A Study to Test the Effectiveness and Safety of RO7790121 for induction and maintenance therapy in Patients with Moderately to Severely Active Crohn's Disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

16 Apr 2025 → ongoing

Decision date (initial)

2025-04-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the efficacy of afimkibart compared with placebo in maintaining response

Secondary objectives 8

1. To evaluate the efficacy of afimkibart compared with placebo in inducing response
2. To evaluate the efficacy of afimkibart compared with placebo in maintaining response
3. To evaluate the efficacy of afimkibart compared with placebo in terms of CD-related symptoms and health-related quality of life
4. To evaluate the efficacy of afimkibart compared with placebo in tumor necrosis factor-like ligand 1A (TL1A) biomarker-defined subgroups
5. To evaluate the efficacy of afimkibart compared with placebo in inducing and/or maintaining response
6. To evaluate the efficacy of afimkibart compared with placebo in terms of the participant’s global impressions and general well-being
7. To evaluate the safety of afimkibart compared with placebo
8. To evaluate the persistence of fistulas of participants treated with afimkibart compared to placebo

Conditions and MedDRA coding

Moderately to Severely Active Crohn's Disease (CD)

Study design 5 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

IPD plan description

NA

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. General Inclusion Criteria Age ≥18 to ≤ 80 years at the time of signing Informed Consent Form
2. General Inclusion Criteria Bodyweight ≥ 40 kg
3. Crohn's Disease-Specific Inclusion Criteria Confirmed diagnosis of CD with supportive clinical, endoscopic and histopathological evidence
4. Crohn's Disease-Specific Inclusion Criteria Moderately to severely active CD, meeting all of the following: - CDAI ≥ 220 and ≤ 450 - SES-CD of ≥ 6 (or ≥ 4 for isolated ileal disease) -
5. Crohn's Disease-Specific Inclusion Criteria Involvement of ileum and/or colon, with at least four colonic segments traversable by an endoscope or a pediatric endoscope, or three 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.
6. Crohn's Disease-Specific Inclusion Criteria Screening for colorectal cancer (CRC) during or prior to screening for all participants (performed according to local standards)  with risk factors for bowel cancer a surveillance ileocolonoscopy must be performed within 12 months prior to screening.  For all other patients, must be up-to date with CRC surveillance (according to CRC risks and local standards)  Screening ileocolonoscopy can be used for CRC surveillance (following local guidelines) and results must be available prior to randomization Any adenomatous polyps must be completely removed according to routine practice prior to their first dose of study drug.

Exclusion criteria 6

1. Inflammatory Bowel Disease Exclusion Criteria Participant with a history of ≥ 3 bowel resections > 2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum
2. Inflammatory Bowel Disease Exclusion Criteria Diagnosis of short gut or short bowel syndrome
3. Medical History Exclusion Criteria Lack of peripheral venous access
4. Medical History Exclusion Criteria Significant uncontrolled medical comorbidity (such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders [excluding CD]), psychiatric, or other condition that in the opinion of the investigator, would confound the study results, compromise patient safety, interfere with the potential participant's provision of informed consent, or compliance with trial procedures.
5. Infection or Infection Risk Exclusion Criteria Any clinically significant infection < 4 weeks prior to randomization that has not resolved, and/or that required hospitalization, and/or IV antibiotics Any clinically significant infection that was opportunistic in nature is not permitted within 3 months prior to randomization
6. Infection or Infection Risk Exclusion Criteria Confirmation of HIV infection (e.g., positive HIV test) at screening

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 1. Clinical remission, defined as CDAI < 150,
2. 2. Endoscopic response, defined as decrease in SES-CD from baseline ≥ 50%,

Secondary endpoints 31

1. 1. Clinical remission, as defined above,
2. 2. Endoscopic response, as defined above,
3. 3. Symptomatic remission,
4. 4. Endoscopic remission,
5. 5. Ulcer-free endoscopy,
6. 6. SF, from baseline
7. 7. APS, from baseline
8. 8. Endoscopic remission,
9. 9. Symptomatic remission,
10. 10. Corticosteroid-free clinical remission,
11. 11. Maintenance of clinical remission,
12. 12. Maintenance of endoscopic response,
13. 13. Clinical remission and endoscopic remission,
14. 14. Ulcer-free endoscopy,
15. 15. Bowel urgency, from baseline
16. 16. Fatigue, as measured by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), from baseline
17. 17. Inflammatory Bowel Disease Questionnaire (IBDQ) score, from baseline
18. 18. Clinical remission
19. 19. Clinical remission
20. 20. Endoscopic response
21. 21. Endoscopic response
22. 22. Clinical response,
23. 23. Symptomatic response,
24. 24. Overall change in CD symptoms,
25. 25. Overall severity in CD symptoms,
26. 26. General well-being, from baseline
27. 27. Incidence and severity of the following: - Adverse events
28. 28. Incidence and severity of the following: - Serious adverse events
29. 29. Incidence and severity of the following: - Adverse events leading to study treatment discontinuation
30. 30. Incidence and severity of the following: - Adverse events of special interest
31. 31. Presence of draining fistulas

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 12

Locations

16 EU/EEA countries · 126 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 198 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

16 submissions — initial application plus substantial / non-substantial modifications