Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN

NCT05755386 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CLNP023B123022022-002328-11
• Study Type: interventional
• Target: 106
• Locations: 23 countries
• Sites: 127

Brief Summary

This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.

Conditions

IC-MPGN

Keywords

LNP023; IC-MPGN; iptacopan; UPCR; eGFR; proteinuria

Outcome Measures

Primary Outcomes (3)

• Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) at 6 months.

  To demonstrate the superiority of iptacopan compared to placebo in reducing proteinuria at 6 months.

  6 months (double-blind)

• Log-transformed ratio to baseline in UPCR at the 18-month visit (each study treatment arm)

  To evaluate the effect of iptacopan on proteinuria at 18 months.

  18 months

• Log-transformed ratio to 12-month visit in UPCR at the 18-month visit in the placebo arm.

  To evaluate the effect of iptacopan on proteinuria at 18 months.

  18 months

Secondary Outcomes (9)

• Change from baseline in eGFR

  12 months and 18 months

• Change in eGFR from the 12-month visit to the 18- month visit of the placebo arm

  18 months

• Proportion of patients achieved a composite renal endpoint

  6 and 12 months

• Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score.

  12 months

• Number of participants with abnormal vital signs, ECGs and safety laboratory measurements as well as study drug discontinuation due to an AE

  up to 18 months

Study Arms (2)

iptacopan 200mg b.i.d

EXPERIMENTAL

iptacopan 200mg b.i.d

Drug: iptacopan

Placebo to iptacopan 200mg b.i.d.

PLACEBO COMPARATOR

Placebo to iptacopan 200mg b.i.d.

Drug: Placebo

Interventions

Placebo DRUG

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

Placebo to iptacopan 200mg b.i.d.

iptacopan DRUG

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

iptacopan 200mg b.i.d

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and female patients including adults (aged at least 18 years to ≤ 60 years) and adolescents (12 -17 years in non-EU countries at screening and 16-17 years in EU countries at screening).
• Diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to screening in adults and within 3 years of screening in adolescents (a biopsy report, review and confirmation by the Investigator is required). If such a biopsy is not available in an adult participant, this must be obtained at screening (performed and assessed locally for adults only).
• Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of renin angiotensin system inhibitors (RASi), e.g an ACEi or ARB for at least 90 days (or as according to local guidelines). The doses of other drugs administered to reduce proteinuria and control the disease including mycophenolic acids (MPAs - mycophenolate mofetil or mycophenolate sodium), corticosteroids, SGLT2 inhibitors and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization
• UPCR ≥ 1.0 g/g (≥ 113 mg/mmol) sampled from the first morning void urine sample at Day -75 and Day -15
• Estimated GFR (using the chronic kidney disease \[CKD\]-EPI formula for adult participants and modified Schwartz formula for adolescents aged 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 infection prior to the start of study treatment. If the participant has not been previously vaccinated, or if a booster is required, the vaccine should be given according to local regulations at least 2 weeks prior to the first administration of study treatment. If the study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated in accordance with local standard of care.
• 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.

You may not qualify if:

• Participants who have undergone cell or solid organ transplantation, including kidney transplantation.
• Participants diagnosed with secondary IC-MPGN including but not limited to any of the following conditions:
• Deposition of antigen-antibody immune complexes as a result of any chronic infections, including
• Hepatitis C virus (HCV) including HCV-associated mixed cryoglobulinemia, hepatitis B virus (HBV);
• Bacterial-endocarditis, infected ventriculo-atrial shunt, visceral abscesses, leprosy, meningococcal meningitis; chronic bacterial infections
• Protozoa/other infections- malaria, schistosomiasis, mycoplasma, leishmaniasis, filariasis, histroplasmosis
• Renal deposition of immune complexes as a result of a systemic autoimmune disease:
• Systemic lupus erythematosus (SLE)
• Sjögren syndrome
• Rheumatoid arthritis
• Mixed connective tissue disease Deposition of monoclonal immunoglobulins because of a monoclonal gammopathy due to plasma cell or B cell disorders. Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.
• Fibrillary glomerulonephritis
• Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with kidney biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli on the most recent biopsy.
• Kidney biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%.
• Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration or the presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (127)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

RECRUITING

Univ Cali Irvine ALS Neuromuscular

Orange, California, 92868, United States

RECRUITING

UCSF

San Francisco, California, 94115, United States

RECRUITING

Olive View UCLA Medical Center

Sylmar, California, 91342, United States

RECRUITING

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Nicklaus Childrens Hospital

Miami, Florida, 33155, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Boston Univ School of Medicine

Boston, Massachusetts, 02118, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Washington University in St Louis

St Louis, Missouri, 63110, United States

RECRUITING

University of New Mexico

Albuquerque, New Mexico, 87131-0001, United States

RECRUITING

Col Uni Med Center New York Presby

New York, New York, 10032, United States

RECRUITING

University Of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

OHSU Dept of Nephrology

Portland, Oregon, 97239, United States

RECRUITING

Univ of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MUSC Health Lancaster Med Ctr

