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 study to assess the efficacy and safety of induction therapy with RO7790121 in patients with moderately to severely active ulcerative colitis
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
SR Kalla Memorial Gastro & General Hospital, Jaipur 78-79
Dhuleshwar garden, Sardar Patel Marg, C Scheme, Jaipur,
Rajasthan 302006 India
Jaipur RAJASTHAN 302006 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, Lal Bahadur Shastri Marg, Ghatkopar, Mumbai - 400 086, Maharashtra
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, Lal Bahadur Shastri Marg, Ghatkopar, Mumbai - 400 086, Maharashtra
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
Grenzacherstrasse 124 4058 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
Argentina Australia Austria Belgium Brazil Bulgaria Canada Chile China Croatia Czech Republic Denmark Egypt France Germany Hungary India Israel Italy Mexico Netherlands Poland Portugal United Kingdom United States of America Republic of Korea Romania Serbia Slovakia Spain Taiwan Thailand
Asian Institute of Gastroentereology, IBD Department, Room No. 2, 6th floor, Main Building Tower A,
Survey No 136, 4/5 Plot No 2/3, Mindspace road, P Janardhan Reddy Nagar Gachibowli, Hyderabad,
Telangana, 500032, India Hyderabad TELANGANA
9849287530
rupabanerjee.aig@gmail.com
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 Samir Patil
Kingsway Hospital KIMS
Medisearch Life Sciences Pvt. Ltd., SPANV, Kingsway Road, Near Kasturchand Park, Nagpur, Maharashtra 440001, India Nagpur MAHARASHTRA
8928686680
samirspatil@gmail.com
Dr Shrikant Mukewar
MIDAS Multispecialty Hospital, Nagpur
Midas Multispeciality Hospital,392, Behind Empress Palace, Opp Singh Saab Dhaba,
Wardha Road, Parsodi, Nagpur -440018 Nagpur MAHARASHTRA
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
Dr Ravi Shankar Bagepally
Yashoda Hospitals - Secunderabad
Yashoda Hospitals, Behind Hari Hara Kala Bhavan SP Road,
Secunderabad- 500003, Telangana, India Hyderabad TELANGANA
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. Confirmed diagnosis of UC with supportive clinical, endoscopic, and histopathological evidence. Active UC confirmed by endoscopy (flexible sigmoidoscopy or colonoscopy)
extending more than 15cm from the anal verge.
Participants with proctitis only at baseline will be capped at 10% of the total enrollment.
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
Evaluate the efficacy of RO7790121 compared with placebo in inducing remission
Clinical remission, defined as mMS less than or equal to 2 with SFS equal to 0 or 1, RBS equal to 0, and ES equal to 0 or 1, at Week 12
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.
pmMS from baseline to Week 2. Endoscopic improvement and remission at Week 12. Histologic-endoscopic mucosal improvement less than or equal to 3.1 and ES equal to 0 or 1, at Week 12. Histologic-endoscopic remission less than 2 and ES equal to 0 or 1, at week 12. Clinical response of at least 2 points and 30% from baseline at week 12. Among TL1A biomarker subgroups, clinical remission and endoscopic improvement at week 12.
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"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
The goal of this study is to evaluate how well and how safely RO7790121 works in people with moderate to severe ulcerative colitis (UC). RO7790121 is a type of antibody that targets a protein called TL1A, which is important for immune responses in the gut. By blocking TL1A, this treatment aims to reduce inflammation and prevent tissue damage in UC. Over the past decade, many new treatments have become available for UC, including biologics and small molecule drugs. Despite these advancements, there is still a need for treatments that are more effective and have fewer side effects, to help manage inflammation and improve long-term outcomes for patients with UC