Back to resultsA Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis (X-PLORE)
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CNTO 1959 (5 mg)
CNTO 1959 (15 mg)
CNTO 1959 (50 mg)
CNTO 1959 (100 mg)
CNTO 1959 (200 mg)
Adalimumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Moderate to Severe Plaque-Type Psoriasis, Psoriasis, Plaque-type psoriasis, CNTO 1959, adalimumab
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
CNTO 1959 (5 mg)
CNTO 1959 (15 mg)
CNTO 1959 (50 mg)
CNTO 1959 (100 mg)
CNTO 1959 (200 mg)
Adalimumab (approved psoriasis dosing)
Placebo to CNTO 1959 (100 mg)
Arm Description
CNTO 1959 5 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
CNTO 1959 15 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40
CNTO 1959 50 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
CNTO 1959 100 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40
CNTO 1959 200 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
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.)
Placebo at weeks 0, 4, and 8; then crossover to CNTO 1959 100 mg at Week 16, then every 8 weeks through Week 40
Outcomes
Primary Outcome Measures
Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at 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).
Secondary Outcome Measures
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at 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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01483599
Brief Title
A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis
Acronym
X-PLORE
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 10, 2011 (Actual)
Primary Completion Date
November 27, 2012 (Actual)
Study Completion Date
August 5, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Inc.
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Moderate to Severe Plaque-Type Psoriasis, Psoriasis, Plaque-type psoriasis, CNTO 1959, adalimumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
293 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CNTO 1959 (5 mg)
Arm Type
Experimental
Arm Description
CNTO 1959 5 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
Arm Title
CNTO 1959 (15 mg)
Arm Type
Experimental
Arm Description
CNTO 1959 15 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40
Arm Title
CNTO 1959 (50 mg)
Arm Type
Experimental
Arm Description
CNTO 1959 50 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
Arm Title
CNTO 1959 (100 mg)
Arm Type
Experimental
Arm Description
CNTO 1959 100 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40
Arm Title
CNTO 1959 (200 mg)
Arm Type
Experimental
Arm Description
CNTO 1959 200 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
Arm Title
Adalimumab (approved psoriasis dosing)
Arm Type
Active Comparator
Arm Description
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.)
Arm Title
Placebo to CNTO 1959 (100 mg)
Arm Type
Placebo Comparator
Arm Description
Placebo at weeks 0, 4, and 8; then crossover to CNTO 1959 100 mg at Week 16, then every 8 weeks through Week 40
Intervention Type
Drug
Intervention Name(s)
CNTO 1959 (5 mg)
Intervention Description
Subcutaneous (SC) injections
Intervention Type
Drug
Intervention Name(s)
CNTO 1959 (15 mg)
Intervention Description
SC injections
Intervention Type
Drug
Intervention Name(s)
CNTO 1959 (50 mg)
Intervention Description
SC injections
Intervention Type
Drug
Intervention Name(s)
CNTO 1959 (100 mg)
Intervention Description
SC injections
Intervention Type
Drug
Intervention Name(s)
CNTO 1959 (200 mg)
Intervention Description
SC injections
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Intervention Description
SC injections
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
SC injections
Primary Outcome Measure Information:
Title
Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16
Description
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).
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16
Description
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.
Time Frame
Week 16
Title
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
Description
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).
Time Frame
Week 16
Title
Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40
Description
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).
Time Frame
Week 40
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
Description
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.
Time Frame
Baseline and Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Inc. Clinical Trial
Organizational Affiliation
Janssen Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Bakersfield
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Santa Monica
State/Province
California
Country
United States
City
Ocala
State/Province
Florida
Country
United States
City
Alpharetta
State/Province
Georgia
Country
United States
City
Arlington Heights
State/Province
Illinois
Country
United States
City
Skokie
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Andover
State/Province
Massachusetts
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
New York
State/Province
New York
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Brussel
Country
Belgium
City
Gent
Country
Belgium
City
Liege
Country
Belgium
City
Edmonton
State/Province
Alberta
Country
Canada
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Moncton
State/Province
New Brunswick
Country
Canada
City
Halifax
State/Province
Nova Scotia
Country
Canada
City
Hamilton
State/Province
Ontario
Country
Canada
City
London
State/Province
Ontario
Country
Canada
City
Oakville
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Waterloo
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Quebec
Country
Canada
City
Hamburg
Country
Germany
City
Mahlow
Country
Germany
City
Munster
Country
Germany
City
Schwerin
Country
Germany
City
Gdansk
Country
Poland
City
Konskie N/A
Country
Poland
City
Lodz
Country
Poland
City
Wroclaw
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
26154787
Citation
Gordon KB, Duffin KC, Bissonnette R, Prinz JC, Wasfi Y, Li S, Shen YK, Szapary P, Randazzo B, Reich K. A Phase 2 Trial of Guselkumab versus Adalimumab for Plaque Psoriasis. N Engl J Med. 2015 Jul 9;373(2):136-44. doi: 10.1056/NEJMoa1501646.
Results Reference
derived
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A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis
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