Recruiting

Phase 2

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

Sponsor:

Novartis Pharmaceuticals

Code:

NCT06470048

Conditions

Diffuse Cutaneous Systemic Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Placebo

Ianalumab

Study Details

Brief 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

Conditions

Diffuse Cutaneous Systemic Sclerosis

Study ID

NCT06470048

Start date

Oct 9, 2024

Status verified date

Aug, 2026

Completion date

Jul 31, 2034

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

Placebo

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

Ianalumab

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

Primary outcome measure

3/5 rCRISS25 response [ Time Frame: Week 52 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111 novartis.email@novartis.com

Locations

Arizona Arthritis and Rheumatology Research PLLC

Recruiting

Mesa, Arizona, United States, 85202

Contacts

Debra Mc Dermed

+1 602 386 4970 Debra.McDermed@azarthritis.com

Principal Investigator:

Nehad Soloman

UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Lauren Nam

+1 310 488 0162 lnam@mednet.ucla.edu

Principal Investigator:

Suzanne Kafaja

Hoag Hospital

Recruiting

Newport Beach, California, United States, 92663

Contacts

Vicki Tan

+1 949 791 3049 vicki.tan@hoag.org

Principal Investigator:

Christine Thai

Clinical Res Of W Florida

Recruiting

Clearwater, Florida, United States, 33765

Contacts

Amber Tipker

+1 727 466 0078 atipker@crwf.com

Principal Investigator:

Rodney Daniel

GNP Research

Recruiting

Cooper City, Florida, United States, 33024

Contacts

Melissa Pierce

+1 754 248 3589 melissa@gnpresearch.com

Principal Investigator:

Mark Jaffe

IRIS Research and Development

Recruiting

Plantation, Florida, United States, 33324

Contacts

Jhon Galindo

+1 954 476 2338 jgalindo@irisrheumatology.com

Principal Investigator:

Guillermo Valenzuela

University of Chicago Hospitals

Recruiting

Chicago, Illinois, United States, 60637

Contacts

J Heannhehbelle Rosier

+1 773 702 3853 jrosier@uchicagomedicine.org

Principal Investigator:

Michael Macklin

UMC New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Sean Barry

sbarr2@lsuhsc.edu

Principal Investigator:

Stephen Lindsey

Uni Of Michigan Health System

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Christopher Floyd

+1 734 936 5504 cjfloyd@med.umich.edu

Principal Investigator:

Carleigh Zahn

Wayne State University

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Biljana Basic-Panic

bbasicpanic@med.wayne.edu

Principal Investigator:

Ilyes Benchaala

Clinical Research Inst of MI

Recruiting

Saint Clair Shores, Michigan, United States, 48081

Contacts

Amelia Laurence

+1 586 777 7577 alaurence@researchmi.com

Principal Investigator:

Andrew Sulich

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Liza Morales

+1 212 774 2596 moralesli@HSS.EDU

Principal Investigator:

Kimberly Showalter Lakin

West Tennessee Research Institute

Recruiting

Jackson, Tennessee, United States, 38305

Contacts

Sherry Wiggins

17316330119 swiggins@arthritisclinic.org

Principal Investigator:

Jacob A Aelion

Arthritis and Rheumatology Ins

Recruiting

Allen, Texas, United States, 75035

Contacts

Samina Shehzad

shehzad.s@dfwarthritis.com

Principal Investigator:

Megha Patel Banker

Novel Research LLC

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Hassan Khan

khan@novelresearch.net

Principal Investigator:

Wajeeha Yousaf

Prolato Clinical Research Center

Recruiting

Houston, Texas, United States, 77054

Contacts

Mohammad Alsayed

+1 832 338 9118 malsayed@prolato.org

Principal Investigator:

Michelle Eisenberg

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-08-19.