Back to resultsRVT-3101 for the Treatment of Moderate to Severe Active Crohn's Disease
Primary Purpose
Crohn Disease
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RVT-3101
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease
Eligibility Criteria
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
Sites / Locations
- Telavant SiteRecruiting
- Telavant SiteRecruiting
- Telavant SiteRecruiting
- Telavant SiteRecruiting
- Televant SiteRecruiting
- Telavant SiteRecruiting
- Telavant SiteRecruiting
- Telavant SiteRecruiting
- Telavant SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental: Treatment Sequence A; Drug: RVT-3101 Induction dose A and Maintenance dose
Experimental: Treatment Sequence B; Drug: RVT-3101 Induction dose B and Maintenance dose
Arm Description
Outcomes
Primary Outcome Measures
Proportion of participants achieving clinical remission by CDAI
Induction of Clinical Remission by CDAI
Secondary Outcome Measures
Proportion of participants achieving endoscopic response
Induction of Endoscopic Response
Proportion of participants achieving clinical response by CDAI
Induction of Clinical Response by CDAI
Proportion of participants achieving endoscopic remission
Induction of Endoscopic Remission
Proportion of participants achieving clinical remission by CDAI and endoscopic response
Induction of Clinical Remission by CDAI and Endoscopic Response
Incidence of treatment-emergent adverse events (TEAE), serious adverse events (SAE) and AE leading to discontinuation
Safety and Tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05910528
Brief Title
RVT-3101 for the Treatment of Moderate to Severe Active Crohn's Disease
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Telavant, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Treatment Sequence A; Drug: RVT-3101 Induction dose A and Maintenance dose
Arm Type
Experimental
Arm Title
Experimental: Treatment Sequence B; Drug: RVT-3101 Induction dose B and Maintenance dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RVT-3101
Intervention Description
Induction and maintenance treatment
Primary Outcome Measure Information:
Title
Proportion of participants achieving clinical remission by CDAI
Description
Induction of Clinical Remission by CDAI
Time Frame
Week 14
Secondary Outcome Measure Information:
Title
Proportion of participants achieving endoscopic response
Description
Induction of Endoscopic Response
Time Frame
Week 14
Title
Proportion of participants achieving clinical response by CDAI
Description
Induction of Clinical Response by CDAI
Time Frame
Week 14
Title
Proportion of participants achieving endoscopic remission
Description
Induction of Endoscopic Remission
Time Frame
Week 14
Title
Proportion of participants achieving clinical remission by CDAI and endoscopic response
Description
Induction of Clinical Remission by CDAI and Endoscopic Response
Time Frame
Week 14
Title
Incidence of treatment-emergent adverse events (TEAE), serious adverse events (SAE) and AE leading to discontinuation
Description
Safety and Tolerability
Time Frame
Week 54
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanne Vyvoda
Phone
8015567244
Email
info@telavanttx.com
Facility Information:
Facility Name
Telavant Site
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
info@telavanttx.com
Facility Name
Telavant Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
info@telavanttx.com
Facility Name
Telavant Site
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
info@telavanttx.com
Facility Name
Telavant Site
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
info@telavanttx.com
Facility Name
Televant Site
City
Santa Clarita
State/Province
California
ZIP/Postal Code
91355
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
info@telavanttx.com
Facility Name
Telavant Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
info@telavanttx.com
Facility Name
Telavant Site
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
info@telavanttx.com
Facility Name
Telavant Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
info@telavanttx.com
Facility Name
Telavant Site
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
info@telavanttx.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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RVT-3101 for the Treatment of Moderate to Severe Active Crohn's Disease
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