Last Update: Jul 31, 2025
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CVAY736S12201
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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 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.

Diffuse Cutaneous Systemic Sclerosis
Phase2
Recruiting
200
Oct 09, 2024
Jul 15, 2030
All
18 Years - 70 Years (Adult, Older Adult)

Interventions

Drug

Ianalumab

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

Placebo

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

Eligibility Criteria

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.

Novartis Investigative Site

Recruiting

CABA,Buenos Aires,C1221adc,Argentina

Novartis Investigative Site

Recruiting

Caba,Buenos Aires,C1280aeb,Argentina

Novartis Investigative Site

Recruiting

Ciudad Autonoma de Bs As,Buenos Aires,C1015abo,Argentina

Novartis Investigative Site

Recruiting

Caba,C1426,Argentina

Novartis Investigative Site

Recruiting

San Miguel de Tucumán,4000,Argentina

Novartis Investigative Site

Recruiting

Graz,8036,Austria

Novartis Investigative Site

Recruiting

Leuven,3000,Belgium

Novartis Investigative Site

Recruiting

Salvador,Estado de Bahia,40150 150,Brazil

Novartis Investigative Site

Recruiting

Porto Alegre,Rio Grande do Sul,90035-074,Brazil

Novartis Investigative Site

Recruiting

São José do Rio Preto,São Paulo,15090 000,Brazil

Novartis Investigative Site

Recruiting

Curitiba,Paraná,80030-110,Brazil

Novartis Investigative Site

Recruiting

São Paulo,São Paulo,04038-002,Brazil

Novartis Investigative Site

Recruiting

São Paulo,São Paulo,05403-000,Brazil

Novartis Investigative Site

Recruiting

Chengdu,Sichuan,610041,China

Novartis Investigative Site

Recruiting

Beijing,100191,China

Novartis Investigative Site

Recruiting

Nanning,Guangxi,530021,China

Novartis Investigative Site

Recruiting

Zhejiang,315016,China

Novartis Investigative Site

Recruiting

Changchun,Jilin,130021,China

Novartis Investigative Site

Recruiting

Beijing,100730,China

Novartis Investigative Site

Recruiting

Tianjin,300052,China

Novartis Investigative Site

Recruiting

Zhengzhou,Henan,450052,China

Novartis Investigative Site

Recruiting

Medellín,Antioquia,050001,Colombia

Novartis Investigative Site

Recruiting

Bogotá,110221,Colombia

Novartis Investigative Site

Recruiting

Medellín,050021,Colombia

Novartis Investigative Site

Recruiting

Bogota,Cundinamarca,110111,Colombia

Novartis Investigative Site

Recruiting

Bogotá,110231,Colombia

Novartis Investigative Site

Recruiting

Santiago de Cali,760012,Colombia

Novartis Investigative Site

Recruiting

Dijon,21034,France

Novartis Investigative Site

Recruiting

Le Mans,72000,France

Novartis Investigative Site

Recruiting

Lille,59037,France

Novartis Investigative Site

Recruiting

Montpellier,34295,France

Novartis Investigative Site

Recruiting

Paris,75014,France

Novartis Investigative Site

Recruiting

Strasbourg,67000,France

Novartis Investigative Site

Recruiting

Rennes,35000,France

Novartis Investigative Site

Recruiting

Toulouse,31054,France

Novartis Investigative Site

Recruiting

Berlin,13353,Germany

Novartis Investigative Site

Recruiting

Würzburg,97080,Germany

Novartis Investigative Site

Recruiting

Jena,07740,Germany

Novartis Investigative Site

Recruiting

Athens,115 21,Greece

Novartis Investigative Site

Recruiting

Alexandroupoli,Evros,681 00,Greece

Novartis Investigative Site

Recruiting

Athens,115 27,Greece

Novartis Investigative Site

Recruiting

Debrecen,4032,Hungary

Novartis Investigative Site

Recruiting

Pécs,7623,Hungary

Novartis Investigative Site

Recruiting

Kochi,Kerala,682018,India

Novartis Investigative Site

Recruiting

Mumbai,Maharashtra,400078,India

Novartis Investigative Site

Recruiting

Jaipur,Rajasthan,302004,India

Novartis Investigative Site

Recruiting

New Delhi,National Capital Territory of Delhi,110 060,India

Novartis Investigative Site

Recruiting

New Delhi,110029,India

Novartis Investigative Site

Recruiting

Mumbai,Maharashtra,400 013,India

Novartis Investigative Site

Recruiting

Ancona,AN,60126,Italy

Novartis Investigative Site

Recruiting

Roma,RM,00168,Italy

Novartis Investigative Site

Recruiting

Verona,VR,37134,Italy

Novartis Investigative Site

Recruiting

Milan,MI,20100,Italy

Novartis Investigative Site

Recruiting

Rozzano,MI,20089,Italy

Novartis Investigative Site

Recruiting

Palermo,PA,90127,Italy

Novartis Investigative Site

Recruiting

Pavia,PV,27100,Italy

Novartis Investigative Site

Recruiting

Modena,MO,41124,Italy

Novartis Investigative Site

Recruiting

Seoul,04763,Korea, Republic of

Novartis Investigative Site

Recruiting

Busan,49241,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,06273,Korea, Republic of

