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

Sponsor
Telavant, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05910528
Collaborator
(none)
105
2
28.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jun 12, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: Treatment Sequence A; Drug: RVT-3101 Induction dose A and Maintenance dose

Drug: RVT-3101
Induction and maintenance treatment

Experimental: Experimental: Treatment Sequence B; Drug: RVT-3101 Induction dose B and Maintenance dose

Drug: RVT-3101
Induction and maintenance treatment

Outcome Measures

Primary Outcome Measures

  1. Proportion of participants achieving clinical remission by CDAI [Week 14]

    Induction of Clinical Remission by CDAI

Secondary Outcome Measures

  1. Proportion of participants achieving endoscopic response [Week 14]

    Induction of Endoscopic Response

  2. Proportion of participants achieving clinical response by CDAI [Week 14]

    Induction of Clinical Response by CDAI

  3. Proportion of participants achieving endoscopic remission [Week 14]

    Induction of Endoscopic Remission

  4. Proportion of participants achieving clinical remission by CDAI and endoscopic response [Week 14]

    Induction of Clinical Remission by CDAI and Endoscopic Response

  5. Incidence of treatment-emergent adverse events (TEAE), serious adverse events (SAE) and AE leading to discontinuation [Week 54]

    Safety and Tolerability

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Telavant, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Telavant, Inc.
ClinicalTrials.gov Identifier:
NCT05910528
Other Study ID Numbers:
  • RVT 3101-201
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2023