The goal is to check how well and how safely the drug Afimkibart works for patients with moderate to severe Crohns disease
Scientific Title of Study
A phase III, multicenter, double-blind, placebo-controlled, treat-through study to assess the efficacy and safetyof induction and maintenance therapy with RO7790121 in patients with moderately to severely active Crohnsdisease
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 PatelMarg, C Scheme, Jaipur, Rajasthan
Jaipur RAJASTHAN 302006 India
Phone
9829050622
Fax
Email
drmkalla@rediffmail.com
Details of Contact Person Scientific Query
Name
Dr Jyotii Poddaar
Designation
Lead- 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 CityMall, Lal Bahadur Shastri Marg, Ghatkopar, Mumbai - 400 086, Maharashtra
Mumbai MAHARASHTRA 400086 India
Phone
9136064373
Fax
Email
jyotii.poddaar@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 CityMall, 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 Colombia Costa Rica Croatia Czech Republic Denmark Dominican Republic Egypt France Germany Guatemala Hungary India Israel Italy Japan Mexico Netherlands Panama Poland Portugal Republic of Korea Romania Saudi Arabia Serbia Slovakia Spain Taiwan Thailand United Arab Emirates United Kingdom United States of America
AIIMS HNU, Old OT Block room no. 123, 1st Floor , Near Nursing College, Ansari Nagar, New Delhi-110029 India New Delhi DELHI
011-26589070
vineet.aiims@gmail.com
Dr Shine Sadasivan
Amrita Institute of Medical Sciences and Research Centre
Dept. of Gastroenterology, Amrita Institute of Medical Sciences and Research Centre
AIMS Ponekkara P.O,Kochi-682041 Ernakulam KERALA
9497556339
shines1560@aims.amrita.edu
Dr Rupa Banerjee
Asian Institute of Gastroenterology
IBD Department, Room No. 2, 6thfloor, 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 Malladi Uma Devi
Gandhi Hospital
In Patient block, 5th floor, Department of Gastroenterology, Gandhi Hospital, Musheerabad, Secunderabad, Hyderabad,Telangana-500003 Hyderabad TELANGANA
9849278271
drmumadevi66@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 Rajib Sarkar
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
SDLD, Dept. of Gastroenterology,1st Floor, Animal House, 244,AJCBose Road, Kolkata-700020 ,West Bengal, India Kolkata WEST BENGAL
9477371103
dr.rajibsarkar2023@gmail.com
Dr G Mohan Reddy
Kurnool Medical College/ Govt. General Hospital
Kurnool Medical College and Govt. General Hospital, Department of Gastroentrology, O.P no 26, Budhwara Peta, Kurnool – 518002, Andhra Pradesh, India Kurnool ANDHRA PRADESH
27- Navjyot park Corner, 150 Ft. ring road, Rajkot-360005 Rajkot GUJARAT
9825077472
mehtacn@hotmail.com
Dr Sudhir Maharshi
SMS Super-Speciality Hospital
Department of
Gastroenterology,10-9,
Vivekanand Marg, Panch Batti,
Sangram Colony, Ashok Nagar,
Jaipur, Rajasthan-302007,India Jaipur RAJASTHAN
9829272233
drsudhirmaharshi05@gmail.com
Dr Mukesh Kalla
SR Kalla Memorial Gastro & General Hospital
78-79 Dhuleshwar garden, Sardar Patel Marg, C Scheme, Jaipur,Rajasthan-302001, India Jaipur RAJASTHAN
9829050622
drmkalla@rediffmail.com
Dr Rajiv Manhar 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
9879863510
rmgastro@yahoo.com
Dr Ravi Shankar Bagepally
Yashoda Hospitals
Behind Hari Hara Kala Bhavan, SP Road, Secunderabad-500003,Telangana, India Hyderabad TELANGANA
(1) ICD-10 Condition: K508||Crohns disease of both small andlarge intestine,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Placebo
RO7790121 (500 mg) or placebo will be administered IV at Weeks 0, 2, 6, and 10(induction phase). RO7790121 (450 mg or 150 mg) or placebo will then be administered SC every 4 weeks (Q4W) from Week 12 through Week 52(maintenance phase).
Intervention
RO7790121
RO7790121 (500 mg) or placebo will be administered IV at Weeks 0, 2, 6, and 10(induction phase). RO7790121 (450 mg or 150 mg) or placebo will then be administered SC every 4 weeks (Q4W) from Week 12 through Week 52(maintenance phase).
Males and females of childbearing potential who are abstinent or use contraception, and refrain from sperm or egg donation, during the treatment period and for 95 days after the final dose of drug. Confirmed diagnosis of CD with supportive clinical, endoscopic, and histopathological evidence. Moderate to severely Active CD with more than equal to 220 and less than equal to 450; SES-CD of more than equal to 6 confirmed through a centrally read endoscopy. Involvement of ileum and/or colon, with at least 4 colonic segments traversable by an endoscope or a pediatric endoscope, or 3 segments for patients who have undergone a bowel resection among the following segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum. Any adenomatous polyps must be completely removed according to routine practice prior to their first dose of study drug.
