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

August 18, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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, T4000AXL
        • Recruiting
        • Novartis Investigative Site
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1221ADC
        • Recruiting
        • Novartis Investigative Site
      • CABA, Buenos Aires, Argentina, C1280AEB
        • 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
        • Active, not recruiting
        • Novartis Investigative Site
      • Medellín, Colombia, 050034
        • Active, not recruiting
        • Novartis Investigative Site
    • Antioquia
      • Medellín, Antioquia, Colombia, 050001
        • Active, not recruiting
        • Novartis Investigative Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 110221
        • Active, not recruiting
        • Novartis Investigative Site
      • Bogota, Cundinamarca, Colombia, 110111
        • Active, not recruiting
        • Novartis Investigative Site
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760012
        • Active, not recruiting
        • Novartis Investigative Site
  • France
      • Dijon, France, 21000
        • Active, not recruiting
        • Novartis Investigative Site
      • Le Mans, France, 72000
        • Recruiting
        • Novartis Investigative Site
      • Lille, France, 59037
        • Active, not recruiting
        • Novartis Investigative Site
      • Montpellier, France, 34295
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75014
        • Active, not 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, 1083
        • Active, not 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
    • Kerala
      • Kochi, Kerala, India, 682018
        • Active, not recruiting
        • Novartis Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400013
        • Recruiting
        • Novartis Investigative Site
      • Mumbai, Maharashtra, India, 400078
        • Active, not recruiting
        • Novartis Investigative Site
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110060
        • Active, not recruiting
        • Novartis Investigative Site
    • New Delhi
      • New Delhi, New Delhi, India, 110029
        • Active, not recruiting
        • Novartis Investigative Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • Active, not recruiting
        • Novartis Investigative Site
  • Italy
    • AN
      • Ancona, AN, Italy, 60020
        • 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
    • 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
        • Active, not recruiting
        • Novartis Investigative Site
    • Osaka
      • Suita, Osaka, Japan, 5650871
        • 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
    • Toyama
      • Toyama, Toyama, Japan, 9300194
        • Recruiting
        • Novartis Investigative Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • Novartis Investigative Site
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Active, not recruiting
        • Novartis Investigative Site
  • Mexico
    • Chihuahua
      • Chihuahua City, Chihuahua, Mexico, 31000
        • Active, not 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
        • Active, not recruiting
        • Novartis Investigative Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Active, not 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, 04763
        • Recruiting
        • Novartis Investigative Site
    • Seoul
      • Seoul, Seoul, South Korea, 03080
        • Active, not 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, 833
        • 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
        • Active, not recruiting
        • Novartis Investigative Site
      • London, United Kingdom, NW3 2QG
        • Active, not recruiting
        • Novartis Investigative Site
    • Hampshire
      • Basingstoke, Hampshire, United Kingdom, RG24 9NA
        • Active, not 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
        • Principal Investigator:
          • Guillermo Valenzuela
        • Contact:
      • Sarasota, Florida, United States, 34239
        • Active, not recruiting
        • Sarasota Arthritis Res Ctr
    • 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
        • Principal Investigator:
          • Jacob A Aelion
        • Contact:
    • Texas
      • Allen, Texas, United States, 75035
        • Recruiting
        • Arthritis and Rheumatology Ins
        • Principal Investigator:
          • Megha Patel Banker
        • Contact:
      • 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
        • Active, not recruiting
        • Novartis Investigative Site
    • VNM
      • Ho Chi Minh City, VNM, Vietnam, 700000
        • Active, not 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2034

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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