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Monoclonal Antibodies

Ianalumab for Low Platelet Count

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Confirmed response

Secondary outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single-armExperimental Treatment1 Intervention

All eligible participants will receive ianalumab at the same dose.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,860 Previous Clinical Trials

4,198,269 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have joined this research endeavor?

"Affirmative, sources on clinicaltrials.gov suggest that recruitment is ongoing for this trial which first appeared online in August 16th 2023. As of October 17th 2023, there are 40 patients needed to be recruited from 7 medical centres."

Answered by AI

How many health care centers are administering this trial?

"Presently, seven research centres worldwide are enrolling participants in this trial. These sites are situated in Dijon, Dresden and Seoul along with other metropolitan hubs. To reduce travel needs if you choose to take part, it is recommended that you select the closest location possible."

Answered by AI

Are the risks associated with Single-arm treatment minimal?

"As this is a phase 2 trial, with some evidence of safety but none regarding efficacy, the Single-arm study received an assessment score of 2."

Answered by AI

Is this trial still open for enrollment of participants?

"Affirmative, clinicaltrials.gov attests that this medical trial is open for enrollment. The study was posted on August 16th 2023 and revised on October 17th 2023. 40 participants are needed to be recruited from 7 participating sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies

2023. "A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05885555.

All > Thrombocytopenia