Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN
NCT ID: NCT03955445
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
225 participants
INTERVENTIONAL
2019-10-03
2036-05-30
Brief Summary
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Detailed Description
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The primary (at 9 months) and longer-term (\>9 months) efficacy and safety data of iptacopan collected from CLNP023X2202 participants will be used to support health authority submissions.
This umbrella protocol will also allow:
* continued access to iptacopan to patients enrolled in the ongoing Phase 3 programs (C3G and IC-MPGN)
* C3G study (CLNP023B12301): adults and adolescents
* IC-MPGN study (CLNP023B12302): adults and adolescents
* provision of additional efficacy and safety information following longer-term treatment in C3G and IC-MPGN populations to support health authority submissions.
Efficacy and safety assessments at the 9 month visit of this extension study in combination with data from CLNP023X2202 (baseline plus 3 months of treatment) allowed evaluation of the effects of iptacopan on potential endpoint(s) at 12 months of iptacopan treatment in C3G participants. The enrollment of C3G and IC-MPGN participants (adults and adolescents) from Phase 3 studies, CLNP023B12301 and CLNP023B12302, permits longer-term evaluation of the persistence of effects observed after iptacopan treatment. These longer term efficacy and safety assessments may be compared to historical/concurrent control data available from relevant real world databases in C3G or IC-MPGN patients and used as supportive information for registration purposes.
This extension study is expected to continue until the drug product becomes commercially available and accessible (anticipated to be up to approximately 168 months from the first patient first visit date), or the benefit-risk profile is no longer positive, or the program is discontinued for business or strategic reasons.
"Baseline" refers to the Day 1 visit (pre-dose) of CLNP023X2202, CLNP023B12301 or CLNP023B12302, whereas the Day 1 visit for this C3G/IC-MPGN extension study (CLNP023B12001B) is identified as "Extension Day 1".
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort B: participants with transplanted kidneys and recurrent C3G from CLNP023X2202
C3G participants from study CLNP023X2202 who have undergone kidney transplant and have recurrence of C3G receiving iptacopan capsules 200 mg b.i.d
LNP023
LNP023 capsules
Cohort C: Participants with native C3G randomized to placebo in CLNP023B12301
Native C3G Participants (adults and adolescents) from CLNP023B12301 study who were randomized to placebo in the core study receiving iptacopan capsules 200mg b.i.d
LNP023
LNP023 capsules
Cohort D: particpants with native C3G randomised to iptacopan in CLNP023B12301
Native C3G participants (adults and adolescents) from study CLNP023B12301 who were randomized to iptacopan in the core study. Receiving iptacopan capsules 200mg b.i.d
LNP023
LNP023 capsules
Cohort E: participants with IC-MPGN randomized to placebo in CLNP023B12302
IC-MPGN participants (adults and adolescents) from study CLNP023B12302 who were randomized to placebo in the core study receiving iptacopan capsules 200mg b.i.d
LNP023
LNP023 capsules
Cohort F: participants with IC-MPGN randomized to ipatocan in CLNP023B12302
IC-MPGN participants (adults and adolescents) from study CLNP023B12302 who were randomized to iptacopan in the core study receiving iptacopan capsules 200mg b.i.d
LNP023
LNP023 capsules
Cohort A: participants with native kidneys from CLNP023X2202
C3G participants from study CLNP023X2202 with native kidneys receiving iptacopan capsules 200 mg b.i.d
LNP023
LNP023 capsules
Interventions
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LNP023
LNP023 capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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 or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects
* History of HIV or any other immunodeficiency disease
12 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Bern, , Switzerland
Novartis Investigative Site
Köseköy, Kocaeli, Turkey (Türkiye)
Novartis Investigative Site
Kayseri, Melikgazi, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye)
Novartis Investigative Site
London, London, United Kingdom
Novartis Investigative Site
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Childrens Hospital Colorado
Aurora, Colorado, United States
Georgia Nephrology Research Inst
Lawrenceville, Georgia, United States
University of Iowa Health Care
Iowa City, Iowa, United States
University of Minnesota
Minneapolis, Minnesota, United States
Col Uni Med Center New York Presby
New York, New York, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
Buenos Aires, , Argentina
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
Botucatu, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Salvador, , Brazil
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Prague, , Czechia
Novartis Investigative Site
Montpellier, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Erlangen, , Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Mainz, , Germany
Novartis Investigative Site
Heraklion Crete., , Greece
Novartis Investigative Site
Petah Tikva, , Israel
Novartis Investigative Site
Petah Tikva, , Israel
Novartis Investigative Site
Ranica, BG, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Asahikawa, Hokkaido, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Takatsuki, Osaka, Japan
Novartis Investigative Site
Ohtsu, Shiga, Japan
Novartis Investigative Site
Hachiōji, Tokyo, Japan
Novartis Investigative Site
Niigata, , Japan
Novartis Investigative Site
Leiden, South Holland, Netherlands
Novartis Investigative Site
Seville, Andalusia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Pamplona, Navarre, Spain
Novartis Investigative Site
Cardiff, , United Kingdom
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Facility Contacts
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Role: primary
Other Identifiers
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2018-004253-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-509343-27-00
Identifier Type: OTHER
Identifier Source: secondary_id
CLNP023B12001B
Identifier Type: -
Identifier Source: org_study_id
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