The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05910528
Recruitment Status : Active, not recruiting
First Posted : June 18, 2023
Last Update Posted : May 9, 2024
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Crohn Disease Drug: RVT-3101 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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
Actual Study Start Date : July 24, 2023
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : November 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Proportion of participants achieving clinical remission by CDAI [ Time Frame: Week 14 ]
    Induction of Clinical Remission by CDAI


Secondary Outcome Measures :
  1. Proportion of participants achieving endoscopic response [ Time Frame: Week 14 ]
    Induction of Endoscopic Response

  2. Proportion of participants achieving clinical response by CDAI [ Time Frame: Week 14 ]
    Induction of Clinical Response by CDAI

  3. Proportion of participants achieving endoscopic remission [ Time Frame: Week 14 ]
    Induction of Endoscopic Remission

  4. Proportion of participants achieving clinical remission by CDAI and endoscopic response [ Time Frame: 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 [ Time Frame: Week 54 ]
    Safety and Tolerability

  6. Proportion of participants achieving clinical response by PRO2 [ Time Frame: Week 14 ]
    Induction of clinical response by PRO2

  7. Proportion of participants achieving clinical remission by PRO2 [ Time Frame: Week 14 ]
    Induction of clinical remission by PRO2

  8. Trough Concentration (Ctrough) [ Time Frame: Up to Week 64 ]
  9. Percentage of Participants with Anti-drug antibodies (ADA) [ Time Frame: Up to Week 64 ]
  10. Percentage of Participants with Neutralizing Antibodies (NAb) [ Time Frame: Up to Week 64 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05910528


Locations
Show Show 27 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05910528    
Obsolete Identifiers: NCT06370858
Other Study ID Numbers: GA45392
First Posted: June 18, 2023    Key Record Dates
Last Update Posted: May 9, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/).

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases