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

April 16, 2024 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • UZ Gent
      • Roeselare, Belgium, 8800
        • AZ Delta
  • Bulgaria
      • Sliven, Bulgaria, 8800
        • MBAL Hadzi Dimitar
      • Stara Zagora, Bulgaria, 6000
        • UMHAT Prof. Dr. Stoyan Kirkovich
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • (G.I.R.I.) GI Research Institute
    • Ontario
      • Woodbridge, Ontario, Canada, L4L 4Y7
        • TDDA Specialty Research
  • France
      • Nantes cedex 1, France, 44093
        • CHU de Nantes
      • Neuilly sur Seine, France, 92200
        • Institut des MICI, Clinique Ambroise Paré
      • Vandoeuvre Les Nancy, France, 54500
        • CHRU de Nancy Brabois
  • Germany
      • Berlin, Germany, 14050
        • Praxis Westend Studien
      • Saarbrücken, Germany, 66111
        • Zentrum für Gastroenterologie Saar MVZ GmbH
  • Hungary
      • Budapest, Hungary, 1033
        • Clinexpert Kft.
      • Budapest, Hungary, 1088
        • Semmelweis Egyetem, II. Belgyogyaszati Klinika
      • Budapest, Hungary, 1083
        • Semmelweis University Belgyogyaszati es Onkologiai Klinika
  • Poland
      • Cz?stochowa, Poland, 42-202
        • Synexus Polska Sp. z o.o. Oddzial w Czestochowie
      • Knurów, Poland, 44-190
        • MZ Badania Slowik Zymla Sp.j.
      • Szczecin, Poland, 71-434
        • Twoja Przychodnia-Szczecinskie Centrum Medyczne
      • Warszawa, Poland, 00-728
        • WIP Warsaw IBD Point Profesor Kierkus
      • Wroc?aw, Poland, 52-210
        • MIGRE Polskie Centrum Leczenia Migreny
  • Slovakia
      • Bratislava, Slovakia, 821 07
        • ABAWI spol. s r.o.
      • Košice, Slovakia, 040 13
        • Gastro Ambulancia - Endomed
  • Spain
      • Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada
      • Sevilla, Spain, 41009
        • FISEVI
      • Valencia, Spain, 46026
        • Hospital Universitario y Politécnico La Fe de Valencia
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialists
    • California
      • Garden Grove, California, United States, 92845
        • VVCRD Research
      • Los Alamitos, California, United States, 90702
        • United Medical Doctors
      • Orange, California, United States, 92868
        • NRC Research Institute
      • Rialto, California, United States, 92377
        • Inland Empire Liver Foundation
      • Santa Clarita, California, United States, 91355
        • Amicis Research Center
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Medical Research Center of Connecticut, LLC
    • Florida
      • Brooksville, Florida, United States, 34613
        • Access Research Institute
      • Kissimmee, Florida, United States, 34741
        • I.H.S Health Northwell Health
      • Orange Park, Florida, United States, 32073
        • Digestive Disease Consultants
      • Orlando, Florida, United States, 32803
        • Endoscopic Research, Inc.
      • Orlando, Florida, United States, 32807
        • Revival Clinical Research
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving endoscopic response
Time Frame: Week 14
Induction of Endoscopic Response
Week 14
Proportion of participants achieving clinical response by CDAI
Time Frame: Week 14
Induction of Clinical Response by CDAI
Week 14
Proportion of participants achieving clinical remission by CDAI and endoscopic response
Time Frame: Week 14
Induction of Clinical Remission by CDAI and Endoscopic Response
Week 14
Proportion of participants achieving clinical response by PRO2
Time Frame: Week 14
Induction of clinical response by PRO2
Week 14
Proportion of participants achieving clinical remission by PRO2
Time Frame: Week 14
Induction of clinical remission by PRO2
Week 14
Proportion of participants achieving endoscopic remission
Time Frame: Week 14
Induction of Endoscopic Response
Week 14
Incidence of treatment-emergent adverse events (TEAE), serious adverse events (SAE) and AE leading to discontinuation
Time Frame: Week 14
Safety and Tolerability
Week 14
Trough Concentration (Ctrough)
Time Frame: Up to Week 64
Up to Week 64
Percentage of Participants with Anti-drug antibodies (ADA)
Time Frame: Up to Week 64
Up to Week 64
Percentage of Participants with Neutralizing Antibodies (NAb)
Time Frame: Up to Week 64
Up to Week 64

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA45392

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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