| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504265-23-00 | EU Trial (CTIS) Number |
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This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of Afimkibart (RO7790121, RVT-3101) in adult participants with moderate to severe active Crohn's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence A; Drug: Afimkibart (RO7790121) Induction dose A, Maintenance dose and OLE dose | Experimental |
| |
| Treatment Sequence B; Drug: Afimkibart (RO7790121) Induction dose B, Maintenance dose and OLE dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afimkibart | Drug | Afimkibart will be administered during the Induction, Maintenance and OLE period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and AE Leading to Discontinuation | Until end of study, approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving Endoscopic Response | Endoscopic response defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) >=50% from Baseline at Week 14 | Week 14 |
| Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Health Specialists | Dothan | Alabama | 36305 | United States | ||
| Medical Research Center of Connecticut, LLC |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Clinical remission defined as CDAI <150 at Week 14 |
| Week 14 |
| Proportion of Participants Achieving Clinical Remission by Patient Reported Outcome 2 (PRO2) | Clinical remission by PRO2 defined as average daily very soft or liquid stool frequency (SF) <= 2.8 and abdominal pain (AP) score <=1, and not worse than Baseline at Week 14. | Week 14 |
| Trough Concentration (Ctrough) | Up to Week 64 |
| Hamden |
| Connecticut |
| 06518 |
| United States |
| I.H.S Health Northwell Health | Kissimmee | Florida | 34741 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Clinical Research Institute of Michigan | Chesterfield | Michigan | 48047 | United States |
| AZ Delta | Roeselare | 8800 | Belgium |
| CHU de Nantes | Nantes | 44093 | France |
| Institut des MICI, Clinique Ambroise Paré | Neuilly-sur-Seine | 92200 | France |
| CHRU de Nancy Brabois | Vandœuvre-lès-Nancy | 54500 | France |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne | Szczecin | 71-434 | Poland |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | 00-728 | Poland |
| D007410 | Intestinal Diseases |