Recruiting
Phase 1

Afimkibart

Sponsor:

Hoffmann-La Roche

Code:

NCT07665723

Conditions

Active Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Afimkibart

Caffeine

Warfarin

Omeprazole

Dextromethorphan

Study Details

Brief summary:

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).

Conditions

Active Ulcerative Colitis

Study ID

NCT07665723

Start date

Jun 29, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Afimkibart Treatment and CYP Cocktail Group

Participants will receive doses of a CYP cocktail and doses of afimkibart in the DDDI phase, followed by an optional long-term extension phase.

Interventions

Afimkibart

Afimkibart will be administered as per the schedule defined in the protocol.

Caffeine

Caffeine will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.

Warfarin

Warfarin will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.

Omeprazole

Omeprazole will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.

Dextromethorphan

Dextromethorphan will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.

Midazolam

Midazolam will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.

Vitamin K

Vitamin K will be administered orally as a rescue medication following warfarin administration per the schedule outlined in the protocol.

Primary outcome measure

  • Area Under the Plasma Concentration-time Curve Up to Time t (AUC0-t [AUC last]) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine) [ Time Frame: Up to approximately 13 weeks ]
  • Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine) [ Time Frame: Up to approximately 13 weeks ]
  • Maximum Plasma Concentration (Cmax) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine) [ Time Frame: Up to approximately 13 weeks ]
  • Time to Maximum Concentration (Tmax) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine) [ Time Frame: Up to approximately 13 weeks ]
  • Elimination Half-life (T1/2) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine) [ Time Frame: Up to approximately 13 weeks ]
  • Metabolite-to-parent Area Under the Curve From Time 0 (AUC0-t) Ratio for CYP Probe Substrates (Midazolam and 1-OH-Midazolam, Omeprazole and 5-OH-Omeprazole, Dextromethorphan and Dextrorphan, and Caffeine and Paraxanthine) [ Time Frame: Up to approximately 13 weeks ]
  • Metabolite-to-parent Area Under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) Ratio for CYP Probe Substrates (Midazolam and 1-OH-Midazolam, Omeprazole and 5-OH-Omeprazole, Dextromethorphan and Dextrorphan, and Caffeine and Paraxanthine) [ Time Frame: Up to approximately 13 weeks ]
  • Metabolite-to-parent Concentration of CYP Probe Substrates (Midazolam and 1-OH-Midazolam, Omeprazole and 5-OH-Omeprazole, Dextromethorphan and Dextrorphan, and Caffeine and Paraxanthine) [ Time Frame: Up to approximately 13 weeks ]

Central Contacts and Locations

Central contacts

Reference Study ID Number : GA46438 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

Locations

Erick H. Alayo Medical Corporation - Gastro SB Clinic

Recruiting

Chula Vista, California, United States, 91910

Allied Biomedical Research Institute, Inc

Recruiting

Miami, Florida, United States, 33155

Gastro Health Research

Recruiting

Miami, Florida, United States, 33176-2416

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-20.