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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Inc.
ClinicalTrials.gov Identifier:
NCT01483599
First received: November 29, 2011
Last updated: February 7, 2014
Last verified: February 2014
  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
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
Study Completion Date: August 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483599

  Hide Study 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
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
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: February 7, 2014
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
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 21, 2014