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ACTIVE NOT RECRUITING Phase 2

Afimkibart (RO7790121) for the Treatment of Moderate to Severe Active Crohn's Disease

NCT05910528 · View on ClinicalTrials.gov ↗

Study Summary

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

Conditions Studied

Interventions

  • DRUG Afimkibart

Study Locations (11)

Other

  • AZ Delta — Roeselare
  • CHU de Nantes — Nantes
  • Institut des MICI, Clinique Ambroise Paré — Neuilly-sur-Seine
  • CHRU de Nancy Brabois — Vandœuvre-lès-Nancy
  • Twoja Przychodnia-Szczecinskie Centrum Medyczne — Szczecin
  • WIP Warsaw IBD Point Profesor Kierkus — Warsaw

Alabama

  • Digestive Health Specialists — Dothan

Connecticut

  • Medical Research Center of Connecticut, LLC — Hamden

Florida

  • I.H.S Health Northwell Health — Kissimmee

Massachusetts

  • Brigham and Women's Hospital — Boston

Michigan

  • Clinical Research Institute of Michigan — Chesterfield

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2023-07-24
Est. Completion 2030-12-31
Phase Phase 2

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05910528

The ClinicalTrials.gov registry entry for NCT05910528 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 21 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 Crohns Disease appearing as the primary indexed condition, and to 1 intervention — of which Afimkibart 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: NCT05910528 reports 11 study locations spanning 6 distinct geographic areas — top geographies include Other, Alabama, Connecticut. 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 NCT05910528 about?

NCT05910528 is a clinical study titled "Afimkibart (RO7790121) for the Treatment of Moderate to Severe Active Crohn's Disease". This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of Afimkibart (RO7790121, RVT-3101) in adult participants with moderate to severe active Crohn's disease.

What is the current status of trial NCT05910528?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2023-07-24. Estimated completion is 2030-12-31.

What conditions does trial NCT05910528 study?

This clinical trial studies the following conditions: 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 NCT05910528?

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

Who is sponsoring clinical trial NCT05910528?

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 NCT05910528 being conducted?

This trial has 11 study locations across Alabama, Connecticut, Florida, Massachusetts, Michigan. 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