Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Act… (NCT05672199) | Clinical Trial Compass
TerminatedPhase 2
Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
Stopped: The parent study 20170104 was terminated due to the study meeting a prespecified futility rule. Consequently, this study was terminated.
United States, Argentina25 participantsStarted 2023-04-28
Plain-language 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).
Who can participate
Age range18 Years – 80 Years
SexALL
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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 exclusion criteria:
* Any current sporadic adenoma without dysplasia (adenomatous polyps occurring proximal to known areas of colitis) that has not been removed.
* Dysplasia occurring in flat mucosa, sporadic adenomas containing dysplasia, and dysplasia-associated lesions or masses will be managed as follows:
* 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 ha…
What they're measuring
1
Number of Participants with Treatment-emergent Adverse Events (TEAEs)