Clinical trial NCT05910528: RO7790121 for the Treatment of Moderate to Severe Active Crohn's Disease
Official title: A Phase 2, Multicenter, Double-blind, Two-arm Study of Subcutaneous RO7790121 for the Treatment of Subjects With Moderate to Severe Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Crohns Disease
Keywords: Crohns Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of RO7790121 (RVT-3101) in adult participants with moderate to severe active Crohn's disease.


Eligibility criteria: Inclusion Criteria:

* Moderately to severely active CD as defined by CDAI and 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

Exclusion Criteria:

* Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease
* Short gut syndrome
* Presence of an ostomy or ileoanal pouch
* Bowel resection or diversion with \~6-months

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and AE Leading to Discontinuation
timeFrame: Until end of study, approximately 5 years
Secondary outcomes:
measure: Proportion of Participants Achieving Endoscopic Response
timeFrame: Week 14
measure: Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI)
timeFrame: Week 14
measure: Proportion of Participants Achieving Clinical Remission by Patient Reported Outcome 2 (PRO2)
timeFrame: Week 14
measure: Trough Concentration (Ctrough)
timeFrame: Up to Week 64
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists
state: Alabama
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Kissimmee
country: United States
facility: I.H.S Health Northwell Health
state: Florida
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan
state: Michigan
city: Roeselare
country: Belgium
facility: AZ Delta
city: Nantes cedex 1
country: France
facility: CHU de Nantes
city: Neuilly sur Seine
country: France
facility: Institut des MICI, Clinique Ambroise Paré
city: Vandoeuvre Les Nancy
country: France
facility: CHRU de Nancy Brabois
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne
city: Warszawa
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: