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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: March 29, 2016
Last verified: March 2016
History of Changes
  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:

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab
U.S. FDA Resources

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 to 99 Years   (Adult, Senior)
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

  Show 40 Study Locations
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):

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: March 29, 2016
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
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 23, 2016