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New treatment option for Diffuse Cutaneous Systemic Sclerosis
Official title A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
ClinicalTrials.gov ID: NCT06470048
What this study is testing
What is Ianalumab?
Ianalumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for diffuse cutaneous systemic sclerosis.
Also referred to as VAY736.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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)...
- Disease duration of =\< 60 months (defined as time from the first non-Raynaud phenomenon manifestation, e.g., puffy hands, scleroderma, digital...
- 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:
You likely can't join if
- Rheumatic disease other than dcSSc, including limited cutaneous disease (lcSSc) or sine scleroderma at the screening visit. Secondary Sjogren's...
- 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...
- WHO Functional Class 3 or higher assessment for pulmonary arterial hypertension (PAH, as defined on right heart catheterization), receiving IV...
- Participants treated with cyclophosphamide within 12 weeks prior to Baseline.
See the full eligibility 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...
- 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 assigned by chance study population. Key
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Mesa, Arizona, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Clearwater, Florida, United States
- Cooper City, Florida, United States
- Plantation, Florida, United States
- Sarasota, Florida, United States
- Chicago, Illinois, United States
- New Orleans, Louisiana, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Saint Clair Shores, Michigan, United States
- New York, New York, United States
- Jackson, Tennessee, United States
- Allen, Texas, United States
- Bellaire, Texas, United States
- Houston, Texas, United States
- CABA, Buenos Aires, Argentina
- Caba, Argentina
- San Miguel de Tucumán, Argentina
+ 98 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mesa, Arizona, United States; Los Angeles, California, United States; Newport Beach, California, United States; Clearwater, Florida, United States; Cooper City, Florida, United States; Plantation, Florida, United States and 112 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.