Active Ulcerative Colitis
Afimkibart and Medicine Processing in Adults With Active Ulcerative Colitis
This Phase 1 study examines how afimkibart changes the body's processing of five cytochrome P450 probe medicines in adults with moderately to severely active ulcerative colitis.
Registry title: 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
3 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–60 Years
- Treatment
- Afimkibart or Caffeine
- Design
- Not provided
- Central study contact
- 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
- Sponsor
- Hoffmann-La Roche
Research question
How does treatment with afimkibart affect the pharmacokinetics—how the body processes—selected medicines that rely on cytochrome P450 enzymes?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 60.
- The study is looking for people with a confirmed diagnosis of ulcerative colitis supported by clinical, endoscopic, and tissue evidence.
- Ulcerative colitis must be active on endoscopy and extend at least 15 centimeters from the anal verge.
- Disease must be moderately to severely active, with a modified Mayo score of 5 to 9 and a centrally confirmed endoscopic subscore of 2 or 3.
- Recruiting locations are listed in the United States, Belgium, Germany, Poland, and the United Kingdom.
Participation overview
What participation may involve
Participants receive a five-medicine cytochrome P450 probe cocktail and afimkibart during the disease-drug-drug interaction phase, with oral vitamin K after warfarin; an optional long-term extension follows. What participation may involve: - Receive afimkibart according to the schedule defined in the study protocol. - Take oral caffeine, warfarin, omeprazole, dextromethorphan, and midazolam as the cytochrome P450 probe cocktail. - Receive oral vitamin K as rescue medication after warfarin according to the protocol schedule. - Have plasma concentrations of the probe medicines and their metabolites assessed, and serum concentrations of afimkibart measured. - Participants may enter an optional long-term extension after the interaction phase.
Study interventions
What participants may receive or do
- Afimkibart: Participants receive afimkibart according to the protocol schedule so researchers can assess its effect on the processing of the cytochrome P450 probe medicines.
- Caffeine: Participants take caffeine by mouth as one medicine in the cytochrome P450 probe cocktail, according to the protocol schedule.
- Warfarin: Participants take warfarin by mouth as one medicine in the cytochrome P450 probe cocktail, according to the protocol schedule.
- Omeprazole: Participants take omeprazole by mouth as one medicine in the cytochrome P450 probe cocktail, according to the protocol schedule.
- Dextromethorphan: Participants take dextromethorphan by mouth as one medicine in the cytochrome P450 probe cocktail, according to the protocol schedule.
- Midazolam: Participants take midazolam by mouth as one medicine in the cytochrome P450 probe cocktail, according to the protocol schedule.
- Vitamin K: Participants receive vitamin K by mouth as rescue medication after warfarin, according to the protocol schedule.
Study design
How the comparison works
This is an open-label Phase 1 study in which all participants are assigned to one experimental group receiving the probe-drug cocktail and afimkibart; an optional long-term extension follows the interaction phase. The registry lists allocation as not applicable and uses a single-group design, so participants are not assigned among multiple study groups. The study is open-label, meaning the registry reports no masking. There is no separate control group; researchers compare the processing of the probe medicines when given alone and after afimkibart within the single study group. The registry does not describe a placebo or sham intervention.
Reported activities
Procedures and tests
- Screening must confirm ulcerative colitis using clinical, endoscopic, and histopathological evidence.
- Active disease must be confirmed by flexible sigmoidoscopy or colonoscopy and extend at least 15 centimeters from the anal verge.
- A central reader must confirm a Mayo endoscopic subscore of 2 or 3 as part of the modified Mayo score assessment.
- Plasma concentration measurements assess the probe medicines and specified metabolites over time.
- Predose and peak serum concentrations of afimkibart are measured.
- Adverse events are monitored as a secondary outcome.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Body weight must be at least 40 kilograms.
- Participants must agree to follow the study's contraceptive requirements.
- Ulcerative colitis must be confirmed with supportive clinical, endoscopic, and histopathological evidence.
- Endoscopy must confirm active ulcerative colitis extending at least 15 centimeters from the anal verge.
- Disease must be moderately to severely active, with a modified Mayo score of 5 to 9 that includes a centrally confirmed Mayo endoscopic subscore of 2 or 3.
- The registry's eligible age range is 18 through 60 years.
Possible reasons someone may not be able to join
- People are excluded for a current diagnosis of Crohn's disease, indeterminate colitis, inflammatory bowel disease unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease.
- An abdominal, intra-abdominal, or perianal fistula or abscess is exclusionary.
- People with an ostomy or ileoanal pouch are excluded.
- A current diagnosis or suspicion of primary sclerosing cholangitis is exclusionary.
- People without peripheral venous access are excluded.
- Major surgery within six weeks before screening, or major surgery planned during the study, is exclusionary.
- A history of alcohol, drug, or chemical abuse within one year before screening is exclusionary.
Important unknowns
What the record does not make clear
- The registry does not state how many visits are required, how often they occur, or whether any overnight stays are involved.
- Primary drug-processing outcomes are assessed up to approximately 13 weeks, while secondary outcomes extend up to approximately five years and the arm description mentions an optional long-term extension; individual participation length is not stated.
- The registry does not explain which current ulcerative colitis treatments may continue during the study.
- The registry does not provide washout rules for current medicines or restrictions related to the cytochrome P450 probe drugs.
- Vitamin K is identified as rescue medication after warfarin, but its timing and the plan for an ulcerative colitis flare or other study-drug effects are not described.
- Eligibility requires centrally read endoscopy, but the registry does not say whether a new study endoscopy is always required or whether recent results can be used.
- The registry does not state which study-related or routine-care costs are covered or billed to insurance.
- The registry does not state whether participants receive compensation.
- The registry does not describe reimbursement or support for transportation, lodging, or meals.
- The registry does not say whether any visits or assessments can be completed remotely or locally.
- The registry does not explain whether afimkibart is available after required participation or the optional extension ends.
- The registry lists individual locations as recruiting, but availability for a particular person or cohort must be confirmed directly with the study team.
Before contacting the site
Questions for the study team
- What is the complete schedule for the required interaction phase and the optional long-term extension?
- What are the doses and timing of afimkibart, each probe medicine, and vitamin K?
- Which current medicines, supplements, foods, or drinks must be continued, stopped, or avoided?
- Does screening require a new endoscopy, and would it include biopsies or sedation?
- What blood-sampling schedule is required after the probe medicines and afimkibart, and are any overnight stays needed?
- What happens if ulcerative colitis worsens during the study, and what rescue treatment is permitted?
- Which costs are covered, and is compensation or travel support available?
- Is the nearest listed location still enrolling, and can any assessments be completed remotely or locally?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis now, and what would a study-related treatment change mean in my clinical situation?
- How might the probe medicines—especially warfarin and midazolam—interact with my current medicines or health conditions?
- What approved treatment alternatives should I understand before deciding whether to contact the study team?
- If I contact the study, how should your office and the research team coordinate medication changes, endoscopy records, and care during a flare?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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).
Study design and administration
- Organization
- Hoffmann-La Roche
- Organization class
- Industry
- Organization study ID
- GA46438
- Lead sponsor
- Hoffmann-La Roche
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Single Group
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult
Study 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: Drug: Afimkibart, Drug: Caffeine, Drug: Warfarin, Drug: Omeprazole, Drug: Dextromethorphan, Drug: Midazolam, Other: Vitamin K
Interventions
Drug
Afimkibart
Afimkibart will be administered as per the schedule defined in the protocol.
Drug
Caffeine
Caffeine will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Drug
Warfarin
Warfarin will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Drug
Omeprazole
Omeprazole will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Drug
Dextromethorphan
Dextromethorphan will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Drug
Midazolam
Midazolam will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Other
Vitamin K
Vitamin K will be administered orally as a rescue medication following warfarin administration per the schedule outlined in the protocol.
Eligibility
18 Years–60 Years
All
Not accepted
Inclusion criteria (5)
- Body weight \>= 40kgRegistry-derived · unreviewed
- Agreement to adhere to the contraceptive requirementsRegistry-derived · unreviewed
- Confirmed diagnosis of UC with supportive clinical, endoscopic, and histopathological evidenceRegistry-derived · unreviewed
- Active UC confirmed by endoscopy (flexible sigmoidoscopy or colonoscopy) extending \>=15 cm from the anal vergeRegistry-derived · unreviewed
- 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 endoscopyRegistry-derived · unreviewed
Exclusion criteria (6)
- 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 diseaseRegistry-derived · unreviewed
- Presence of an ostomy or ileoanal pouchRegistry-derived · unreviewed
- Current diagnosis or suspicion of primary sclerosing cholangitisRegistry-derived · unreviewed
- Lack of peripheral venous accessRegistry-derived · unreviewed
- Any major surgery within 6 weeks prior to screening or a major surgery planned during the studyRegistry-derived · unreviewed
- History of alcohol, drug, or chemical abuse \< 1 year prior to screeningRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
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
Primary outcome
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
Primary outcome
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
Primary outcome
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
Primary outcome
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
Primary outcome
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
Primary outcome
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
Primary outcome
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
Secondary outcome
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to approximately 5 years
Secondary outcome
Predose and Peak Serum Concentration of Afimkibart
Time frame: Up to approximately 5 years
Recruiting locations in the United States
Erick H. Alayo Medical Corporation - Gastro SB Clinic
RecruitingChula Vista, California, 91910, United States
Allied Biomedical Research Institute, Inc
RecruitingMiami, Florida, 33155, United States
Gastro Health Research
RecruitingMiami, Florida, 33176-2416, United States
This study also lists 14 locations outside the United States. They are not shown here.
Central study contacts
Reference Study ID Number : GA46438 https://forpatients.roche.com/ No attachments to email below.
Contact
888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Registry dates
- First posted
- Jun 24, 2026
- Primary completion
- Jul 31, 2027
- Overall completion
- Dec 31, 2030
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.