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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06220604




Registration number
NCT06220604
Ethics application status
Date submitted
15/01/2024
Date registered
24/01/2024

Titles & IDs
Public title
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)
Scientific title
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
Secondary ID [1] 0 0
77242113PSO3004
Secondary ID [2] 0 0
77242113PSO3004
Universal Trial Number (UTN)
Trial acronym
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 - JNJ-77242113 Matching Placebo
Treatment: Drugs - Deucravacitinib
Treatment: Drugs - Deucravacitinib Matching Placebo

Experimental: JNJ-77242113 - Participants will receive JNJ-77242113 from Week 0 through Week 156 and deucravacitinib matching placebo from Week 0 through Week 24.

Placebo comparator: Placebo - Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for deucravacitinib from Week 0 through Week 24 and JNJ-77242113 from Week 16 through Week 156.

Active comparator: Deucravacitinib - Participants will receive deucravacitinib from Week 0 through Week 24 and matching placebo for JNJ-77242113 from Week 0 through Week 24 and JNJ-77242113 from Week 24 through Week 156.


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

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

Treatment: Drugs: Deucravacitinib
Deucravacitinib will be administered orally.

Treatment: Drugs: Deucravacitinib Matching Placebo
Deucravacitinib matching placebo will be administered orally.
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 Achieving an 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
Baseline and 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
Baseline and Week 16
Secondary outcome [1] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving an IGA Score of 0 at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 75 Response at Weeks 4 and 16
Timepoint [2] 0 0
Baseline, Weeks 4 and 16
Secondary outcome [3] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 90 Response at Week 8
Timepoint [3] 0 0
Baseline and Week 8
Secondary outcome [4] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 100 Response at Week 16
Timepoint [4] 0 0
Baseline and Week 16
Secondary outcome [5] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Scalp-specific Investigator Global Assessment (ss-IGA) Score of 0 or 1 and a >=2-grade Improvement From Baseline at Week 16
Timepoint [5] 0 0
Baseline and Week 16
Secondary outcome [6] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Symptom and Sign Diary (PSSD) Symptoms Score of 0 at Weeks 8 and 16
Timepoint [6] 0 0
Weeks 8 and 16
Secondary outcome [7] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving >=4 Point Improvement From Baseline in PSSD Itch Score at Weeks 4 and 16
Timepoint [7] 0 0
Baseline, Weeks 4 and 16
Secondary outcome [8] 0 0
JNJ-77242113 and Deucravacitinib Group: : Percentage of Participants Achieving an IGA Score of 0 or 1 and >=2 Grade Improvement From Baseline at Weeks 16 and 24
Timepoint [8] 0 0
Baseline, Weeks 16 and 24
Secondary outcome [9] 0 0
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving an IGA Score of 0 at Weeks 16 and 24
Timepoint [9] 0 0
Weeks 16 and 24
Secondary outcome [10] 0 0
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 75 Response at Weeks 16 and 24
Timepoint [10] 0 0
Baseline, Weeks 16 and 24
Secondary outcome [11] 0 0
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 90 Response at Weeks 16 and 24
Timepoint [11] 0 0
Baseline, Weeks 16 and 24
Secondary outcome [12] 0 0
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 100 Response at Weeks 16 and 24
Timepoint [12] 0 0
Weeks 16 and 24
Secondary outcome [13] 0 0
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants With PSSD Symptom Score of 0 at Week 16
Timepoint [13] 0 0
Week 16
Secondary outcome [14] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [14] 0 0
Up to 165 weeks
Secondary outcome [15] 0 0
Number of Participants with Serious Adverse Events (SAEs)
Timepoint [15] 0 0
Up to 165 weeks
Secondary outcome [16] 0 0
Change From Baseline in Body Surface Area (BSA) at Week 16
Timepoint [16] 0 0
Baseline and Week 16
Secondary outcome [17] 0 0
Change from Baseline in PASI Score at Week 16
Timepoint [17] 0 0
Baseline and Week 16
Secondary outcome [18] 0 0
Percent Improvement in PASI Score From Baseline at Week 16
Timepoint [18] 0 0
Baseline and Week 16
Secondary outcome [19] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and >=2-grade Improvement From Baseline to Week 16
Timepoint [19] 0 0
Baseline and Week 16
Secondary outcome [20] 0 0
JNJ-77242113 and Placebo Group: 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 From Baseline to Week 16
Timepoint [20] 0 0
Baseline and Week 16
Secondary outcome [21] 0 0
JNJ-77242113 and Placebo Group: Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16
Timepoint [21] 0 0
Baseline and Week 16
Secondary outcome [22] 0 0
JNJ-77242113 and Placebo Group: Percent of Participants Achieving Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16
Timepoint [22] 0 0
Week 16
Secondary outcome [23] 0 0
JNJ-77242113 and Placebo Group: Change From Baseline in PSSD Symptom Score at Week 16
Timepoint [23] 0 0
Baseline and Week 16
Secondary outcome [24] 0 0
JNJ-77242113 and Placebo Group: Change From Baseline in PSSD Sign Score at Week 16
Timepoint [24] 0 0
