Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New ulcerative colitis drug put through drug interaction test

NCT ID NCT07665723

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 5 times

Summary

This early-phase study is testing whether afimkibart, an experimental drug for ulcerative colitis, changes how the body processes common medications like caffeine, warfarin, and omeprazole. About 25 people with moderate to severe active ulcerative colitis will receive afimkibart along with a cocktail of these drugs to measure any interactions. The goal is to gather safety and drug-processing data, not to treat the disease directly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Afimkibart (also known as RO7790121, PF-06480605, RVT-3101)
What this could lead to
If successful, this study will show whether afimkibart changes how the body processes other drugs, helping doctors prescribe safer combinations for ulcerative colitis.
What could go wrong
This is a very early, small study (25 people) focused on drug interactions, not on treating the disease itself. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Body weight \>= 40kg * Agreement to adhere to the contraceptive requirements UC Specific Inclusion Criteria: * Confirmed diagnosis of UC with supportive clinical, endoscopic, and histopathological evidence * Active UC confirmed by endoscopy (flexible sigmoidoscopy or colonoscopy) extending \>=15 cm from the anal verge * Moderately to severely active UC, defined as an modified Mayo score of 5 to 9 points, including a Mayo endoscopic subscore of 2 or 3, confirmed through centrally read endoscopy Exclusion Criteria: Inflammatory Bowel Disease (IBD) Exclusion Criteria: * Current diagnosis of Crohn's disease (CD),abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease * Presence of an ostomy or ileoanal pouch * Current diagnosis or suspicion of primary sclerosing cholangitis Medical History Exclusion Criteria: * Lack of peripheral venous access * Any major surgery within 6 weeks prior to screening or a major surgery planned during the study * History of alcohol, drug, or chemical abuse \< 1 year prior to screening

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Active ulcerative colitis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Delta (Campus Rumbeke)

    RECRUITING

    Roeselare, 8800, Belgium

  • Allied Biomedical Research Institute, Inc

    RECRUITING

    Miami, Florida, 33155, United States

  • Allmedica Badania Kliniczne Sp z o.o. Sp K.

    RECRUITING

    Nowy Targ, 34-400, Poland

  • Amicare Sp. z o.o. S.K.

    RECRUITING

    Lodz, 91-495, Poland

  • Centralny Szpital Kliniczny MSW w Warszawie

    RECRUITING

    Warsaw, 02-507, Poland

  • Centrum Medyczne "Medis"

    RECRUITING

    Bydgoszcz, 85-229, Poland

  • Charite Research Organisation GmbH

    RECRUITING

    Berlin, 10117, Germany

  • Erick H. Alayo Medical Corporation - Gastro SB Clinic

    RECRUITING

    Chula Vista, California, 91910, United States

  • Gastro Health Research

    RECRUITING

    Miami, Florida, 33176-2416, United States

  • Medrise sp z o.o

    RECRUITING

    Lublin, 20-582, Poland

  • NZOZ Eskulap Pabianice

    RECRUITING

    Pabianice, 92-500, Poland

  • PlanetMed sp. z o.o.

    RECRUITING

    Wroc?aw, 52-210, Poland

  • Royal Liverpool University Hospital

    RECRUITING

    Liverpool, L7 8XP, United Kingdom

  • Royal Victoria Infirmary

    RECRUITING

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • SOLUMED Centrum Medyczne

    RECRUITING

    Późna, 60-529, Poland

  • UZ Leuven Gasthuisberg

    RECRUITING

    Leuven, 3000, Belgium

  • University College London Hospitals

    RECRUITING

    London, W1T 7HA, United Kingdom

  • WIP Warsaw IBD Point Profesor Kierkus

    RECRUITING

    Warsaw, 04-501, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.