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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
25
Subcutaneous (SC) injection
SC injection
Santa Maria Gastroenterology Medical Group
Santa Maria, California, United States
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 to Week 110
Number of Participants with Clinical Response at Week 52
Time frame: Week 52
Number of Participants with Clinical Response at Week 104
Time frame: Week 104
Number of Participants with Clinical Remission at Week 52
Time frame: Week 52
Number of Participants with Clinical Remission at Week 104
Time frame: Week 104
Number of Participants with Durable Clinical Remission at Week 52
Time frame: Week 52
Number of Participants with Durable Clinical Remission at Week 104
Time frame: Week 104
Number of Participants with Endoscopic Remission at Week 52
Time frame: Week 52
Number of Participants with Endoscopic Remission at Week 104
Time frame: Week 104
Number of Participants with Histologic Remission at Week 52
Time frame: Week 52
Number of Participants with Histologic Remission at Week 104
Time frame: Week 104
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Indian Health Service Health Research
Kissimmee, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
Clinica Independencia
Munro, Buenos Aires, Argentina
Cer Instituto Medico
Quilmes, Buenos Aires, Argentina
Diagnostic-Consultative Center Convex EOOD
Sofia, Bulgaria
Herlev Hospital
Herlev, Denmark
Universitaetsklinikum Ulm
Ulm, Germany
MIND Klinika Kft
Budapest, Hungary
...and 15 more locations
Number of Participants with Corticosteroid-free Remission
Measured in participants receiving corticosteroids at randomization of parent Study 20170104.
Time frame: Week 52
Number of Participants with Corticosteroid-free Remission
Measured in participants receiving corticosteroids at randomization of parent Study 20170104.
Time frame: Week 104
Number of Participants with Combined Endoscopic and Histologic Remission at Week 52
Time frame: Week 52
Number of Participants with Combined Endoscopic and Histologic Remission at Week 104
Time frame: Week 104
Number of Participants with Symptomatic Remission at Week 52
Time frame: Week 52
Number of Participants with Symptomatic Remission at Week 104
Time frame: Week 104
Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 52
Time frame: Baseline of Study 20170104 to Week 52 of Long Term Extension Study (up to approximately 104 weeks)
Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 104
Time frame: Baseline of Study 20170104 to Week 104 of Long Term Extension Study (up to approximately 156 weeks)