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Monoclonal Antibodies

Ianalumab for Low Platelet Count

Phase 2
Waitlist Available
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
No Placebo-Only Group

Summary

This trial will test a new drug to treat a common blood disorder, to see if it's safe and effective.

Who is the study for?
This trial is for adults with primary ITP who have low platelet counts and have tried at least two treatments, including corticosteroids and TPO-RAs. Participants must be over 18, provide consent, and not have had certain other treatments like B-cell depleting therapy or a splenectomy recently.
What is being tested?
The study tests the effectiveness of Ianalumab in treating ITP after previous therapies. It aims to see how safe and tolerable this drug is for patients who've already used steroids and TPO-RA but still need treatment.
What are the potential side effects?
While specific side effects are not listed here, common ones may include reactions at the infusion site, increased risk of infections due to immune system suppression, fatigue, headaches, or potential allergic reactions.

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
Confirmed response
Secondary study objectives
Bleeding events according to the Modified World Health Organization (WHO) bleeding scale
Bleeding events in the second course according to the Modified World Health Organization (WHO) bleeding scale
Change from baseline in immunoglobulins
+28 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single-armExperimental Treatment1 Intervention
All eligible participants will receive ianalumab at the same dose.

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,911 Previous Clinical Trials
4,250,614 Total Patients Enrolled
~26 spots leftby Mar 2027
Unbiased ResultsWe believe in providing patients with all the options.
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