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  • NCT03943147

Active, Not Recruiting

An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis - IM011-073

Oppdatert: 29 Juli, 2021   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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Vis detaljer

  • Phase 2

    Fase

  • Kjønn

  • 18-75

    Aldersgruppe

  • Active, Not Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Experimental: BMS-986165 Dose 1 oral administration
Drug: BMS-986165
Experimental: BMS-986165 Dose 2 oral administration
Drug: BMS-986165
Placebo Comparator: Placebo oral administration
Drug: Placebo

Nøkkelkriterier for kvalifikasjon

For more information regarding Bristol Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Meets the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria for SLE - Renal biopsy confirming a histologic diagnosis of active LN: International Society of Nephrology/Renal Pathology Society (ISN/RPS) Classes III (A or A/C), IV-S (A or A/C), or IV-G (A or A/C); or Class V (in combination with Class III or IV) - Urine protein:creatinine ratio (UPCR) ≥1.5 mg/mg Exclusion Criteria: - Pure ISN/RPS Class V membranous LN - Screening estimated glomerular filtration rate (eGFR; calculated using the Modification of Diet in Renal Disease [MDRD] equation) ≤30 mL/min/1.73 m2 - Dialysis within 12 months before screening or plans for dialysis within 6 months after enrollment in the study Other protocol defined inclusion/exclusion criteria could apply

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For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon

MLTNO2000046