A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis (X-PLORE)

• ClinicalTrials.gov Identifier: NCT01483599
• Recruitment Status: Completed
• First Posted: December 1, 2011
• Results First Posted: August 2, 2017
• Last Update Posted: August 2, 2017
• Sponsor: Janssen Inc.
• Information provided by (Responsible Party): Janssen Inc.

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.

Condition or disease	Intervention/treatment	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	Phase 2

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.

Study Design

• 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

Arms and Interventions

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	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.)	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

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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.
2. 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).
3. 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).
4. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

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

Sponsors and Collaborators

Janssen Inc.

Investigators

• Study Director: Janssen Inc. Clinical Trial; Janssen Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• 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

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; Anti-Inflammatory Agents; Antirheumatic Agents