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CTRI Number  CTRI/2026/02/104567 [Registered on: 24/02/2026] Trial Registered Prospectively
Last Modified On: 26/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to Evaluate the Efficacy and Safety of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis 
Scientific Title of Study   A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults with an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis 
Trial Acronym  ICONIC-UC 
Secondary IDs if Any  
Secondary ID  Identifier 
2025-521381-10  EudraCT 
77242113UCO3001 Amendment 1 dated 24 Jul 2025  Protocol Number 
NCT07196748  ClinicalTrials.gov 
 
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 Research and Development 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 Research and Development 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 Research and Development 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 Pvt Ltd. Arena Space Jogeshwari East, Mumbai.  
 
Primary Sponsor  
Name  Johnson and Johnson Private Limited  
Address  HIGI House, L. B. S. Marg, Mulund (West) Maharashtra (India) – 400080 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Brazil
China
India
Israel
Japan
Switzerland
Taiwan
United Kingdom
Australia
Belgium
Canada
Czech Republic
France
Germany
Greece
Hungary
Italy
Malaysia
Netherlands
Poland
Portugal
Romania
Spain
Sweden
Turkey
United States of America
Republic of Korea  
Sites of Study  
No of Sites = 19  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sudhir Kumar  All India Institute of Medical Sciences  All India Institute of Medical Sciences, Department of Gastroenterology, Aiims Patna Road, Phulwarisharif, Patna 801507, Bihar
Patna
BIHAR 		 917070953635

quantumsudhir@gmail.com  
Dr Rupa Banerjee  AIG Hospitals  AIG Hospitals, OPD Ground Floor, Room No 8, Inflammatory Bowel Disease, Plot No 2/3/4/5, Survey No 136, 1, Mindspace Road, Gachibowli, Hyderabad 500032, Telangana
Hyderabad
TELANGANA 		 919849287530

rupabanerjee.aig@gmail.com  
Dr Vineet Ahuja  All India Institute of Medical Sciences   All India Institute of Medical Sciences, Department of Gastroenterology, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi 110029, Delhi
New Delhi
DELHI 		 911126589070

vineet.aiims@gmail.com  
Dr Kayal Vizhi Nagarajan  ASTER CMI Hospital  ASTER CMI Hospital, #43/2, New Airport Road, NH.7, Sahakara Nagar. Hebbal, Bangaluru, Karnataka 560092, India
Bangalore
KARNATAKA 		 919986559403

kayal.doc@gmail.com  
Dr Vandana Midha   Dayanand Medical College and Hospital   Dayanand Medical College and Hospital, Tagore Nagar , Civil Lines , Ludhiana , Punjab , 141001 India
Ludhiana
PUNJAB 		 919815528289

vandana_midha2@yahoo.co.in  
Dr Nitin Behl   Fortis Hospitals  Fortis Hospitals,Chandigarh Road, near Radha Soami Satsang Bhavan, Mundian Kalan, Ludhiana, Punjab 141123, India
Ludhiana
PUNJAB 		 918427000080

nitin.behl@fortishealthcare.com  
Dr Gourdas Choudhuri   Fortis Memorial Research Institute   Fortis Memorial Research Institute, Sector - 44, Opposite Millenium City Centre Metro Station, Gurugram, 122002, Haryana, India
Gurgaon
HARYANA 		 9196506 43222

gourdas.choudhuri@fortishealthcare.com  
Dr Saumin P Shah   Gujarat Gastro and Vascular Hospital  Gujarat Gastro and Vascular Hospital, Opposite Shree Ram Petrol Pump, Anand Mahal Road, Adajan, Surat 395009, Gujarat, India.
Surat
GUJARAT 		 919408042224

dr.sauminpshah@gmail.com  
Dr Yogesh Batra   Indraprastha Apollo Hospitals  Department of Gastroenterology, Indraprastha Apollo Hospitals, Sarita Vihar, Delhi Mathura Road, New Delhi-110076, India
New Delhi
DELHI 		 919891226150

dryogeshbatra@gmail.com  
Dr Mathew Philip   Lisie Hospital  Lisie Hospital, P.B No. 3053, District Ernakulam, North Kaloor, Lisie Junction, Kochi, Kerala, India 682018
Ernakulam
KERALA 		 919846045469

