CTRI/2023/05/053075 [Registered on: 23/05/2023] Trial Registered Prospectively
Last Modified On:
02/04/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
A clinical research evaluating the long term efficacy and safety of 2 different doses of obefazimod given once daily in subjects with moderate to severe ulcerative colitis
Scientific Title of Study
A randomized, double-blind, multicenter phase III study to evaluate the long-term efficacy and safety of ABX464 25 mg or 50 mg once daily as a maintenance therapy in subjects with moderately to severely active ulcerative colitis. – ABTECT Maintenance
Argentina Australia Austria Belgium Bosnia and Herzegovina Brazil Canada China Czech Republic France Germany Greece Hungary India Israel Italy Japan Mexico Netherlands New Zealand Poland Portugal Republic of Korea Romania Serbia Spain Switzerland Turkey United Kingdom United States of America Bulgaria
Ward No.3,Clinical Research Department, round Floor, Block B, Near Psychiatry department Wardha MAHARASHTRA
7768901370
drvijendrakirnake@gmail.com
Dr Vineet Ahuja
All India Institute of Medical Sciences
Room No.123, old OT block, 1st floor, human nutrition unit 110029 Central DELHI
9810707170
vineet.aiims@gmail.com
Dr Shine Sadasivan
Amrita Institute Of Medical Sciences Healthcare, Education and Research
Education and Research, Department of Gastroenterology and Hepatology, AIMS-Ponekkara - 682041 Ernakulam KERALA
9497556339
shines1560@aims.amrita.edu
Dr Kirankumar Puna Jadhav
B.J. Government Medical College & Sassoon General Hospital
Jai Prakash Narayan Road, Near Pune Railway Station 411001 Pune MAHARASHTRA
9823949126
drj.kirankumar@gmail.com
Dr Tushar Hiralal Sankalecha
Chopda Medicare & Research Centre Pvt. Ltd
Magnum Heart Institute, 3/5, Patil Lane No. 1, Laxmi Nagar, Near K.B.H. Vidyalaya, Canada Corner, Nashik-422005, Maharashtra, India Nashik MAHARASHTRA
0253-2316200
dr.tushar30@gmail.com
Dr Ajit Sood
Dayanand Medical College and Hospital
Research and Develpoment center
Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines -141001 Ludhiana PUNJAB
9815400718
ajitsoodl0@gmail.com
Dr Pankaj Puri
Fortis Escorts Heart Institute, Escorts Heart Institute and Research Centre
Academic and Research Department,A 23,2nd Floor,Residential Tower
Fortis Escorts Heart Institute, Escorts Heart Institute and Research Centre Ltd, Okhla Road - 110025 Central DELHI
9717233996
Pankaj.puri@fortishealthcare.com
Dr Gourdas Choudhuri
Fortis Memorial Research Institute
Department of Gastroenterology, 2nd Floor, Sector 44 (Opp Huda City Centre Metro Station) -122002 Gurgaon HARYANA
9650643222
gourdas.choudhuri@fortishealthcare.com
Dr Shravan Kumar Porika
Gandhi Hospital
Inpatient Block, 5th Floor, Department of Gastroenterology, Musheerabad -500003 Hyderabad TELANGANA
Room no. 1, Ground floor, Cardiac Building, Grant Medical Foundation Ruby Hall Clinic, 40, Sassoon Road, -411001 Pune MAHARASHTRA
91982008682
nitinpai.gastro@gmail.com
Dr Saumin Prakashbhai Shah
Gujarat Hospital-Gastro and Vascular Centre
Opposite Shree Ram Petrol Pump, Anand Mahal Road, Adajan -395009 Surat GUJARAT
9408042224
dr.sauminpshah@gmail.com
Dr Rajib Sarkar
Institute of Post Graduate Medical Education And Research
Gastroenterology SDLD Department,1st Floor,Animal House,Institute of Post Graduate Medical Education And Research, 244 Acharya, Jagadish Chandra Bose Road -700020 Kolkata WEST BENGAL
King Georges Medical University, Gandhi Memorial and associated Hospital
Research Room no. 5, Department of Surgical Gastroenterology, Shatabdi hospital phase 1, Gandhi Memorial and associated Hospital, King Georges Medical University - 226003 Lucknow UTTAR PRADESH
9335920302
abhijitchandra@hotmail.com
Dr Varadaraj P Gokak
KLES Dr. Prabhakar Kore Hospital and Medical Research Centre
Site Management Office,2nd Floor,Sharawathi Ward,KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, J. N. Medical College, Nehru Nagar, -590010 Belgaum KARNATAKA
917353691777
vpgokak@gmail.com
Dr Abraham Koshy
Lakeshore Hospital &.Research Centre Ltd
New building, 5th floor, Room No- 5009, XVl/612, Maradu, Nettoor P.O - 682040 Ernakulam KERALA
04842154517
koshyabe@yahoo.com
Dr Meghraj Ananda Ingle
Lokmanya Tilak Muncipal Medical College and Lokmanya Tilak Municipal General Hospital
Room no 446,4 th floor college building,
Lokmanya Tilak Muncipal Medical College and Lokmanya Tilak Municipal General Hospital, Department of Gestroentrology, Sion -400022 Mumbai MAHARASHTRA
9320979659
drmeghraj@gmail.com
Dr Avinash Balekuduru
M. S. Ramaiah Medical College and Hospital
M. S. Ramaiah Medical College and Hospital, 1st floor, M.S. Ramaiah Advanced Learning Centre, MS Ramaiah Nagar, MSRIT Post - 560054 Bangalore KARNATAKA
9731879792
avinashbalekuduru@gmail.com
Dr Vivek Bhatia
Maharaja Agrasen Hospital
Room no 3,Ground Floor,
Maharaja Agrasen Hospital, West Punjabi Bagh 110026 Central DELHI
9811028897
Email-drvivekbhatia@yahoo.com
Dr Shrikant Vasantrao Mukewar
Midas Multispeciality Hospital
First Floor ,Research Room
Midas Multispeciality Hospital, Midas Heights, 07, Central Bazar Road, Ramdaspeth -440010 Nagpur MAHARASHTRA
7720033280
shrikant_mukewar@yahoo.com
Dr Ishan Anil kumar Shah
Navneet Memorial Hospital “SUSHRUSHAâ€
Opp. Sardar Patel Seva Samaj Hall, In the Lane, Opp. Tele Exchange, Navrangpura, Ahmedabad-380006 Ahmadabad GUJARAT
9599555795
docishanshah@gmail.com
Dr Manas Kumar Mondal
Nilratan Sircar Medical Collge and Hospital, Medical Gastroenterology
Medical Gastroenterology Division, 138, Acharya Jagadish Chandra Bose Road - 700014 Kolkata WEST BENGAL
9073593883
manaskumarmondal79@gmail.com
Dr Mohammed Aejaz Habee
Origin Hospital Centre A division of of Centre for Liver Research and Diagnostics
S. No. 2-5-36/CLRD/1 Chintalmet X Road, Near Pillar No.177, PVNR Expressway, Attapur -500048 Hyderabad TELANGANA
7286916520
aejazhabeeb@hotmail.com
Dr Usha Dutta
Postgraduate Institute of Medical Education and Research
Department of Gestroentrology, F- Block, Ground Floor, Nehru Hospital, Sector-12 - 160012 Chandigarh CHANDIGARH
Sr. No. 163, Bhosale Nagar, Hadapsar - 411028 Pune MAHARASHTRA
9986003257
dr.kiranshinde@gmail.com
Dr Akash Shukla
Seth G. S. Medical College King Edward Memorial Hospital
Department Of Gastroenterology,
Ward 32 A,9 TH Floor,M.S Building,
Seth G. S. Medical College King Edward Memorial Hospital, Department of Gastroenterology, Acharya Donde Marg, Parel 400012 Mumbai MAHARASHTRA
9869256376
drakashshukla@yahoo.com
Dr Chetan Nalin Mehta
Shree Giriraj Multispeciality Hospital
CRC Department,Shree Giriraj Multispeciality Hospital, A unit of Shree Giriraj Lifecare Pvt Ltd, 27-Navjyot Park, 150 Feet Ring Road 360005 Rajkot GUJARAT
9825077472
mehtacn@hotmail.com
Dr Rajiv Manhar Mehta
SIDS Hospital and Research Centre
Off Ring Road, Near Shell Petrol Pump, Ring Road- Sosyo Circle Lane, Surat- 395002, Gujarat, India Surat GUJARAT
9879863510
rmgastro@yahoo.com
Dr Balakrishnan Siddhartha Ramakrishna
SRM Institutes for Medical Science
Department Of Clinical Research,B Block,Second Floor,SRM Institutes for Medical Science, No.1, Jawaharlal Nehru Salai(100 Feet Road),Vadapalani -600026 Chennai TAMIL NADU
9994614890
drramakrishna.bs@simshospitals.com
Dr Pintukumar Devshibhai Bhakhar
Unity Trauma Center and ICU (Unity Hospital),
Nr. D.R. World, Opp. Raghuvir business Empire, Aai Mata Road, Parvat Patiya, Surat, Gujarat, India-395010 Surat GUJARAT
9979587580
drpintudbhakhar@gmail.com
Dr Hamsraj Alva
Vinaya Hospital and Research Centre (Unit of Karnataka institute of Medical Sciences)
A subject will be eligible to participate in this study if ALL the following criteria are met:
1. Male or female (at birth) at least 16 years old, except in EU/EEA, Israel, Serbia and Ukraine,where subjects must be at least 18 years old at the time of eligibility assessment. Where enrolment of adolescents is allowed, adolescent subjects must weigh > 40 kg and meet the definition of Tanner stage 5 at screening.
2. Subjects must have completed the induction treatment study (ABX464-105 or ABX464-106), and subjects’ clinical response status must be available.
3. Subjects with a valid endoscopy performed at the end of the induction study and results from central reader available at Day 1.
4. Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures. For under-aged subjects, national requirements
regarding consent should also be met.
5. WOCBP subjects and male subjects with a WOCBP partner must agree to comply withcontraception requirements as described in Section 4.4 of this protocol.
6. Subjects must be able and willing to comply with study visits and procedures as per protocol.
7. Subjects should be affiliated to a health insurance policy whenever required by a participating country or state.
ExclusionCriteria
Details
Subjects who meet ANY of the following exclusion criteria will be excluded from the study:
1. Subjects who permanently discontinued the study drug during the induction study (either ABX464-105 or ABX464-106).
2. Subjects who have developed any major illness/condition (eg. primary sclerosis cholangitis, Crohn’s disease, colectomy, diverting ileostomy, colon cancer or colonic adenomas [low or high grade dysplasia]).
3. Subjects with evidence of an unstable clinical condition (eg. toxic megacolon, fulminant colitis, bowel perforation, uncontrolled ischemic disease, congestive heart failure with NYHA class 3 or 4 symptoms) during the induction study that, in the investigator’s judgment, will substantially increase the risk to the subject if he or she participates in the study.
4. Subjects who plan to participate in other investigational studies during the maintenance study.
5. Male or female subjects planning a pregnancy, or pregnant female subjects.
6. Introduction during induction study of prohibited medications, dosages, surgical or nonmedicinal procedures indicated for UC (except antidiarrheals and motility agents for acute
diarrhea).
7. Any changes in the laboratory values during the induction period that could jeopardize subject’s safety in the opinion of the investigator. If any doubts, the investigator should contact the sponsor study medical monitor.
8. Subject who is planning to receive live vaccine during the study.
9. Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
To evaluate the efficacy of ABX464 versus placebo on the proportion of subjects in clinical remission at Week 44
• To compare the efficacy of obefazimod versus placebo on endoscopic improvement.
• To compare the efficacy of obefazimod versus placebo on CS-free clinical remission.
• To compare the efficacy of obefazimod versus placebo on sustained clinical remission.
• To compare the efficacy of obefazimod versus placebo on HEMI.
• To evaluate the efficacy of obefazimod versus placebo on endoscopic remission.
Week 44
Target Sample Size
Total Sample Size="1100" Sample Size from India="70" 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
This is a multicenter, randomized,
blinded study to evaluate the long-term efficacy and safety of ABX464 50mg and
25mg administered once daily (QD) as maintenance therapy following completion
of 8-week induction treatment (Induction Studies ABX464-105 or ABX464-106) in
subjects with moderately to severely active ulcerative colitis who have
inadequate response, no response, a loss of response, or an intolerance to
either conventional therapies [corticosteroids, immunosuppressant (i.e.
azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies
[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor
modulators, and/or JAK inhibitors].
This study is the maintenance phase
of the Phase 3 clinical development program sequential to previous induction
studies ABX464-105 and ABX464-106.
All eligible subjects who have
completed either one of the induction studies above mentioned, will be
encouraged to take part in the present ABX464-107 maintenance study and will be
randomized to either a double blind, placebo-controlled part (Part #1) or
allocated to ABX464 50mg or 25mg blinded ABX464 treatment arms (Part #2)
depending on their clinical response at the end of induction as shown below.
This study consists of a 44-week treatment phase
and a 28-days follow-up period concluding in the End of Study (EOS) visit.