Moderately to Severely Active Ulcerative Colitis study: Afimkibart
Official title A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT07158242
What this study is testing
What is Afimkibart?
Afimkibart is an investigational medicine being studied as a potential treatment for moderately to severely active ulcerative colitis in pediatric patients.
Also referred to as PF-06480605, RVT-3101, RG6631, RO7790121.
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 study aims to find out whether Afimkibart is safe and works to treat ulcerative colitis in children.
- Who it's for
- Children who have moderate to severe active ulcerative colitis.
- What's involved
- Participants will be randomly given Afimkibart or a placebo in a double‑blind trial, with regular clinic visits for treatment and monitoring during the induction and maintenance phases.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Bodyweight \>= 10 kilogram (kg)
- Confirmed diagnosis of UC
- Moderately to severely active UC, defined as modified Mayo Score (mMS) or 5 to 9 points, including endoscopic score of 2 or 3, confirmed by centrally...
- Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: systemic corticosteroids, immunomodulators...
You likely can't join if
- Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD)
- 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
- Any major surgery within 6 weeks prior to screening or a major planned surgery during the study
- Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT)
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
- Hartford, Connecticut, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- St Louis, Missouri, United States
- Lake Success, New York, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Harlingen, Texas, United States
- South Brisbane, Queensland, Australia
- Parkville, Victoria, Australia
- Nedlands, Western Australia, Australia
- Porto Alegre, Rio Grande do Sul, Brazil
- Jaú, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Toronto, Ontario, Canada
- Hangzhou, Zhejiang, China
- Shanghai, China
- Bloemfontein, South Africa
+ 7 more site(s).
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, but 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, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States; Hartford, Connecticut, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; St Louis, Missouri, United States; Lake Success, New York, United States and 21 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.