Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis

Más betegség

• Subjects with diagnosis of Crohn's disease, inflammatory bowel disease-unclassified (indeterminate colitis), microscopic colitis, ischemic colitis, or clinical findings suggestive of Crohn’s disease.

Egyéb

• Subjects with UC limited to the rectum (ie, within 15cm of the anal verge).
• Subjects with evidence of toxic megacolon, fulminant colitis, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon.
• Subjects with a history or colectomy.

• Subject has provided informed consent prior to initiation of any study specific activities or procedures.
• Diagnosis of UC established >= 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report.
• Moderately to severely active UC as defined by a modified Mayo score of 5 to 9, with a centrally read endoscopy score >= 2.
• 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).
• Subjects must have stable doses of oral 5-aminosalicylaltes (ASA; stable dose for >= 2 weeks), oral corticosteroids (dose must be <=20mg/day prenisone or its equivalent and must have been stable for >= 2 weeks), budesonide (extended release tablets 9mg/day; stable dose for >= 2 weeks), beclomethasone dipropionate (gastro-resistant prolongued-release tablet 5mg/day; stable dose for >=2 weeks), and conventional immunomodulators (azathioprine, 6-mercaptopurine, methotrexate; stable dose for >=12 weeks).
• Age >= 18 years to <80years at screening visit, except in South Korea where age >= 19 years to <80 years at screening visit.