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NCT06589986 · ClinicalTrials.gov registry record · Phase 3

A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy 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.

Active
Registry status
Phase 3
Development phase
400
Enrollment target
20
Study locations

NCT06589986 is a Phase 3 study of Moderately to Severely Active Ulcerative Colitis that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 400 participants. The trial reports 20 study locations across 5 states.

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The verdict

NCT06589986, a Phase 3 study of Moderately to Severely Active Ulcerative Colitis, is active but no longer recruiting, sponsored by Hoffmann-La Roche.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
400 participants
Enrollment target
20
Study locations

Study Summary

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

Interventions

  • DRUG Placebo
  • DRUG Afimkibart

Study Locations (20)

Florida

  • Access Research Institute - Brooksville
  • Gastro Florida - Clearwater
  • HealthMed Clinical Center Inc. - Coral Gables
  • J&A Clinical Research - Doral
  • Clinical Research of Osceola, LLC - Kissimmee
  • Auzmer Research - Lakeland
  • Florida Research Institute - Lakewood - Lakewood Rch
  • Homestead Associates in Research, Inc. - Miami
  • Allied Biomedical Research Institute, Inc - Miami

California

  • Om Research LLC - Lancaster
  • UCLA - Los Angeles
  • University of California Irvine - Orange
  • Stanford Medicine Outpatient Center - Redwood City
  • Acclaim Clinical Research, Inc. - San Diego
  • UCSF/Medical Center at Mount Zion - San Francisco
  • Amicis Research Center - Santa Clarita

Colorado

  • Peak Gastroenterology Associates - Colorado Springs
  • Peak Gastroenterology Surgery Center - Lone Tree

Alabama

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

Arizona

  • Arizona Digestive Health, P.C (ADH) - Sun City

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2024-09-17
Est. Completion 2031-01-30
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT06589986

The ClinicalTrials.gov registry entry for NCT06589986 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 400 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.

NCT06589986 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Florida, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT06589986 about?

NCT06589986 is a clinical study titled "A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis". This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

What is the current status of trial NCT06589986?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2024-09-17. Estimated completion is 2031-01-30.

What conditions does trial NCT06589986 study?

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

What interventions are being tested in trial NCT06589986?

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

Who is sponsoring clinical trial NCT06589986?

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

Where is trial NCT06589986 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.