CTRI/2025/04/084370 [Registered on: 08/04/2025] Trial Registered Prospectively
Last Modified On:
12/01/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
A Study of the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants with Active Psoriatic Arthritis
Scientific Title of Study
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
Trial Acronym
ICONIC-PsA 1
Secondary IDs if Any
Secondary ID
Identifier
2023-509239-19
EudraCT
77242113PSA3001 Amendment1 dated 18 Nov 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sanish Davis
Designation
R and D Director GCO India
Affiliation
Johnson and Johnson Private Limited
Address
Janssen Pharmaceutical Companies of Johnson and Johnson Private Limited Arena Space, Jogeshwari East Mumbai MAHARASHTRA 400060 India
Phone
919820958943
Fax
Email
sdavis20@its.jnj.com
Details of Contact Person Scientific Query
Name
Dr Sanish Davis
Designation
R and D Director GCO India
Affiliation
Johnson and Johnson Private Limited
Address
Janssen Pharmaceutical Companies of Johnson and Johnson Private Limited Arena Space, Jogeshwari East Mumbai MAHARASHTRA 400060 India
Phone
919820958943
Fax
Email
sdavis20@its.jnj.com
Details of Contact Person Public Query
Name
Dr Sanish Davis
Designation
R and D Director GCO India
Affiliation
Johnson and Johnson Private Limited
Address
Janssen Pharmaceutical Companies of Johnson and Johnson Private Limited Arena Space, Jogeshwari East Mumbai MAHARASHTRA 400060 India
Phone
919820958943
Fax
Email
sdavis20@its.jnj.com
Source of Monetary or Material Support
Johnson and Johnson Private Limited Arena Space Jogeshwari East Mumbai MAHARASHTRA
Primary Sponsor
Name
Johnson and Johnson Private Limited
Address
L. B. S. Marg, Mulund West Maharashtra – 400080 India
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NA
NA
Countries of Recruitment
Argentina Australia Bulgaria China Denmark Germany Hong Kong Hungary India Japan Poland Spain Taiwan Thailand United States of America
Room no 2222, Department Clinical Immunology and Rheumatology, JSS Hospital Mahatma Gandhi Road, Fort Mohalla, Mysuru, Karnataka-570004 Mysore KARNATAKA
9902475755
drshivaravi@gmail.com
Dr Jyotsna Oak
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
First floor, Rao Saheb, Rao Saheb Achutrao Patwardhan Marg, Four Bungalows, Andheri West, Mumbai- 400053 Mumbai MAHARASHTRA
9324717618
jyotsna.oak@kokilabenhospitals.com
Dr Reena Sharma
Marengo CIMS hospital
Clinical Research department, West wing, Marengo CIMS hospital, plot no.67/1 Near Shukan Mall, Off Science City Road, Sola, 380060, Ahmedabad Ahmadabad GUJARAT
9978662400
reena141@gmail.com
Dr Amirtha Gopalan
Nizams Institute of Medical Sciences
Millennium Block, 4th floor, Department of Clinical immunology and rheumatology, Punjagutta Rd, Punjagutta, Hyderabad, Telangana-500082 Hyderabad TELANGANA
8971074763
amirtha.192@gmail.com
Dr Alpana Parmar
SIDS Hospital and Research Centre
Clinical Research Department, Ground floor, Off Ring Road, Near Shell Petrol Pump, Ring Road, Sosyo Circle Lane-Surat, Gujrat-395002 Surat GUJARAT
Participants will receive icotrokinra Dose 1 once daily up to Week 52. Participants who continue into a long term extension (LTE till 104 weeks) will continue to receive icotrokinra dose 1.
Intervention
JNJ-77242113 (Icotrokinra) dose 2
Participants will receive icotrokinra Dose 2 once daily up to Week 52. Participants who continue into a long term extension (LTE till 104 weeks) will continue to receive icotrokinra dose 2.
Comparator Agent
Placebo
Participants will receive icotrokinra placebo once daily upto week 16 and will be crossed over to receive icotrokinra dose 1 or dose 2 after week16. Participants who continue into a long term extension (LTE till 104 weeks) will continue to receive icotrokinra dose 1 or dose 2.
Comparator Agent
Ustekinumab
Participants will receive active reference drug, ustekinumab till Week 52. Dose: 90 mg or 45 mg
Route of Administration: subcutaneous
Frequency: initial dose
(Week 0), 4 weeks, then
every 12 weeks thereafter (Week 16, 28, and 40)
injection as per local label. Participants who continue into a long term extension (LTE till 104 weeks) will crossed over to receive icotrokinra dose 1 or dose 2 in LTE.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
-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 per 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 greater than or equal to 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
ExclusionCriteria
Details
- 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
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Proportion of Participants who Achieve an American College of Rheumatology ACR 20 Response
Week 16
Secondary Outcome
Outcome
TimePoints
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 Greater Than Equal to 2 at Baseline
Week 16
Proportion of Participants Who Achieve PASI 90 Response at Week 16 Among Participants with Baseline BSA Greater Than Equal to 3 percent and an IGA Score of Greater Than Equal to 2 at Baseline
Week 16
Proportion of Participants Who Achieve PASI 100 Response at Week 16 Among Participants with Baseline BSA Greater Than Equal to 3 percent and an IGA Score of Greater Than Equal to 2 at Baseline
Week 16
Proportion of Participants with an Investigator Global Assessment (IGA) Psoriasis Score of 0 or 1 And Greater Than Equal to 2 Grade Improvement From Baseline at Week 16 Among Participants with Baseline BSA Greater Than Equal to 3 percent and an IGA Score of Greater Than Equal to 2 at Baseline
Week 16
Proportion of Participants who Achieve an ACR 50 Response at Week 16. The ACR 50 responders are participants with an improvement of Greater Than Equal to 50 percent from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patients assessment of pain VAS, patients global assessment of disease activity VAS scale, physicians global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).
Week 16
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16. The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional area are scored from 0 to 3 (0-no difficulty and
3-inability to perform a task in that area). Overall score is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range is 0-3 where 0 - least difficulty and 3 - extreme difficulty.
From baseline to Week 16
Changes From Baseline in 36 Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains are averaged to calculate PCS. Total score range for PCS is 0-100 (100-highest level of physical functioning).
From baseline to Week 16
Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to lateral elbow epicondyle, left and right, medial femoral condyle, left and right, and achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score, 6 sites with tenderness). Resolution is defined as participants have enteritis (LEI score greater than 0) at baseline and no enthesis (LEO score -0) at the visit (week 16).
week 16
Change From Baseline in Enthesitis Score (LEI) at Week 16 in Participants With Enthesitis at Baseline Enthesitis will be assessed using the LEI. The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI total scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
From baseline to Week 16
Proportion of Participants who Achieve Minimal Disease Activity (MDA) at Week 16 MDA criteria are a composite of 7 outcome measures used in PsA. Participants are classified as achieving MDA if they fulfill 5 of 7 outcome measures: tender joint count less than or equal to 1; swollen joint count less than or equal to 1; psoriasis activity and severity index less than or equal to 1 or body surface area less than or equal to 3, patient pain VAS score of less than or equal to 15, patient global disease activity VAS (arthritis and psoriasis) score of less than or equal to 20, health assessment questionnaire (HAQ) score less than or equal to 0.5, and tender entheseal points less than or equal to 1.
Week 16
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16 The FACIT-fatigue is a self-administered, 13 item questionnaire measuring items on tiredness, weakness, and difficulty conducting usual activities due to fatigue. Responses to all items are rated on a 5-point likert response scale ranging from 0 -not at all to 4 -very much. The total score ranges from 0 to 52, with higher values indicating less fatigue.
From baseline to Week 16
Target Sample Size
Total Sample Size="540" Sample Size from India="72" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Active psoriatic arthritis (PsA) is a chronic disease that causes joint pain and swelling. Participants may also have red patches on their skin. Psoriatic arthritis can affect any joint in the body, including fingers, toes, knees, and the spine. This can make it harder to move around and do everyday tasks.
The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
This study is a 52-week main study with a 52-week blinded long term extension (LTE). The main study will consist of screening period (up to 5 weeks), blinded active-reference and placebo-controlled period (up to 16 weeks), blinded active-reference period (up to 36 weeks) and safety follow-up visit (4 weeks after the last dose of the study intervention, i.e., up to Week 56).
All participants that complete the main study will have an option to participate in the 52-week blinded LTE period (48 weeks of active treatment plus 4 weeks of safety follow-up).