At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Placebo (drug), Ianalumab (drug)
- How long the study runs
- Study runs about 117 months (dates as stated)
- About the drug or intervention
- Placebo — drug: Ianalumab matching placebo subcutaneous (s.c.) injection as defined in the protocol · Ianalumab — drug: subcutaneous (s.c.) injection as defined in the protocol
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 70 Years
- Who
- All
- Number of participants
- 200
- Started
- 2024-10-09
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for diffuse cutaneous systemic sclerosis
- • Phase2 - 200 participants
- • The purpose of this study is to evaluate efficacy, safety and tolerability of s
Who can take part?
- • Ages 18 Years to 70 Years
- • Diagnosed with diffuse cutaneous systemic sclerosis
Where?
- • Basingstoke - Novartis Investigative Site
- • Bristol - Novartis Investigative Site
- • London - Novartis Investigative Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 70 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Male and female participants \>= 18 and =\< 70 years (at the time of the screening visit).
- ✓Disease duration of =\< 60 months (defined as time from the first non-Raynaud phenomenon manifestation, e.g., puffy...
- ✓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
Who cannot take part
- ✗Rheumatic disease other than dcSSc, including limited cutaneous disease (lcSSc) or sine scleroderma at the screening...
- ✗Positive anti-centromere antibody (ACA+) without positive ATA or anti-RNAP3 autoantibody result at the screening visit
- ✗Previous improvement (decrease) in mRSS \> 10 units
- ✗lung disease with FVC ≤ 50% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO, corrected...
- ✗Participants treated with cyclophosphamide within 12 weeks prior to Baseline.
See the full criteria
Where Is This Study? (3 UK sites)
Novartis Investigative Site
Basingstoke RG24 9NA, United Kingdom
Novartis Investigative Site
Bristol BS10 5NB, United Kingdom
Novartis Investigative Site
London NW3 2QG, United Kingdom
How to Get in Touch
Novartis Pharmaceuticals
Sponsor contactCONTACT
Novartis Pharmaceuticals
Sponsor contactCONTACT
