NCT07665723RecruitingPhase 1
An Early-Stage Study in Multiple Clinics of How Afimkibart May Affect the Body's Processing of Medicines That Rely on Cytochrome P450 Enzymes in Participants With Ulcerative Colitis
A Phase I, Multicenter, Open-Label, Single-Agent Study to Assess the Pharmacokinetics of Cytochrome P450 Substrates After Treatment With Afimkibart in Participants With Moderately to Severely Active Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the disease-drug-drug interaction (DDDI) potential of afimkibart (also known as RO7790121). This will be assessed by the characterization of the pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme substrates alone and after administration of afimkibart in participants with moderately to severely active ulcerative colitis (UC).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 19 Jun 2026
- Start date
- 29 Jun 2026
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Ulcerative colitis
- NCT number
- NCT07665723
- EU CT number
- 2025-524060-38-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 25
- From 29 Jun 2026 to the primary completion date, 31 Jul 2027
- 18 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Presence of an ostomy or ileoanal pouch
- Current diagnosis or suspicion of primary sclerosing cholangitis
- Medical History Exclusion Criteria:
- Lack of peripheral venous access
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Algemeen Ziekenhuis Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
| Charite Research Organisation GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Royal Liverpool University Hospital Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Recruiting |
| University College London Hospitals Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Victoria Infirmary Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Recruiting |
| Manermed Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Amicare Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Medrise Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Allmedica Badania Kliniczne Sp z o.o. Sp K. Coordinator of this site? Confirm its status | Nowy Targ | Poland | Recruiting |
| Eskulap Pabianice Sp. z o.o. Coordinator of this site? Confirm its status | Pabianice | Poland | Recruiting |
| Solumed Sp. z o.o. sp.k. Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| PlanetMed Sp. z o.o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Erick H. Alayo Medical Corporation - Gastro SB Clinic Coordinator of this site? Confirm its status | Chula Vista | United States | Recruiting |
| Allied Biomedical Research Institute, Inc Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Gastro Health Research Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.