A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis

June 4, 2026 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Caba, Argentina, C1015ABO
        • Recruiting
        • Novartis Investigative Site
      • Caba, Argentina, C1427CCL
        • Recruiting
        • Novartis Investigative Site
      • San Miguel de Tucumán, Argentina, 4000
        • Recruiting
        • Novartis Investigative Site
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1221ADC
        • Recruiting
        • Novartis Investigative Site
      • CABA, Buenos Aires, Argentina, 1280
        • Recruiting
        • Novartis Investigative Site
  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Novartis Investigative Site
  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • Novartis Investigative Site
  • Brazil
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40150 150
        • Recruiting
        • Novartis Investigative Site
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-110
        • Recruiting
        • Novartis Investigative Site
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
        • Recruiting
        • Novartis Investigative Site
    • São Paulo
      • Sao Jose Rio Preto, São Paulo, Brazil, 15090 000
        • Recruiting
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 04038-002
        • Recruiting
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 05403-000
        • Recruiting
        • Novartis Investigative Site
  • China
      • Beijing, China, 100730
        • Recruiting
        • Novartis Investigative Site
      • Beijing, China, 100191
        • Recruiting
        • Novartis Investigative Site
      • Tianjin, China, 300052
        • Recruiting
        • Novartis Investigative Site
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Novartis Investigative Site
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Novartis Investigative Site
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Novartis Investigative Site
    • Zhejiang
      • Ningbo, Zhejiang, China, 315016
        • Recruiting
        • Novartis Investigative Site
  • Colombia
      • Bogotá, Colombia, 110231
        • Recruiting
        • Novartis Investigative Site
      • Medellín, Colombia, 050034
        • Recruiting
        • Novartis Investigative Site
    • Antioquia
      • Medellín, Antioquia, Colombia, 050001
        • Recruiting
        • Novartis Investigative Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 110111
        • Recruiting
        • Novartis Investigative Site
      • Bogota, Cundinamarca, Colombia, 110221
        • Recruiting
        • Novartis Investigative Site
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760012
        • Recruiting
        • Novartis Investigative Site
  • France
      • Dijon, France, 21000
        • Recruiting
        • Novartis Investigative Site
      • Le Mans, France, 72000
        • Recruiting
        • Novartis Investigative Site
      • Lille, France, 59037
        • Recruiting
        • Novartis Investigative Site
      • Montpellier, France, 34295
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75014
        • Recruiting
        • Novartis Investigative Site
      • Rennes, France, 35033
        • Recruiting
        • Novartis Investigative Site
      • Strasbourg, France, 67000
        • Recruiting
        • Novartis Investigative Site
      • Toulouse, France, 31054
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Novartis Investigative Site
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Recruiting
        • Novartis Investigative Site
    • Thuringia
      • Jena, Thuringia, Germany, 07740
        • Recruiting
        • Novartis Investigative Site
  • Greece
      • Alexandroupoli, Greece, 681 00
        • Recruiting
        • Novartis Investigative Site
      • Athens, Greece, 115 27
        • Recruiting
        • Novartis Investigative Site
      • Athens, Greece, 115 21
        • Recruiting
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, H-1083
        • Recruiting
        • Novartis Investigative Site
    • Baranya
      • Pécs, Baranya, Hungary, 7623
        • Recruiting
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Hungary, 4032
        • Recruiting
        • Novartis Investigative Site
  • India
      • New Delhi, India, 110029
        • Recruiting
        • Novartis Investigative Site
    • Kerala
      • Kochi, Kerala, India, 682018
        • Recruiting
        • Novartis Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400078
        • Recruiting
        • Novartis Investigative Site
      • Mumbai, Maharashtra, India, 400013
        • Recruiting
        • Novartis Investigative Site
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110060
        • Recruiting
        • Novartis Investigative Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • Recruiting
        • Novartis Investigative Site
  • Italy
    • AN
      • Ancona, AN, Italy, 60126
        • Recruiting
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italy, 20100
        • Recruiting
        • Novartis Investigative Site
      • Rozzano, MI, Italy, 20089
        • Recruiting
        • Novartis Investigative Site
    • MO
      • Modena, MO, Italy, 41124
        • Recruiting
        • Novartis Investigative Site
    • PA
      • Palermo, PA, Italy, 90127
        • Recruiting
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italy, 27100
        • Recruiting
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00168
        • Recruiting
        • Novartis Investigative Site
    • VR
      • Verona, VR, Italy, 37134
        • Recruiting
        • Novartis Investigative Site
  • Japan
      • Fukuoka, Japan, 8128582
        • Recruiting
        • Novartis Investigative Site
      • Hiroshima, Japan, 7348551
        • Recruiting
        • Novartis Investigative Site
      • Ishikawa, Japan, 9208641
        • Recruiting
        • Novartis Investigative Site
      • Kyoto, Japan, 6068507
        • Recruiting
        • Novartis Investigative Site
      • Toyama, Japan, 9300194
        • Recruiting
        • Novartis Investigative Site
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 4578510
        • Recruiting
        • Novartis Investigative Site
      • Toyoake, Aichi-ken, Japan, 4701192
        • Recruiting
        • Novartis Investigative Site
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 8078556
        • Recruiting
        • Novartis Investigative Site
    • Gunma
      • Maebashi, Gunma, Japan, 3718511
        • Recruiting
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0608543
        • Recruiting
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Novartis Investigative Site
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0004
        • Recruiting
        • Novartis Investigative Site
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Recruiting
        • Novartis Investigative Site
    • Saitama
      • Iruma-gun, Saitama, Japan, 3500495
        • Recruiting
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Recruiting
        • Novartis Investigative Site
      • Chuo Ku, Tokyo, Japan, 104-8560
        • Recruiting
        • Novartis Investigative Site
      • Shinjuku Ku, Tokyo, Japan, 1628666
        • Recruiting