Baseline and Week 16
Secondary outcome [25] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants With PSSD Sign Score of 0 at Week 16
Timepoint [25] 0 0
Week 16
Secondary outcome [26] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16
Timepoint [26] 0 0
Week 16
Secondary outcome [27] 0 0
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Total Score of 0 or 1 at Week 16
Timepoint [27] 0 0
Week 16
Secondary outcome [28] 0 0
JNJ-77242113 and Placebo Group: Change From Baseline in Total DLQI Score at Week 16
Timepoint [28] 0 0
Baseline and Week 16
Secondary outcome [29] 0 0
JNJ-77242113 and Placebo Group: Change from Baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16
Timepoint [29] 0 0
Baseline and Week 16
Secondary outcome [30] 0 0
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving DLQI Score of 0 or 1 at Weeks 16 and 24
Timepoint [30] 0 0
Weeks 16 and 24
Secondary outcome [31] 0 0
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PSSD Symptom Score of 0 at Week 24
Timepoint [31] 0 0
Week 24
Secondary outcome [32] 0 0
Percentage of Participants Who Achieve PASI 75 Response After Week 24 Among PASI 75 Non-responders to Deucravacitinib at Week 24
Timepoint [32] 0 0
Baseline and from Week 24 through Week 156
Secondary outcome [33] 0 0
Percentage of Participants Who Achieve PASI 90 Response After Week 24 Among PASI 90 Non-responders to Deucravacitinib at Week 24
Timepoint [33] 0 0
Baseline and from Week 24 through Week 156
Secondary outcome [34] 0 0
Percentage of Participants Achieving IGA Score of 0 or 1 after Week 24, Among Participants with IGA score >=2 at Week 24 in the Deucravacitinib Group
Timepoint [34] 0 0
From Week 24 through Week 156

Eligibility
Key inclusion criteria
* Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), 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
Minimum age
18 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, deucravacitinib or to any of the excipients or components of the study intervention
* Major surgical procedure, (for example, 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

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
9/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/09/2027
Actual
Sample size
Target
Accrual to date
Final
731
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Skin Centre - Benowa
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
Premier Specialists - Kogarah
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
ISHI dermatology - Mitcham
Recruitment hospital [6] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
4217 - Benowa
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3132 - Mitcham
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Georgia
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United States of America
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Illinois
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Missouri
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Utah
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Virginia
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Botucatu
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Brazil
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Brasilia
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Brazil
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Ribeirao Preto
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Santo Andre
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Sao Paulo
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Kielce
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Krakow
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Warsaw
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Warszawa
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Wroclaw
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Cluj-Napoca
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Craiova
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Romania
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Iasi
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Romania
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Oradea
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Romania
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Targu Mures
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Timisoara
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Spain
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Alcorcon
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Badalona
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Barcelona
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Spain
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Manises
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Spain
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Salamanca
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Spain
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Sevilla
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Villajoyosa
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Zaragoza
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei

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 Clinicaltrial
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
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
Participate-In-This-Study@its.jnj.com
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/NCT06220604