| CTRI Number |
CTRI/2025/03/082923 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the efficiency and safety of the test drug in patients having moderate to severe ulcerative colitis |
|
Scientific Title of Study
|
A Phase III, multicenter, double-blind, placebo-controlled, treat-through study to assess the efficacy and safety of induction and maintenance therapy with RO7790121 in patients with moderately to severely active ulcerative colitis |
| Trial Acronym |
Ametrine I |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| GA45329_V4.0_16Feb2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukesh Kalla |
| Designation |
Principal Investigator |
| Affiliation |
SR Kalla Memorial Gastro & General Hospital, Jaipur |
| Address |
Director and Gastroenterologist
4th Floor ,Clinical Research Department, S.R.Kalla Memorial Gastro & General Hospital, 78-79 Dhulehswar Garden Behinh HSBC Bank Sardar Patel Marg, C-Scheme Jaipur-302001
Jaipur
RAJASTHAN
302001
India |
| Phone |
9829050622 |
| Fax |
|
| Email |
drmkalla@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Viraj Suvarna |
| Designation |
Chief Medical Officer |
| Affiliation |
Roche Products (India) Pvt. Ltd. |
| Address |
Roche Products (India) Pvt. Ltd.
146-B, 166 A, Unit No. 7, 8, 9
8th Floor, R City Office, R City Mall
Mumbai MAHARASHTRA 400086 India
Mumbai
MAHARASHTRA
400086
India |
| Phone |
8657896002 |
| Fax |
|
| Email |
viraj.suvarna@roche.com |
|
Details of Contact Person
Public Query
|
| Name |
Heta Khokhani |
| Designation |
Manager- Clinical Operations |
| Affiliation |
Roche Products (India) Pvt. Ltd. |
| Address |
Roche Products (India) Pvt. Ltd.
146-B, 166 A, Unit No. 7, 8, 9
8th Floor, R City Office, R City Mall
Mumbai MAHARASHTRA 400086 India
Mumbai
MAHARASHTRA
400086
India |
| Phone |
9892440927 |
| Fax |
|
| Email |
heta.khokhani@roche.com |
|
|
Source of Monetary or Material Support
|
| F. Hoffmann La Roche Ltd CH-4070 Basel, Switzerland |
|
|
Primary Sponsor
|
| Name |
F Hoffmann La Roche Ltd |
| Address |
F Hoffmann La Roche Ltd, Grenzacherstrasse 124, CH-4070 Basel, Switzerland |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Roche Products India Pvt Ltd |
146-B, 166 A, Unit No. 7, 8, 9, 8th Floor, R City
Office, R City Mall Lal Bahadur Shastri Marg,
Ghatkopar, Mumbai- 400086 Maharashtra, India |
|
|
Countries of Recruitment
|
India
Argentina
Australia
Austria
Brazil
Canada
Chile
Croatia
Czech Republic
Denmark
Egypt
France
Germany
Hungary
Israel
Italy
Japan
Mexico
Netherlands
Poland
Portugal
Republic of Korea
Romania
Serbia
Slovakia
Spain
Taiwan
Thailand
United Kingdom
United States of America
Belgium
Bulgaria
China |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saumin Prakashbhai Shah |
Gujarat Gastro and Vascular Hospital |
Opposite Shree Ram Petrol Pump, Anand Mahal Road, Adajan, Surat – 395009, Gujarat, India
Surat
GUJARAT |
9408042224
dr.sauminpshah@gmail.com |
| Dr Mukesh Kalla |
SR Kalla Memorial Gastro & General Hospital |
78-79 Dhuleshwar garden, Sardar Patel Marg, C Scheme, Jaipur, Rajasthan 302006
Jaipur
RAJASTHAN |
9829050622
drmkalla@rediffmail.com |
| Dr Rajiv Mehta |
Surat Institute of Digestive Sciences Hospitals |
SIDS Hospital and Research Centre, A unit of SIDS Healthcare Private Limited.
Off Ring Road, Near Shell petrol Pump, Ring Road – Sosyo circle lane,
Surat – 395002, Gujarat, India
Surat
GUJARAT |
9537799664
rmgastro@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| S.R.Kalla Memorial Ethical Committee For Human Research |
Approved |
| Surat Institute of digestive sciences ethics committee |
Approved |
| UNITY HOSPITAL ETHICS COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K519||Ulcerative colitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
placebo IV at Weeks 0, 2, 6, and 10, followed by placebo SC Q4W from
Week 12 through Week 52 |
| Intervention |
RO7790121 |
500 mg IV at Weeks 0, 2, 6, and 10, followed by 450 mg SC every
4 weeks (Q4W) from Week 12 through Week 52 |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Males and females of childbearing potential who are abstinent or use contraception, and refrain from donating sperm, during the treatment period and for 95 days after the final dose with Active UC confirmed by biopsy and endoscopy. Participants must have experienced intolerance, inadequate response or loss of response to at least one amongst Steroids, Immunomodulators, Aminosalicylates, Anti-TNF agents, Anti-integrins, Anti-IL12/IL23, JAK inhibitors, S1P receptor modulators. Moderately to severely active UC (mMS of 5-9), including an ES of ≥2. Patients at risk of colon cancer must have had surveillance colonoscopy within two years prior to baseline; if not, they must be willing to have a colonoscopy at screening |
|
| ExclusionCriteria |
| Details |
Severe UC (fulminant colitis, toxic megacolon, bowel perforation), Crohn’s disease, IBD unclassified, sclerosing cholangitis CMV Colitis, treatment for Clostridioides difficile, positive HIV, HbsAg, TB during screening, Apheresis. Any major surgery within 6 weeks prior to screening or a major surgery planned during the study. History of malignancy within 5 years prior to screening visit, Organ transplant, congenital immunodeficiency. Clinically significant abnormality on laboratory tests during screening - Platelet count less than 100,000/µL; Hemoglobin less than 8 g/dL; Absolute lymphocyte count less than 500/µL. Use of approved UC treatment, or any IMP, or IV corticosteroid, use of NSAID. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
- To evaluate efficacy of RO7790121 compared with placebo in inducing remission.
- To evaluate the efficacy of RO7790121 compared with placebo in maintaining remission.
|
- Clinical remission defined as Mms less than equal to 2 with SFS equal to 0 or 1, RBS equal to 0, and ES equal to 0 or 1, at week 12.
- Clinical remission, as defined above, at Week 52. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Evaluate the efficacy of RO7790121 compared with placebo in inducing and maintaining response.
- Evaluate the efficacy of RO7790121 compared with placebo in TL1A biomarker-defined subpopulations of participants.
- Evaluate the efficacy of RO7790121 compared with placebo in terms of UC-related symptoms and health-related quality of life
|
Endoscopic improvement and remission. Maintenance of remission, at both Weeks 12 and 52. Corticosteroid-free remission, at Week 52 and no use of corticosteroids for UC at least 8 weeks prior to Week 52. Endoscopic improvement and remission at Week 52. Histologic-endoscopic mucosal improvement and remission at Week 52. Clinical remission at Week 12 and Week 52. Endoscopic improvement at Week 12 and week 52. Bowel urgency and Abdominal pain from baseline through Week 52. |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="35"
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)
|
20/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
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
|
This study aims to see how well and how safely a drug called RO7790121 works for people with moderate to severe ulcerative colitis (UC). RO7790121 is a type of medicine made from human antibodies that targets a protein called TL1A. TL1A is important for controlling immune responses in the gut and is involved in the development of inflammatory bowel disease by interacting with another protein called death receptor 3. This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of RO7790121 compared with placebo in patients with moderately to severely active UC. |