Clinical trial NCT02325219: An Efficacy and Safety of CNTO 1959 (Guselkumab) in Participants With Moderate to Severe Plaque-type Psoriasis
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Psoriasis
CNTO 1959
Guselkumab
Placebo
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2014-12-24
Enrollment: 192
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the superiority of CNTO 1959 (guselkumab) to placebo in the treatment of participants with moderate to severe plaque-type psoriasis (A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches).

Detailed description: A Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know about the study treatment), placebo-controlled (a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect) study of CNTO 1959 (Guselkumab) in the treatment of participants with moderate to severe plaque-type psoriasis. Participants will receive either treatment of CNTO 1959 (guselkumab) 50 milligram (mg) or 100 mg or Placebo 50 mg or 100 mg. Participants will primarily be assessed for Investigator's Global Assessment (IGA) Score and Psoriasis Area and Severity Index (PASI). Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months before Screening
* Have a PASI greater than or equal to (\>=) 12 at Screening and at Baseline
* Have an IGA \>= 3 at Screening and at Baseline
* Have an involved body surface area (BSA) \>=10 percent (%) at Screening and at Baseline
* Be a candidate for phototherapy or systemic treatment for psoriasis (either naive or history of previous treatment)

Exclusion Criteria:

* Has a history of or current signs or symptoms of severe, progressive, or uncontrolled cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances
* Has unstable cardiovascular disease, defined as a recent clinical deterioration (example, unstable angina, atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months before Screening
* Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before Screening
* Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly
* Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

Primary outcomes:
measure: Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Who Achieved PASI 75 Response at Week 16
timeFrame: Week 16
measure: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
timeFrame: Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
timeFrame: Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percent Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16
measure: Percent Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52
timeFrame: Baseline and Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52
measure: Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16
measure: Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52
timeFrame: Baseline and Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Change From Baseline in Body Surface Area (BSA) Involvement by Psoriatic Lesions at Week 48
timeFrame: Baseline and Week 48
measure: Change From Baseline in Nail Psoriasis Area and Severity Index (NAPSI) Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52
timeFrame: Baseline and Weeks 28, 36, 48, 52
measure: Percent Change From Baseline in NAPSI Score at Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52
timeFrame: Baseline and Weeks 28, 36, 48, 52
measure: Percentage of Participants With a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Week 16
timeFrame: Week 16
measure: Percentage of Participants With an Ss-IGA Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Weeks 28, 48 and 52
timeFrame: Week 28, 48 and 52
measure: Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
timeFrame: Week 28, 48 and 52
measure: Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 8 and 16
timeFrame: Weeks 8 and 16
measure: Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 28, 36, 48, and 52
timeFrame: Weeks 28, 36, 48, and 52
measure: Change From Baseline in the DLQI Total Score at Week 8
timeFrame: Baseline and Weeks 8
measure: Change From Baseline in the DLQI Total Score at Weeks 28, 36, 48, 52
timeFrame: Baseline and Weeks 28, 36, 48, 52
measure: Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 8 and 16
timeFrame: Weeks 8 and 16
measure: Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 28, 36, 48, and 52
timeFrame: Weeks 28, 36, 48, and 52
measure: Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Weeks 28 and 48
timeFrame: Baseline and Weeks 28, 48
measure: Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Weeks 28, 48
timeFrame: Baseline and Weeks 28, 48
measure: Change From Baseline in the Physical and Mental Component Summary (PCS and MCS) Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in the PCS and MCS Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Weeks 28 and 48
timeFrame: Baseline and Weeks 28, 48
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Weeks 28 and 48
timeFrame: Baseline and Weeks 28, 48
measure: Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, and 16
timeFrame: Weeks 4, 8, and 16
measure: Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52
timeFrame: Weeks 28, 36, 48, and 52
measure: Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
timeFrame: Weeks 4, 8, and 16
measure: Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
timeFrame: Weeks 28, 36, 48, and 52
measure: Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
timeFrame: Baseline and Weeks 4, 8, 16
measure: Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
timeFrame: Baseline and Weeks 28, 36, 48, 52
measure: Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 4, 8, 16
timeFrame: Baseline and Weeks 4, 8, 16
measure: Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 28, 36, 48, 52
timeFrame: Baseline and Weeks 28, 36, 48, 52
measure: Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 4, 8, 16
timeFrame: Baseline and Weeks 4, 8, 16
measure: Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 28, 36, 48, and 52
timeFrame: Baseline and Weeks 28, 36, 48, 52
measure: Percentage of Participants Who Achieved Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Weeks 4, 8 and 16
timeFrame: Weeks 4, 8, and 16
measure: Percentage of Participants Who Achieved HAQ-DI Response at Weeks 28, 36, 48, 52
timeFrame: Weeks 28, 36, 48, 52
Other outcomes:
Locations:
city: Asahikawa
country: Japan
city: Chuo
country: Japan
city: Gifu
country: Japan
city: Isehara-city,
country: Japan
city: Izumo
country: Japan
city: Kanazawa
country: Japan
city: Kawasaki
country: Japan
city: Kita-Gun
country: Japan
city: Kochi
country: Japan
city: Kurume
country: Japan
city: Kyoto
country: Japan
city: Matsumoto
country: Japan
city: Miyagi
country: Japan
city: Morioka
country: Japan
city: Nagoya
country: Japan
city: Osaka-Sayama
country: Japan
city: Osaka
country: Japan
city: Sapporo
country: Japan
city: Shimotsuke
country: Japan
city: Shinjuku-ku
country: Japan
city: Tokushima
country: Japan
city: Tokyo
country: Japan
city: Toon
country: Japan
city: Tsukuba
country: Japan
city: Tsu
country: Japan
city: Ube
country: Japan
city: Yokosuka
country: Japan
Study officials:
References: