A Study to Assess the Effectiveness and Safety of Induction Therapy with RO7790121 in Participants 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], Phenomena and Processes [G] - Immune System Phenomena [G13]

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 Ltd

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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

Secondary objectives 7

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

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

IPD plan description

N/A

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 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: - SES-CD of ≥ 6 (or ≥ 4 for isolated ileal disease) - CDAI ≥ 220 and ≤ 450
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 (colon and/or ileum) 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 five 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 Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
4. 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 o 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 Crohn's disease activity index (CDAI) < 150
2. 2. Endoscopic response, defined as decrease in Simple Endoscopic Score for Crohn's disease (SES-CD) from baseline≥ 50%

Secondary endpoints 20

1. 1. Symptomatic remission,
2. 2. Endoscopic remission,
3. 3. Ulcer-free endoscopy,
4. 4. Average of daily number of liquid or very soft stools in the past week (SF), from baseline
5. 5. Average of daily abdominal pain scores in the past week (APS) from baseline
6. 6. Bowel urgency, from baseline
7. 7. Fatigue, as measured by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), from baseline
8. 8. Inflammatory Bowel Disease Questionnaire (IBDQ) score, from baseline
9. 9. Among biomarker-defined subgroups of participants: Clinical remission
10. 10. Among biomarker-defined subgroups of participants: Endoscopic response
11. 11. Clinical response, defined as a decrease in CDAI from baseline
12. 12. Symptomatic response,
13. 13. Overall change in CD symptoms, as measured by PGIC, from baseline
14. 14. Overall severity in CD symptoms, as measured by Patient Global Impression of Severity (PGIS), from baseline
15. 15. General well-being, from baseline
16. 16. Incidence and severity of the following: Adverse events
17. 17. Incidence and severity of the following: Serious adverse events
18. 18. Incidence and severity of the following: Adverse events leading to study treatment discontinuation
19. 19. Incidence and severity of the following: Adverse events of special interest
20. 20. 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

14 EU/EEA countries · 78 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 181 files

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

Application history

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