A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
NCT ID: NCT06470048
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2024-10-09
2030-07-15
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Ianalumab
subcutaneous (s.c.) injection as defined in the protocol
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
Placebo
Ianalumab matching placebo subcutaneous (s.c.) injection as defined in the protocol
Ianalumab
subcutaneous (s.c.) injection as defined in the protocol
Interventions
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Placebo
Ianalumab matching placebo subcutaneous (s.c.) injection as defined in the protocol
Ianalumab
subcutaneous (s.c.) injection as defined in the protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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).
18 Years
70 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Arizona Arthritis and Rheumatology Research PLLC
Mesa, Arizona, United States
UCLA
Los Angeles, California, United States
Hoag Hospital
Newport Beach, California, United States
Clinical Res Of W Florida
Clearwater, Florida, United States
GNP Research
Cooper City, Florida, United States
IRIS Research and Development
Plantation, Florida, United States
Sarasota Arthritis Res Ctr
Sarasota, Florida, United States
University of Chicago Hospitals
Chicago, Illinois, United States
UMC New Orleans
New Orleans, Louisiana, United States
Uni Of Michigan Health System
Ann Arbor, Michigan, United States
Clinical Research Inst of MI
Saint Clair Shores, Michigan, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Arthritis and Rheumatology Ins
Allen, Texas, United States
Novel Research LLC
Bellaire, Texas, United States
Prolato Clinical Research Center
Houston, Texas, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
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CABA, Buenos Aires, Argentina
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Caba, , Argentina
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Caba, , Argentina
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San Miguel de Tucumán, , Argentina
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Graz, , Austria
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Leuven, , Belgium
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Salvador, Estado de Bahia, Brazil
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Curitiba, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Sao Jose Rio Preto, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Nanning, Guangxi, China
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Zhengzhou, Henan, China
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Changchun, Jilin, China
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Chengdu, Sichuan, China
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Ningbo, Zhejiang, China
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Beijing, , China
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Beijing, , China
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Tianjin, , China
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Medellín, Antioquia, Colombia
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Bogota, Cundinamarca, Colombia
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Bogota, Cundinamarca, Colombia
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Cali, Valle del Cauca Department, Colombia
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Bogotá, , Colombia
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Medellín, , Colombia
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Dijon, , France
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Le Mans, , France
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Lille, , France
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Montpellier, , France
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Paris, , France
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Rennes, , France
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Strasbourg, , France
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Toulouse, , France
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Würzburg, Bavaria, Germany
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Jena, Thuringia, Germany
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Berlin, , Germany
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Alexandroupoli, , Greece
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Athens, , Greece
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Athens, , Greece
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Pécs, Baranya, Hungary
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Debrecen, Hajdu Bihar Megye, Hungary
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Kochi, Kerala, India
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Mumbai, Maharashtra, India
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Mumbai, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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Jaipur, Rajasthan, India
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New Delhi, , India
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Ancona, AN, Italy
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Milan, MI, Italy
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Rozzano, MI, Italy
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Modena, MO, Italy
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Palermo, PA, Italy
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Pavia, PV, Italy
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Roma, RM, Italy
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Verona, VR, Italy
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Nagoya, Aichi-ken, Japan
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Kitakyushu, Fukuoka, Japan
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Maebashi, Gunma, Japan
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Sapporo, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Kanazawa, Ishikawa-ken, Japan
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Yokohama, Kanagawa-ku, Japan
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Iruma-gun, Saitama, Japan
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Bunkyo-ku, Tokyo, Japan
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Chuo Ku, Tokyo, Japan
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Shinjuku Ku, Tokyo, Japan
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Fukuoka, , Japan
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Hiroshima, , Japan
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Toyama, , Japan
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Cheras, Kuala Lumpur, Malaysia
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Kuala Lumpur, , Malaysia
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Chihuahua City, , Mexico
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Bydgoszcz, , Poland
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Warsaw, , Poland
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Coimbra, , Portugal
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Lisbon, , Portugal
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Vila Nova de Gaia, , Portugal
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Seoul, Korea, South Korea
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Busan, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Valencia, Valencia, Spain
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Barcelona, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Salamanca, , Spain
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Changhua, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taoyuan District, , Taiwan
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Khon Kaen, THA, Thailand
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Bangkok, , Thailand
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Istanbul, Fatih, Turkey (Türkiye)
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Ankara, Sihhiye-Altindag, Turkey (Türkiye)
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Ankara, Yenimahalle, Turkey (Türkiye)
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Basingstoke, Hampshire, United Kingdom
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Bristol, , United Kingdom
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London, , United Kingdom
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Ho Chi Minh City, VNM, Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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Debra Mc Dermed
Role: primary
Lauren Nam
Role: primary
Vicki Tan
Role: primary
Carrie Rycort
Role: primary
Melissa Pierce
Role: primary
Jhon Galindo
Role: primary
Carole Kringel
Role: primary
J Heannhehbelle Rosier
Role: primary
Cathryn Leggio
Role: primary
Marco Santella
Role: primary
Amelia Paliewicz
Role: primary
Sherry Wiggins
Role: primary
Samina Shehzad
Role: primary
Hassan Khan
Role: primary
Mohammad Alsayed
Role: primary
Other Identifiers
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2024-511933-36-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CVAY736S12201
Identifier Type: -
Identifier Source: org_study_id