Yamanashi Prefectural Central Hospital | Yamanashi, Japan
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About
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC).
Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in the opinion of the investigator, they may benefit from continued treatment. During the long-term period, participants randomized to efavaleukin alfa will remain on the same efavaleukin alfa blinded dose; participants randomized to placebo who achieved clinical response at week 12 will remain on placebo; and placebo non-responders (ie, participants randomized to placebo who did not achieve clinical response at week 12) will receive efavaleukin alfa in a blinded manner during continued treatment. All participants will complete a safety follow-up visit 6 weeks after their last dose of investigational product.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Participant has provided informed consent prior to initiation of any study specific activities or procedures.
Men and women aged ≥ 18 to < 80 years at screening visit (≥ 19 to < 80 in South Korea).
Diagnosis of UC established ≥ 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report. If a histopathology report is not available at screening, then additional biopsies may be taken during the screening period for local histopathology analysis to corroborate.
Moderately to severely active UC as defined by a modified Mayo score of 5 to 9, with a centrally read endoscopy subscore ≥ 2.
Has documentation of:
Participants must have demonstrated inadequate response, loss of response, or intolerance to at least 1 conventional therapy, biologic therapy, or targeted small molecule therapy (ie, Janus kinase [JAK]-inhibitor or or S1P modulators), as follows:
Conventional therapy failed participants:
Biologic or targeted small molecule therapy failed participants: those who demonstrated inadequate response or loss of response or intolerance to biologic therapy for UC (eg, anti-TNF antibodies or IL-12/23 antagonists, anti-integrin antibodies) or targeted small molecules (eg, JAK inhibitors or S1P modulators). The therapy used to qualify the participant for entry into this category must be approved for the treatment of UC in the country of use, at the time of use. Participants must fulfil one of the following criteria:
If receiving any of the following therapies, participants must have stable dosage for the specified duration:
Key Exclusion Criteria:
Diagnosis of Crohn's disease, inflammatory bowel disease unclassified (indeterminate colitis), microscopic colitis, ischemic colitis, or clinical findings suggestive of Crohn's disease.
Evidence of toxic megacolon, fulminant colitis, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon.
Participant has had extensive surgery for UC (for example, subtotal colectomy), or is likely to require surgery for the treatment of UC during the study.
Currently receiving or had treatment within 12 months prior to screening with T cell depleting agents (eg, antithymocyte globulin, Campath).
Participant has received any of the following prescribed medication or therapy within the specified time period:
Primary purpose
Allocation
Interventional model
Masking
224 participants in 4 patient groups, including a placebo group
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Central trial contact
Amgen Call Center
Data sourced from clinicaltrials.gov
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