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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
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

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UZ Leuven
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LeuvenBelgiumRecruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumRecruiting
Charite Research Organisation GmbH
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BerlinGermanyCompleted
Royal Liverpool University Hospital
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LiverpoolUnited KingdomRecruiting
University College London Hospitals
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LondonUnited KingdomRecruiting
Royal Victoria Infirmary
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Newcastle upon TyneUnited KingdomRecruiting
Manermed Sp. z o.o.
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BydgoszczPolandRecruiting
Amicare Sp. z o.o. S.K.
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LodzPolandRecruiting
Medrise Sp. z o.o.
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LublinPolandRecruiting
Allmedica Badania Kliniczne Sp z o.o. Sp K.
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Nowy TargPolandRecruiting
Eskulap Pabianice Sp. z o.o.
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PabianicePolandRecruiting
Solumed Sp. z o.o. sp.k.
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PoznanPolandRecruiting
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
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WarsawPolandRecruiting
Medical Network Sp z o o
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WarsawPolandRecruiting
PlanetMed Sp. z o.o.
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WroclawPolandRecruiting
Erick H. Alayo Medical Corporation - Gastro SB Clinic
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Chula VistaUnited StatesRecruiting
Allied Biomedical Research Institute, Inc
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MiamiUnited StatesRecruiting
Gastro Health Research
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MiamiUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.