Efavaleukin Alfa for Ulcerative Colitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called efavaleukin alfa to determine if it can help individuals with moderately to severely active ulcerative colitis (UC) achieve remission, where symptoms improve or disappear. Participants will receive one of three doses of the treatment or a placebo for 12 weeks, with the option to continue long-term if beneficial. It suits those diagnosed with UC for at least three months who have not found success with previous treatments, such as certain medications or therapies. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you must stop all current medications, but you need to have stable doses of certain medications like 5-aminosalicylates, corticosteroids, and immunomodulators before joining. Some medications, like anti-TNF antibodies and JAK inhibitors, must be stopped a few weeks before the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that efavaleukin alfa has been tested for safety in people with conditions like ulcerative colitis. In earlier studies, researchers did not stop the treatment due to safety problems but because it didn't achieve certain goals, indicating that safety wasn't a major issue.
The treatment has undergone testing for long-term use, focusing on patient tolerance over time. So far, these studies have not found any major safety problems.
Overall, efavaleukin alfa appears to be well-tolerated by patients. While more research is needed, current evidence does not suggest any serious safety concerns.12345Why do researchers think this study treatment might be promising for ulcerative colitis?
Researchers are excited about efavaleukin alfa for ulcerative colitis because it offers a unique approach by targeting the immune system differently than current treatments. Most standard therapies, like aminosalicylates and corticosteroids, work to reduce inflammation in a broad sense. However, efavaleukin alfa is a novel biologic that specifically modulates the activity of certain immune cells involved in the inflammation process of ulcerative colitis. This targeted mechanism could potentially lead to more effective symptom control with fewer side effects. Additionally, efavaleukin alfa is administered via subcutaneous injection every two weeks, which might offer a more convenient dosing schedule compared to some existing therapies.
What evidence suggests that efavaleukin alfa might be an effective treatment for ulcerative colitis?
Research has shown that efavaleukin alfa targets specific immune cells responsible for inflammation. This is significant because ulcerative colitis (UC) involves immune system-induced inflammation of the colon. Patients with similar conditions have responded well to treatments with similar mechanisms. Early results suggest that efavaleukin alfa may reduce inflammation and improve symptoms in people with UC. Further studies are underway to confirm these effects.23678
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
Adults aged 18-80 with moderately to severely active ulcerative colitis (UC) diagnosed at least 3 months prior, who haven't responded well or are intolerant to certain UC therapies like corticosteroids, immunomodulators, biologics, or small molecule drugs. They must have a stable dose of current medications and cannot have had recent treatment with T cell depleting agents.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period
Long-term Treatment (optional)
Participants may enter an exploratory long-term treatment period for up to 40 weeks if they may benefit from continued treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Efavaleukin alfa
Trial Overview
The trial is testing the safety and effectiveness of Efavaleukin Alfa in achieving clinical remission in UC patients compared to a placebo. Participants will receive one of three doses or a placebo for 12 weeks, with an optional extension up to 52 weeks for responders.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Efavaleukin alfa Dose 3 administered by SC injection Q2W
Efavaleukin alfa Dose 2 administered by SC injection Q2W
Efavaleukin alfa Dose 1 administered by SC injection once every two weeks (Q2W)
Placebo Q2W
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Citations
Safety and Efficacy of Efavaleukin Alfa in Participants With ...
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely ...
Long-term Safety and Efficacy of Efavaleukin Alfa in ...
The primary objective of this study is to evaluate the long-term safety and tolerability of efavaleukin alfa in participants with moderate to severe ...
Long-term Safety and Efficacy of Efavaleukin Alfa in ...
The primary objective of this study is to evaluate the long-term safety and tolerability of efavaleukin alfa in participants with moderate to severe ...
4.
trial.medpath.com
trial.medpath.com/clinical-trial/2f7bcb9b31dcb794/euctr2021-002537-41-de-efavaleukin-alfa-ulcerative-colitisSafety and Efficacy of Efavaleukin Alfa in Subjects ... - MedPath
Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis ... Outcome data and publication updates.
5.
humanforschung-schweiz.ch
humanforschung-schweiz.ch/en/trial-search/study-detail/58839/translate/en/?cHash=0fb7ad19a559476e492cf960f7313880Protocol 20170104: Randomized, double-blind, placebo ...
This study is being conducted to learn more about the investigational drug Efavaleukin alfa in individuals with moderately to severely active ...
NCT04987307 | Safety and Efficacy of Efavaleukin Alfa in ...
The study was terminated due to meeting a prespecified futility rule and not related to any safety concerns. Safety and Efficacy of Efavaleukin Alfa in ...
7.
go.drugbank.com
go.drugbank.com/drugs/DB16149/clinical_trials?conditions=DBCOND0029012&phase=2&purpose=treatment&status=terminatedEfavaleukin alfa Terminated Phase 2 Trials for Ulcerative ...
Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis. Efavaleukin alfa (DB16149) ...
A Phase 2 Long-Term Extension (LTE) Study to Evaluate ...
This phase 2 long-term extension (LTE) study will assess the long-term safety and efficacy of efavaleukin alfa in subjects with moderately to ...
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