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Tests treatment safety and results for Moderately to Severely Active Crohns Disease
Official title A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov ID: NCT07298421
What this study is testing
What is Afimkibart?
Afimkibart is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for moderately to severely active crohns disease.
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
- This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).
- Phase 3: a large, late-stage study
- This is a blinded study.
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
- Body weight \>= 10 kilogram (kg)
- Active CD confirmed by endoscopy (ileocolonoscopy)
- Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score \>= 30, and Simple Endoscopic Score Crohn's...
- Inadequate response, loss of response, and/or intolerance to at least one of the following conventional therapies (aminosalicylates, corticosteroids...
You likely can't join if
- Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD)
- History of \>= 3 bowel resections: \> 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and...
- Current diagnosis of ulcerative colitis (UC), abdominal/intraabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified...
- Symptomatic bowel strictures, fulminant colitis, or toxic megacolon
- Presence of abdominal or perianal abscess
- Current diagnosis or suspicion of primary sclerosing cholangitis
The study team makes the final eligibility decision.
Where it's taking place
- Parkville, Victoria, Australia
- Nedlands, Western Australia, Australia
- Taipei, Taiwan
- Bangkok, Thailand
- Sheffield, 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, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Parkville, Victoria, Australia; Nedlands, Western Australia, Australia; Taipei, Taiwan; Bangkok, Thailand; Sheffield, 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.