The inclusion criteria have been updated as follows (Section 5.1):– CD-specific inclusion criteria have been updated to clarify the timing of centrally-read endoscopy, including standard of care endoscopy performed prior to screening.
– The reproductive inclusion criteria have been updated and a new subsection has been added to align with current CTCG guidance on contraception and pregnancy in clinical trials (Sections 5.1 and 5.3.4). Note that this additional language is not based on new information (e.g., new safety data).
– Language around the requirements for colorectal cancer screening has been refined for clarification.
– The prior medications inclusion criteria have been updated to more clearly define conventional therapy failure and advanced therapy failure.
ExclusionCriteria
Details
Participant with a history of more than equal to 3 bowel resections. 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum. Diagnosis of short gut or short bowel syndrome. Presence of ileostomy, colostomy, or ileo-anal pouch. Patients with symptomatic bowel strictures, fulminant colitis, or toxic megacolon. Current diagnosis of UC or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, or microscopic colitis. Presence of abdominal or perianal abscess. Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas, or perianal fistulas with more than 3 openings and/or the anticipated need for surgery during the study (except surgery for seton placement and/or removal). Current diagnosis or suspicion of primary sclerosing cholangitis.
The exclusion criteria have been updated as follows:
The medical history exclusion criteria have been updated to include significant uncontrolled medical conditions or comorbidities that would confound the study results or compromise patient safety, and to clarify requirements for recording medical history and baseline conditions (Sections 5.2 and 8).
– To ensure the safety of participants, the infection or infection risk exclusion criteria have been updated to clarify the exclusion of clinically significant infections (including infections that are opportunistic in nature), and to include guidance for the investigator re: C. difficile screening, tuberculosis, and hepatitis B/C (Sections 5.2 and 7.1).
– The laboratory results exclusion criteria have been updated to clarify the exception to allow patients with an established diagnosis of Gilbert’s syndrome (with required documentation) with total bilirubin levels < 3 ´ upper limit of normal, and the exclusion of patients with estimated glomerular filtration rate < 30 mL/min/1.73 m2 (Section 5.2).
– Language regarding permitted and prohibited medications has been clarified to describe the criteria related to immunosuppressive therapies, treatment with oral traditional Chinese medicine, and IV antibiotics, and to indicate the maximum allowed daily dose of oral prednisone prior to screening endoscopy (or standard of care endoscopy) (Sections 5.2 and 6.8 [Table 7 and 8]).
To evaluate the efficacy of afimkibart compared with placebo in inducing response Corresponding
· Clinical remission, as defined above, at Week 12
· Endoscopic response, as defined above, at Week 12
· Symptomatic remission, defined as SF £ 2.8 & APS £ 1 with neither score greater than baseline, at Week 12
· Endoscopic remission, defined as SES-CD = 0 to 4 with decrease from baseline ³ 2 & no subscore 1, at Week 12
· Ulcer-free endoscopy, defined as SES-CD ulcerated surface subscore of 0, at Week 12
· SF, from baseline through Week 12
· APS, from baseline through Week 12
To evaluate the efficacy of afimkibart compared with placebo in maintaining response
Endoscopic remission, Symptomatic remission & Corticosteroid-free clinical remission defined as clinical remission at Week 52 & no use of corticosteroids for CD at least 8 weeks prior to Week 52, Maintenance of clinical remission defined as clinical remission at both Weeks 12 & 52, Maintenance of endoscopic response defined as endoscopic response at both Weeks 12 & 52. Clinical remission & endoscopic remission as defined above at Week 52. Ulcer-free endoscopy as defined above at Week 52
To evaluate the efficacy of afimkibart compared with placebo in terms of CD-related symptoms & health-related quality of life
· Bowel urgency, from baseline through Week 12 & Week 52 · Fatigue, as measured by FACIT-F, from baseline to Week 12 & Week 52
· IBDQ score, from baseline to Week 12 & Week 52
To evaluate the efficacy of afimkibart compared with placebo in TL1A biomarker defined subgroups
Among TL1A biomarker-defined subgroups of participants:
· Clinical remission at Week 12
· Clinical remission at Week 52
· Endoscopic response at Week 12
· Endoscopic response at Week 52
Target Sample Size
Total Sample Size="600" 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 3
Date of First Enrollment (India)
20/08/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
02/12/2024
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="4" 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 - NO
Brief Summary
The purpose of this study is to assess the efficacy and safety of RO7790121 referred to herein as afimkibart, in patients with moderately to severely active Crohn’s disease (CD). Afimkibart is a fully human neutralizing immunoglobulin G1 (IgG1) monoclonal antibody (mAb) against tumor necrosis factor-like ligand 1A (TL1A). TL1A plays a central role in the regulation of gut mucosal immunity and participates in immunological and fibrosis pathways involved in inflammatory bowel disease pathogenesis by binding its receptor, death receptor 3. Therapeutic options have expanded substantially over the past decade, with biologics and small molecule treatments now available in addition to conventional therapies. However, a high unmet medical need remains for treatments with better benefit risk profiles that attenuate inflammation and clinical sequelae and provide sustained control to improve the long-term prognosis of patients with CD.