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CTRI Number  CTRI/2024/01/061432 [Registered on: 12/01/2024] Trial Registered Prospectively
Last Modified On: 24/05/2024
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 of JNJ-77242113 in Participants with Moderately to Severely Active Ulcerative Colitis. 
Scientific Title of Study   A Phase 2b Multicenter, Randomized, Placebo- Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderately to Severely Active Ulcerative Colitis 
Trial Acronym  ANTHEM-UC 
Secondary IDs if Any  
Secondary ID  Identifier 
2023-504673-20-00  EudraCT 
77242113UCO2001 Amendment 1 25 July 2023  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  Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd. 
Address  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  Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd. 
Address  Johnson and Johnson Private Limited, Arena Space, Jogeshwari East,


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  Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd. 
Address  Johnson and Johnson Private Limited, Arena Space, Jogeshwari East,


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, Mumbai 400080,INDIA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Australia
Belgium
Brazil
Canada
China
Czech Republic
France
Germany
Hungary
India
Italy
Japan
Malaysia
Mexico
Poland
Republic of Korea
Romania
Spain
Turkey
United Kingdom
United States of America  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashok Dalal  Govind Ballabh Pant Institute of Postgraduate Medical Education and Research  2nd Floor, Academic Block, 1, Jawaharlal Nehru Marg, 64 Khamba, Raj Ghat, New Delhi, 110002
New Delhi
DELHI 		 9718599219

drashokdalal83@gmail.com 
Dr Shrikant Mukewar  Midas Multispeciality Hospital  Dept of. Gastroenterology, 392, Behind Empress Palace, Opp Singh Saab Dhaba, Wardha Road, Parsodi, 441108
Nagpur
MAHARASHTRA 		 7720033280

shrikant_mukewar@yahoo.com 
Dr Mukesh Kalla  S. R. Kalla Memorial General Hospital  Dept. of Gastroenterology, 78-79 Dhuleshwar garden, Sardar Patel Marg, C Scheme, 302006.
Jaipur
RAJASTHAN 		 9829050531

drmkalla@rediffmail.com 
Dr Kabrawala Mayank Vasantlal  SIDS Hospital and Research Centre  Clinical Research Department, Ground floor, A unit of SIDS Healthcare Pvt. Ltd., Off Ring Road, Near Shell Petrol Pump, Ring Road-Sosyo circle lane, 395002
Surat
GUJARAT 		 9825130363

mayankkabrawala@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College   Approved 
Institutional Ethics Committee, Midas Multispecialty Hospital Pvt Ltd  Approved 
SR Kalla Memorial Ethical Committee for Human research  Approved 
Surat Institute of digestive sciences 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  JNJ-77242113 Dose-1  Participants will receive JNJ-77242113 Dose-1 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76. 
Intervention  JNJ-77242113 Dose-2  Participants will receive JNJ-77242113 Dose-2 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76. 
Intervention  JNJ-77242113 Dose-3  Participants will receive JNJ-77242113 Dose-3 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76. 
Comparator Agent  Placebo  Participants will receive placebo tablets orally from Week 0 through Week 28. Placebo-treated participants who meet the criteria of inadequate response at Week 16, will receive JNJ-77242113 Dose-3 tablet orally through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention, will continue in the 48-week LTE period and receive the same treatment up to Week 76. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Signed informed consent form 18 years of age or older. Documented diagnosis of ulcerative colitis of at least 12 weeks prior to screening. Moderately to severely active UC as per the modified Mayo score. Demonstrated inadequate response to or intolerance of conventional therapy and or or advanced therapy as defined in the protocol 
 
ExclusionCriteria 
Details  Participants with current or prior diagnosis of fulminant colitis and or or toxic megacolon. UC limited to rectum only or to less than 15 centimeters (cm) of colon. Presence of a stoma. Presence or history of fistula. History of extensive colonic resection (example, less than 30 cm of colon remaining). Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn’s colitis or clinical findings suggestive of Crohn’s disease 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to 30 percent and greater than or equal to 2 points, with either a greater than or equal to 1 point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.  Week 12 
 
Secondary Outcome  
Outcome  TimePoints 
Symptomatic remission is defined as stool frequency subscore of 0 or 1, where the stool frequency subscore has not increased from baseline, and a rectal bleeding subscore of 0.  Week 12 
Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.  Week 12 
Histologic-endoscopic mucosal improvement is defined as a combination of histologic remission and endoscopic improvement. Histologic remission and endoscopic improvement are based on the histologic grading and the Mayo endoscopy subscore.  Week 12 
Clinical remission is defined as stool frequency subscore of 0 or 1, where the stool frequency subscore has not increased from baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.  Week 12 
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical product. An AE does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose- results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important.  Up to Week 76 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="20" 
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 
Date of First Enrollment (India)   20/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/11/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Ulcerative colitis (UC) is a chronic disease of the large intestine (colon) in which the lining of the colon becomes inflamed and develops tiny open sores (ulcers).The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis. 
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