A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis (X-PLORE)
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ClinicalTrials.gov Identifier: NCT01483599 |
Recruitment Status :
Completed
First Posted : December 1, 2011
Results First Posted : August 2, 2017
Last Update Posted : August 2, 2017
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Condition or disease | Intervention/treatment | Phase |
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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 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 293 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, 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) |
Actual Study Start Date : | November 10, 2011 |
Actual Primary Completion Date : | November 27, 2012 |
Actual Study Completion Date : | August 5, 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: CNTO 1959 (5 mg)
CNTO 1959 5 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
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Drug: CNTO 1959 (5 mg)
Subcutaneous (SC) injections |
Experimental: CNTO 1959 (15 mg)
CNTO 1959 15 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40
|
Drug: CNTO 1959 (15 mg)
SC injections |
Experimental: CNTO 1959 (50 mg)
CNTO 1959 50 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
|
Drug: CNTO 1959 (50 mg)
SC injections |
Experimental: CNTO 1959 (100 mg)
CNTO 1959 100 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40
|
Drug: CNTO 1959 (100 mg)
SC injections |
Experimental: CNTO 1959 (200 mg)
CNTO 1959 200 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
|
Drug: CNTO 1959 (200 mg)
SC injections |
Active Comparator: Adalimumab (approved psoriasis dosing)
Adalimumab 80 mg at week 0 followed by 40 mg at week 1 and every second week through Week 39 (i.e., Weeks 3, 5, 7, etc.)
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Drug: Adalimumab
SC injections |
Placebo Comparator: Placebo to CNTO 1959 (100 mg)
Placebo at weeks 0, 4, and 8; then crossover to CNTO 1959 100 mg at Week 16, then every 8 weeks through Week 40
|
Drug: CNTO 1959 (100 mg)
SC injections Drug: Placebo SC injections |
- Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 [ Time Frame: Week 16 ]PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema [0 (no evidence of plaque) to 5 (dusky to deep red coloration)], induration [0 (no plaque evaluation) to 5 (marked plaque evaluation)] and scaling [0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).
- Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 [ Time Frame: Week 16 ]The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.
- Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16 [ Time Frame: Week 16 ]PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema [0 (no evidence of plaque) to 5 (dusky to deep red coloration)], induration [0 (no plaque evaluation) to 5 (marked plaque evaluation)] and scaling [0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).
- Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40 [ Time Frame: Week 40 ]PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema [0 (no evidence of plaque) to 5 (dusky to deep red coloration)], induration [0 (no plaque evaluation) to 5 (marked plaque evaluation)] and scaling [0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).
- Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 [ Time Frame: Baseline and Week 16 ]The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483599
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 | |
Brussel, 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 | |
Canada | |
Quebec, Canada | |
Germany | |
Hamburg, Germany | |
Mahlow, Germany | |
Munster, Germany | |
Schwerin, Germany | |
Poland | |
Gdansk, Poland | |
Konskie N/A, Poland | |
Lodz, Poland | |
Wroclaw, Poland |
Study Director: | Janssen Inc. Clinical Trial | Janssen Inc. |
Responsible Party: | Janssen Inc. |
ClinicalTrials.gov Identifier: | NCT01483599 |
Other Study ID Numbers: |
CR100673 CNTO1959PSO2001 ( Other Identifier: Janssen Inc. ) 2011-001066-17 ( EudraCT Number ) |
First Posted: | December 1, 2011 Key Record Dates |
Results First Posted: | August 2, 2017 |
Last Update Posted: | August 2, 2017 |
Last Verified: | July 2017 |
Studies a U.S. FDA-regulated Device Product: | No |
Moderate to Severe Plaque-Type Psoriasis Psoriasis Plaque-type psoriasis CNTO 1959 adalimumab |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |