Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN) (NCT05248659) | Clinical Trial Compass
By InvitationPhase 2/3
Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)
United States600 participantsStarted 2022-04-05
Plain-language summary
To evaluate the long-term safety and tolerability of sibeprenlimab in subjects with IgAN
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subjects who completed Trial 417-201-00007 (at least 20 of the 26 doses over a 2-year duration and the end-of-trial visit) or Trial VIS649-201 (at least 9 of the 12 doses over a 1-year duration and the end-of-trial visit) without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab for IgAN.
* Ability to provide written, informed consent prior to initiation of any trial-specific procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
Exclusion Criteria:
* Subjects who have not completed participation in Trials 417-201-00007 or VIS649-201.
* Subjects with treatment-limiting AEs during Trials 417-201-00007 or VIS649-201 considered related to IMP per investigator judgement.
* Noncompliance, due to subject's repeated failure to follow trial procedures during the course of their participation in Trials 417-201-00007 and VIS649-201 (eg, subjects deemed to be noncompliant with the visit schedule, trial assessments, or treatment regimen). The medical monitor should be contacted if the investigator is unsure of a subject's eligibility.
* Subjects who have a positive pregnancy test result prior to receiving IMP.
* Heterosexually active biological males or subjects of childbearing potential, or their partners, who do not agree to adhere to contraceptive requirements from the time of consent through the end of the subject's particip…
What they're measuring
1
Adverse Events
Timeframe: From baseline to the end-of-trial visit in Week 112.
Trial details
NCT IDNCT05248659
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.