Clinical Trials List
2014-11-01 - 2020-12-31
Phase III
Terminated5
ICD-10L40.9
Psoriasis, unspecified
A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis
-
Trial Applicant
Johnson & Johnson
-
Sponsor
Janssen Research & Development, LLC
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chung-Yao Hsu Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chih-Hung Lee Division of Dermatology
- 鄭裕文 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 林子凱 Division of Dermatology
- Tak-Wah Wong Division of Dermatology
- 趙曉秋 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Investigator’s Global Assessment (IGA)
Psoriasis Area and Severity Index (PASI)
Scalp Specific Investigator's Global Assessment (ss-IGA)
Nail Psoriasis Area and Severity Index (NAPSI)
Fingernail Physician’s Global Assessment (f-PGA)
Physician's Global Assessment of Hands and/or Feet (hf-PGA)
Dermatology Life Quality Index (DLQI)
Psoriasis Symptom and Sign Diary (PSSD)
The co-primary endpoints are the proportion of subjects who achieve an IGA score of cleared (0) or
minimal (1) and the proportion of subjects who achieve a PASI 90 response at Week 16, comparing the
guselkumab group and the placebo group.
Inclution Criteria
• Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study agent
• Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening and at Baseline
• Have an Investigator's Global Assessment (IGA) score >=3 at Screening and at Baseline
• Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline
• Must be a candidate for either systemic therapy or phototherapy for psoriasis
Exclusion Criteria
• Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
• Participants who have ever received guselkumab or adalimumab
• History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
• Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
• Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug
The Estimated Number of Participants
-
Taiwan
50 participants
-
Global
750 participants
