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

April 12, 2024 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

500

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • Cordoba, Argentina, X5016KET
        • Recruiting
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000EPV
        • Recruiting
        • Novartis Investigative Site
  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Novartis Investigative Site
    • Victoria
      • Parkville, Victoria, Australia, 3065
        • Recruiting
        • Novartis Investigative Site
  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • Novartis Investigative Site
      • Roeselare, Belgium, 8800
        • Recruiting
        • Novartis Investigative Site
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Recruiting
        • Novartis Investigative Site
  • Brazil
    • PR
      • Curitiba, PR, Brazil, 80440-020
        • Recruiting
        • Novartis Investigative Site
    • RS
      • Porto Alegre, RS, Brazil, 90020-090
        • Recruiting
        • Novartis Investigative Site
    • SP
      • Sao Paulo, SP, Brazil, 05403 000
        • Recruiting
        • Novartis Investigative Site
      • São Paulo, SP, Brazil, 04038-002
        • Recruiting
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • Recruiting
        • Novartis Investigative Site
  • China
      • Beijing, China, 100034
        • Recruiting
        • Novartis Investigative Site
      • Qingdao, China, 266000
        • Recruiting
        • Novartis Investigative Site
      • Shanghai, China, 200040
        • Recruiting
        • Novartis Investigative Site
      • Shanxi, China, 710063
        • Recruiting
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Novartis Investigative Site
    • Ningxia
      • Yinchuan, Ningxia, China, 100039
        • Recruiting
        • Novartis Investigative Site
  • Czechia
      • Praha, Czechia, 12808
        • Recruiting
        • Novartis Investigative Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Recruiting
        • Novartis Investigative Site
      • Arhus N, Denmark, DK-8200
        • Recruiting
        • Novartis Investigative Site
      • Copenhagen, Denmark, DK-2100
        • Recruiting
        • Novartis Investigative Site
  • France
      • Paris, France, 75015
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Novartis Investigative Site
      • Freiburg, Germany, 79106
        • Recruiting
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Recruiting
        • Novartis Investigative Site
      • Magdeburg, Germany, 39120
        • Recruiting
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Recruiting
        • Novartis Investigative Site
  • Hong Kong
      • Hong Kong SAR, Hong Kong
        • Recruiting
        • Novartis Investigative Site
  • India
      • New Delhi, India, 110029
        • Recruiting
        • Novartis Investigative Site
    • Karnataka
      • Bangalore, Karnataka, India, 560004
        • Recruiting
        • Novartis Investigative Site
  • Israel
      • Ashkelon, Israel, 78278
        • Recruiting
        • Novartis Investigative Site
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Novartis Investigative Site
      • Petach Tikva, Israel, 4941492
        • Recruiting
        • Novartis Investigative Site
  • Italy
      • Napoli, Italy, 80100
        • Recruiting
        • Novartis Investigative Site
  • Japan
      • Kyoto, Japan, 605-0981
        • Recruiting
        • Novartis Investigative Site
      • Osaka, Japan, 534-0021
        • Recruiting
        • Novartis Investigative Site
    • Aichi
      • Toyoake city, Aichi, Japan, 470 1192
        • Recruiting
        • Novartis Investigative Site
      • Toyota, Aichi, Japan, 471-8513
        • Recruiting
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8604
        • Recruiting
        • Novartis Investigative Site
      • Sapporo-city, Hokkaido, Japan, 006-8555
        • Recruiting
        • Novartis Investigative Site
    • Kanagawa
      • Yokohama-city, Kanagawa, Japan, 236-0004
        • Recruiting
        • Novartis Investigative Site
    • Miyagi
      • Sendai, Miyagi, Japan, 981-3205
        • Active, not recruiting
        • Novartis Investigative Site
    • Nagano
      • Matsumoto, Nagano, Japan, 390-8621
        • Recruiting
        • Novartis Investigative Site
    • Okayama
      • Okayama-city, Okayama, Japan, 700-8558
        • Recruiting
        • Novartis Investigative Site
    • Osaka
      • Osaka-city, Osaka, Japan, 530-0012
        • Recruiting
        • Novartis Investigative Site
      • Osaka-city, Osaka, Japan, 530-8480
        • Recruiting
        • Novartis Investigative Site
    • Shiga
      • Omihachiman, Shiga, Japan, 523-0082
        • Recruiting
        • Novartis Investigative Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 06973
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 134 727
        • Recruiting
        • Novartis Investigative Site
      • Taegu, Korea, Republic of, 41944
        • Recruiting
        • Novartis Investigative Site
    • Chungcheongbuk Do
      • Cheongju si, Chungcheongbuk Do, Korea, Republic of, 28644
        • Recruiting
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 03312
        • Recruiting
        • Novartis Investigative Site
    • Seocho Gu
      • Seoul, Seocho Gu, Korea, Republic of, 06591
        • Recruiting
        • Novartis Investigative Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • Novartis Investigative Site
      • Kuala Lumpur, Malaysia, 50589
        • Recruiting
        • Novartis Investigative Site
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • Novartis Investigative Site
  • Norway
      • Bergen, Norway, 5021
        • Recruiting
        • Novartis Investigative Site
    • Oslo
      • Nordbyhagen, Oslo, Norway, 1478
        • Recruiting
        • Novartis Investigative Site
  • Russian Federation
      • Rostov On Don, Russian Federation, 344022
        • Active, not recruiting
        • Novartis Investigative Site
      • St. Petersburg, Russian Federation, 197110
        • Active, not recruiting
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169608
        • Recruiting
        • Novartis Investigative Site
  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Recruiting
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Recruiting
        • Novartis Investigative Site
      • Taichung, Taiwan, 40705
        • Recruiting
        • Novartis Investigative Site
      • Taipei, Taiwan, 10048
        • Recruiting
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 33305
        • Recruiting
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Recruiting
        • Novartis Investigative Site
      • Bangkok, Thailand, 10330
        • Recruiting
        • Novartis Investigative Site
  • Turkey
      • Kocaeli, Turkey, 41380
        • Recruiting
        • Novartis Investigative Site
      • Talas / Kayseri, Turkey, 38039
        • Recruiting
        • Novartis Investigative Site
    • TUR
      • Istanbul, TUR, Turkey, 34098
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • Leicester, United Kingdom, LE5 4PW
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • Novartis Investigative Site
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Recruiting
        • Novartis Investigative Site
    • Cambrigdeshire
      • Cambridge, Cambrigdeshire, United Kingdom, CB2 0QQ
        • Active, not recruiting
        • Novartis Investigative Site
    • Manchester
      • Salford, Manchester, United Kingdom, M6 8HD
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Recruiting
        • AZ Kidney Dise and Hypertension Ctr
        • Contact:
        • Principal Investigator:
          • Peter Santos
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Active, not recruiting
        • University of Colorado Anschutz
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Nephrology Associates PA
        • Contact:
        • Principal Investigator:
          • Theodore Saad
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Active, not recruiting
        • Clinical Research Consultants LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • Recruiting
        • DaVita Clinical Research
        • Principal Investigator:
          • Mark Vishnepolsky
        • Contact:
    • Texas
      • Houston, Texas, United States, 77054
        • Recruiting
        • Prolato Clinical Research Center
        • Contact:
        • Principal Investigator:
          • Sreedhar Mandayam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • For LNP023X2203, participants must have completed part 1 or part 2 of the trial. For LNP023A2301, participants must have completed the entire core trial defined as the full 24 month treatment 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 ACEi or ARB* as per KDIGO guidelines.

