A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)
Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy
Approximately 330 participants with eGFR ≥ 30 mL/min/1.73m^2 and with biopsy-proven IgAN will be randomized to receive 600 mg Q2W BION-1301, Novartis FUB523, or a matched placebo for 104 weeks. An additional exploratory cohort, not included in the primary analysis, will be comprised of approximately 20 participants (10 participants per arm) with biopsy-confirmed IgAN and eGFR of ≥ 20 to < 30 mL/min/1.73 m^2. The exploratory cohort will be randomized using the same schema as the primary cohort.
The primary objective of the study is to evaluate the effect of BION-1301 versus placebo on eGFR as measured by the change from Baseline in eGFR.
Following completion of the 104-week treatment period, subjects may be eligible to enroll in an open-label extension (OLE) study to receive open-label treatment with BION-1301 under a separate protocol. Subjects who do not enroll in the OLE will enter the protocol-specified 24-week safety follow-up period.
To facilitate study participation over this time period, other visits may be remote (away from study site) for participants who elect to self-administer the study drug.
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Birmingham, Alabama 35233-1926, United States
Fort Wayne, Indiana 46804, United States
Cincinnati, Ohio 45267-2827, United States
Fairfax, Virginia 22033-1907, United States
Wulumuji, Xinjiang 830054, China
Heralkion, 71409, Greece
Hyderabad, Andhra Pradesh 500084, India
Kasugai-Shi, Aiti 486-0804, Japan
Toyoake-shi, Aiti 470-1192, Japan
Urayasu-Shi, Chiba 279-0021, Japan
Bunkyo-Ku, Tokyo 113-8431, Japan
Hachioji-Shi, Tokyo 192-0071, Japan
Minato-Ku, Tokyo 105-8471, Japan
Shinjuku-Ku, Tokyo 162-0054, Japan
Yufu-Shi, Ôita 879-5503, Japan
Barrio Belisario Domínguez Secc, Mexico City 14080, Mexico
Oaxaca, Mexico City 68000, Mexico
Jongno-gu, Seoul Teugbyeolsi 03080, South Korea
Seodaemun-gu, Seoul Teugbyeolsi 03722, South Korea
Seongbuk-Gu, Seoul Teugbyeolsi 02841, South Korea
Changhua County, 50006, Taiwan