drmathewphilip@gmail.com 
Dr Ashok Dalal  Maulana Azad Medical College and GB Pant Hospital  Maulana Azad Medical College and Govind Ballabh Pant Hospital, G B Pant Hospital (GIPMER), Dept. of Gastroenterology ,Academic Block, 2nd Floor, JLN Marg, New Delhi-110 002, India
New Delhi
DELHI 		 919718599219

drashokdalal83@gmail.com  
Dr Uday Nagesh Shivaji   Mazumdar Shaw Medical Centre -Narayana Health  Mazumdar Shaw Medical Center- a unit of Narayana Hrudayalya Limited No. 258/A, Bommasandra Industrial Area, Anekal Taluk, Bengaluru, Karnataka-560099, India
Bangalore
KARNATAKA 		 917204933468

udaynagesh.shivaji.dr@narayanahealth.org 
Dr Devendra Desai   P.D. Hinduja National Hospital and - Medical Research Center   P.D. Hinduja National Hospital and Medical Research Centre,1st Floor, OPD Wing, Veer Savarkar Marg, Mahim, Mumbai 400016, India
Mumbai
MAHARASHTRA 		 919322596152

devendracdesai@gmail.com 
Dr Mukesh Kalla   S. R. Kalla Memorial Gastro & General Hospital  S. R. Kalla Memorial Gastro & General Hospital, 78-79 Dhuleshwar Garden Behind HSBC Bank Sardar Patel Marg C Scheme Jaipur 302001 Rajasthan India
Jaipur
RAJASTHAN 		 919829050622

drmkalla@rediffmail.com 
Dr Mayank Kabrawala  SIDS Hospital and Research Centre  SIDS Hospital and Research Centre, A unit of SIDS Healthcare Pvt. Ltd., Off Ring Road, Near Shell Petrol Pump, Ring Road-Sosyo Circle lane, Surat-395002, Gujarat, India
Surat
GUJARAT 		 919825130363

mayankkabrawala@hotmail.com 
Dr Naresh Kumar Bansal  Sir Ganga Ram Hospital  Sir Ganga Ram Hospital, SGRH Marg, Rajinder Nagar, New Delhi-110060, India
New Delhi
DELHI 		 919310246832

drnbansal@ymail.com 
Dr Ayaskanta Singh  SUM Ultimate Medicare  SUM Ultimate Medicare, K-8 Kalinga Nagar, Ghatikia, Bhubaneshwar 751003, Orissa, India
Khordha
ORISSA 		 918260501643

ayaskant1ce@gmail.com 
Dr Kiran Kumar Peddi  Yashoda Healthcare Services Private Limited  Yashoda Healthcare Services Private Limited Raj Bhavan Road, Soumajiguda, Hyderabad, Telangana 500082 India
Hyderabad
TELANGANA 		 918121234888

kiranpeddi0@gmail.com 
Dr B Ravi Shankar  Yashoda Hospitals  Yashoda Hospitals, Yashoda Healthcare Private Limited S P Road, Secunderabad 500003, Telangana, India
Hyderabad
TELANGANA 		 91676996053

b_ravishankar@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 19  
Name of Committee  Approval Status 
Aster CMI Hospital Institutional Ethics Committee   Approved 
Institute Ethics Committee AIIMS Delhi  Submittted/Under Review 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee Asian Institute of Gastroenterology   Approved 
Institutional Ethics Committee Clinical Studies, Indraprastha Apollo Hospital   Approved 
Institutional Ethics Committee Fortis Gurgaon  Approved 
Institutional Ethics Committee Lisie Hospital  Approved 
Institutional Ethics Committee of MAMC  Submittted/Under Review 
Institutional Ethics Committee P.D. Hinduja National Hospital and MRC  Approved 
Institutional Ethics Committee Yashoda Academy of Medical Education and Research IEC-YAMER Dr Peddi  Approved 
Institutional Ethics Committee Yashoda Academy of Medical Education and Research IEC-YAMER Dr Ravi B  Approved 
Institutional Ethics Committee-AIIMS Patna  Approved 
Institutional Ethics Committee-Clinical Research and Studies  Approved 
Narayana Health Medical Ethics Committee  Approved 
S. R. Kalla Memorial Ethical Committee For Human Research  Approved 
Sir Ganga Ram Hospital Ethics Committee   Approved 
Surat Institute of Digestive Sciences Ethics Committee  Approved 
The Chairman Drug Trial Ethics Committee   Approved 
Unity Hospital Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K519||Ulcerative colitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Icotrokinra Dose 1   Participants will receive oral Icotrokinra once daily. Route: Oral Frequency: Once daily. Total duration: Adult Participant Induction: starting at induction Week 0 (Week I-0) through Week I-12. Maintenance: Clinical response to induction treatment with icotrokinra (icotrokinra clinical responders) will be randomized to icotrokinra or placebo (2:1) during the maintenance study, receiving icotrokinra or placebo daily, orally starting at maintenance week 0 (Week M-0) through Week M-40. In addition, participants without clinical response to icotrokinra (icotrokinra clinical nonresponders) will enter maintenance study directly and continue to receive icotrokinra daily dosing. Adolescent participant: Participants will receive icotrokinra in induction 12 weeks and maintenance 40 weeks.  
Comparator Agent  Placebo   Participants will receive oral matching Placebo once daily. Route: Oral Frequency: Once daily. Total duration: Adult: Induction: Participants will receive placebo daily in induction study, starting at Week I-0 through Week I-12. Maintenance. Participants in clinical response to placebo (placebo clinical responders) will receive placebo daily, orally starting at Week M-0 through Week M-40. Participants with clinical response to placebo (placebo clinical responders) will also enter maintenance study directly and continue to receive placebo daily dosing. Participants without clinical response to placebo (placebo clinical nonresponders) will enter maintenance study directly and receive icotrokinra daily dosing. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC.

2. Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy.

3. An endoscopy subscore greater than or equal to 2 as obtained during central review of the screening video endoscopy.

4. For adolescent participants greater than or equal to 12 to less than 18 years of age, body weight must be greater than equal to 40 kilograms (kg) at baseline (Week I-0)
5. 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 I-0 prior to administration of study intervention and agree to further pregnancy tests
6. Demonstrated an inadequate response, loss of response, or failure to tolerate previous conventional therapy (advanced drug therapy ADT naive) or advanced therapy defined as biologics and or advanced oral agents for the treatment of UC (ADT-inadequate responder) as defined in the protocol  
 
ExclusionCriteria 
Details  1. Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study

2. Presence of a stoma

3. Presence or history of a fistula

4. Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed within 12 weeks before baseline

5. History of extensive colonic resection (that is, less than 30 centimeter of colon remaining) or colonic resection that could impair the use of disease severity assessments (for example Mayo Score) to assess response to study intervention 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Adult Participants
1. Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12

2.Double Blind Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40

Adolescent Participants
1.Open-Label (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40 		 Adult Participants
For Double-blind Induction Study-Week I-12
For Double Blind Maintenance Study Week M-40
Adolescent Participants
Open Label Maintenance Phase-Week M-40 
 
