BridgeMD
New treatment option for Active Ulcerative Colitis
Official 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
ClinicalTrials.gov ID: NCT07665723
What this study is testing
What is Afimkibart?
Afimkibart is an investigational medicine, being studied as a potential treatment for active ulcerative colitis.
Also referred to as RO7790121, PF-06480605.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Body weight \>= 40kg
- Agreement to adhere to the contraceptive requirements UC Specific
- 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...
You likely can't join if
- Inflammatory Bowel Disease (IBD) Exclusion Criteria:
- Current diagnosis of Crohn's disease (CD),abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified...
- 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
See the full eligibility criteria
- Body weight \>= 40kg
- Agreement to adhere to the contraceptive requirements UC Specific
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chula Vista, California, United States
- Miami, Florida, United States
- Berlin, Germany
- Liverpool, United Kingdom
- London, United Kingdom
- Newcastle upon Tyne, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chula Vista, California, United States; Miami, Florida, United States; Berlin, Germany; Liverpool, United Kingdom; London, United Kingdom; Newcastle upon Tyne, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.