Lancaster, South Carolina, 29720, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

RECRUITING

Prolato Clinical Research Center

Houston, Texas, 77054, United States

RECRUITING

Baylor Scott and White Research

Temple, Texas, 76502, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84113, United States

RECRUITING

University of Wisconsin

Madison, Wisconsin, 53792, United States

RECRUITING

Novartis Investigative Site

CABA, Buenos Aires, C1425AGC, Argentina

RECRUITING

Novartis Investigative Site

CABA, Buenos Aires, C1425EFD, Argentina

RECRUITING

Novartis Investigative Site

Córdoba, Córdoba Province, X5000, Argentina

RECRUITING

Novartis Investigative Site

Buenos Aires, W3400ABH, Argentina

RECRUITING

Novartis Investigative Site

CABA, C1181ACH, Argentina

RECRUITING

Novartis Investigative Site

Santa Fe, S3000EPV, Argentina

RECRUITING

Novartis Investigative Site

Fortaleza, Ceará, 60430 370, Brazil

RECRUITING

Novartis Investigative Site

Brasília, Federal District, 71635-580, Brazil

WITHDRAWN

Novartis Investigative Site

Belo Horizonte, Minas Gerais, 30150-221, Brazil

RECRUITING

Novartis Investigative Site

Recife, Pernambuco, 50740-900, Brazil

RECRUITING

Novartis Investigative Site

Niterói, Rio de Janeiro, 24020 096, Brazil

WITHDRAWN

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, 22211-230, Brazil

WITHDRAWN

Novartis Investigative Site

Natal, Rio Grande do Norte, 59012 300, Brazil

RECRUITING

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

RECRUITING

Novartis Investigative Site

Botucatu, São Paulo, 18618-970, Brazil

RECRUITING

Novartis Investigative Site

Santo André, São Paulo, 09090-790, Brazil

RECRUITING

Novartis Investigative Site

Sao Jose Rio Preto, São Paulo, 15090-000, Brazil

RECRUITING

Novartis Investigative Site

São Paulo, São Paulo, 04038-002, Brazil

RECRUITING

Novartis Investigative Site

São Paulo, São Paulo, 05403 000, Brazil

WITHDRAWN

Novartis Investigative Site

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Novartis Investigative Site

Salvador, 40323-010, Brazil

RECRUITING

Novartis Investigative Site

Etobicoke, Ontario, M9W 6V1, Canada

RECRUITING

Novartis Investigative Site

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Novartis Investigative Site

Montreal, Quebec, H2X 1R9, Canada

RECRUITING

Novartis Investigative Site

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

Novartis Investigative Site

Prague, 128 08, Czechia

RECRUITING

Novartis Investigative Site

Aarhus N, 8200, Denmark

RECRUITING

Novartis Investigative Site

Copenhagen, DK-2100, Denmark

RECRUITING

Novartis Investigative Site

Marseille, 13005, France

RECRUITING

Novartis Investigative Site

Montpellier, 34295, France

RECRUITING

Novartis Investigative Site

Paris, 75015, France

RECRUITING

Novartis Investigative Site

Rennes, 35033, France

RECRUITING

Novartis Investigative Site

Toulouse, 31054, France

RECRUITING

Novartis Investigative Site

Munich, Bavaria, 81377, Germany

RECRUITING

Novartis Investigative Site

Würzburg, Bavaria, 97080, Germany

RECRUITING

Novartis Investigative Site

Dresden, Saxony, 01307, Germany

RECRUITING

Novartis Investigative Site

Jena, Thuringia, 07740, Germany

RECRUITING

Novartis Investigative Site

Berlin, 13353, Germany

RECRUITING

Novartis Investigative Site

Essen, 45147, Germany

RECRUITING

Novartis Investigative Site

Hamburg, 20246, Germany

RECRUITING

Novartis Investigative Site

Hanover, 30625, Germany

RECRUITING

Novartis Investigative Site

Mainz, 55131, Germany

RECRUITING

Novartis Investigative Site

Ulm, 89081, Germany

RECRUITING

Novartis Investigative Site

Athens, 115 27, Greece

RECRUITING

Novartis Investigative Site

Chaïdári, 124 62, Greece

RECRUITING

Novartis Investigative Site

Heraklion Crete., 715 00, Greece

RECRUITING

Novartis Investigative Site

Ioannina, 455 00, Greece

RECRUITING

Novartis Investigative Site

Pátrai, 265 04, Greece

RECRUITING

Novartis Investigative Site

Thessaloniki, 54636, Greece

RECRUITING

Novartis Investigative Site

Thessaloniki, 570 10, Greece

RECRUITING

Novartis Investigative Site

Bangalore, Karnataka, 560004, India

RECRUITING

Novartis Investigative Site

Nagpur, Maharashtra, 440015, India

RECRUITING

Novartis Investigative Site

Pune, Maharashtra, 411011, India

