A Randomized, Double-blind, Parallel Group, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety and Tolerability of Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis

Status: Recruiting
Location: See all (116) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Male and female participants \>= 18 and =\< 70 years (at the time of the screening visit).

• 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)

• Disease duration of =\< 60 months (defined as time from the first non-Raynaud phenomenon manifestation, e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea)

• mRSS units of \>= 15 and =\< 45 at the time of the screening visit

• 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

• 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.

Locations
United States
Arizona
Arizona Arthritis and Rheumatology Research PLLC
RECRUITING
Mesa
California
Hoag Hospital
RECRUITING
Newport Beach
Florida
Clinical Res Of W Florida
RECRUITING
Clearwater
GNP Research
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Cooper City
IRIS Research and Development
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Plantation
Sarasota Arthritis Res Ctr
RECRUITING
Sarasota
Illinois
University of Chicago Hospitals
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Chicago
Louisiana
UMC New Orleans
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New Orleans
Michigan
Uni Of Michigan Health System
RECRUITING
Ann Arbor
Clinical Research Inst of MI
RECRUITING
Saint Clair Shores
Tennessee
West Tennessee Research Institute
RECRUITING
Jackson
Texas
Arthritis and Rheumatology Ins
RECRUITING
Allen
Novel Research LLC
RECRUITING
Bellaire
Prolato Clinical Research Center
RECRUITING
Houston
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
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Caba
Novartis Investigative Site
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Caba
Novartis Investigative Site
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Ciudad De Buenos Aires
Novartis Investigative Site
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San Miguel De Tucumán
Austria
Novartis Investigative Site
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Graz
Belgium
Novartis Investigative Site
RECRUITING
Leuven
Brazil
Novartis Investigative Site
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Curitiba
Novartis Investigative Site
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Porto Alegre
Novartis Investigative Site
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Salvador
Novartis Investigative Site
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Sao Jose Rio Preto
Novartis Investigative Site
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São Paulo
Novartis Investigative Site
RECRUITING
São Paulo
China
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
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Beijing
Novartis Investigative Site
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Changchun
Novartis Investigative Site
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Chengdu
Novartis Investigative Site
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Nanning
Novartis Investigative Site
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Ningbo
Novartis Investigative Site
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Tianjin
Novartis Investigative Site
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Zhengzhou
Colombia
Novartis Investigative Site
RECRUITING
Bogota
Novartis Investigative Site
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Bogota
Novartis Investigative Site
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Bogotá
Novartis Investigative Site
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Cali
Novartis Investigative Site
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Medellín
Novartis Investigative Site
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Medellín
France
Novartis Investigative Site
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Dijon
Novartis Investigative Site
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Le Mans
Novartis Investigative Site
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Lille
Novartis Investigative Site
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Montpellier
Novartis Investigative Site
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Paris
Novartis Investigative Site
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Rennes
Novartis Investigative Site
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Strasbourg
Novartis Investigative Site
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Toulouse
Germany
Novartis Investigative Site
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Berlin
Novartis Investigative Site
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Jena
Novartis Investigative Site
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Würzburg
Greece
Novartis Investigative Site
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Alexandroupoli
Novartis Investigative Site
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Athens
Novartis Investigative Site
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Athens
Hungary
Novartis Investigative Site
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Debrecen
Novartis Investigative Site
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Pécs
India
Novartis Investigative Site
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Jaipur
Novartis Investigative Site
RECRUITING
Kochi
Novartis Investigative Site
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Mumbai
Novartis Investigative Site
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Mumbai
Novartis Investigative Site
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New Delhi
Novartis Investigative Site
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New Delhi
Italy
Novartis Investigative Site
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Ancona
Novartis Investigative Site
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Milan
Novartis Investigative Site
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Modena
Novartis Investigative Site
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Palermo
Novartis Investigative Site
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Pavia
Novartis Investigative Site
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Roma
Novartis Investigative Site
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Rozzano
Novartis Investigative Site
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Verona
Japan
Novartis Investigative Site
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Bunkyo-ku
Novartis Investigative Site
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Chuo Ku
Novartis Investigative Site
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Fukuoka
Novartis Investigative Site
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Hiroshima
Novartis Investigative Site
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Kanazawa
Novartis Investigative Site
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Kitakyushu
Novartis Investigative Site
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Maebashi
Novartis Investigative Site
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Nagoya
Novartis Investigative Site
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Sapporo
Novartis Investigative Site
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Toyama
Novartis Investigative Site
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Yokohama
Malaysia
Novartis Investigative Site
RECRUITING
Cheras
Novartis Investigative Site
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Kuala Lumpur
Mexico
Novartis Investigative Site
RECRUITING
Chihuahua City
Novartis Investigative Site
RECRUITING
Guadalajara
Novartis Investigative Site
RECRUITING
Mexico City
Novartis Investigative Site
RECRUITING
Mexico City
Poland
Novartis Investigative Site
RECRUITING
Bydgoszcz
Novartis Investigative Site
RECRUITING
Warsaw
Portugal
Novartis Investigative Site
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Coimbra
Novartis Investigative Site
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Lisbon
Novartis Investigative Site
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Vila Nova De Gaia
Republic of Korea
Novartis Investigative Site
RECRUITING
Busan
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
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Málaga
Novartis Investigative Site
RECRUITING
Salamanca
Novartis Investigative Site
RECRUITING
Valencia
Taiwan
Novartis Investigative Site
RECRUITING
Changhua
Novartis Investigative Site
RECRUITING
Kaohsiung City
Novartis Investigative Site
RECRUITING
Taichung
Novartis Investigative Site
RECRUITING
Taoyuan District
Thailand
Novartis Investigative Site
RECRUITING
Bangkok
Novartis Investigative Site
RECRUITING
Khon Kaen
Turkey
Novartis Investigative Site
RECRUITING
Ankara
Novartis Investigative Site
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Ankara
Novartis Investigative Site
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Istanbul
United Kingdom
Novartis Investigative Site
RECRUITING
Basingstoke
Novartis Investigative Site
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Bristol
Novartis Investigative Site
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London
Viet Nam
Novartis Investigative Site
RECRUITING
Ho Chi Minh City
Novartis Investigative Site
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Time Frame
Start Date: 2024-10-09
Estimated Completion Date: 2030-07-15
Participants
Target number of participants: 200
Treatments
Experimental: 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
Placebo_comparator: 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
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov