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Corticosteroid

Ianalumab + Corticosteroids for Low Platelet Count (VAYHIT1 Trial)

Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights
Pivotal Trial

Summary

This trial studies two doses of ianalumab to see if they can help maintain platelet counts in adults with primary ITP.

Who is the study for?
Adults diagnosed with primary ITP within the last 3 months, having a platelet count below 30 G/L before treatment, and who've responded to corticosteroids can join. Excluded are those with other blood disorders, neutrophil counts below 1.0 G/L, life-threatening bleeding, previous ITP treatments (other than specific first-line therapies), or use of B-cell depleting therapy.
What is being tested?
The trial is testing two doses of Ianalumab versus a placebo in combination with corticosteroids to see if they help maintain platelet counts above 30 G/L in adults with primary ITP. Participants will be randomly assigned to receive either Ianalumab or a placebo.
What are the potential side effects?
Ianalumab may cause side effects such as infections due to immune system suppression, infusion reactions similar to allergic responses, fatigue, headaches and potentially impact liver function. Corticosteroids can also have multiple side effects like increased appetite, mood changes and higher blood sugar levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time from randomization to treatment failure (TTF)
Secondary study objectives
Change from baseline in ITP-PAQ domain scores
Change from baseline in absolute number of CD19+ B cell counts
Change from baseline in frequency of CD19+ B cell counts
+21 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Ianalumab Lower doseExperimental Treatment2 Interventions
Lower dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified)
Group II: Ianalumab Higher doseExperimental Treatment2 Interventions
Higher dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified)
Group III: PlaceboPlacebo Group2 Interventions
Placebo administered intravenously with corticosteroids oral or parental (if clinically justified)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Corticosteroids
2003
Completed Phase 4
~8270

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,912 Previous Clinical Trials
4,252,478 Total Patients Enrolled

Media Library

Corticosteroids (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05653349 — Phase 3
ITP Research Study Groups: Ianalumab Higher dose, Ianalumab Lower dose, Placebo
ITP Clinical Trial 2023: Corticosteroids Highlights & Side Effects. Trial Name: NCT05653349 — Phase 3
Corticosteroids (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05653349 — Phase 3
~103 spots leftby Apr 2026
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