CER Instituto Medico | Buenos Aires, Argentina
Status and phase
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Treatments
Study type
Funder types
Identifiers
About
The primary objective of this study is to evaluate the long-term safety and tolerability of efavaleukin alfa in participants with moderate to severe ulcerative colitis (UC).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Disease Related:
Adenoma and dysplasia exclusion criteria:
Any history or current evidence of high-grade dysplasia.
Any history or current evidence of dysplasia occurring in flat mucosa.
This includes histopathology reporting indefinite for dysplasia, low-grade dysplasia, and high-grade dysplasia.
Any history or current evidence of a nonadenoma like dysplasia associated lesions or masses, with or without evidence of dysplasia.
Any current sporadic adenoma containing dysplasia or any current adenoma-like dysplasia-associated lesions or masses that has not been removed.
Other Medical Conditions:
Prior/Concurrent Clinical Study Experience:
Other Exclusions:
Primary purpose
Allocation
Interventional model
Masking
92 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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