Novartis Investigative Site

Recruiting

Mexico City,Mexico City,11850,Mexico

Novartis Investigative Site

Recruiting

Guadalajara,Jalisco,44650,Mexico

Novartis Investigative Site

Recruiting

Chihuahua City,31000,Mexico

Novartis Investigative Site

Recruiting

Mexico City,Mexico City,06700,Mexico

Novartis Investigative Site

Recruiting

Bydgoszcz,85 168,Poland

Novartis Investigative Site

Recruiting

Warsaw,00-874,Poland

Novartis Investigative Site

Recruiting

Vila Nova de Gaia,4434 502,Portugal

Novartis Investigative Site

Recruiting

Coimbra,3000 075,Portugal

Novartis Investigative Site

Recruiting

Lisbon,1649 035,Portugal

Novartis Investigative Site

Recruiting

Busan,49241,South Korea

Novartis Investigative Site

Recruiting

Seoul,04763,South Korea

Novartis Investigative Site

Recruiting

Seoul,06273,South Korea

Novartis Investigative Site

Recruiting

Salamanca,Castille and León,37007,Spain

Novartis Investigative Site

Recruiting

Barcelona,08041,Spain

Novartis Investigative Site

Recruiting

Madrid,28009,Spain

Novartis Investigative Site

Recruiting

Málaga,29010,Spain

Novartis Investigative Site

Recruiting

Taichung,40447,Taiwan

Novartis Investigative Site

Recruiting

Changhua,50006,Taiwan

Novartis Investigative Site

Recruiting

Taoyuan District,33305,Taiwan

Novartis Investigative Site

Recruiting

Kaohsiung City,83301,Taiwan

Novartis Investigative Site

Recruiting

Khon Kaen,THA,40002,Thailand

Novartis Investigative Site

Recruiting

Bangkok,10400,Thailand

Novartis Investigative Site

Recruiting

Ankara,06230,Turkey

Novartis Investigative Site

Recruiting

Ankara,06500,Turkey

Novartis Investigative Site

Recruiting

Istanbul,34093,Turkey

Novartis Investigative Site

Recruiting

Ankara,06230,Turkey (Türkiye)

Novartis Investigative Site

Recruiting

Ankara,06500,Turkey (Türkiye)

Novartis Investigative Site

Recruiting

Istanbul,34093,Turkey (Türkiye)

Novartis Investigative Site

Recruiting

Bristol,Bs10 5nb,United Kingdom

Clinical Res Of W Florida

Recruiting

Clearwater,Florida,33765,United States

Kelly Mitchell
Rodney Daniel

West Tennessee Research Institute

Recruiting

Jackson,Tennessee,38305,United States

Jacob A Aelion
Judith Padilla

Prolato Clinical Research Center

Recruiting

Houston,Texas,77054,United States

Michelle Eisenberg
Rafi Zaman

Sarasota Arthritis Res Ctr

Recruiting

Sarasota,Florida,34239,United States

Jaishree Manohar
Nancy Alvarado

Arthritis and Rheumatology Ins

Recruiting

Allen,Texas,75013,United States

Megha Patel Banker
Stephen Thomas

Uni Of Michigan Health System

Recruiting

Ann Arbor,Michigan,48109,United States

Carleigh Zahn
Christopher Floyd

Arizona Arthritis and Rheumatology Research PLLC

Recruiting

Mesa,Arizona,85202,United States

Nathaly Navarro
Nehad Soloman

GNP Research

Recruiting

Cooper City,Florida,33024,United States

Mark Jaffe
Rossana Villaverde

Clinical Research Inst of MI

Recruiting

Saint Clair Shores,Michigan,48081,United States

Andrew Sulich
Latrece Keaton

Novel Research LLC

Recruiting

Bellaire,Texas,77401,United States

Hina Arshad
Wajeeha Yousaf

Novartis Investigative Site

Recruiting

Ho Chi Minh City,700000,Vietnam

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

Novartis Pharmaceuticals