ong-term efficacy, safety and tolerability of LNP023 in C3G or IC-MPG

Phase 1

• Conditions: C3 Glomerulopathy or idiopathic immune-complex membranoproliferative glomerulonephritis; MedDRA version: 20.0Level: PTClassification code 10077827Term: C3 glomerulopathySystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 27.0Level: PTClassification code 10089346Term: Immune-complex membranoproliferative glomerulonephritisSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-004253-24-GR
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-15
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

Participants must have completed the treatment period of the
CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study
drug.
Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 158
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Severe concurrent co-morbidities, e.g., advanced cardiac disease (New York Heart Association (NYHA) class IV), severe pulmonary arterial hypertension (WHO class IV), or any illness or medical condition that in the opinion of the investigator and sponsor is likely to prevent the patient from safely tolerating iptacopan or complying with the requirements of the study.
• Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to screening,
or
The presence of fever = 38oC (100.4oF) within 7 days prior to screening.
• History of human immunodeficiency virus (HIV) or any other immunodeficiency disease.
• History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified