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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06095115




Registration number
NCT06095115
Ethics application status
Date submitted
18/10/2023
Date registered
23/10/2023

Titles & IDs
Public title
A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis
Scientific title
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Retreatment
Secondary ID [1] 0 0
77242113PSO3001
Secondary ID [2] 0 0
77242113PSO3001
Universal Trial Number (UTN)
Trial acronym
ICONIC-LEAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-77242113
Treatment: Drugs - Placebo

Experimental: JNJ-77242113 - Adolescent and adult participants will receive JNJ-77242113 from Week 0 through Week 156. At Week 24, adult participants who are psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieve an IGA score of 0 or 1 and have \>=2-grade improvement from baseline) will be re-randomized either to continue JNJ-77242113 or to placebo (and will be retreated with JNJ-77242113 upon loss of \>=50% of their Week 24 PASI improvement). Adult participants identified as both PASI 75 and IGA 0 or 1 score non-responders will continue to receive JNJ-77242113 through Week 52. From Week 52 to Week 156, all adult participants will receive JNJ-77242113. Adolescents will not participate in re-randomization regardless of their PASI score or IGA score at Week 24. Adolescents will continue to receive JNJ-77242113 from Week 0 through Week 156.

Experimental: Placebo - Adolescent and adult participants will receive JNJ-77242113 matching placebo from Week 0 to Week 16. Participants will cross-over to receive JNJ-77242113 from Week 16 through Week 156.


Treatment: Drugs: JNJ-77242113
JNJ-77242113 will be administered orally.

