RVT-3101 for the Treatment of Moderate to Severe Active Crohn's Disease

Study Overview
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Brief Summary
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This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of RVT-3101 in adult participants with moderate to severe active Crohn's disease.

Official Title
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A Phase 2, Multicenter, Double-blind, Two-arm Study of Subcutaneous RVT-3101 for the Treatment of Subjects With Moderate to Severe Active Crohn's Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Drug: RVT-3101


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderately to severely active CD as defined by Crohn's Disease Activity Index (CDAI) and Simple Endoscopic Score for CD (SES-CD), assessed by central read Elevated very soft or liquid stool frequency and/or abdominal pain Must have no response, insufficient response, loss of response and/or intolerance to at least 1 conventional therapy (e.g. corticosteroids) or advanced therapy Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease Exclusion Criteria: Short gut syndrome Presence of an ostomy or ileoanal pouch Bowel resection or diversion with  6-months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Treatment Sequence A; Drug: RVT-3101 Induction dose A and Maintenance dose<br> | Drug: RVT-3101<br>* Induction and maintenance treatment<br>|
| Experimental: Experimental: Treatment Sequence B; Drug: RVT-3101 Induction dose B and Maintenance dose<br> | Drug: RVT-3101<br>* Induction and maintenance treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving clinical remission by CDAI | Induction of Clinical Remission by CDAI | Week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving endoscopic response | Induction of Endoscopic Response | Week 14 | 
| Proportion of participants achieving clinical response by CDAI | Induction of Clinical Response by CDAI | Week 14 | 
| Proportion of participants achieving endoscopic remission | Induction of Endoscopic Remission | Week 14 | 
| Proportion of participants achieving clinical remission by CDAI and endoscopic response | Induction of Clinical Remission by CDAI and Endoscopic Response | Week 14 | 
| Incidence of treatment-emergent adverse events (TEAE), serious adverse events (SAE) and AE leading to discontinuation | Safety and Tolerability | Week 54 | 
| Proportion of participants achieving clinical response by PRO2 | Induction of clinical response by PRO2 | Week 14 | 
| Proportion of participants achieving clinical remission by PRO2 | Induction of clinical remission by PRO2 | Week 14 | 
| PK Parameters of RVT-3101 | PK of RVT-3101 in moderate-severe active CD | Week 14 |