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Clinical trial

A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy

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Last updated:26th Sep 2021
Status: Recruiting
Identifier: NCT04557462
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy


Brief Summary:
The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.

Detailed Description:
This is an open-label, non-randomized, multicenter roll-over extension program (REP) to:
- CLNP023X2203, a Phase II trial investigating the dose ranging effects of LNP023 on efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability in primary IgAN patients, and
- CLNP023A2301, a Phase III trial, investigating the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of LNP023 in patients with primary IgAN.

Subjects completing the CLNP023X2203 and CLNP023A2301 trials on study drug, who want to continue treatment and who meet the inclusion/exclusion requirements of the roll over extension program, will have the opportunity to receive iptacopan until:
- 3 years from LPFV of this study CLNP023A2002B, or
- the participant no longer derives benefit from iptacopan according to the Investigator, or
- the benefit-risk profile of the product in IgAN is no longer positive, or
- initiation of maintenance hemodialysis, kidney transplantation or eGFR < 15 mL/min/1.73m2 , or
- the product becomes commercially available in a specific country following product launch and subsequent reimbursement for IgAN, where applicable, or
- if a marketing application or reimbursement of an investigational product is rejected/not pursued in a region/country for the indication under study or which ever is sooner


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 410 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan in Adult Participants With Primary IgA Nephropathy Who Have Completed Study CLNP023X2203 or CLNP023A2301
Actual Study Start Date: September 20, 2021
Estimated Primary Completion Date: January 4, 2029
Estimated Study Completion Date: January 4, 2029

Arm:
- Experimental: LNP023

Category Value
Study type(s) Interventional
Estimated enrolment 410
Actual Study start date 20 September 2021
Estimated Study Completion Date 04 January 2029

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