Treatment: Drugs: Placebo
Placebo will be administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>= )2-Grade Improvement From Baseline to Week 16
Timepoint [1] 0 0
Baseline to Week 16
Primary outcome [2] 0 0
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Timepoint [2] 0 0
Baseline to Week 16
Secondary outcome [1] 0 0
Percentage of Participants Achieving an IGA Score of 0 at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving PASI 75 Response at Weeks 4 and 16
Timepoint [2] 0 0
Baseline to Weeks 4 and 16
Secondary outcome [3] 0 0
Percentage of Participants Achieving PASI 90 Response at Week 8
Timepoint [3] 0 0
Baseline to Week 8
Secondary outcome [4] 0 0
Percentage of Participants Achieving PASI 100 Response at Week 16
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Percentage of Participants Achieving Scalp-specific Investigator Global Assessment (ss-IGA) Score of 0 or 1 and >=2 Grade Improvement Baseline to Week 16
Timepoint [5] 0 0
Baseline to Week 16
Secondary outcome [6] 0 0
Percentage of Participants Achieving Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16
Timepoint [6] 0 0
Weeks 8 and 16
Secondary outcome [7] 0 0
Percentage of Participants Achieving >=4-Point Improvement From Baseline in PSSD Itch Score to Weeks 4 and 16
Timepoint [7] 0 0
Baseline to Weeks 4 and 16
Secondary outcome [8] 0 0
Time to Loss of PASI 75
Timepoint [8] 0 0
Week 24 up to Week 52
Secondary outcome [9] 0 0
Time to Loss of PASI 90
Timepoint [9] 0 0
Week 24 up to Week 52
Secondary outcome [10] 0 0
Number of Participants with Treatment-emergent Adverse Events (AEs)
Timepoint [10] 0 0
Up to 160 weeks
Secondary outcome [11] 0 0
Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)
Timepoint [11] 0 0
Up to 160 weeks
Secondary outcome [12] 0 0
Change from Baseline in Body Surface Area (BSA) at Week 16
Timepoint [12] 0 0
Baseline to Week 16
Secondary outcome [13] 0 0
Change from Baseline in PASI Total Score to Week 16
Timepoint [13] 0 0
Baseline to Week 16
Secondary outcome [14] 0 0
Percent Improvement in PASI Score From Baseline to Week 16
Timepoint [14] 0 0
Baseline to Week 16
Secondary outcome [15] 0 0
Percentage of Participants Achieving a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and at Least a 2-grade Improvement in Genital Psoriasis From Baseline to Week 16
Timepoint [15] 0 0
Baseline to Week 16
Secondary outcome [16] 0 0
Percentage of Participants Achieving a Physician's Global Assessment of Hands and Feet (hf-PGA) Score of 0 or 1 and at Least a 2-grade Improvement at Week 16
Timepoint [16] 0 0
Week 16
Secondary outcome [17] 0 0
Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16
Timepoint [17] 0 0
Baseline to Week 16
Secondary outcome [18] 0 0
Percent of Participants Achieving Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16
Timepoint [18] 0 0
At Week 16
Secondary outcome [19] 0 0
Change From Baseline in PSSD Symptom Score to Week 16
Timepoint [19] 0 0
Baseline to Week 16
Secondary outcome [20] 0 0
Change From Baseline in PSSD Sign Score to Week 16
Timepoint [20] 0 0
Baseline to Week 16
Secondary outcome [21] 0 0
Percentage of Participants Achieving PSSD Sign Score of 0 at Week 16
Timepoint [21] 0 0
Week 16
Secondary outcome [22] 0 0
Percentage of Participants Achieving Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16
Timepoint [22] 0 0
Week 16
Secondary outcome [23] 0 0
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
Timepoint [23] 0 0
Week 16
Secondary outcome [24] 0 0
Change From Baseline in Total DLQI Score at Week 16
Timepoint [24] 0 0
Baseline to Week 16
Secondary outcome [25] 0 0
Change from Baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16
Timepoint [25] 0 0
Baseline to Week 16
Secondary outcome [26] 0 0
Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16
Timepoint [26] 0 0
Week 16
Secondary outcome [27] 0 0
Change From Baseline in CDLQI at Week 16
Timepoint [27] 0 0
Baseline to Week 16
Secondary outcome [28] 0 0
Change From Baseline in the Domain Scores of the PROMIS-25 Pediatric Score at Week 16
Timepoint [28] 0 0
Baseline to Week 16
Secondary outcome [29] 0 0
Percentage of Participants Achieving IGA Score of 0 at Week 52
Timepoint [29] 0 0
Week 52
Secondary outcome [30] 0 0
Percentage of Participants Achieving PASI 100 Response at Week 52
Timepoint [30] 0 0
Week 52
Secondary outcome [31] 0 0
Time to Loss of IGA 0 to 1 Response
Timepoint [31] 0 0
Week 24 to Week 52
Secondary outcome [32] 0 0
Percentage of Adolescent Participants Achieving IGA Score of 0 or 1 and >=2 Improvement From Baseline to Week 52
Timepoint [32] 0 0
Baseline to Week 52
Secondary outcome [33] 0 0
Percentage of Adolescent Participants Achieving PASI 75 Response at Week 52
Timepoint [33] 0 0
Baseline to Week 52
Secondary outcome [34] 0 0
Percentage of Adolescent Participants Achieving PASI 90 Response at Week 52
Timepoint [34] 0 0
Baseline to Week 52

Eligibility
Key inclusion criteria
* Diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 weeks prior to the first administration of study intervention
* Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
* Total psoriasis area and severity index (PASI) >=12 at screening and baseline
* Total investigator global assessment (IGA) >=3 at screening and baseline
* Candidate for phototherapy or systemic treatment for plaque psoriasis
* A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
* Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* 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
* Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
* Major surgical procedures, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from a surgical procedure or has a surgical procedure planned during the time the participant is expected to participate in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/04/2027
Actual
Sample size
Target
Accrual to date
Final
684
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Dr Rodney Sinclair Pty Ltd - East Melbourne
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Kingsway Dermatology & Aesthetics - Miranda
Recruitment hospital [4] 0 0
ISHI dermatology - Mitcham
Recruitment hospital [5] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [6] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
2228 - Miranda
Recruitment postcode(s) [4] 0 0
3132 - Mitcham
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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Illinois
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Indiana
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Minnesota
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Nebraska
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Alcorcon
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Alicante
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Barcelona
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Bilbao
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Madrid
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Valencia
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Reading
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Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06095115