A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Patients with Moderately to Severely Active Ulcerative Colitis
Published: 12/13/2021
General Information:
To evaluate the effect of efavaleukin alfa on induction of clinical remission.
Eligibility:
Patients may be eligible to participate in this study if they:
- Are between the ages of 18 and 80
- Have had a diagnosis of Moderately to Severely Active Ulcerative Colitis (UC) for 3 months or longer
- Have experienced inadequate response, loss of response, or intolerance to conventional therapy, biologic therapy, OR targeted small molecule therapy
- do NOT have: Crohn’s disease, indeterminate colitis, UC limited to the rectum, fulminant colitis, or toxic megacolon.
Study Details:
Study Description:
The goal of treatment for moderately to severely active UC is to achieve resolution of rectal bleeding, normalization of bowel habits, and colonic healing in order to delay UC-associated complications such as colectomy and colon cancer, and to maintain an acceptable health related quality of life. This phase 2 dose-finding study will assess the safety and efficacy of efavaleukin alfa as a viable treatment option for patients with moderately to severely active UC who have failed at least 1 of the following: conventional therapy (eg, immunomodulators, corticosteroids), biologic therapy, or small targeted molecule therapy (ie, Janus kinase [JAK] inhibitor). Total study duration for an individual patient may be up to 61 weeks.
Description of treatment or intervention (mechanism of action):
Efavaleukin alfa is a novel therapy designed to restore balance in the immune system by expanding regulatory T cells, which are important for controlling inflammation and autoimmune disease. Efavaleukin alfa is an investigational drug and is not currently approved by the FDA.
Patient Participation Requirements:
This study will require a pre-screening phone call, and a screening visit where patients will complete non-surgical medical procedures (e.g. blood work, endoscopy, biopsy and/or others) and answer electronic questionnaires.
Patients will complete daily electronic surveys and return to the clinical site for additional visits.
Possible risks and side effects:
The clinical trial investigator will review all of the known potential side effects with you to help you determine if you would like to participate in the trial.