RO7790121 for Moderately to severely active Crohn's disease

Inclusion criteria

• {"criterion_text":"- General Inclusion Criteria Age ≥18 to ≤ 80 years at the time of signing Informed Consent Form"}
• {"criterion_text":"- General Inclusion Criteria Bodyweight ≥ 40 kg"}
• {"criterion_text":"- Crohn's Disease-Specific Inclusion Criteria Confirmed diagnosis of CD with supportive clinical, endoscopic and histopathological evidence"}
• {"criterion_text":"- 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) -"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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

• {"criterion_text":"- 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"}
• {"criterion_text":"- Inflammatory Bowel Disease Exclusion Criteria Diagnosis of short gut or short bowel syndrome"}
• {"criterion_text":"- Medical History Exclusion Criteria Lack of peripheral venous access"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Infection or Infection Risk Exclusion Criteria Confirmation of HIV infection (e.g., positive HIV test) at screening"}

Primary endpoints

• {"endpoint_text":"- 1. Clinical remission, defined as CDAI < 150,","definition_or_measurement_approach":"Clinical remission defined as Crohn's Disease Activity Index (CDAI) < 150"}
• {"endpoint_text":"- 2. Endoscopic response, defined as decrease in SES-CD from baseline ≥ 50%,","definition_or_measurement_approach":"Endoscopic response defined as a ≥50% decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from baseline"}

Secondary endpoints

• {"endpoint_text":"- 1. Clinical remission, as defined above,","definition_or_measurement_approach":"See primary definition: CDAI < 150"}
• {"endpoint_text":"- 2. Endoscopic response, as defined above,","definition_or_measurement_approach":"See primary definition: ≥50% decrease in SES-CD from baseline"}
• {"endpoint_text":"- 3. Symptomatic remission,","definition_or_measurement_approach":""}
• {"endpoint_text":"- 4. Endoscopic remission,","definition_or_measurement_approach":""}
• {"endpoint_text":"- 5. Ulcer-free endoscopy,","definition_or_measurement_approach":""}
• {"endpoint_text":"- 6. SF, from baseline","definition_or_measurement_approach":""}
• {"endpoint_text":"- 7. APS, from baseline","definition_or_measurement_approach":""}
• {"endpoint_text":"- 8. Endoscopic remission,","definition_or_measurement_approach":""}
• {"endpoint_text":"- 9. Symptomatic remission,","definition_or_measurement_approach":""}
• {"endpoint_text":"- 10. Corticosteroid-free clinical remission,","definition_or_measurement_approach":""}
• {"endpoint_text":"- 11. Maintenance of clinical remission,","definition_or_measurement_approach":""}
• {"endpoint_text":"- 12. Maintenance of endoscopic response,","definition_or_measurement_approach":""}
• {"endpoint_text":"- 13. Clinical remission and endoscopic remission,","definition_or_measurement_approach":""}
• {"endpoint_text":"- 14. Ulcer-free endoscopy,","definition_or_measurement_approach":""}
• {"endpoint_text":"- 15. Bowel urgency, from baseline","definition_or_measurement_approach":""}
• {"endpoint_text":"- 16. Fatigue, as measured by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), from baseline","definition_or_measurement_approach":"Fatigue measured by FACIT-F scale"}
• {"endpoint_text":"- 17. Inflammatory Bowel Disease Questionnaire (IBDQ) score, from baseline","definition_or_measurement_approach":"Health-related quality of life measured by IBDQ"}
• {"endpoint_text":"- 18. Clinical remission","definition_or_measurement_approach":"CDAI-based definition as above"}
• {"endpoint_text":"- 19. Clinical remission","definition_or_measurement_approach":"CDAI-based"}
• {"endpoint_text":"- 20. Endoscopic response","definition_or_measurement_approach":"SES-CD based"}
• {"endpoint_text":"- 21. Endoscopic response","definition_or_measurement_approach":"SES-CD based"}
• {"endpoint_text":"- 22. Clinical response,","definition_or_measurement_approach":""}
• {"endpoint_text":"- 23. Symptomatic response,","definition_or_measurement_approach":""}
• {"endpoint_text":"- 24. Overall change in CD symptoms,","definition_or_measurement_approach":""}
• {"endpoint_text":"- 25. Overall severity in CD symptoms,","definition_or_measurement_approach":""}
• {"endpoint_text":"- 26. General well-being, from baseline","definition_or_measurement_approach":""}
• {"endpoint_text":"- 27. Incidence and severity of the following: - Adverse events","definition_or_measurement_approach":"Safety assessed by incidence and severity of adverse events"}
• {"endpoint_text":"- 28. Incidence and severity of the following: - Serious adverse events","definition_or_measurement_approach":"Safety assessed by incidence and severity of serious adverse events"}
• {"endpoint_text":"- 29. Incidence and severity of the following: - Adverse events leading to study treatment discontinuation","definition_or_measurement_approach":""}
• {"endpoint_text":"- 30. Incidence and severity of the following: - Adverse events of special interest","definition_or_measurement_approach":""}
• {"endpoint_text":"- 31. Presence of draining fistulas","definition_or_measurement_approach":""}

Methods

• Social media posts (documents: K2_social media_text, K4_Social Media Posts_IBD) — digital outreach to patients and public
• Patient-facing materials: posters and flyers (K2_Patient Poster, K2_Patient Flyer) — placed in clinics and hospitals to reach IBD patients
• Database letters / patient database communications (K2_Recruitment material_Database Letter) — contacting patients in existing databases
• Communication to doctors/GPs and professional outreach (K1_Recruitment Arrangements / Communication to Doctors) — engaging clinicians to refer eligible patients
• eCOA / electronic patient-reported outcome tools (third-party eCOA vendor documents present) — digital data capture and participant contact

Hungary

Earliest CTIS Part Ii Submission Date

28-03-2025

Latest Decision Or Authorization Date

26-08-2025

Processing Time Days

151

Number Of Sites

8

Number Of Participants

21

Portugal

Earliest CTIS Part Ii Submission Date

27-03-2025

Latest Decision Or Authorization Date

22-08-2025

Processing Time Days

148

Number Of Sites

5

Number Of Participants

5

Netherlands

Earliest CTIS Part Ii Submission Date

03-04-2025

Latest Decision Or Authorization Date

22-08-2025

Processing Time Days

141

Number Of Sites

6

Number Of Participants

18

Denmark

Earliest CTIS Part Ii Submission Date

18-12-2024

Latest Decision Or Authorization Date

27-08-2025

Processing Time Days

252

Number Of Sites

1

Number Of Participants

3

Spain

Earliest CTIS Part Ii Submission Date

21-03-2025

Latest Decision Or Authorization Date

25-08-2025

Processing Time Days

157

Number Of Sites

7

Number Of Participants

14

Croatia

Earliest CTIS Part Ii Submission Date

01-04-2025

Latest Decision Or Authorization Date

22-04-2025

Processing Time Days

167

Number Of Sites

3

Number Of Participants

10

Italy

Earliest CTIS Part Ii Submission Date

26-03-2025

Latest Decision Or Authorization Date

26-08-2025

Processing Time Days

153

Number Of Sites

17

Number Of Participants

47

Germany

Earliest CTIS Part Ii Submission Date

26-03-2025

Latest Decision Or Authorization Date

22-08-2025

Processing Time Days

149

Number Of Sites

11

Number Of Participants

31

France

Earliest CTIS Part Ii Submission Date

04-04-2025

Latest Decision Or Authorization Date

27-08-2025

Processing Time Days

145

Number Of Sites

12

Number Of Participants

57

Poland

Earliest CTIS Part Ii Submission Date

10-03-2025

Latest Decision Or Authorization Date

05-12-2025

Processing Time Days

270

Number Of Sites

28

Number Of Participants

35

Romania

Earliest CTIS Part Ii Submission Date

02-04-2025

Latest Decision Or Authorization Date

02-02-2026

Processing Time Days

306

Number Of Sites

3

Number Of Participants

9

Czechia

Earliest CTIS Part Ii Submission Date

25-03-2025

Latest Decision Or Authorization Date

18-11-2025

Processing Time Days

238

Number Of Sites

4

Number Of Participants

22

Belgium

Earliest CTIS Part Ii Submission Date

11-03-2025

Latest Decision Or Authorization Date

12-01-2026

Processing Time Days

307

Number Of Sites

13

Number Of Participants

23

Austria

Earliest CTIS Part Ii Submission Date

26-03-2025

Latest Decision Or Authorization Date

17-11-2025

Processing Time Days

236

Number Of Sites

4

Number Of Participants

11

Bulgaria

Earliest CTIS Part Ii Submission Date

02-04-2025

Latest Decision Or Authorization Date

02-03-2026

Processing Time Days

334

Number Of Sites

5

Number Of Participants

30

Slovakia

Earliest CTIS Part Ii Submission Date

28-03-2025

Latest Decision Or Authorization Date

01-12-2025

Processing Time Days

248

Number Of Sites

4

Number Of Participants

12

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Global CRO

Name

IQVIA Limited

Responsibilities

sponsorDuties code: 1

Name

PPD Development LP

Responsibilities

sponsorDuties code: 4

Third parties

• {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Central Imaging","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pathai Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Global CRO","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translations","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Mobile Nursing","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}