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/dL) - Presence of 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.
  • - Previous treatment with chlorambucil, bone marrow transplantation or total lymphoid irradiation.
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 Austria, China, Germany, Greece, Hungary, India, Italy, Korea, Republic of, Poland, Portugal, Spain, Taiwan, Thailand, Turkey, 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.

Clinical Res Of W Florida, Clearwater, Florida

Status

Recruiting

Address

Clinical Res Of W Florida

Clearwater, Florida, 33765

Site Contact

Sydney K Mullen

[email protected]

727-466-0078

Sarasota Arthritis Res Ctr, Sarasota, Florida

Status

Recruiting

Address

Sarasota Arthritis Res Ctr

Sarasota, Florida, 34239

Site Contact

Angi Gomez

[email protected]

941-366-1244

West Tennessee Research Institute, Jackson, Tennessee

Status

Recruiting

Address

West Tennessee Research Institute

Jackson, Tennessee, 38305

Site Contact

Brittany Appleton

[email protected]

731-664-7824

Arthritis and Rheumatology Ins, Allen, Texas

Status

Recruiting

Address

Arthritis and Rheumatology Ins

Allen, Texas, 75013

Site Contact

Kiran Khandelwal

[email protected]

1-888-669-6682

Prolato Clinical Research Center, Houston, Texas

Status

Recruiting

Address

Prolato Clinical Research Center

Houston, Texas, 77054

Site Contact

Romeo Parada

[email protected]

832-338-9118

International Sites

Novartis Investigative Site, Graz, Austria

Status

Recruiting

Address

Novartis Investigative Site

Graz, , 8036

Novartis Investigative Site, Nanning, Guangxi, China

Status

Recruiting

Address

Novartis Investigative Site

Nanning, Guangxi, 530021

Novartis Investigative Site, Chengdu, Sichuan, China

Status

Recruiting

Address

Novartis Investigative Site

Chengdu, Sichuan, 610041

Novartis Investigative Site, Beijing, China

Status

Recruiting

Address

Novartis Investigative Site

Beijing, , 100191

Novartis Investigative Site, Zhejiang, China

Status

Recruiting

Address

Novartis Investigative Site

Zhejiang, , 315016

Novartis Investigative Site, Berlin, Germany

Status

Recruiting

Address

Novartis Investigative Site

Berlin, , 13353

Novartis Investigative Site, Wuerzburg, Germany

Status

Recruiting

Address

Novartis Investigative Site

Wuerzburg, , 97080

Novartis Investigative Site, Athens, Greece

Status

Recruiting

Address

Novartis Investigative Site

Athens, , 115 21

Novartis Investigative Site, Debrecen, Hungary

Status

Recruiting

Address

Novartis Investigative Site

Debrecen, , 4032

Novartis Investigative Site, Kochi, Kerala, India

Status

Recruiting

Address

Novartis Investigative Site

Kochi, Kerala, 682018

Novartis Investigative Site, Mumbai, Maharashtra, India

Status

Recruiting

Address

Novartis Investigative Site

Mumbai, Maharashtra, 400078

Novartis Investigative Site, Jaipur, Rajasthan, India

Status

Recruiting

Address

Novartis Investigative Site

Jaipur, Rajasthan, 302004

Novartis Investigative Site, Ancona, AN, Italy

Status

Recruiting

Address

Novartis Investigative Site

Ancona, AN, 60126

Novartis Investigative Site, Roma, RM, Italy

Status

Recruiting

Address

Novartis Investigative Site

Roma, RM, 00168

Novartis Investigative Site, Verona, VR, Italy

Status

Recruiting

Address

Novartis Investigative Site

Verona, VR, 37134

Novartis Investigative Site, Busan, Korea, Republic of

Status

Recruiting

Address

Novartis Investigative Site

Busan, , 49241

Novartis Investigative Site, Seoul, Korea, Republic of

Status

Recruiting

Address

Novartis Investigative Site

Seoul, , 03080

Novartis Investigative Site, Seoul, Korea, Republic of

Status

Recruiting

Address

Novartis Investigative Site

Seoul, , 04763

Novartis Investigative Site, Bydgoszcz, Poland

Status

Recruiting

Address

Novartis Investigative Site

Bydgoszcz, , 85 168

Novartis Investigative Site, Warszawa, Poland

Status

Recruiting

Address

Novartis Investigative Site

Warszawa, , 00-874

Novartis Investigative Site, Vila Nova De Gaia, Portugal

Status

Recruiting

Address

Novartis Investigative Site

Vila Nova De Gaia, , 4434 502

Novartis Investigative Site, Malaga, Andalucia, Spain

Status

Recruiting

Address

Novartis Investigative Site

Malaga, Andalucia, 29010

Novartis Investigative Site, Changhua, Taiwan

Status

Recruiting

Address

Novartis Investigative Site

Changhua, , 50006

Novartis Investigative Site, Taichung, Taiwan

Status

Recruiting

Address

Novartis Investigative Site

Taichung, , 40447

Novartis Investigative Site, Taoyuan, Taiwan

Status

Recruiting

Address

Novartis Investigative Site

Taoyuan, , 33305

Novartis Investigative Site, Khon Kaen, THA, Thailand

Status

Recruiting

Address

Novartis Investigative Site

Khon Kaen, THA, 40002

Novartis Investigative Site, Bangkok, Thailand

Status

Recruiting

Address

Novartis Investigative Site

Bangkok, , 10400

Novartis Investigative Site, Ankara, Turkey

Status

Recruiting

Address

Novartis Investigative Site

Ankara, , 06230

Novartis Investigative Site, Ankara, Turkey

Status

Recruiting

Address

Novartis Investigative Site

Ankara, , 06500

Novartis Investigative Site, Istanbul, Turkey

Status

Recruiting

Address

Novartis Investigative Site

Istanbul, , 34093

Novartis Investigative Site, Ho Chi Minh, VNM, Vietnam

Status

Recruiting

Address

Novartis Investigative Site

Ho Chi Minh, VNM, 700000

Novartis Investigative Site, Ho Chi Minh, Vietnam

Status

Recruiting

Address

Novartis Investigative Site

Ho Chi Minh, , 700000