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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06470048
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Novartis Pharmaceuticals
Principal Investigator Affiliation	Novartis Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Austria, Belgium, Brazil, China, Colombia, France, Germany, Greece, Hungary, India, Italy, Mexico, Poland, Portugal, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States, Vietnam
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Diffuse Cutaneous Systemic Sclerosis

Additional Details

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.

Arms & Interventions

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

Drug: - Placebo

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

Drug: - Ianalumab

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mesa 5304391, Arizona 5551752

Status

Recruiting

Address

Arizona Arthritis and Rheumatology Research PLLC

Mesa 5304391, Arizona 5551752, 85202

Site Contact

Nathaly Navarro

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