A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

Amgen Inc.0 sites320 target enrollmentFebruary 8, 2022

Overview

No summary available.

Registry

who.int

Start Date

February 8, 2022

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•101 Subject has provided informed consent prior to initiation of study .
•102 Aged from 18 years to 80 years at screening visit, except in South Korea where from age 19 years to 80 years at screening visit; and in Taiwan where age from 20 years to 80 years at screening visit.
•103 Diagnosis of UC established at least 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report.
•104 Moderately to severely active UC as defined by a modified Mayo score of 5 to 9, with a centrally read rectosigmoidoscopy endoscopic subscore at least 2 and no subscore less than 1 prior to day 1\.
•105 Has documentation of
•A surveillance colonoscopy within 12 months of day 1 visit for subjects with pancolitis of at least 8 years duration, or subjects with left\-sided colitis of over 12 years duration, or subjects with
•primary sclerosing cholangitis.
•For all other subjects, up\-to\-date colorectal cancer surveillance
•(performed according to local standard). Subjects who do not have a
•colonoscopy report available in source documentation will have a

•201 Diagnosis of Crohn’s disease, inflammatory bowel disease\-unclassified, microscopic colitis, ischemic colitis, or clinical findings suggestive of Crohn’s disease.
•202 Disease limited to the rectum.
•203 Evidence of toxic megacolon, fulminant colitis, intra\-abdominal abscess, or stricture/stenosis within the small bowel or colon.
•204 Previous bowel resection or intestinal or intra\-abdominal surgery.
•Have had extensive surgery for UC, or are likely to require surgery for the treatment of UC during the study. Subjects who have had limited surgery for UC may be allowed in the study, if this does not affect the assessment of efficacy. Discussion with the sponsor must occur prior to screening of such subjects.
•Have had any small bowel or colonic surgery within 6 months of day 1\.
•Have had any nonintestinal intra\-abdominal surgery within 3 months of day 1\.
•205 Adenoma and dysplasia exclusion criteria:
•Any current sporadic adenoma without dysplasia that has not been removed. Once completely removed, the subject is eligible for study.
•Dysplasia occurring in flat mucosa, sporadic adenomas containing dysplasia, and dysplasia\-associated lesions or masses will be managed as follows: