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Monoclonal Antibodies
Ianalumab for Systemic Sclerosis
Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Disease duration of =< 18 months defined as time from the first non-Raynaud phenomenon manifestation
Male and female participants >= 18 and =< 70 years (at the time of the screening visit).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, week 8, week 12, week 24, week 36, week 52, week 64, week 76, week 88, week 104, week 108, week 112, week 116, week 120, week 124 and week 208
Summary
This trial will test how well a medication called ianalumab works in patients with a type of autoimmune disease called diffuse cutaneous systemic sclerosis. The researchers will look at how effective, safe, and
Who is the study for?
This trial is for adults aged 18-70 with diffuse cutaneous systemic sclerosis, a type of scleroderma. Participants must have interstitial lung disease, ATA autoantibody positivity, and a specific disease duration and severity as measured by skin thickness score (mRSS). They should not have had the condition for more than 60 months.
What is being tested?
The study tests Ianalumab's effectiveness compared to a placebo in treating systemic sclerosis. It measures how well it works, its safety, and if there are any negative effects when given subcutaneously (under the skin) to participants.
What are the potential side effects?
While specific side effects are not listed here, typically such interventions may cause injection site reactions, allergic responses, potential immune system changes leading to increased risk of infections or other autoimmune conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition started less than 18 months ago, not counting Raynaud's phenomenon.
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I am between 18 and 70 years old.
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My symptoms started less than 5 years ago, not counting Raynaud's.
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I have interstitial lung disease and positive for ATA autoantibodies.
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I have been diagnosed with systemic sclerosis according to specific criteria.
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My skin has gotten significantly tighter in the last 6 months.
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Two new parts of my body have been affected in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 4, week 8, week 12, week 24, week 36, week 52, week 64, week 76, week 88, week 104, week 108, week 112, week 116, week 120, week 124 and week 208
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, week 8, week 12, week 24, week 36, week 52, week 64, week 76, week 88, week 104, week 108, week 112, week 116, week 120, week 124 and week 208
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
3/5 rCRISS25 response
Secondary study objectives
Change from baseline in FVC% predicted at Week 52
Change from baseline in HAQ-DI at Week 52
Change from baseline in mRSS at Week 52
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: VAY736 (Ianalumab)Experimental Treatment1 Intervention
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
Group II: PlaceboPlacebo Group2 Interventions
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
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,919 Previous Clinical Trials
4,254,307 Total Patients Enrolled
1 Trials studying Scleroderma
10 Patients Enrolled for Scleroderma