RECRUITING

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

Conditions

Diffuse Cutaneous Systemic Sclerosis 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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

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

Quick Facts

Study Start:2024-10-09

Study Completion:2030-07-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06470048

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Novartis Pharmaceuticals

CONTACT

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

novartis.email@novartis.com

Principal Investigator

Novartis Pharmaceuticals

STUDY_DIRECTOR

Novartis Pharmaceuticals

Study Locations (Sites)

Clinical Res Of W Florida

Clearwater, Florida, 33765

United States

West Tennessee Research Institute

Jackson, Tennessee, 38305

United States

Prolato Clinical Research Center

Houston, Texas, 77054

United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-09

Study Completion Date2030-07-15

Study Record Updates

Study Start Date2024-10-09

Study Completion Date2030-07-15

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Diffuse Cutaneous Systemic Sclerosis