A rollover extension program (REP) to evaluate the long-term safety andtolerability of open label iptacopan in adult participants with primary IgAnephropathy

Phase 3

• Conditions: Health Condition 1: N027- Recurrent and persistent hematuriawith diffuse crescentic glomerulonephritis

• Registration Number: CTRI/2024/01/061242
• Lead Sponsor: ovartis Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Signed informed consent must be obtained prior to participation in the REP; participants should be able to communicate well with the Investigator,

understand and comply with the requirements of the study.

- For CLNP023X2203, participants must have completed Part 1 or Part 2 of the trial. For CLNP023A2301, participants must have completed the entire parent trial defined as the full 24 month double-blind period.

-eGFR = 20 mL/min/1.73m2

--eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines)

-Per Investigator’s clinical judgement, the participant may benefit from receiving the open-label treatment of iptacopan 200 mg b.i.d.

-Prior vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e. any boosters required administered according to local regulations).

-All participants must be on supportive care regimen of stable dose of ACEi or ARB as per

--Participants with allergies or intolerance to ACEi and ARB are eligible for the study but the Investigator should clearly document the reasons for not being on maximal ACEi/ARB dose in the source documents.

Exclusion Criteria

-Participants who screen or baseline failed in the CLNP023X2203 Part 1 or Part 2, or CLNP023A2301 studies or who prematurely withdrew from either study for any reason.

-Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with iptacopan.

-Current (within 4 weeks prior to study treatment administration in the REP) acute kidney injury (AKI) defined by AKIN criteria.)

-Presence of Rapidly Progressive Glomerulonephritis (RPGN) as defined by 50% decline in eGFR within the last 3 months.

-Participants treated with immunosuppressive or other immunmodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus and/or systemic corticosteroids exposure ( >7.5 mg/d prednisone/prednisolone equivalent) within 5 half-lives of respective medication or 90 days prior to first study drug administration, whichever is shorter. Rituximab requires 180 days wash out.

-Use of other investigational drugs at the time of enrollment, or within 5 halflives of enrollment or within 30 days whichever is longer.

-All transplanted participants (any solid organ, or bone marrow transplantation).

-History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus, pneumococcus, and H. influenzae.

-Any medical condition deemed likely to interfere with the participant’s participation in the study.

-Active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study treatment administration.

-Presence of fever = 38C (100.4F) within 7 days prior to study treatment administration.

-History of Human Immunodeficiency Virus (HIV) infection (known history of HIV or test positive for HIV antibody at Screening).

-Liver disease such as active HBV or HCV infection defined as HBsAg positive or HCV RNA positive or liver injury as indicated by abnormal liver function tests (LFT) at screening as defined below. ALT (SGPT), AST (SGOT), GGT, alkaline phosphatase and serum bilirubin will be tested.

--Any single parameter of ALT, AST, GGT, alkaline phosphatase must not exceed 3 × upper limit of normal (ULN)

--Serum bilirubin must not exceed 2 × ULN

-History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes or any participant who discontinued study treatment in the parent study due to a suspected treatment related adverse event.

-Pregnant or breastfeeding females, where pregnancy is confirmed by a positive Human Chorionic Gonadotrophin (HCG) test.

-Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of investigational drug and for 1 week after stopping of investigational drug.

Study & Design

• Study Type: Interventional
• Study Design: Not specified