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

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)

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Placebo; 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

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 Type: Interventional
• Enrollment (Actual): 293
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium
  • Gent, Belgium
  • Liege, Belgium
• Canada
  • Quebec, Canada
  • Alberta
    • Edmonton, Alberta, Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
  • New Brunswick
    • Moncton, New Brunswick, Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
  • Ontario
    • Hamilton, Ontario, Canada
    • London, Ontario, Canada
    • Oakville, Ontario, Canada
    • Toronto, Ontario, Canada
    • Waterloo, Ontario, Canada
  • Quebec
    • Montreal, Quebec, Canada
• Germany
  • Hamburg, Germany
  • Mahlow, Germany
  • Munster, Germany
  • Schwerin, Germany
• Poland
  • Gdansk, Poland
  • Konskie N/A, Poland
  • Lodz, Poland
  • Wroclaw, Poland
• United States
  • Alabama
    • Birmingham, Alabama, United States
  • California
    • Bakersfield, California, United States
    • Los Angeles, California, United States
    • Santa Monica, California, United States
  • Florida
    • Ocala, Florida, United States
  • Georgia
    • Alpharetta, Georgia, United States
  • Illinois
    • Arlington Heights, Illinois, United States
    • Skokie, Illinois, United States
  • Indiana
    • Indianapolis, Indiana, United States
  • Kentucky
    • Louisville, Kentucky, United States
  • Massachusetts
    • Andover, Massachusetts, United States
    • Boston, Massachusetts, United States
  • Missouri
    • Saint Louis, Missouri, United States
  • New Mexico
    • Albuquerque, New Mexico, United States
  • New York
    • New York, New York, United States
  • Oregon
    • Portland, Oregon, United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States
  • Texas
    • Houston, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

7

Arms and Interventions

Participant Group / 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: Placebo; SC injections; Drug: CNTO 1959 (100 mg); SC injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 16
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).	Week 16
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).	Week 40
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.	Baseline and Week 16

Collaborators and Investigators

• Sponsor: Janssen Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2011
• Primary Completion (Actual): November 27, 2012
• Study Completion (Actual): August 5, 2013

Study Registration Dates

• First Submitted: November 29, 2011
• First Submitted That Met QC Criteria: November 29, 2011
• First Posted (Estimate): December 1, 2011

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Psoriasis; adalimumab; Plaque-type psoriasis; CNTO 1959; Moderate to Severe Plaque-Type Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: CR100673; CNTO1959PSO2001 (Other Identifier: Janssen Inc.); 2011-001066-17 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No