Clinical Trial TitleSafety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
National Clinical Trial Number:NCT04987307
Clinical Trial Protocol Description:
This is a randomized, double-blind, multicenter clinical trial to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis. A description of this clinical trial will be available at www.ClinicalTrials.gov, as required by U.S. law.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are male or female and are 18 to 80 years of age at screening visit. \
- Have a diagnosis of UC established ≥ 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report.
- Have moderately to severely active UC as defined by a modified Mayo score of 5 to 9, with a centrally read endoscopy subscore ≥ 2 and no subscore < 1 prior to day 1.
You will be excluded from the study if any of the following criteria apply to you:
- Have a diagnosis of Crohn's disease, inflammatory bowel disease unclassified (indeterminate colitis), microscopic colitis, ischemic colitis, or clinical findings suggestive of Crohn's disease.
- Have evidence of toxic megacolon, fulminant colitis, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon.
- Have had extensive surgery for ulcerative colitis (for example, subtotal colectomy), or are likely to require surgery for the treatment of ulcerative colitis during the study.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.