Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Complement 3 Glomerulopathy.

ClinicalTrials.gov Identifier: NCT04817618

Novartis Reference Number: CLNP023B12301

Last Update: Sep 22, 2022

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.

Condition 
C3G
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Jul 28, 2021
Completion date 
Aug 24, 2023
Gender 
All
Age(s)
18 Years - 60 Years (Adult)

Interventions

Drug
Placebo
Placebo to iptacopan 200mg b.i.d.
Drug
iptacopan
iptacopan 200 mg b.i.d.

Eligibility Criteria

Inclusion Criteria:

Male and female participants age ≥ 18 and ≤ 60 years at screening.
Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to enrollment.
Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 90 days. The doses of other antiproteinuric medications including mycophenolic acid, corticosteroids and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization.
Reduced serum C3 (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening.
UPCR ≥ 1.0 g/g sampled from the first morning void urine sample at Day -75 and Day -15.
Estimated GFR (using the CKD-EPI formula) or measured GFR ≥ 30 ml/min/1.73m2 at screening and Day -15.
Vaccination against Neisseria meningitidis infection prior to the start of study treatment. Vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given, if available and according to local regulations.

Exclusion Criteria:

Participants who have received any cell or organ transplantation, including a kidney transplantation.
Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.
Renal biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%.
Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.
Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration
The presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.
A history of recurrent invasive infections caused by encapsulated organisms, e.g., N. meningitidis and S. pneumoniae.
The use of inhibitors of complement factors (e.g., Factor B, Factor D, C3 inhibitors, anti C5 antibodies, C5a receptor antagonists) within 6 months prior to the Screening visit.
The use of immunosuppressants (except mycophenolic acids), cyclophosphamide or systemic corticosteroids at a dose >7.5 mg/day (or equivalent for a similar medication) within 90 days of study drug administration.

Study Locations

United States
Novartis Investigative Site
Recruiting
Aurora, 80045
Colorado
United States
Novartis Investigative Site
Recruiting
Lawrenceville, 30046
Georgia
United States
Novartis Investigative Site
Recruiting
Iowa City, 52242
Iowa
United States
Novartis Investigative Site
Recruiting
Baltimore, 21287
Maryland
United States
Novartis Investigative Site
Recruiting
Boston, 02115
Massachusetts
United States
Novartis Investigative Site
Recruiting
Albany, 12208
New York
United States
Novartis Investigative Site
Recruiting
New York, 10032
New York
United States
Argentina
Novartis Investigative Site
Recruiting
Caba, C1181ACH
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Buenos Aires, W3400ABH
-
Argentina
Belgium
Novartis Investigative Site
Recruiting
Edegem, 2650
Antwerpen
Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Brazil
Novartis Investigative Site
Recruiting
Belo Horizonte, 30150-221
MG
Brazil
Novartis Investigative Site
Recruiting
Joinville, 893227-680
Santa Catarina
Brazil
Novartis Investigative Site
Recruiting
Santo Andre, 09090-790
SP
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 05403 000
SP
Brazil
Novartis Investigative Site
Recruiting
São Paulo, 04038-002
SP
Brazil
Canada
Novartis Investigative Site
Recruiting
London, N6A 5A5
Ontario
Canada
China
Novartis Investigative Site
Recruiting
Beijing, 100034
-
China
Novartis Investigative Site
Recruiting
Shanghai, 200040
-
China
Novartis Investigative Site
Recruiting
Wuhan, 430022
-
China
Czech Republic
Novartis Investigative Site
Recruiting
Praha, 12808
-
Czech Republic
France
Novartis Investigative Site
Recruiting
Lille Cedex, 59037
-
France
Novartis Investigative Site
Recruiting
Marseille Cédex 5, 13385
-
France
Novartis Investigative Site
Recruiting
Montpellier, 34295
-
France
Novartis Investigative Site
Recruiting
Paris, 75015
-
France
Germany
Novartis Investigative Site
Recruiting
Aachen, 52074
-
Germany
Novartis Investigative Site
Recruiting
Erlangen, 91054
-
Germany
Novartis Investigative Site
Recruiting
Essen, 45147
-
Germany
Novartis Investigative Site
Recruiting
Hannover, 30625
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55131
-
Germany
Greece
Novartis Investigative Site
Recruiting
Thessaloniki, 56403
Macedoni
Greece
Novartis Investigative Site
Recruiting
Athens, 115 27
-
Greece
Novartis Investigative Site
Recruiting
Heraklion Crete, 711 10
-
Greece
India
Novartis Investigative Site
Recruiting
New Delhi, 110 017
Delhi
India
Novartis Investigative Site
Recruiting
Lucknow, 226014
Uttar Pradesh
India
Novartis Investigative Site
Recruiting
DehraDun, 248001
Uttarakhand
India
Novartis Investigative Site
Recruiting
New Delhi, 110029
-
India
Israel
Novartis Investigative Site
Recruiting
Petach Tikva, 4941492
-
Israel
Novartis Investigative Site
Recruiting
Petach-Tikva, 49202
-
Israel
Italy
Novartis Investigative Site
Recruiting
Ranica, 24020
BG
Italy
Novartis Investigative Site
Recruiting
Roma, 00165
RM
Italy
Japan
Novartis Investigative Site
Recruiting
Nagoya, 466 8560
Aichi
Japan
Novartis Investigative Site
Recruiting
Asahikawa-city, 078-8510
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Sapporo-city, 060-8543
Hokkaido
Japan
Netherlands
Novartis Investigative Site
Recruiting
Leiden, 2333 ZA
Zuid-Holland
Netherlands
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08025
Catalunya
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Madrid, 28041
-
Spain
Switzerland
Novartis Investigative Site
Recruiting
Bern, 3010
-
Switzerland
Novartis Investigative Site
Recruiting
Lausanne, 1005
-
Switzerland
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34098
TUR
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34093
-
Turkey
United Kingdom
Novartis Investigative Site
Recruiting
London, W12 0NN
UK
United Kingdom
Novartis Investigative Site
Recruiting
Glasgow, G51 4TF
-
United Kingdom
Novartis Investigative Site
Recruiting
Newcastle Upon Tyne, NE7 7DN
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]