Felzartamab for IgA nephropathy

Resolution Criteria Trial: NCT06935357 Selected endpoint key: 3bdf5c21e1bcd8263aa18191a9a6070bad8f7f9c3ba8935d5735fee57b399c1f Selected endpoint: Percent Change From Baseline in Proteinuria as Measured by the Urine Protein: Creatinine Ratio (UPCR) Endpoint type: other Protocol outcome group: primary Endpoint description: Not provided by ClinicalTrials.gov. Endpoint timeframe: Baseline up to Week 36 ClinicalTrials.gov population: Adults diagnosed with immunoglobulin A nephropathy (IgAN) Market population: Adults diagnosed with immunoglobulin A nephropathy (IgAN) Analysis set: Not specified in the enumerated protocol outcome Comparison: Felzartamab infusions versus placebo Success direction: lower Success rule: In adults with IgAN, felzartamab must produce a statistically significantly greater reduction than placebo in percent change from baseline in proteinuria measured by UPCR through Week 36, meeting the prespecified statistical success criterion. The enumerated protocol outcome does not specify a numerical threshold or analysis set. ClinicalTrials.gov source: https://clinicaltrials.gov/study/NCT06935357?tab=researcher#outcome-measures:~:text=Percent%20Change%20From%20Baseline%20in%20Proteinuria%20as%20Measured%20by%20the%20Urine%20Protein%3A%20Creatinine%20Ratio%20(UPCR) YES 1. The exact selected endpoint (Percent Change From Baseline in Proteinuria as Measured by the Urine Protein: Creatinine Ratio (UPCR)) satisfies the approved success rule in the specified population, analysis set, comparison, and timepoint. 2. The result is supported by a qualifying source in the approved evidence hierarchy. NO 1. The exact selected endpoint (Percent Change From Baseline in Proteinuria as Measured by the Urine Protein: Creatinine Ratio (UPCR)) misses its approved success rule. 2. No qualifying disclosure of the selected endpoint is available by 2029-12-31 at 23:59:59 UTC. NO DECISION / ADMIN REVIEW 1. Available evidence is contradictory, incomplete, pooled, interim, subgroup-only, or does not match the approved population, analysis set, comparison, and timepoint. Resolution deadline: 2029-12-31T23:59:59Z Deadline evidence: AI bounded approximation (confidence 93/100): official source supports 2029-01-01 through 2029-12-31; market deadline 2029-12-31 is the conservative end of that window. Official Biogen investor materials state that Phase 3 data for felzartamab in IgAN are expected in 2029 and note that estimated timelines are subject to change. Because only a calendar year is provided, the conservative market deadline is the last calendar day of that official window. Deadline evidence source: https://investors.biogen.com/static-files/70854655-4e66-4089-a422-9abb511340b0 Evidence precedence 1. ClinicalTrials.gov posted results 2. Sponsor regulatory filing or official release 3. Peer-reviewed publication or official conference abstract Only the selected endpoint in the specified population, analysis set, comparison, and timeframe can resolve YES. Overall positive messaging, another endpoint, interim results, pooled analyses, or an unmatched subgroup cannot resolve YES.