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RECRUITING

NCT04817618

PHASE3

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol. 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.

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

Key Details

Gender

All

Age Range

12 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2021-07-28

Completion Date

2027-01-29

Last Updated

2026-04-01

Healthy Volunteers

Conditions

C3G

Interventions

DRUG

Placebo

Placebo to iptacopan 200mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)

DRUG

iptacopan

iptacopan 200 mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)

Inclusion Criteria: * Male and female participants age ≥ 12 and ≤ 60 years at screening. * Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to enrollment in adults and within 3 years in adolescents. * 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 for ages ≥ 18 years and modified Schwartz formula for ages 12 to 17 years) or measured GFR ≥ 30 ml/min/1.73m2 at screening and Day -15. * Mandatory vaccination against Neisseria meningitidis and Streptococcus pneumoniae prior to the start of study treatment. * If not previously vaccinated or if a booster is required, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to the first study treatment administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated. 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. * Acute post-infectious glomerulonephritis at screening based upon the opinion of the investigator.

Locations (87)

Childrens Hospital Colorado

Aurora, Colorado, United States

Nicklaus Childrens Hospital

Miami, Florida, United States

Georgia Nephrology Research Inst

Lawrenceville, Georgia, United States

IN University School of Med

Indianapolis, Indiana, United States

University of Iowa Health Care

Iowa City, Iowa, United States

University of Iowa Health Care

Iowa City, Iowa, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Brigham and Womens Hosp Harvard Med School

Boston, Massachusetts, United States

Hackensack Uni Medical Center

Hackensack, New Jersey, United States

Albany Medical Center

Albany, New York, United States

Col Uni Med Center New York Presby

New York, New York, United States

Baylor Scott and White Research

Temple, Texas, United States

University of Wisconsin

Madison, Wisconsin, United States

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

CABA, Argentina

Novartis Investigative Site

Edegem, Belgium

Novartis Investigative Site

Leuven, Belgium

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

Novartis Investigative Site

Recife, Pernambuco, Brazil

Novartis Investigative Site

Passo Fundo, Rio Grande do Sul, Brazil

Novartis Investigative Site

Joinville, Santa Catarina, Brazil

Novartis Investigative Site

Santo André, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

Salvador, Brazil

Novartis Investigative Site

London, Ontario, Canada

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Guangzhou, Guangdong, China

Novartis Investigative Site

Wuhan, Hubei, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Shanghai, China

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Lille, France

Novartis Investigative Site

Marseille, France

Novartis Investigative Site

Montpellier, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Novartis Investigative Site

Aachen, Germany

Novartis Investigative Site

Erlangen, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Hamburg, Germany

Novartis Investigative Site

Hanover, Germany

Novartis Investigative Site

Heidelberg, Germany

Novartis Investigative Site

Mainz, Germany

Novartis Investigative Site

Athens, Greece

Novartis Investigative Site

Heraklion Crete., Greece

Novartis Investigative Site

Thessaloniki, Greece

Novartis Investigative Site

Thessaloniki, Greece

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, India

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, India

Novartis Investigative Site

Hyderabad, Telangana, India

Novartis Investigative Site

Lucknow, Uttar Pradesh, India

Novartis Investigative Site

Dehradun, Uttarakhand, India

Novartis Investigative Site

Petah Tikva, Israel

Novartis Investigative Site

Petah Tikva, Israel

Novartis Investigative Site

Ranica, BG, Italy

Novartis Investigative Site

Milan, MI, 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

Niigata, Japan

Novartis Investigative Site

Nijmegen, Gelderland, Netherlands

Novartis Investigative Site

Leiden, South Holland, Netherlands

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

Port de Sagunt, Valencia, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Málaga, Spain

Novartis Investigative Site

Seville, Spain

Novartis Investigative Site

Bern, Switzerland

Novartis Investigative Site

Lausanne, Switzerland

Novartis Investigative Site

Istanbul, Fatih, Turkey (Türkiye)

Novartis Investigative Site

Istanbul, Fatih, Turkey (Türkiye)

Novartis Investigative Site

Kayseri, Melikgazi, Turkey (Türkiye)

Novartis Investigative Site

Ankara, Yenimahalle, Turkey (Türkiye)

Novartis Investigative Site

Ankara, Yenimahalle, Turkey (Türkiye)

Novartis Investigative Site

Glasgow, Scotland, United Kingdom

Novartis Investigative Site

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

London, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (87)