A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis (X-PLORE)
This study is ongoing, but not recruiting participants.
Sponsor:
Janssen Inc.
Information provided by (Responsible Party):
Janssen Inc.
ClinicalTrials.gov Identifier:
NCT01483599
First received: November 29, 2011
Last updated: June 3, 2013
Last verified: June 2013
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Purpose
The purpose of this study is to evaluate the efficacy and safety of CNTO 1959 in the treatment of patients with moderate to severe plaque psoriasis.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: CNTO 1959 (5 mg) Drug: CNTO 1959 (15 mg) Drug: CNTO 1959 (50 mg) Drug: CNTO 1959 (100 mg) Drug: CNTO 1959 (200 mg) Drug: Adalimumab Drug: Placebo to CNTO 1959 (100 mg) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2 Multicenter, Randomized, Placebo- and Active-Comparator-Controlled, Dose-Ranging Trial to Evaluate CNTO 1959 for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis (X-PLORE) |
Resource links provided by NLM:
Further study details as provided by Janssen Inc.:
Primary Outcome Measures:
- Physician's Global Assessment (PGA) score of cleared or minimal [ Time Frame: Week 16 ] [ Designated as safety issue: No ]Overall assessment of induration, scaling, and erythema
Secondary Outcome Measures:
- Psoriasis Area and Severity Index (PASI) 75% or greater improvement from baseline [ Time Frame: Week 16 ] [ Designated as safety issue: No ]Overall assessment of induration, scaling, and erythema and body surface area involved by the disease
- The difference in the PGA score of cleared (0) or minimal (1) response rate between CNTO 1959 treatment groups and adalimumab treatment group [ Time Frame: Weeks 16 and 40 ] [ Designated as safety issue: No ]Overall assessment of induration, scaling, and erythema
- The change from baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]Assessment of the impact of the disease on a subject's quality of life
| Enrollment: | 293 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: CNTO 1959 (5 mg) |
Drug: CNTO 1959 (5 mg)
CNTO 1959: type=exact number, unit=mg, number=5, form=solution for injection, route=subcutaneous use, at Wks 0, 4, and 16, then every 12 weeks through Wk 40.
|
| Experimental: CNTO 1959 (15 mg) |
Drug: CNTO 1959 (15 mg)
CNTO 1959: type=exact number, unit=mg, number=15, form=solution for injection, route=subcutaneous use, Wks 0, 8, and 16, then every 8 weeks through Wk 40.
|
| Experimental: CNTO 1959 (50 mg) |
Drug: CNTO 1959 (50 mg)
CNTO 1959: type=exact number, unit=mg, number=50, form=solution for injection, route=subcutaneous use, Wks 0, 4, and 16, then every 12 weeks through Wk 40.
|
| Experimental: CNTO 1959 (100 mg) |
Drug: CNTO 1959 (100 mg)
CNTO 1959: type=exact number, unit=mg, number=100, form=solution for injection, route=subcutaneous use, Wks 0, 8, and 16, then every 8 weeks through Wk 40.
|
| Experimental: CNTO 1959 (200 mg) |
Drug: CNTO 1959 (200 mg)
CNTO 1959: type=exact number, unit=mg, number=200, form=solution for injection, route=subcutaneous use, Wks 0, 4, and 16, then every 12 weeks through Wk 40.
|
| Active Comparator: Adalimumab (approved psoriasis dosing) |
Drug: Adalimumab
Adalimumab: type=exact, unit=mg, form=solution for injection, route=subcutaneous use, number=80, Wk 0; number=40, Wk 1 and every second week through Wk 39 (e.g., Wks 3, 5, 7, etc.)
|
| Placebo Comparator: Placebo to CNTO 1959 (100 mg) |
Drug: Placebo to CNTO 1959 (100 mg)
Form=solution for injection, route=subcutaneous use, Wks 0, 4, and 8; then crossover to CNTO 1959, 100 mg, at Week 16, then every 8 weeks through Wk 40.
|
Detailed Description:
This is a multicenter, dose-ranging study of CNTO 1959 in patients with moderate to severe plaque psoriasis. Patients who satisfy all inclusion and exclusion criteria will be assigned by chance to one of 7 treatment groups: a placebo group (a placebo is a treatment identical in appearance to CNTO 1959 but does not contain active drug), 1 of 5 dose groups for CNTO 1959, or adalimumab. Patients assigned to adalimumab will be dosed according to the labeled dosing for psoriasis. At Week 16, patients initially assigned to placebo will begin receiving CNTO 1959. Patients initially assigned to CNTO 1959 will continue to receive the same assigned dose level of study agent from Week 16 through Week 40. Patients receiving adalimumab will continue the labeled dosing regimen. All patients will be reassessed for clinical response every 4 weeks from Week 4 through Week 40. Patients will continue dosing through Week 40, with a subsequent efficacy and safety follow-up visit at Week 52. Patient safety will be monitored throughout the study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent
- Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)
- Must be considered, in the opinion of the investigator, suitable candidates for adalimumab therapy
- If a woman, she must be postmenopausal, or if premenopausal, she must be either surgically sterile, practicing a highly effective method of birth control, or not heterosexually active during the study and for 5 months after receiving the last dose of study drug
- If a man, he must agree to use a double-barrier method of birth control (or must have been surgically sterilized) and to not donate sperm during the study and for 5 months after receiving the last dose of study drug.
Exclusion Criteria:
- History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- Has a contra-indication to anti-TNF therapy
- Has a history of chronic or recurrent infectious disease
- Has a nonplaque form of psoriasis or has drug-induced psoriasis
- Has been previously treated with adalimumab
- Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23, (including but not limited to ustekinumab, briakinumab [ABT-874], AIN457, and SCH900222) within 6 months of the first administration of study agent.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483599
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Hide Study LocationsLocations
| United States, Alabama | |
| Birmingham, Alabama, United States | |
| United States, California | |
| Bakersfield, California, United States | |
| Los Angeles, California, United States | |
| Santa Monica, California, United States | |
| United States, Florida | |
| Ocala, Florida, United States | |
| United States, Georgia | |
| Alpharetta, Georgia, United States | |
| United States, Illinois | |
| Arlington Heights, Illinois, United States | |
| Skokie, Illinois, United States | |
| United States, Indiana | |
| Indianapolis, Indiana, United States | |
| United States, Kentucky | |
| Louisville, Kentucky, United States | |
| United States, Massachusetts | |
| Andover, Massachusetts, United States | |
| Boston, Massachusetts, United States | |
| United States, Missouri | |
| Saint Louis, Missouri, United States | |
| United States, New Mexico | |
| Albuquerque, New Mexico, United States | |
| United States, New York | |
| New York, New York, United States | |
| United States, Oregon | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Texas | |
| Houston, Texas, United States | |
| Belgium | |
| Brussels, Belgium | |
| Gent, Belgium | |
| Liege, Belgium | |
| Canada, Alberta | |
| Edmonton, Alberta, Canada | |
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada | |
| Canada, New Brunswick | |
| Moncton, New Brunswick, Canada | |
| Canada, Nova Scotia | |
| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
| Hamilton, Ontario, Canada | |
| London, Ontario, Canada | |
| Oakville, Ontario, Canada | |
| Toronto, Ontario, Canada | |
| Waterloo, Ontario, Canada | |
| Canada, Quebec | |
| Montreal, Quebec, Canada | |
| Sainte-Foy, Quebec, Canada | |
| Germany | |
| Berlin, Germany | |
| Hamburg, Germany | |
| Mahlow, Germany | |
| Munster, Germany | |
| Schwerin, Germany | |
| Poland | |
| Gdansk, Poland | |
| Konskie N/A, Poland | |
| Lodz, Poland | |
| Wroclaw, Poland | |
Sponsors and Collaborators
Janssen Inc.
Investigators
| Study Director: | Janssen Inc. Clinical Trial | Janssen Inc. |
More Information
No publications provided
| Responsible Party: | Janssen Inc. |
| ClinicalTrials.gov Identifier: | NCT01483599 History of Changes |
| Other Study ID Numbers: | CR100673, CNTO1959PSO2001, 2011-001066-17 |
| Study First Received: | November 29, 2011 |
| Last Updated: | June 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Janssen Inc.:
|
Moderate to Severe Plaque-Type Psoriasis Psoriasis Plaque-type psoriasis CNTO 1959 adalimumab |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Adalimumab |
Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 18, 2013