En klinisk studie for å evaluere Ianalumab hos deltakere med diffus kutan systemisk sklerose
12. oktober 2026 oppdatert av: Novartis Pharmaceuticals
En randomisert, dobbeltblind, parallell gruppe, placebokontrollert multisenterstudie for å evaluere effektivitet, sikkerhet og tolerabilitet av Ianalumab hos deltakere med diffus kutan systemisk sklerose
The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The study consists of the following periods:
- Screening Period, with a duration of up to 6 weeks;
- Treatment Period 1, with a duration of 52 weeks;
- Treatment Period 2 (Open-label treatment), with a duration of 52 weeks;
- Post-treatment Follow-up Period, with a duration of at least 20 weeks post last dose and up to 2 years.
Studietype
Intervensjonell
Registrering (Faktiske)
201
Fase
- Fase 2
Utvidet tilgang
Tilgjengelig utenfor den kliniske utprøvingen.
Se utvidet tilgangspost.
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Caba, Argentina, C1015ABO
- Novartis Investigative Site
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Caba, Argentina, C1427CCL
- Novartis Investigative Site
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San Miguel de Tucumán, Argentina, T4000AXL
- Novartis Investigative Site
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Buenos Aires
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CABA, Buenos Aires, Argentina, C1221ADC
- Novartis Investigative Site
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Leuven, Belgia, 3000
- Novartis Investigative Site
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Estado de Bahia
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Salvador, Estado de Bahia, Brasil, 40150-150
- Novartis Investigative Site
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Paraná
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Curitiba, Paraná, Brasil, 80030-110
- Novartis Investigative Site
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90035-074
- Novartis Investigative Site
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São Paulo
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Sao Jose Rio Preto, São Paulo, Brasil, 15090-000
- Novartis Investigative Site
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São Paulo, São Paulo, Brasil, 04038-002
- Novartis Investigative Site
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Bogotá, Colombia, 110231
- Novartis Investigative Site
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Medellín, Colombia, 050034
- Novartis Investigative Site
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Antioquia
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Medellín, Antioquia, Colombia, 050001
- Novartis Investigative Site
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Cundinamarca
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Bogota, Cundinamarca, Colombia, 110111
- Novartis Investigative Site
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Bogota, Cundinamarca, Colombia, 110221
- Novartis Investigative Site
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colombia, 760012
- Novartis Investigative Site
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Arizona
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Mesa, Arizona, Forente stater, 85202
- Arizona Arthritis and Rheumatology Research PLLC
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California
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Los Angeles, California, Forente stater, 90095
- UCLA
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Newport Beach, California, Forente stater, 92663
- Hoag Hospital
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Florida
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Clearwater, Florida, Forente stater, 33765
- Clinical Res Of W Florida
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Cooper City, Florida, Forente stater, 33024
- GNP Research
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Plantation, Florida, Forente stater, 33324
- IRIS Research and Development
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Sarasota, Florida, Forente stater, 34239
- Sarasota Arthritis Res Ctr
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Illinois
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Chicago, Illinois, Forente stater, 60637
- University of Chicago Hospitals
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- Uni Of Michigan Health System
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New York
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New York, New York, Forente stater, 10021
- Hospital for Special Surgery
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Tennessee
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Jackson, Tennessee, Forente stater, 38305
- West Tennessee Research Institute
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Texas
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Bellaire, Texas, Forente stater, 77401
- Novel Research LLC
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Frisco, Texas, Forente stater, 75035
- Arthritis and Rheumatology Ins
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Houston, Texas, Forente stater, 77054
- Prolato Clinical Research Center
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Dijon, Frankrike, 21000
- Novartis Investigative Site
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Le Mans, Frankrike, 72000
- Novartis Investigative Site
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Lille, Frankrike, 59037
- Novartis Investigative Site
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Montpellier, Frankrike, 34295
- Novartis Investigative Site
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Paris, Frankrike, 75014
- Novartis Investigative Site
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Rennes, Frankrike, 35033
- Novartis Investigative Site
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Strasbourg, Frankrike, 67000
- Novartis Investigative Site
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Toulouse, Frankrike, 31054
- Novartis Investigative Site
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Alexandroupoli, Hellas, 681 00
- Novartis Investigative Site
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Athens, Hellas, 115 27
- Novartis Investigative Site
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Athens, Hellas, 115 21
- Novartis Investigative Site
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Kerala
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Kochi, Kerala, India, 682018
- Novartis Investigative Site
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Maharashtra
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Mumbai, Maharashtra, India, 400078
- Novartis Investigative Site
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, India, 110060
- Novartis Investigative Site
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New Delhi
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New Delhi, New Delhi, India, 110029
- Novartis Investigative Site
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Rajasthan
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Jaipur, Rajasthan, India, 302004
- Novartis Investigative Site
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AN
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Ancona, AN, Italia, 60020
- Novartis Investigative Site
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MI
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Milan, MI, Italia, 20100
- Novartis Investigative Site
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Rozzano, MI, Italia, 20089
- Novartis Investigative Site
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MO
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Modena, MO, Italia, 41124
- Novartis Investigative Site
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PA
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Palermo, PA, Italia, 90127
- Novartis Investigative Site
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PV
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Pavia, PV, Italia, 27100
- Novartis Investigative Site
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RM
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Roma, RM, Italia, 00168
- Novartis Investigative Site
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VR
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Verona, VR, Italia, 37134
- Novartis Investigative Site
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Hiroshima, Japan, 7348551
- Novartis Investigative Site
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Ishikawa, Japan, 9208641
- Novartis Investigative Site
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Kyoto, Japan, 6068507
- Novartis Investigative Site
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 4578510
- Novartis Investigative Site
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Toyoake, Aichi-ken, Japan, 4701192
- Novartis Investigative Site
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Kanagawa
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Yokohama, Kanagawa, Japan, 2360004
- Novartis Investigative Site
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Saitama
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Iruma-gun, Saitama, Japan, 3500495
- Novartis Investigative Site
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 1138603
- Novartis Investigative Site
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Shinjuku Ku, Tokyo, Japan, 1628666
- Novartis Investigative Site
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Toyama
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Toyama, Toyama, Japan, 9300194
- Novartis Investigative Site
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Beijing, Kina, 100191
- Novartis Investigative Site
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Tianjin, Kina, 300052
- Novartis Investigative Site
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Guangxi
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Nanning, Guangxi, Kina, 530021
- Novartis Investigative Site
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Henan
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Zhengzhou, Henan, Kina, 450003
- Novartis Investigative Site
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- Novartis Investigative Site
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Zhejiang
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Ningbo, Zhejiang, Kina, 315016
- Novartis Investigative Site
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Kuala Lumpur, Malaysia, 59100
- Novartis Investigative Site
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Kuala Lumpur
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Cheras, Kuala Lumpur, Malaysia, 56000
- Novartis Investigative Site
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Chihuahua
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Chihuahua City, Chihuahua, Mexico, 31000
- Novartis Investigative Site
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Jalisco
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Guadalajara, Jalisco, Mexico, 44650
- Novartis Investigative Site
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Mexico City
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Mexico City, Mexico City, Mexico, 11850
- Novartis Investigative Site
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64460
- Novartis Investigative Site
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Bydgoszcz, Polen, 85-168
- Novartis Investigative Site
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Warsaw, Polen, 00-874
- Novartis Investigative Site
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Vila Nova de Gaia, Portugal, 4434-502
- Novartis Investigative Site
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Barcelona, Spania, 08041
- Novartis Investigative Site
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Madrid, Spania, 28009
- Novartis Investigative Site
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Salamanca, Spania, 37007
- Novartis Investigative Site
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Andalusia
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Málaga, Andalusia, Spania, 29009
- Novartis Investigative Site
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Bristol, Storbritannia, BS10 5NB
- Novartis Investigative Site
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London, Storbritannia, NW3 2QG
- Novartis Investigative Site
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Seoul, Sør -Korea, 04763
- Novartis Investigative Site
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Seoul, Sør -Korea, 06273
- Novartis Investigative Site
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Seoul
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Seoul, Seoul, Sør -Korea, 03080
- Novartis Investigative Site
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Changhua, Taiwan, 50006
- Novartis Investigative Site
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Kaohsiung City, Taiwan, 833
- Novartis Investigative Site
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Taichung, Taiwan, 40447
- Novartis Investigative Site
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Taoyuan, Taiwan, 33305
- Novartis Investigative Site
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Bangkok, Thailand, 10400
- Novartis Investigative Site
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THA
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Khon Kaen, THA, Thailand, 40002
- Novartis Investigative Site
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Fatih
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Istanbul, Fatih, Tyrkia (Türkiye), 34093
- Novartis Investigative Site
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Sihhiye Altindag
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Ankara, Sihhiye Altindag, Tyrkia (Türkiye), 06230
- Novartis Investigative Site
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Yenimahalle
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Ankara, Yenimahalle, Tyrkia (Türkiye), 06500
- Novartis Investigative Site
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Berlin, Tyskland, 13353
- Novartis Investigative Site
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Bavaria
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Würzburg, Bavaria, Tyskland, 97080
- Novartis Investigative Site
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Thuringia
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Jena, Thuringia, Tyskland, 07740
- Novartis Investigative Site
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Budapest, Ungarn, 1083
- Novartis Investigative Site
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Baranya
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Pécs, Baranya, Ungarn, 7623
- Novartis Investigative Site
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Hajdu Bihar Megye
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Debrecen, Hajdu Bihar Megye, Ungarn, 4032
- Novartis Investigative Site
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Ho Chi Minh City, Vietnam, 700000
- Novartis Investigative Site
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VNM
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Ho Chi Minh City, VNM, Vietnam, 700000
- Novartis Investigative Site
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Graz, Østerrike, 8036
- Novartis Investigative Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Key Inclusion Criteria:
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Male and female participants >= 18 and =< 70 years (at the time of the screening visit).
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Diagnosis of systemic sclerosis, as defined by the 2013 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) classification criteria for SSc (van den Hoogen et al 2013) and meet the dcSSc subset classification according to LeRoy (LeRoy 1988)
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Disease duration of =< 60 months (defined as time from the first non-Raynaud phenomenon manifestation, e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea)
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mRSS units of >= 15 and =< 45 at the time of the screening visit
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Active disease that meets at least one of the following criteria at screening:
- Disease duration of =< 18 months defined as time from the first non-Raynaud phenomenon manifestation
- Increase in mRSS of >= 3 units compared with the most recent assessment performed within the previous 6 months
- Involvement of one new body area and an increase in mRSS of >= 2 units compared with the most recent assessment performed within the previous 6 months
- Involvement of two new body areas within the previous 6 months
- Elevated acute phase reactants (ESR) >= 30 mm/hr or high-sensitivity C-reactive protein (hsCRP) >= 6 mg/L)
- Presence of SSc-interstitial lung disease (ILD) and ATA autoantibody positivity
- Modified EUSTAR disease activity index (mDAI) ≥ 2.5
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Participant must be positive for at least one of the following autoantibodies:
- anti-topoisomerase I (ATA) (also known as anti-SCL-70)
- anti-RNA polymerase III (anti-RNAP3)
- anti-nuclear antibody (ANA) (≥ 1:80) Participants who are positive only for ANA (while being negative for both ATA /anti-RNAP3) will be limited to 30% of the overall randomized study population.
Key Exclusion Criteria:
- Rheumatic disease other than dcSSc, including limited cutaneous disease (lcSSc) or sine scleroderma at the screening visit. Secondary Sjogren's disease and scleroderma myopathy are not exclusionary.
- Positive anti-centromere antibody (ACA+) without positive ATA or anti-RNAP3 autoantibody result at the screening visit
- Previous improvement (decrease) in mRSS > 10 units
- Pulmonary disease with FVC ≤ 50% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO, corrected for hemoglobin) ≤ 40% of predicted at the screening visit
- WHO Functional Class 3 or higher assessment for pulmonary arterial hypertension (PAH, as defined on right heart catheterization), receiving IV therapy for PAH or evidence of other moderately severe pulmonary disease
- Participants treated with cyclophosphamide within 12 weeks prior to Baseline.
- Prior use of a B-cell depleting therapy other than ianalumab (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) administered within 36 weeks prior to randomization, or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower).
- Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 12 weeks or 5 half-lives (whichever is longer) prior to baseline visit, unless explicitly allowed in inclusion criteria.
- Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit.
- Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone, or tyrosine kinase inhibitors (e.g., nintedanib, nilotinib, imatinib, dasatinib) in the 4 weeks prior to baseline visit. Patients with SSc-ILD requiring antifibrotics for management of ILD during the study, as per investigator judgement, should be excluded.
- Previous treatment with chlorambucil, bone marrow transplantation or total lymphoid irradiation.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for 6 months after stopping study treatment.
Other protocol-defined inclusion/exclusion criteria may apply.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: VAY736 (Ianalumab)
Treatment Period 1: Ianalumab subcutaneous (s.c.) injection as defined in the protocol Treatment Period 2: Open-label (OL) Ianalumab subcutaneous (s.c.) injection as defined in the protocol |
subcutaneous (s.c.) injection as defined in the protocol
Andre navn:
|
|
Placebo komparator: Placebo
Treatment Period 1: Placebo to Ianalumab subcutaneous (s.c.) injection as defined in the protocol Treatment Period 2: Open-label (OL) Ianalumab subcutaneous (s.c.) injection as defined in the protocol |
subcutaneous (s.c.) injection as defined in the protocol
Andre navn:
Ianalumab matching placebo subcutaneous (s.c.) injection as defined in the protocol |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
3/5 rCRISS25 response
Tidsramme: Week 52
|
To demonstrate the superiority of ianalumab, compared to placebo, in achieving 3/5 Revised Composite Response Index in Systemic Sclerosis 25 (rCRISS25) response at Week 52 |
Week 52
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in FVC% predicted at Week 52
Tidsramme: Week 52
|
To demonstrate the superiority of ianalumab, compared to placebo, on change from baseline in percent-predicted forced vital capacity (FVC%) at Week 52 |
Week 52
|
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Change from baseline in mRSS at Week 52
Tidsramme: Week 52
|
To demonstrate the superiority of ianalumab, compared to placebo, on change from baseline in modified Rodnan Skin Score (mRSS) at Week 52 |
Week 52
|
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Change from baseline in HAQ-DI at Week 52
Tidsramme: Week 52
|
To demonstrate the superiority of ianalumab, compared to placebo, on change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52 |
Week 52
|
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Ianalumab concentrations in serum during treatment and Follow-up Period
Tidsramme: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, Week 64, Week 76, Week 88, Week 104, Week 108, Week 112, Week 116, Week 120, Week 124 and Week 208
|
To assess the pharmacokinetics of ianalumab |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, Week 64, Week 76, Week 88, Week 104, Week 108, Week 112, Week 116, Week 120, Week 124 and Week 208
|
|
Incidence and titer of anti-drug (ianalumab) antibodies (ADAs) in serum over time
Tidsramme: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, Week 64, Week 76, Week 88, Week 104, Week 124, Week 208
|
To evaluate the immunogenicity of ianalumab |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, Week 64, Week 76, Week 88, Week 104, Week 124, Week 208
|
|
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Up to Week 208
|
The distribution of adverse events for ianalumab will be done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs) through the monitoring of relevant clinical and laboratory safety parameters. |
Up to Week 208
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
9. oktober 2024
Primær fullføring (Antatt)
30. juli 2027
Studiet fullført (Antatt)
31. juli 2034
Datoer for studieregistrering
Først innsendt
17. juni 2024
Først innsendt som oppfylte QC-kriteriene
17. juni 2024
Først lagt ut (Faktiske)
24. juni 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. oktober 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. oktober 2026
Sist bekreftet
1. oktober 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- B-celleutarming
- Diffus systemisk sklerose
- Sklerodermi, diffus
- tvungen vital kapasitet
- Diffus sklerodermi
- Diffus kutan systemisk sklerose (dcSSc)
- Sklerodermi, progressiv
- Sklerose, progressiv systemisk
- Plutselig innsettende sklerodermi
- Revidert sammensatt responsindeks i systemisk sklerose 25 (rCRISS25)
- endret Rodnan hudscore
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CVAY736S12201
- 2024-511933-36-00 (Registeridentifikator: EU CT number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .