Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.

Recruiting Phase 3 Interventional Study
C3G
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
12 – 60
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
98 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
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About This Trial

The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol. The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Male and female participants age ≥ 12 and ≤ 60 years at screening. * Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to enrollment in adults and within 3 years in adolescents. * Prior to randomization, all participants must have been on a maximally recomme…
Contacts

Novartis Pharmaceuticals

1-888-669-6682

novartis.email@novartis.com

CONTACT

Novartis Pharmaceuticals

+41613241111

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