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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06934226




Registration number
NCT06934226
Ethics application status
Date submitted
11/04/2025
Date registered
18/04/2025
Date last updated
23/05/2025

Titles & IDs
Public title
A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis
Scientific title
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Ustekinumab Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Secondary ID [1] 0 0
77242113PSO3006
Secondary ID [2] 0 0
77242113PSO3006
Universal Trial Number (UTN)
Trial acronym
ICONIC-ASCEND
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 - Matching Placebo to JNJ-77242113
Treatment: Drugs - Ustekinumab
Treatment: Drugs - Matching Placebo to Ustekinumab

Experimental: Arm 1: JNJ 77242113 - Participants will receive JNJ-77242113 once daily from Week 0 through Week 104. All participant will receive ustekinumab matching placebo at Week 0, 4 and 16 to maintain the blind.

Placebo comparator: Arm 2: Placebo - Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for ustekinumab at Week 0, 4 and 16 and JNJ-77242113 from Week 16 through Week 104.

Active comparator: Arm 3: Ustekinumab - Participants will receive Ustekinumab at Week 0, Week 4, and Week 16 followed by JNJ-77242113 once daily from Week 28 through Week 104. Participants will receive both Ustekinumab and placebo for JNJ-77242113 to maintain the blind through Week 28.


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

Treatment: Drugs: Matching Placebo to JNJ-77242113
Matching placebo will be administered orally.

Treatment: Drugs: Ustekinumab
Ustekinumab will be administered subcutaneously.

Treatment: Drugs: Matching Placebo to Ustekinumab
Matching placebo will be administered subcutaneously.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants with Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater than or Equal to (>=) 2 Grade Improvement from Baseline at Week 16
Timepoint [1] 0 0
Week 16
Primary outcome [2] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Timepoint [2] 0 0
Week 16
Secondary outcome [1] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 75 Response at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 100 Response at Week 16
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants with IGA Score of 0 at Week 16
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
JNJ-77242113 and Ustekinumab Group: Percentage of Participants with IGA Score of 0 at Week 28
Timepoint [4] 0 0
Week 28
Secondary outcome [5] 0 0
JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 90 Response at Week 28
Timepoint [5] 0 0
Week 28
Secondary outcome [6] 0 0
JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 100 Response at Week 28
Timepoint [6] 0 0
Week 28
Secondary outcome [7] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants with PSSD Symptom Score of 0 at Week 16
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants with >= 4 Point Improvement from Baseline in PSSD Itch Score at Week 16
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [9] 0 0
Up to Week 108
Secondary outcome [10] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants with PSSD Sign Score of 0 at Week 16
Timepoint [10] 0 0
Week 16
Secondary outcome [11] 0 0
JNJ-77242113 and Placebo Group: Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
Timepoint [11] 0 0
Baseline up to Week 16
Secondary outcome [12] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants with DLQI Score of 0 or 1 at Week 16
Timepoint [12] 0 0
Week 16
Secondary outcome [13] 0 0
JNJ-77242113 and Placebo Group: Change from Baseline in Body Surface Area (BSA) Score at Week 16
Timepoint [13] 0 0
Baseline up to Week 16
Secondary outcome [14] 0 0
JNJ-77242113 and Ustekinumab Group: Percentage of Participants with >= 4 Point Improvement from Baseline in PSSD Itch Score at Week 28
Timepoint [14] 0 0
Week 28
Secondary outcome [15] 0 0
JNJ-77242113 and Ustekinumab Group: Change from Baseline in PSSD Sign Score at Week 28
Timepoint [15] 0 0
Baseline up to Week 28
Secondary outcome [16] 0 0
JNJ-77242113 and Ustekinumab Group: Change from Baseline in PSSD Symptom Score at Week 28
Timepoint [16] 0 0
Baseline up to Week 28
Secondary outcome [17] 0 0
JNJ-77242113 and Ustekinumab Group: Percentage of Participants with PSSD Sign Score of 0 at Week 28
Timepoint [17] 0 0
Week 28
Secondary outcome [18] 0 0
JNJ-77242113 and Ustekinumab Group: Percentage of Participants with PSSD Symptom Score of 0 at Week 28
Timepoint [18] 0 0
Week 28
Secondary outcome [19] 0 0
JNJ-77242113 and Ustekinumab Group: Change from Baseline in DLQI Score at Week 28
Timepoint [19] 0 0
Baseline up to Week 28
Secondary outcome [20] 0 0
JNJ-77242113 and Ustekinumab Group: Percentage of Participants with DLQI Score of 0 or 1 at Week 28
Timepoint [20] 0 0
Week 28
Secondary outcome [21] 0 0
JNJ-77242113 and Ustekinumab Group: Change from Baseline in BSA Score at Week 16
Timepoint [21] 0 0
Baseline up to Week 16
Secondary outcome [22] 0 0
JNJ-77242113 and Ustekinumab Group: Percentage of Participants with IGA Score of 0 at Week 16
Timepoint [22] 0 0
Week 16
Secondary outcome [23] 0 0
JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 90 Response at Week 16
Timepoint [23] 0 0
Week 16
Secondary outcome [24] 0 0
JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 100 Response at Week 16
Timepoint [24] 0 0
Week 16

Eligibility
Key inclusion criteria
* Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), 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
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 [e.g.], erythrodermic, guttate, or pustular)
* Current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* Known allergies, hypersensitivity, or intolerance to JNJ-77242113, ustekinumab, or its excipients
* Major surgical procedure 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
* Transplanted organ (with exception of a corneal transplant greater than [>] 12 weeks before the first administration of study intervention)

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/04/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/12/2027
Actual
Sample size
Target
675
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cornerstone Dermatology - Coorparoo
Recruitment hospital [2] 0 0
Premier Specialists - Kogarah
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [5] 0 0
ISHI dermatology - Mitcham
Recruitment postcode(s) [1] 0 0
4151 - Coorparoo
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Melbourne
Recruitment postcode(s) [5] 0 0
3132 - Mitcham
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
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Ohio
Country [14] 0 0
United States of America
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Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Dakota
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
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Utah
Country [20] 0 0
United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Caba
Country [23] 0 0
Argentina
State/province [23] 0 0
Rosario
Country [24] 0 0
Argentina
State/province [24] 0 0
Tucuman
Country [25] 0 0
Belgium
State/province [25] 0 0
Gent
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Belgium
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Ghent
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Canada
State/province [27] 0 0
Ontario
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Canada
State/province [28] 0 0
Quebec
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Denmark
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Hellerup
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Denmark
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Kobenhavn NV
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Denmark
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Odense
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Denmark
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Roskilde
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Germany
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Bad Bentheim
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Germany
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Berlin
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Germany
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Bramsche
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Germany
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Darmstadt
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Germany
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Friedrichshafen
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Germany
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Kiel
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Germany
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Langenau
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Germany
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Mahlow
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Germany
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Mainz
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Germany
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Muenster
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Germany
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Witten
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Hungary
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Budapest
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Hungary
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Debrecen
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Gyongyos
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Hungary
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Gyula
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Hungary
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Hodmezovasarhely
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Hungary
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Kaposvar
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Hungary
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Kecskemet
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Hungary
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Szolnok
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Hungary
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Veszprem
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Poland
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Bialystok
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Elblag
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Katowice
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Krakow
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Lodz
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Olsztyn
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Poznan
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Warszawa
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Wroclaw
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Portugal
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Braga
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Portugal
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Leiria
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Portugal
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Lisboa
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Portugal
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Porto
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Granada
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Spain
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Madrid
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Spain
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Manises
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Spain
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Santiago Compostela
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Villajoyosa
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Spain
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Zaragoza
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United Kingdom
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Harrow
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United Kingdom
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Kings Lynn
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United Kingdom
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London
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United Kingdom
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Reading
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United Kingdom
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Salford
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United Kingdom
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Southampton
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United Kingdom
State/province [82] 0 0
Wakefield

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
[email protected]
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 Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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://innovativemedicine.jnj.com/our-innovation/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/NCT06934226