RECRUITING

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

Novartis Investigative Site

Hyderabad, Telangana, 500082, India

RECRUITING

Novartis Investigative Site

Haifa, 3109601, Israel

RECRUITING

Novartis Investigative Site

Jerusalem, 9103102, Israel

RECRUITING

Novartis Investigative Site

Petah Tikva, 4920235, Israel

RECRUITING

Novartis Investigative Site

Bari, BA, 70124, Italy

RECRUITING

Novartis Investigative Site

Ranica, BG, 24020, Italy

RECRUITING

Novartis Investigative Site

Brescia, BS, 25123, Italy

RECRUITING

Novartis Investigative Site

Milan, MI, 20122, Italy

RECRUITING

Novartis Investigative Site

Roma, RM, 00165, Italy

RECRUITING

Novartis Investigative Site

Torino, TO, 10126, Italy

RECRUITING

Novartis Investigative Site

Naples, 80131, Italy

RECRUITING

Novartis Investigative Site

Fuchū, Tokyo, 1838561, Japan

RECRUITING

Novartis Investigative Site

Hachiōji, Tokyo, 193-0998, Japan

RECRUITING

Novartis Investigative Site

Okayama, 7008558, Japan

RECRUITING

Novartis Investigative Site

Osaka, 558-8558, Japan

RECRUITING

Novartis Investigative Site

Groningen, 9713 GZ, Netherlands

RECRUITING

Novartis Investigative Site

Poznan, Greater Poland Voivodeship, 60-355, Poland

RECRUITING

Novartis Investigative Site

Bialystok, 15-540, Poland

RECRUITING

Novartis Investigative Site

Krakow, 30-688, Poland

RECRUITING

Novartis Investigative Site

Olsztyn, 10-561, Poland

RECRUITING

Novartis Investigative Site

Warsaw, 02-006, Poland

RECRUITING

Novartis Investigative Site

Warsaw, 02-097, Poland

RECRUITING

Novartis Investigative Site

Wroclaw, 50-417, Poland

WITHDRAWN

Novartis Investigative Site

Martin, Slovakia, 036 59, Slovakia

RECRUITING

Novartis Investigative Site

Košice, 041 90, Slovakia

RECRUITING

Novartis Investigative Site

Seoul, Seoul, 03080, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 03722, South Korea

RECRUITING

Novartis Investigative Site

Pamplona, Navarre, 31008, Spain

RECRUITING

Novartis Investigative Site

Almería, 04009, Spain

RECRUITING

Novartis Investigative Site

Barcelona, 08035, Spain

RECRUITING

Novartis Investigative Site

Barcelona, 08036, Spain

RECRUITING

Novartis Investigative Site

Madrid, 28040, Spain

RECRUITING

Novartis Investigative Site

Madrid, 28041, Spain

RECRUITING

Novartis Investigative Site

Madrid, 280796, Spain

RECRUITING

Novartis Investigative Site

Salamanca, 37007, Spain

RECRUITING

Novartis Investigative Site

Bern, 3010, Switzerland

RECRUITING

Novartis Investigative Site

Lausanne, 1011, Switzerland

RECRUITING

Novartis Investigative Site

Zurich, 8091, Switzerland

RECRUITING

Novartis Investigative Site

Kaohsiung City, 81346, Taiwan

RECRUITING

Novartis Investigative Site

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

Novartis Investigative Site

Izmir, Karsiyaka, 35575, Turkey (Türkiye)

RECRUITING

Novartis Investigative Site

Köseköy, Kocaeli, 41380, Turkey (Türkiye)

RECRUITING

Novartis Investigative Site

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

RECRUITING

Novartis Investigative Site

Ankara, Yenimahalle, 06500, Turkey (Türkiye)

RECRUITING

Novartis Investigative Site

Mersin, Yenisehir, 33110, Turkey (Türkiye)

RECRUITING

Novartis Investigative Site

Belfast, BT9 7AB, United Kingdom

RECRUITING

Novartis Investigative Site

Cardiff, CF14 4XW, United Kingdom

RECRUITING

Novartis Investigative Site

London, NW3 2QG, United Kingdom

RECRUITING

Novartis Investigative Site

London, WC1N 3JH, United Kingdom

RECRUITING

Novartis Investigative Site

Manchester, M13 9WL, United Kingdom

RECRUITING

Novartis Investigative Site

Salford, M6 8HD, United Kingdom

RECRUITING

Novartis Investigative Site

Ho Chi Minh City, 700000, Vietnam

RECRUITING

Related Links

• WCN24-1146 SAFETY AND EFFICACY OF IPTACOPAN IN ADOLESCENT PATIENTS WITH IC-MPGN in Elsivier Journal

MeSH Terms

Conditions

Proteinuria

Interventions

iptacopan

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 6, 2023
• Study Start: October 2, 2023
• Primary Completion (Estimated): October 27, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (5); CH (3); NL (1); DK (2); BR (15); JP (4); KR (2); DE (10); ES (8); IL (3); TU (6); GB (6); GR (7); CA (4); IN (5); VN (1); US (21); PL (7); TW (1); CZ (1); IT (7); SL (2); AR (6)