Secondary Outcome  
Outcome  TimePoints 
Double Blind Induction Study: Percentage of Adult Participants in Clinical Response   At Week 12 
Double Blind Induction Study: Percentage of Adult Participants with Endoscopic Improvement  At Week 12 
Double Blind Induction Study: Percentage of Adult Participants in Symptomatic Remission   At Week 12 
Double Blind Induction Study: Percentage of Adult Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Remission   At Week 12 
Double Blind Induction Study: Percentage of Adult Participants with Histologic-Endoscopic Mucosal Improvement (HEMI)   At Week 12 
Double Blind Induction Study: Percentage of Adult Participants with Fatigue Response  At Week 12 
DB Induction Study: Percentage of Adult Participants in Symptomatic Remission   At Week 4 
Double Blind Induction Study: Percentage of Adult Participants in Endoscopic Remission   At Week 12 
Double Blind Induction Study: Percentage of Adult Participants with No Bowel Urgency   At Week 12 
Double Blind Induction Study: Percentage of Adult Participants with No Abdominal Pain   At Week 12 
Double Blind Induction Study: Percentage of Adult Participants with No Bowel Incontinence  At Week 12 
Double Blind Induction Study: Percentage of Adult Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)   At Week 12 
Double Blind Maintenance Study: Percentage of Adult Participants with Endoscopic Improvement  At Week 40 
Double Blind Maintenance Study: Percentage of Adult Participants in Symptomatic Remission   At Week 40 
Double Blind Maintenance Study: Percentage of Adult Participants with 90-day Corticosteroid-free Clinical Remission  At Week 40 
Double Blind Maintenance Study: Percentage of Adult Participants with Histologic Endoscopic Mucosal Improvement HEMI   At Week 40 
Double Blind Maintenance Study: Percentage of Adult Participants with Inflammatory Bowel Disease Questionnaire IBDQ Remission  At Week 40 
Double Blind Maintenance Study: Percentage of adult participants in Endoscopic Remission
Endoscopic remission is defined as an endoscopy subscore of 0 		 At Week 40 
Double Blind Maintenance Study:Percentage of Adult Participants in Clinical Remission at Week M-40 Among the Participants who had Achieved Clinical Remission at Maintenance Baseline  At Week 40  
Double Blind Maintenance Study: Percentage of Adult Participants in Histologic-Endoscopic Mucosal Remission at Week M-40  At Week 40 
Double Blind Maintenance Study: Percentage of Adult Participants with Fatigue Response  At Week 40 
Double Blind Maintenance Study: Percentage of Adult Participants with Disease Clearance  At Week 40 
Double Blind Maintenance Study: Percentage of Adult Participants with No Bowel Urgency  At Week 40  
Double Blind Maintenance Study: Percentage of Adult Participants with No Abdominal Pain  At Week 40 
Double Blind Maintenance Study: Study: Percentage of Adult Participants with No Bowel Incontinence  At Week 40 
Open Label Induction Phase: Percentage of Adolescent Participants in Clinical Response  At Week 12 
Open Label Induction Phase: Percentage of Adolescent Participants in Clinical Remission  At Week 12 
Open Label Induction Phase: Percentage of Adolescent Participants with HEMI  At Week 12 
Open Label Induction Phase: Percentage of Adolescent Participants with Endoscopic Improvement   At Week 12 
Open Label Induction Phase: Percentage of Adolescent Participants in Symptomatic Remission  At Week 12 
Open Label Induction Phase: Percentage of Adolescent Participants in Endoscopic Remission  At Week 12 
Open Label Induction Phase: Percentage of Adolescent Participants in Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission  At Week 12 
Open Label Induction Phase: Percentage of Adolescent Participants with AEs and SAEs  Up to week 12 
Open Label Maintenance Study: Percentage of Adolescent Participants with Endoscopic Improvement   At Week 40 
Open Label Maintenance Phase: Percentage of Adolescent Participants in Symptomatic Remission  At Week 40 
OL Maintenance Phase: Percentage of Adolescent Participants in 90-day Corticosteroid-free Clinical Remission   At Week 40 
OL Maintenance Phase: Percentage of Adolescent Participants with HEMI  At Week 40 
OL Maintenance Phase: Percentage of Adolescent Participants with Histologic-Endoscopic Mucosal Remission  At Week 40 
OL Maintenance Phase: Percentage of Adolescent Participants with Endoscopic Remission   At Week 40 
OL Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40 Among the Participants who had Achieved Clinical Remission at Maintenance Baseline   At Week 40 
OL Maintenance Phase: Percentage of Adolescent Participants in Clinical Response at Week M-40 Among the Participants who had Achieved Clinical Response at Maintenance Baseline  At Week 40 
OL Maintenance Phase: Percentage of Adolescent Participants in PUCAI Remission   At Week 40 
OL Maintenance Phase: Percentage of Adolescent Participants with AEs and SAEs   Up to Week 40 
Double Blind Maintenance Study: Percentage of Adult Participants with AEs and SAEs  Up to Week 40 
 
Target Sample Size   Total Sample Size="882"
Sample Size from India="94" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   11/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/10/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="6"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  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

  2. What additional supporting information will be shared?
    Response (Others) -  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
  3. Who will be able to view these files?
    Response (Others) -  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

  4. For what types of analyses will this data be available?
    Response (Others) -  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

  5. By what mechanism will data be made available?
    Response (Others) -  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

  6. For how long will this data be available start date provided 01-01-2033 and end date provided 31-12-2038?
    Response (Others) -  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

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - 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
Brief Summary   The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).

This single study will be conducted as separate parts as mentioned below:
• A 12-week Double-blind Induction Study in Adults
• A 40-week Double-blind Maintenance Study in Adults
• A 52-week Open label Induction and Maintenance Study in Adolescents
 
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