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

Crohn Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06370858
• Other study ID #: GA45392
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 24, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: April 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: November 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• RVT-3101
Induction and maintenance treatment

Locations

Country	Name	City	State
Belgium	UZ Gent	Gent
Belgium	AZ Delta	Roeselare
Bulgaria	MBAL Hadzi Dimitar	Sliven
Bulgaria	UMHAT Prof. Dr. Stoyan Kirkovich	Stara Zagora
Canada	(G.I.R.I.) GI Research Institute	Vancouver	British Columbia
Canada	TDDA Specialty Research	Woodbridge	Ontario
France	CHU de Nantes	Nantes cedex 1
France	Institut des MICI, Clinique Ambroise Paré	Neuilly sur Seine
France	CHRU de Nancy Brabois	Vandoeuvre Les Nancy
Germany	Praxis Westend Studien	Berlin
Germany	Zentrum für Gastroenterologie Saar MVZ GmbH	Saarbrücken
Hungary	Clinexpert Kft.	Budapest
Hungary	Semmelweis Egyetem, II. Belgyógyászati Klinika	Budapest
Hungary	Semmelweis University Belgyogyaszati es Onkologiai Klinika	Budapest
Poland	Synexus Polska Sp. z o.o. Oddzial w Czestochowie	Cz?stochowa
Poland	MZ Badania Slowik Zymla Sp.j.	Knurów
Poland	Twoja Przychodnia-Szczecinskie Centrum Medyczne	Szczecin
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warszawa
Poland	MIGRE Polskie Centrum Leczenia Migreny	Wroc?aw
Slovakia	ABAWI spol. s r.o.	Bratislava
Slovakia	Gastro Ambulancia - Endomed	Košice
Spain	Hospital Universitario de Fuenlabrada	Madrid
Spain	FISEVI	Sevilla
Spain	Hospital Universitario y Politecnico la Fe de Valencia	Valencia
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Access Research Institute	Brooksville	Florida
United States	Clinical Research Institute of Michigan	Chesterfield	Michigan
United States	Digestive Health Specialists	Dothan	Alabama
United States	VVCRD Research	Garden Grove	California
United States	Medical Research Center of Connecticut, LLC	Hamden	Connecticut
United States	Baylor College of Medicine.	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	I.H.S Health Northwell Health	Kissimmee	Florida
United States	United Medical Doctors	Los Alamitos	California
United States	NRC Research Institute	Orange	California
United States	Digestive Disease Consultants	Orange Park	Florida
United States	Endoscopic Research, Inc.	Orlando	Florida
United States	Revival Clinical Research	Orlando	Florida
United States	Inland Empire Liver Foundation	Rialto	California
United States	Amicis Research Center	Santa Clarita	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  France,  Germany,  Hungary,  Poland,  Slovakia,  Spain, 

Outcome

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