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, Japan, 1608582
        • Recruiting
        • Novartis Investigative Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • Novartis Investigative Site
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Recruiting
        • Novartis Investigative Site
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Recruiting
        • Novartis Investigative Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Recruiting
        • Novartis Investigative Site
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06700
        • Recruiting
        • Novartis Investigative Site
      • Mexico City, Mexico City, Mexico, 11850
        • Recruiting
        • Novartis Investigative Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Recruiting
        • Novartis Investigative Site
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Active, not recruiting
        • Novartis Investigative Site
      • Warsaw, Poland, 00-874
        • Active, not recruiting
        • Novartis Investigative Site
  • Portugal
      • Coimbra, Portugal, 3004-561
        • Recruiting
        • Novartis Investigative Site
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • Novartis Investigative Site
      • Vila Nova de Gaia, Portugal, 4434 502
        • Recruiting
        • Novartis Investigative Site
  • South Korea
      • Busan, South Korea, 49241
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 06273
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 03080
        • Active, not recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 04763
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28009
        • Recruiting
        • Novartis Investigative Site
      • Salamanca, Spain, 37007
        • Recruiting
        • Novartis Investigative Site
    • Andalusia
      • Málaga, Andalusia, Spain, 29009
        • Recruiting
        • Novartis Investigative Site
    • Valencia
      • Valencia, Valencia, Spain, 46017
        • Recruiting
        • Novartis Investigative Site
  • Taiwan
      • Changhua, Taiwan, 50006
        • Recruiting
        • Novartis Investigative Site
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Recruiting
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 33305
        • Recruiting
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Recruiting
        • Novartis Investigative Site
    • THA
      • Khon Kaen, THA, Thailand, 40002
        • Recruiting
        • Novartis Investigative Site
  • Turkey (Türkiye)
    • Fatih
      • Istanbul, Fatih, Turkey (Türkiye), 34093
        • Recruiting
        • Novartis Investigative Site
    • Sihhiye-Altindag
      • Ankara, Sihhiye-Altindag, Turkey (Türkiye), 06230
        • Recruiting
        • Novartis Investigative Site
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey (Türkiye), 06500
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Novartis Investigative Site
    • Hampshire
      • Basingstoke, Hampshire, United Kingdom, RG24 9NA
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Recruiting
        • Arizona Arthritis and Rheumatology Research PLLC
        • Principal Investigator:
          • Nehad Soloman
        • Contact:
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA
        • Principal Investigator:
          • Suzanne Kafaja
        • Contact:
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Hospital
        • Principal Investigator:
          • Christine Thai
        • Contact:
    • Florida
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • Clinical Res Of W Florida
        • Principal Investigator:
          • Rodney Daniel
        • Contact:
      • Cooper City, Florida, United States, 33024
        • Recruiting
        • GNP Research
        • Principal Investigator:
          • Mark Jaffe
        • Contact:
      • Plantation, Florida, United States, 33324
        • Recruiting
        • IRIS Research and Development
        • Contact:
        • Principal Investigator:
          • Guillermo Valenzuela
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Arthritis Res Ctr
        • Principal Investigator:
          • Jaishree Manohar
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Hospitals
        • Principal Investigator:
          • Michael Macklin
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • UMC New Orleans
        • Principal Investigator:
          • Stephen Lindsey
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • Uni Of Michigan Health System
        • Principal Investigator:
          • Carleigh Zahn
        • Contact:
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University
        • Contact:
        • Principal Investigator:
          • Ilyes Benchaala
      • Saint Clair Shores, Michigan, United States, 48081
        • Recruiting
        • Clinical Research Inst of MI
        • Principal Investigator:
          • Andrew Sulich
        • Contact:
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery
        • Contact:
        • Principal Investigator:
          • Kimberly Showalter Lakin
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Recruiting
        • West Tennessee Research Institute
        • Contact:
        • Principal Investigator:
          • Jacob A Aelion
    • Texas
      • Allen, Texas, United States, 75013
        • Recruiting
        • Arthritis and Rheumatology Ins
        • Contact:
        • Principal Investigator:
          • Megha Patel Banker.
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Novel Research LLC
        • Principal Investigator:
          • Wajeeha Yousaf
        • Contact:
      • Houston, Texas, United States, 77054
        • Recruiting
        • Prolato Clinical Research Center
        • Principal Investigator:
          • Michelle Eisenberg
        • Contact:
  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • Recruiting
        • Novartis Investigative Site
    • VNM
      • Ho Chi Minh City, VNM, Vietnam, 700000
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Ianalumab
subcutaneous (s.c.) injection as defined in the protocol
Other Names:
  • VAY736
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
Drug: Ianalumab
subcutaneous (s.c.) injection as defined in the protocol
Other Names:
  • VAY736
Drug: Placebo
Ianalumab matching placebo subcutaneous (s.c.) injection as defined in the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3/5 rCRISS25 response
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in FVC% predicted at Week 52
Time Frame: 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
Change from baseline in mRSS at Week 52
Time Frame: 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
Change from baseline in HAQ-DI at Week 52
Time Frame: 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
Ianalumab concentrations in serum during treatment and Follow-up Period
Time Frame: 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
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2024

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 31, 2034

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVAY736S12201
  • 2024-511933-36-00 (Registry Identifier: EU CT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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