    • participants who are not taking KDIGO guideline doses because they have documented allergies or intolerance to ACEi and ARB are eligible for the study

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 LNP023.
  • Current (within 4 weeks of study drug administration in the REP) acute kidney injury (AKI)
  • 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 enrolment, or within 5 half-lives of enrolment or within 30 days whichever is longer.
  • History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LNP023
All participants are receiving 200 mg b.i.d
Drug: LNP023
Capsule 200 mg (b.i.d.) taken orally twice a day
Other Names:
  • iptacopan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and percentage of participants with serious adverse event
Time Frame: Date of first administration of (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics on serious adverse events
Date of first administration of (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with adverse event
Time Frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics on adverse events
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with adverse events of special interest
Time Frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual adminstration of study treatment
Summary statistics on adverse events of special interest
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual adminstration of study treatment
Number and percentage of participants with abnormalities in vital signs
Time Frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics on abnormalities in vital sign parameters
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with abnormalities in ECG
Time Frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics in abnormalities in ECG parameters
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with abnormalities in clinical laboratory evaluations
Time Frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics on abnormalities in clinical laboratory evaluations
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized total eGFR slope
Time Frame: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Annualized rate of renal disease progression as measured by mean eGFR slope at post baseline visits
Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Change from baseline in eGFR
Time Frame: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Average change from baseline in eGFR at post-baseline visits
Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Log transformed ratio to baseline in UPCR, UACR
Time Frame: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Log transformed ratio to baseline in UPCR, UACR at post-baseline visits. The log transformation refers to the natural log (base on e)
Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Estimated)

May 31, 2032

Study Completion (Estimated)

May 31, 2032

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLNP023A2002B
  • 2020-002200-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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