnormalities). At a subsequent visit, the
investigator may increase the dose back to 10 mg BID (minimum of 3 months
between increasing from 5 to 10 mg BID).
Study burden and risks
Subjects undergo at each complete or targeted physical examination, blood
sample and urine collection, collection of patient reported outcomes.
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 legal representative) has been informed of all pertinent aspects of the study.
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 consent.
4.Sexually active women of childbearing potential are required to use
highly effective method of contraception during the study and for at
least 28 days after treatment is discontinued.
5. If receiving non-prohibited concomitant medications for any reason, must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to first dose of study drug. Subject must be willing to stay on a stable regimen.
6. Have previously completed participation in a randomized qualifying study of CP-690,550 for the treatment of plaque psoriasis or:
-Were withdrawn from a randomized qualifying study for worsening of psoriasis or lack of efficacy after compliant participation of 12 weeks or greater; OR
- Were discontinued from a randomized qualifying study for not meeting protocol efficacy threshold requirements for continued participation; OR
- Required earlier discontinuation of treatment in a randomized qualifying study for reasons other than CP-690,550 related serious adverse events, with the approval of the Pfizer study clinician.
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 (eg, beta blockers, calcium channel blockers, antimalarial drugs or lithium) 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, intramuscular, intravenous, intraarticular) corticosteroids for any condition.
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 | EUCTR2010-020002-15-NL |
| ClinicalTrials.gov | NCT01163253 |
| CCMO | NL34154.072.10 |