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Diffuse Cutaneous Systemic SclerosisPhase 2NCT06470048

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

A Phase 2 study testing Ianalumab in people with Diffuse Cutaneous Systemic Sclerosis, run by Novartis Pharmaceuticals at 106 sites in 25 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diffuse Cutaneous Systemic Sclerosis
What is being tested?
Ianalumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
201 participants
Where
106 sitesin 25 countries
Study dates
9 Oct 2024to 31 Jul 2034
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

106 sites in 25 countries.

106 sites in 25 countries

United States14 sites

  • Uni Of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Novel Research LLC

    Bellaire, Texas, 77401

  • University of Chicago Hospitals

    Chicago, Illinois, 60637

  • Clinical Res Of W Florida

    Clearwater, Florida, 33765

  • GNP Research

    Cooper City, Florida, 33024

  • Arthritis and Rheumatology Ins

    Frisco, Texas, 75035

  • Prolato Clinical Research Center

    Houston, Texas, 77054

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • UCLA

    Los Angeles, California, 90095

  • Arizona Arthritis and Rheumatology Research PLLC

    Mesa, Arizona, 85202

  • Hospital for Special Surgery

    New York, New York, 10021

  • Hoag Hospital

    Newport Beach, California, 92663

  • IRIS Research and Development

    Plantation, Florida, 33324

  • Sarasota Arthritis Res Ctr

    Sarasota, Florida, 34239

Other trials in United States

Japan10 sites

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 1138603

  • Novartis Investigative Site

    Hiroshima, 7348551

  • Novartis Investigative Site

    Iruma-gun, Saitama, 3500495

  • Novartis Investigative Site

    Ishikawa, 9208641

  • Novartis Investigative Site

    Kyoto, 6068507

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4578510

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 1628666

  • Novartis Investigative Site

    Toyama, Toyama, 9300194

  • Novartis Investigative Site

    Toyoake, Aichi-ken, 4701192

  • Novartis Investigative Site

    Yokohama, Kanagawa, 2360004

Other trials in Japan

France8 sites

  • Novartis Investigative Site

    Dijon, 21000

  • Novartis Investigative Site

    Le Mans, 72000

  • Novartis Investigative Site

    Lille, 59037

  • Novartis Investigative Site

    Montpellier, 34295

  • Novartis Investigative Site

    Paris, 75014

  • Novartis Investigative Site

    Rennes, 35033

  • Novartis Investigative Site

    Strasbourg, 67000

  • Novartis Investigative Site

    Toulouse, 31054

Other trials in France

Italy8 sites

  • Novartis Investigative Site

    Ancona, AN, 60020

  • Novartis Investigative Site

    Milan, MI, 20100

  • Novartis Investigative Site

    Modena, MO, 41124

  • Novartis Investigative Site

    Palermo, PA, 90127

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Roma, RM, 00168

  • Novartis Investigative Site

    Rozzano, MI, 20089

  • Novartis Investigative Site

    Verona, VR, 37134

Other trials in Italy

China6 sites

  • Novartis Investigative Site

    Beijing, 100191

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Nanning, Guangxi, 530021

  • Novartis Investigative Site

    Ningbo, Zhejiang, 315016

  • Novartis Investigative Site

    Tianjin, 300052

  • Novartis Investigative Site

    Zhengzhou, Henan, 450003

Other trials in China

Colombia6 sites

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110111

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110221

  • Novartis Investigative Site

    Bogotá, 110231

  • Novartis Investigative Site

    Cali, Valle del Cauca Department, 760012

  • Novartis Investigative Site

    Medellín, Antioquia, 050001

  • Novartis Investigative Site

    Medellín, 050034

Other trials in Colombia

Brazil5 sites

  • Novartis Investigative Site

    Curitiba, Paraná, 80030-110

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90035-074

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40150-150

  • Novartis Investigative Site

    Sao Jose Rio Preto, São Paulo, 15090-000

  • Novartis Investigative Site

    São Paulo, São Paulo, 04038-002

Other trials in Brazil

India5 sites

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302004

  • Novartis Investigative Site

    Kochi, Kerala, 682018

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400078

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110060

  • Novartis Investigative Site

    New Delhi, New Delhi, 110029

Other trials in India

Argentina4 sites

  • Novartis Investigative Site

    Caba, C1015ABO

  • Novartis Investigative Site

    Caba, C1427CCL

  • Novartis Investigative Site

    CABA, Buenos Aires, C1221ADC

  • Novartis Investigative Site

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Mexico4 sites

  • Novartis Investigative Site

    Chihuahua City, Chihuahua, 31000

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44650

  • Novartis Investigative Site

    Mexico City, Mexico City, 11850

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Spain4 sites

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Madrid, 28009

  • Novartis Investigative Site

    Málaga, Andalusia, 29009

  • Novartis Investigative Site

    Salamanca, 37007

Other trials in Spain

Taiwan4 sites

  • Novartis Investigative Site

    Changhua, 50006

  • Novartis Investigative Site

    Kaohsiung City, 833

  • Novartis Investigative Site

    Taichung, 40447

  • Novartis Investigative Site

    Taoyuan, 33305

