A Study of Icotrokinra in Participants With Moderately to Severely Active Crohns Disease
Scientific Title of Study
A Phase 2b-3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohns Disease
Trial Acronym
ICONIC-CD
Secondary IDs if Any
Secondary ID
Identifier
2025-521382-27-00
EudraCT
77242113CRD3001 Amendment 1 Dated 16 July 2025
Protocol Number
NCT07196722
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 Pvt Ltd.
Address
Janssen Research and Development, Johnson and Johnson Pvt Ltd.
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 Pvt Ltd.
Address
Janssen Research and Development, Johnson and Johnson Pvt Ltd.
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 Pvt Ltd.
Address
Janssen Research and Development, Johnson and Johnson Pvt Ltd.
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-Mumbai – 400060, Maharashtra, India
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
NA
NA
Countries of Recruitment
Argentina Australia Belgium Brazil Canada China Czech Republic France Germany Greece Hungary India Israel Italy Japan Malaysia Netherlands Poland Republic of Korea Romania Spain Sweden Switzerland Taiwan Turkey United Kingdom United States of America
Sites of Study
No of Sites = 19
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
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, Telangana 500032
Hyderabad TELANGANA
9849287530
rupabanerjee.aig@gmail.com
Dr Sudhir Kumar
All India Institute of Medical Sciences
All India Institute of Medical Sciences, Department of Gastroenterology, Aiims Patna Road, Phulwarisharif, Patna, Bihar 801507
Patna BIHAR
70709 53635
quantumsudhir@gmail.com
Dr Vineet Ahuja
All India Institute of Medical Sciences
All India Institute of Medical Sciences, Gastroenterology department, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 New Delhi DELHI
911126589070
vineet.aiims@gmail.com
Dr Kayal Vizhi
ASTER CMI Hospital
ASTER CMI Hospital, Clinical research Department, basement, 43, 2, New Airport Road, NH.7, Sahakara Nagar. Hebbal, Bangalore, Karnataka 560092, India Bangalore KARNATAKA
9986559403
kayal.doc@gmail.com
Dr Vandana Midha
Dayanand Medical College and Hospital
Dayanand Medical College and Hospital, Tagore Nagar , Civil Lines , Ludhiana , Punjab , 141001 Ludhiana PUNJAB
Fortis Memorial research institute, Gastroenterology department, Sector - 44, Opposite HUDA City Centre,
Gastroenterology Department, Gurugram, HR
122002, IN
Gurgaon HARYANA
9650643222
gourdas.choudhuri@fortishealthcare.com
Dr Saumin Shah
Gujarat Gastro and Vascular Hospital
Gastroenterology department, Opp. Shree Ram Petrol Pump, Anandmahal Road, Adajan, Surat 395009, Gujarat, India.
Surat GUJARAT
9408042224
dr.sauminpshah@gmail.com
Dr Yogesh Batra
Indraprastha Apollo Hspital
Indraprastha Apollo Hospital, 3rd floor, Gastroenterology department, Sarita Vihar, Mathura Road, New Delhi-110076
New Delhi DELHI
9891226150
dryogeshbatra@gmail.com
Dr Mathew Philip
Lisie Hospital
Lisie Hospital, P.B No. 3053, District Ernakulam, North Kaloor, Lisie Junction, Kochi, Kerala, 682018
Ernakulam KERALA
9846045469
drmathewphilip@gmail.com
Dr Ashok Dalal
Maulana Azad Medical College and GB Pant Hospital
Maulana Azad Medical College and Govind Ballabh Pant Hospital, Dept. of Gastroenterology ,Academic Block, 2nd Floor, G B Pant Hospital GIPMER, JLN Marg, New Delhi-110 002, India
New Delhi DELHI
9718599219
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
7204933468
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 Center, 914, 9 th floor, Veer Savarkar Marg, Mahim, Mumbai Mumbai MAHARASHTRA
9322596152
devendracdesai@gmail.com
Dr Mukesh Kalla
S. R. Kalla Memorial General Hospital
S. R. Kalla Memorial General Hospital, 4th Floor, Clinical Research Room,
78-79 Dhuleshwar garden, Sardar Patel Marg, C Scheme, Jaipur, Rajasthan 302006 Jaipur RAJASTHAN
1414039432
drmkalla@rediffmail.com
Dr Rajiv Mehta
SIDS Hospital and Research Centre
SIDS Hospital and Research Centre, off Ring Road, Research department, Ground floor, New Opera House, near shell petrol pump, sosyo circle lane, Surat, Gujarat 395002 Surat GUJARAT
9879863510
rmgastro@yahoo.com
Dr Naresh Kumar Bansal
Sir Ganga Ram Hospital
Room No 1192, First Floor Sir Ganga Ram Hospital, SGRH Marg, Rajinder Nagar, New Delhi-110060
New Delhi DELHI
9999336476
drnbansal@ymail.com
Dr Ayaskanta Singh
SUM Ultimate Medicare Hospital
SUM Ultimate Medicare Hospital, Clinical Research Department, second floor, near CSSD, Main Building,
Main Building, SUM Ultimate Medicare Hospital, K-8 Kalinga Nagar, Bhubaneshwar Odisha
Khordha ORISSA
918260501643
ayaskant1ce@gmail.com
Dr B Ravi Shankar
Yashoda Hospitals
Yashoda Hospitals,Department of Clinical Research, First Floor, Flat G-1, Block B Alliance Apartment, Yashoda Hospitals, Behind Hari Hara Kala Bhavan, Alexander Road, SP Road, Secunderabad - 500003, Telangana, India
Hyderabad TELANGANA
91676996053
b_ravishankar@yahoo.com
Dr Kiran Kumar Peddi
Yashoda Hospitals
Yashoda Hospitals, 3rd Floor, A-Block Building
Room 305, Harita Apartment, Department of Clinical Research Yashoda Healthcare services pvt limited, Raj Bhavan road, Somaji guda, Hyderabad-500082 Telangana Hyderabad TELANGANA
Participants will receive oral Icotrokinra dose 1 once daily for following duration.
