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 UlcerativeColitis

Amgen Inc.0 sites320 target enrollmentOctober 8, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Amgen Inc.
Enrollment: 320
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 8, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Amgen Inc.

Eligibility Criteria

Inclusion Criteria

•101 Subject has provided informed consent prior to initiation of study.
•102 Age \=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 \=19 years to \<80 years at screening visit.
•103 Diagnosis of UC established \=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 endoscopy subscore \=2\.
•105 Has documentation of
•\- A surveillance colonoscopy within 12 months of day 1 visit for subjects with pancolitis of \>8 years duration, or subjects with left\-sided colitis of \>12 years duration, or subjects with primary sclerosing cholangitis.
•\- For all other subjects, up\-to\-date colorectal cancer surveillance. At the discretion of the investigator, a colonoscopy may be performed as the screening endoscopy for this study. Subjects who do not have a colonoscopy report available in source documentation will have a colonoscopy instead of rectosigmoidoscopy performed as the screening endoscopy for the study.
•106 Subjects must have demonstrated inadequate response, loss of response, or intolerance to at least 1 conventional therapy, biologic therapy, or targeted small molecule therapy (ie, JAK\-inhibitor).
•1\. Conventional therapy failed subjects:
•\- Corticosteroids (corticosteroid\-refractory colitis, defined as signs and/or symptoms of active UC despite oral prednisone (or equivalent) at doses of at least 30 mg/day for a minimum of 2 weeks; or corticosteroid\-dependent colitis, defined as: an inability to reduce corticosteroids below the equivalent of prednisone 10mg/day within 3 months of starting corticosteroids without a return of signs and/or symptoms of active UC; or a relapse within 3 months of completing a course of corticosteroids

Exclusion Criteria

•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: