Afimkibart for Ulcerative Colitis
(AMETRINE-PEDS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Afimkibart for children and teens with ulcerative colitis (UC), a condition that inflames the colon, causing pain and digestive issues. Researchers aim to determine if Afimkibart can safely and effectively help those whose UC hasn't improved with treatments like steroids or biologics. Participants will receive one of two doses of Afimkibart, first through an IV and then as an injection. Children and teens with a confirmed UC diagnosis who haven't responded to other drugs might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants early access to a potentially effective treatment.
Is there any evidence suggesting that Afimkibart is likely to be safe for humans?
Previous studies have tested afimkibart in people with ulcerative colitis. Reports show that patients generally tolerate this treatment well. Common side effects included low red blood cell count (anemia), tiredness, headache, and fever. Nearly half of the patients experienced at least one side effect early in the treatment, increasing to 59% in later stages. However, the overall balance of benefits and risks was positive, indicating that the benefits outweighed the risks. Side effects can vary from person to person, so discussing any concerns with a healthcare provider is important.12345
Why do researchers think this study treatment might be promising for ulcerative colitis?
Unlike the standard treatments for ulcerative colitis, such as mesalamine, corticosteroids, or immunosuppressants, Afimkibart offers a novel approach with its unique delivery method. Researchers are excited about Afimkibart because it combines intravenous (IV) and subcutaneous (SC) administration, potentially improving the effectiveness and convenience of treatment. This dual delivery system might enhance the drug's ability to reduce inflammation more quickly and with fewer side effects compared to traditional treatments.
What evidence suggests that Afimkibart might be an effective treatment for ulcerative colitis?
Research has shown that afimkibart, a type of antibody, offers promising results for treating ulcerative colitis (UC). Studies have found that patients with moderately to severely active UC experienced more symptom relief with afimkibart than with a placebo. Specifically, one study revealed that 41.6% of patients achieved symptom relief with afimkibart, compared to 16.7% with a placebo. The treatment also remained effective for up to 56 weeks after the first dose. These findings suggest that afimkibart could be a helpful option for managing UC symptoms. Participants in this trial will receive either Afimkibart Dose A or Afimkibart Dose B to further evaluate its effectiveness.12346
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive Afimkibart intravenously to induce remission of ulcerative colitis
Maintenance
Participants receive Afimkibart subcutaneous injections to maintain remission of ulcerative colitis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Afimkibart
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will receive Afimkibart IV followed by Afimkibart SC.
Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
Citations
Anti-TL1A antibody, afimkibart, in moderately-to-severely ...
We evaluated the safety and efficacy of multiple doses of afimkibart, a TL1A-directed antibody, in patients with moderately-to-severely active ...
Anti-TL1A antibody, afimkibart, in moderately-to-severely ...
We evaluated the safety and efficacy of multiple doses of afimkibart, a TL1A-directed antibody, in patients with moderately-to-severely active ...
NCT06588855 | A Study to Assess the Efficacy and Safety ...
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) ...
4.
springermedicine.com
springermedicine.com/ulcerative-colitis/inflammatory-bowel-disease/tuscany-2-trial-afimkibart-mixed-benefits-moderate-to-severe/51348708Afimkibart shows mixed benefits in moderate-to-severe ...
In terms of the primary endpoint at week 14, patients given afimkibart 50 mg, 150 mg, or 450 mg had higher rates of clinical remission than ...
Anti-TL1A antibody, afimkibart, in moderately-to-severely ...
Results from the phase 2b TUSCANY-2 dose-ranging study suggest that afimkibart has a favourable benefit–risk profile; afimkibart is being further assessed in ...
6.
genentech-clinicaltrials.com
genentech-clinicaltrials.com/en/trials/autoimmune-disorder/ibd/a-study-to-assess-the-efficacy-and-safety-of-ro7790121--09855.htmlClinical study | ulcerative colitis RO7790121 | ForPatien...
Researchers want to see if afimkibart works, how well it works and how safe it is when given over a long period of time. This is compared to a placebo in people ...
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