Clinical Trials List
2024-02-01 - 2028-03-01
Phase III
Recruiting7
ICD-10L40.50
Arthropathic psoriasis, unspecified
ICD-10L40.51
Distal interphalangeal psoriatic arthropathy
ICD-10L40.52
Psoriatic arthritis mutilans
ICD-10L40.53
Psoriatic spondylitis
ICD-10L40.54
Psoriatic juvenile arthropathy
ICD-10L40.59
Other psoriatic arthropathy
ICD-9696.0
Psoriatic arthropathy
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
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Trial Applicant
Johnson & Johnson
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Sponsor
Janssen Research & Development, LLC
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 阮昭奎 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 邱莉雯 Division of Dermatology
- Sheng Yiao Lin Division of Dermatology
- 陳盈君 Division of Dermatology
- 孫熒 Division of Dermatology
- Yang-Yi Chen Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
from baseline at Week 16.
PASI 90 at Week 16.
Inclution Criteria
Age
1. ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is
taking place) at the screening visit.
Type of Participant and Disease Characteristic(s)
2. Diagnosis of plaque psoriasis, with or without PsA, for at least 26 weeks prior to the
first administration of study intervention.
3. Total BSA ≥10% at screening and baseline.
4. Total PASI ≥12 at screening and baseline.
5. Total IGA ≥3 at screening and baseline.
6. Candidate for phototherapy or systemic treatment for plaque psoriasis.
7. Suitable candidate without contraindications for deucravacitinib treatment according
to the respective country’s approved deucravacitinib product labeling in the opinion of
the investigator.
Exclusion Criteria
participating in the study:
Medical Conditions
1. Nonplaque form of psoriasis (eg, erythrodermic, guttate, or pustular).
2. Current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of
psoriasis from beta blockers, calcium channel blockers, or lithium).
3. A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal,
liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,
hematologic, rheumatologic, psychiatric, or metabolic disturbances.
4. Criterion modified per Global Amendment 1
4.1 Known allergies, hypersensitivity, or intolerance to JNJ-77242113,
deucravacitinib, or to any of the excipients or components of the study intervention
(refer to the JNJ-77242113 IB, the deucravacitinib label, and Protocol Section 6.1).
5. Major surgical procedure, (eg, requiring general anesthesia) within 8 weeks before
screening, or will not have fully recovered from surgical procedure, or has a surgical
procedure planned during the time the participant is expected to participate in the study.
Note: Participants with planned surgical procedures to be conducted under local
anesthesia may participate.
6. Transplanted organ (with exception of a corneal transplant >12 weeks before the first
administration of study intervention).
7. A PHQ-9 score ≥15 at screening or baseline.
8. Participants with:
Suicidal ideation in the 26 weeks prior to screening that may be defined as a
C-SSRS rating of: Wish to be Dead, Non-Specific Active Suicidal Thoughts,
Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act and
is considered to be at risk by the investigator.
Suicidal ideation or suicidal behavior in the 26 weeks prior to screening that may
be defined as a C-SSRS rating of: Suicidal Ideation with Intention to Act, Suicidal
Ideation with Specific Plan and Intent, Actual suicide attempt, Interrupted suicide
attempt, Aborted suicide attempt, or Preparatory behaviors for making a suicide
attempt, and is considered to be at risk by the investigator based on an evaluation
by a mental health professional.
9. History of drug or alcohol abuse within 1 year before screening.
The Estimated Number of Participants
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Taiwan
46 participants
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Global
675 participants