Induction dose: I-Week 0 to I-Week 12.
Maintenance dose: M-Week 0 to M-Week 40.
Long term extension dose: upto 4 years
Intervention
Icotrokinra Dose 2
Participants will receive oral Icotrokinra dose 2 once daily for following duration.
Induction dose: I-Week 0 to I-Week 12.
Maintenance dose: M-Week 0 to M-Week 40.
Long term extension dose: upto 4 years
Comparator Agent
Placebo
Participants will receive oral matching Placebo once daily for following duration.
Induction dose: I-Week 0 to I-Week 12.
Maintenance dose: M-Week 0 to M-Week 40.
Long term extension dose: upto 4 years
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1 Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD.
2 Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score more than and equal to 220 but less than equal to 450 and either mean daily SF count more than equal to 4, or mean daily AP score more than equal to 2. 3 Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD more than equal to 6 for participants with colonic or ileocolonic disease, and SES-CD more than and equal to 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments.
4 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 I-0 prior to administration of study intervention and agree to further pregnancy tests. 5 Demonstrated an inadequate response, loss of response, or failure to tolerate previous conventional therapy (advanced drug therapy [ADT]-naïve) or advanced therapy defined as biologics and/or advanced oral agents for the treatment of CD (ADT-inadequate responder [IR]) as defined in the protocol.
ExclusionCriteria
Details
1 Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention. 2 Presence of a stoma or ostomy. 3 Participants with presence of active fistulas may be included if there is no surgery needed. 4 Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline. 5 Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization.
Method of Generating Random Sequence
Stratified block randomization
Method of Concealment
Centralized
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Induction Study 1 Phase 2b- Number of Participants with Clinical Response at Week 12
Induction Study 2 Phase 2b- Number of Participants with Clinical Remission and Endoscopic response
Phase 3 maintenance- Number of Participants with Clinical Remission and Endoscopic response
For Induction Study 1 and Induction Study 2-Week 12
For Maintenance Study- Week 40
Secondary Outcome
Outcome
TimePoints
Induction Study 1-Number of Participants with Clinical Remission
At Week 12
Induction Study 1- Number of Participants with Endoscopic Response
At Week 12
Induction Study 1- Number of Participants with Adverse Events and Serious Adverse Events
Up to 4 weeks after last dose of study drug
Induction Study 2- Number of Participants with Patient Reported Outcomes PRO-2 Remission
At Week 12
Induction Study 2-Number of Participants with Clinical Response
At Week 12
Induction Study 2- Number of Participants Reporting Both Clinical Remission and Endoscopic Response
At Week 12
Induction Study 2- Number of Participants with Clinical Response
At Week 4
Induction Study 2- Number of Participants with Endoscopic Remission
At Week 12
Induction Study 2-Number of Participants with Deep Remission
At Week 12
Induction Study 2-Number of Participants with Inflammatory Bowel Disease Questionnaire IBDQ Remission
At Week 12
Induction Study 2- Number of Participants with Fatigue Response
At Week 12
Induction Study 2-Number of Participants with Clinical Remission
At Week 4
Induction Study 2-Number of Participants with AEs and SAEs
Up to 4 weeks after last dose of study drug
Maintenance Study-Number of Participants with PRO-2 remission
At week 40
Maintenance Study-Number of Participants with Endoscopic Remission
At Week 40
Maintenance Study-Number of Participants with 90-Day Corticosteroid-Free Clinical Remission
At Week 40
Maintenance Study-Number of Participants with Maintenance of Clinical Remission
At Week 40
Maintenance Study-Number of Participants Reporting Both Clinical Remission and Endoscopic Response
At Week 40
Maintenance Study-Number of Participants with Deep Remission
At Week 40
Maintenance Study-Number of Participants with IBDQ Remission
At Week 40
Maintenance Study-Number of Participants with Fatigue Response
At Week 40
Maintenance Study-Number of Participants with AEs and SAEs
Up to 4 weeks after last dose of study drug
Target Sample Size
Total Sample Size="789" Sample Size from India="120" 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 2/ Phase 3
Date of First Enrollment (India)
28/01/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
29/10/2025
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="6" Months="6" 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
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
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
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
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
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
For how long will this data be available start date provided 01-06-2034 and end date provided 31-05-2049? 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
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
Crohn’s Disease (CD) is a disease of the digestive system that causes inflammation and ulcers in the intestine (gut). Although there are approved treatment options, participants either do not respond or may not
tolerate them due to side effects. Hence, there is a need for better treatment options.
Overall study consists of 3 separate studies as below:
o Phase 2b Induction Dose-ranging Study (Induction Study 1)