Ulcerative Colitis
Conditions
Keywords
Ulcerative colitis, UC, Moderately to severely active ulcerative colitis, Efavaleukin alfa, AMG 592
Brief summary
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).
Interventions
DRUGEfavaleukin alfa
Subcutaneous (SC) injection
DRUGPlacebo
SC injection
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participant has provided informed consent prior to initiation of any study specific activities/procedures. * Participant has completed the week 52 endoscopy in the phase 2 dose-finding parent study (20170104) and who in the opinion of the investigator may benefit from continued treatment.
Exclusion criteria
* Permanent discontinuation of investigational product during the 52- week phase 2 dose finding parent study (20170104) for any reason * Female subjects of reproductive potential must agree not to donate eggs during the study and for 6 weeks after receiving the last dose of investigational product. Disease Related: * Adenoma and dysplasia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Day 1 to Week 110 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Clinical Response at Week 104 | Week 104 | — |
| Number of Participants with Clinical Remission at Week 52 | Week 52 | — |
| Number of Participants with Clinical Remission at Week 104 | Week 104 | — |
| Number of Participants with Durable Clinical Remission at Week 52 | Week 52 | — |
| Number of Participants with Durable Clinical Remission at Week 104 | Week 104 | — |
| Number of Participants with Endoscopic Remission at Week 52 | Week 52 | — |
| Number of Participants with Endoscopic Remission at Week 104 | Week 104 | — |
| Number of Participants with Histologic Remission at Week 52 | Week 52 | — |
| Number of Participants with Clinical Response at Week 52 | Week 52 | — |
| Number of Participants with Corticosteroid-free Remission | Week 52 | Measured in participants receiving corticosteroids at randomization of parent Study 20170104. |
| Number of Participants with Combined Endoscopic and Histologic Remission at Week 52 | Week 52 | — |
| Number of Participants with Combined Endoscopic and Histologic Remission at Week 104 | Week 104 | — |
| Number of Participants with Symptomatic Remission at Week 52 | Week 52 | — |
| Number of Participants with Symptomatic Remission at Week 104 | Week 104 | — |
| Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 52 | 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 | Baseline of Study 20170104 to Week 104 of Long Term Extension Study (up to approximately 156 weeks) | — |
| Number of Participants with Histologic Remission at Week 104 | Week 104 | — |
Countries
Argentina, Bulgaria, Denmark, Germany, Hungary, Japan, Mexico, Poland, Romania, South Korea, Switzerland, Turkey (Türkiye), United States
Outcome results
None listed