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NCT06588855 · ClinicalTrials.gov registry record · Phase 3

A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 3 study of Moderately to Severely Active Ulcerative Colitis, sponsored by Hoffmann-La Roche.

Recruiting
Registry status
Phase 3
Development phase
350
Enrollment target
20
Study locations

NCT06588855 is a Phase 3 study of Moderately to Severely Active Ulcerative Colitis that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 350 participants. The trial reports 20 study locations across 5 states.

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The verdict

NCT06588855, a Phase 3 study of Moderately to Severely Active Ulcerative Colitis, is actively recruiting participants, sponsored by Hoffmann-La Roche.

RECRUITING
Registry status
Phase 3
Development phase
350 participants
Enrollment target
20
Study locations

Study Summary

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Interventions

  • DRUG Placebo
  • DRUG Afimkibart

Study Locations (20)

Florida

  • Hi Tech and Global Research, LLC - Coral Gables
  • The Sister Life Research - Hialeah
  • LCC Medical Research Institute, LLC - Miami
  • Allied Biomedical Research Institute - Miami
  • Ambert Medical Research - Miami
  • Gastroenterology Institute of Orlando - Orlando
  • Digestive and Liver Center of Florida - Orlando
  • Advanced Medical Research Center - Port Orange
  • University of South Florida School of Medicine Morsani Center for Advanced Health Care - Tampa
  • Guardian Angel Research Center, LLC - Tampa
  • Santos Research Center, CORP - Tampa

California

  • Om Research LLC - Apple Valley
  • Valley View Internal Medicine - Garden Grove
  • Gastro Care Associates - Lancaster
  • Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education - Newport Beach
  • Stanford Medicine Outpatient Center - Redwood City

Arizona

  • Mayo Clinic Hospital - Scottsdale
  • Arizona Digestive Health, P.C (ADH) - Sun City

Alabama

  • Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan - Dothan

Colorado

  • Peak Gastroenterology Associates - Colorado Springs

Trial Details

FieldValue
Enrollment Target 350 participants
Start Date 2024-12-11
Est. Completion 2029-12-30
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT06588855

The ClinicalTrials.gov registry entry for NCT06588855 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Moderately to Severely Active Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06588855 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT06588855 about?

NCT06588855 is a clinical study titled "A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis". This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

What is the current status of trial NCT06588855?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2024-12-11. Estimated completion is 2029-12-30.

What conditions does trial NCT06588855 study?

This clinical trial studies the following conditions: Moderately to Severely Active Ulcerative Colitis.

What interventions are being tested in trial NCT06588855?

The interventions under investigation include: Placebo (DRUG), Afimkibart (DRUG).

Who is sponsoring clinical trial NCT06588855?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06588855 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.