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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06878404




Registration number
NCT06878404
Ethics application status
Date submitted
13/03/2025
Date registered
17/03/2025

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis
Scientific title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-naïve Participants With Active Psoriatic Arthritis
Secondary ID [1] 0 0
77242113PSA3001
Secondary ID [2] 0 0
77242113PSA3001
Universal Trial Number (UTN)
Trial acronym
ICONIC-PsA 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Psoriatic 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Icotrokinra
Treatment: Drugs - Placebo
Treatment: Drugs - Active reference comparator

Experimental: Group I: Icotrokinra Dose 1 - Participants will receive icotrokinra dose 1. Participants who continue into a long term extension (LTE) will continue to receive icotrokinra dose 1.

Experimental: Group II: Icotrokinra Dose 2 - Participants will receive icotrokinra dose 2. Participants who continue into a LTE will continue to receive icotrokinra dose 2.

Placebo comparator: Group III: Placebo - Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra dose 1 or dose 2. Participants who continue into the LTE will continue to receive icotrokinra dose 1 or dose 2.

Active comparator: Group IV: Active Reference Comparator - Participants will receive active reference drug. Participants who continue into a LTE will cross-over to receive icotrokinra dose 1 or dose 2.


Treatment: Drugs: Icotrokinra
Icotrokinra will be administered.

Treatment: Drugs: Placebo
Placebo will be administered.

Treatment: Drugs: Active reference comparator
Active reference drug will be administered.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants who Achieve an American College of Rheumatology (ACR) ACR 20 Response at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Proportion of Participants Who Achieve Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than Equal to (>=) 3 Percent (%) and an IGA Score of >=2 at Baseline
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Proportion of Participants Who Achieve PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Proportion of Participants Who Achieve PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Proportion of Participants with an Investigator Global Assessment (IGA) Psoriasis Score of 0 or 1 And >=2 Grade Improvement From Baseline at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Proportion of Participants who Achieve an ACR 50 Response at Week 16
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Proportion of Participants who Achieve an ACR 70 Response at Week 16
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16
Timepoint [7] 0 0
From Baseline to Week 16
Secondary outcome [8] 0 0
Changes From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
Timepoint [8] 0 0
From Baseline to Week 16
Secondary outcome [9] 0 0
Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
Change From Baseline in Enthesitis Score (LEI) at Week 16 in Participants With Enthesitis at Baseline
Timepoint [10] 0 0
From Baseline to Week 16
Secondary outcome [11] 0 0
Proportion of Participants With Resolution of Dactylitis at Week 16 Among Those With Dactylitis at Baseline
Timepoint [11] 0 0
Week 16
Secondary outcome [12] 0 0
Change From Baseline in Dactylitis Score at Week 16 in Participants With Dactylitis at Baseline
Timepoint [12] 0 0
From Baseline to Week 16
Secondary outcome [13] 0 0
Proportion of Participants who Achieve Minimal Disease Activity (MDA) at Week 16
Timepoint [13] 0 0
Week 16
Secondary outcome [14] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16
Timepoint [14] 0 0
From Baseline to Week 16

Eligibility
Key inclusion criteria
* Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) at screening
* Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (b) C-reactive protein (CRP) greater than or equal to (>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory
* Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
* Have active plaque psoriasis with at least one psoriatic plaque of >= 2 cm diameter or nail changes consistent with psoriasis
* A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has previously received any biologic disease-modifying antirheumatic drugs (DMARDs) for PsA or psoriasis
* Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
* Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients
* Has other inflammatory diseases that might confound the evaluations of benefit of icotrokinra therapy, including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus, or lyme disease
* Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator's opinion, would have potential to interfere with efficacy assessments

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
21/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/12/2028
Actual
Sample size
Target
540
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ipswich Hospital - Ipswich
Recruitment hospital [2] 0 0
Rheumatology Research Unit - Maroochydore
Recruitment hospital [3] 0 0
BJC Health - Parramatta
Recruitment postcode(s) [1] 0 0
4305 - Ipswich
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
2150 - Parramatta
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
China
State/province [2] 0 0
Beijing
Country [3] 0 0
China
State/province [3] 0 0
ChangSha
Country [4] 0 0
China
State/province [4] 0 0
Chengdu
Country [5] 0 0
China
State/province [5] 0 0
Guangzhou
Country [6] 0 0
China
State/province [6] 0 0
Guiyang
Country [7] 0 0
China
State/province [7] 0 0
Linyi City
Country [8] 0 0
China
State/province [8] 0 0
Nantong
Country [9] 0 0
China
State/province [9] 0 0
Pingxiang
Country [10] 0 0
China
State/province [10] 0 0
Shanghai
Country [11] 0 0
China
State/province [11] 0 0
Shijiazhuang
Country [12] 0 0
China
State/province [12] 0 0
Taiyuan
Country [13] 0 0
China
State/province [13] 0 0
Wenzhou
Country [14] 0 0
China
State/province [14] 0 0
Zhenjiang
Country [15] 0 0
Denmark
State/province [15] 0 0
Svendborg
Country [16] 0 0
Denmark
State/province [16] 0 0
Vejle
Country [17] 0 0
Japan
State/province [17] 0 0
Itabashi Ku
Country [18] 0 0
Japan
State/province [18] 0 0
Oita
Country [19] 0 0
Japan
State/province [19] 0 0
Osaka
Country [20] 0 0
Japan
State/province [20] 0 0
Sasebo
Country [21] 0 0
Japan
State/province [21] 0 0
Tokyo
Country [22] 0 0
Japan
State/province [22] 0 0
Tsu
Country [23] 0 0
Spain
State/province [23] 0 0
Cordoba
Country [24] 0 0
Spain
State/province [24] 0 0
Sevilla
Country [25] 0 0
Taiwan
State/province [25] 0 0
Hsin Chu
Country [26] 0 0
Taiwan
State/province [26] 0 0
Kaohsiung City
Country [27] 0 0
Taiwan
State/province [27] 0 0
Taipei
Country [28] 0 0
Taiwan
State/province [28] 0 0
Taoyuan
Country [29] 0 0
Thailand
State/province [29] 0 0
Songkhla

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
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


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/NCT06878404