Ianalumab for Low Platelet Count

Recruiting in Palo Alto (17 mi)

+36 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate the therapeutic efficacy, safety and tolerability of ianalumab in adult patients with primary ITP previously treated with at least one corticosteroid and one TPO-RA.

Eligibility Criteria

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.

Inclusion Criteria

Signed informed consent obtained prior to participation in the study

My last treatment for ITP didn't work or caused side effects.

My platelet count is below 30 G/L and I need treatment.

+5 more

Exclusion Criteria

I have had my spleen removed.

I have been diagnosed with a low platelet count not caused by an initial disease.

I haven't had blood transfusions or specific treatments within the last 14 days.

+4 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Single-armExperimental Treatment1 Intervention

All eligible participants will receive ianalumab at the same dose.