Other trials in Taiwan

Germany3 sites

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Jena, Thuringia, 07740

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080

Other trials in Germany

Greece3 sites

  • Novartis Investigative Site

    Alexandroupoli, 681 00

  • Novartis Investigative Site

    Athens, 115 21

  • Novartis Investigative Site

    Athens, 115 27

Other trials in Greece

Hungary3 sites

  • Novartis Investigative Site

    Budapest, 1083

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032

  • Novartis Investigative Site

    Pécs, Baranya, 7623

Other trials in Hungary

South Korea3 sites

  • Novartis Investigative Site

    Seoul, Seoul, 03080

  • Novartis Investigative Site

    Seoul, 04763

  • Novartis Investigative Site

    Seoul, 06273

Other trials in South Korea

Turkey (Türkiye)3 sites

  • Novartis Investigative Site

    Ankara, Sihhiye Altindag, 06230

  • Novartis Investigative Site

    Ankara, Yenimahalle, 06500

  • Novartis Investigative Site

    Istanbul, Fatih, 34093

Other trials in Turkey (Türkiye)

Malaysia2 sites

  • Novartis Investigative Site

    Cheras, Kuala Lumpur, 56000

  • Novartis Investigative Site

    Kuala Lumpur, 59100

Other trials in Malaysia

Poland2 sites

  • Novartis Investigative Site

    Bydgoszcz, 85-168

  • Novartis Investigative Site

    Warsaw, 00-874

Other trials in Poland

Thailand2 sites

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Khon Kaen, THA, 40002

Other trials in Thailand

United Kingdom2 sites

  • Novartis Investigative Site

    Bristol, BS10 5NB

  • Novartis Investigative Site

    London, NW3 2QG

Other trials in United Kingdom

Vietnam2 sites

  • Novartis Investigative Site

    Ho Chi Minh City, VNM, 700000

  • Novartis Investigative Site

    Ho Chi Minh City, 700000

Other trials in Vietnam

Austria1 site

  • Novartis Investigative Site

    Graz, 8036

Other trials in Austria

Belgium1 site

  • Novartis Investigative Site

    Leuven, 3000

Other trials in Belgium

Portugal1 site

  • Novartis Investigative Site

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

About this study

Official title: 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

Read the 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.
Being tested
Placebo, Ianalumab
Keywords
Diffuse Cutaneous Systemic Sclerosis (dcSSc), Diffuse Scleroderma, Diffuse Systemic Sclerosis, Scleroderma, Diffuse, Scleroderma, Progressive, Sclerosis, Progressive Systemic, Sudden Onset Scleroderma, B cell depletion, Revised Composite Response Index in Systemic Sclerosis 25 (rCRISS25), modified Rodnan skin score, forced vital capacity
Medical subject headings
Scleroderma, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Ianalumab matching placebo subcutaneous (s.c.) injection as defined in the protocol

  • IanalumabDrug

    Also called VAY736

    subcutaneous (s.c.) injection as defined in the protocol

Study groups in NCT06470048
Study groupRoleWhat they receive
VAY736 (Ianalumab)ExperimentalTreatment 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
Receives: Drug: Ianalumab
PlaceboPlacebo comparatorTreatment 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
Receives: Drug: Placebo; Drug: Ianalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3/5 rCRISS25 response

    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

    Measured: Week 52

Secondary outcomes (6)

  1. Change from baseline in FVC% predicted at 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

    Measured: Week 52

  2. Change from baseline in mRSS at Week 52

    To demonstrate the superiority of ianalumab, compared to placebo, on change from baseline in modified Rodnan Skin Score (mRSS) at Week 52

    Measured: Week 52

  3. Change from baseline in HAQ-DI at 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

    Measured: Week 52

  4. Ianalumab concentrations in serum during treatment and Follow-up Period

    To assess the pharmacokinetics of ianalumab

    Measured: 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

  5. Incidence and titer of anti-drug (ianalumab) antibodies (ADAs) in serum over time

    To evaluate the immunogenicity of ianalumab

    Measured: 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

  6. Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    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.

    Measured: Up to Week 208

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2024
  2. Study start9 Oct 2024
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion31 Jul 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06470048
Sponsor's protocol ID
CVAY736S12201
Other IDs
2024-511933-36-00
Status last verified
Oct 2026
First submitted
17 Jun 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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
Expanded access
Available

Publications

  • Lescoat A, Lecureur V, Gudjonsson JE, Khanna D. Systemic sclerosis: pathogenic mechanisms and their implications for treatment. Semin Immunopathol. 2025 Nov 11;47(1):39. doi: 10.1007/s00281-025-01065-6.

    PubMed 41217519

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ianalumab in people with Diffuse Cutaneous Systemic Sclerosis, run by Novartis Pharmaceuticals at 106 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, Japan, France, Italy, China and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3/5 rCRISS25 response (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06470048, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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