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RECRUITING Phase 3

A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease

NCT06819878 · View on ClinicalTrials.gov ↗

Study Summary

This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).

Interventions

  • DRUG Placebo
  • DRUG Afimkibart

Study Locations (20)

California

  • Valley View Internal Medicine — Garden Grove
  • 310 Clinical Research — Inglewood
  • UCSD Medical Center — La Jolla
  • Gastro Care Associates — Lancaster
  • Om Research LLC — Lancaster
  • United Gastroenterologists — Los Alamitos
  • Acclaim Clinical Research, Inc. — San Diego
  • Kaiser Permanente — San Francisco
  • UCSF/Medical Center at Mount Zion — San Francisco

Florida

  • Access Research Institute — Brooksville
  • Gastro Florida — Clearwater
  • HealthMed Clinical Center Inc. — Coral Gables
  • Hi Tech and Global Research, LLC — Coral Gables
  • The Sister Life Research — Hialeah

Arizona

  • Mayo Clinic Hospital — Phoenix
  • Arizona Digestive Health, P.C (ADH) — Sun City
  • University of Arizona-CATS Research Center — Tucson

Colorado

  • Rocky Mountain Gastroenterology — Littleton
  • Peak Gastroenterology Surgery Center — Lone Tree

Alabama

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

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2025-03-17
Est. Completion 2033-12-31
Phase Phase 3

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06819878

The ClinicalTrials.gov registry entry for NCT06819878 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Moderately to Severely Active Crohns Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06819878 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06819878 about?

NCT06819878 is a clinical study titled "A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease". This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).

What is the current status of trial NCT06819878?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2025-03-17. Estimated completion is 2033-12-31.

What conditions does trial NCT06819878 study?

This clinical trial studies the following conditions: Moderately to Severely Active Crohns Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06819878?

The interventions under investigation include: Placebo (DRUG), Afimkibart (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06819878?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06819878 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.

Related

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