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Monoclonal Antibodies

Ianalumab low dose for Autoimmune Hemolytic Anemia (VAYHIA Trial)

Q: What is the current number of patients being recruited for participation in this medical study?

A minimum of 90 eligible participants are required for this clinical investigation to proceed. Novartis Pharmaceuticals, the trial sponsor, will oversee operations at multiple locations such as University of <a href="https://www.withpower.com/clinical-trials/minnesota">Minnesota</a> Med Center in Isehara and AV and Napa Research in Avellino, Chiba.

Q: Are there any available vacancies for participants in this clinical trial?

Indeed, the details on clinicaltrials.gov indicate that recruitment is ongoing for this particular study. Originally shared on December 30th, 2022, and last revised on February 2nd, 2024. The aim is to enroll a total of 90 participants from a network of 68 sites.

Q: What is the safety profile of low-dose Ianalumab in patients?

Ianalumab at a low dose is deemed to have the highest safety rating of 3, according to our team at Power. This assessment stems from its Phase 3 trial status, indicating existing efficacy data and robust safety information gathered over multiple evaluations.

Q: Are there several locations in the city conducting this research study?

This research is conducted at the University of <a href="https://www.withpower.com/clinical-trials/minnesota">Minnesota</a> Medical Center in Isehara, AV, Napa Research in Avellino, Chiba, and Inspira Medical Center Mullica Hill in Selangor, Hyogo. Additionally, it is being carried out at 68 other sites.

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

Patients must be 18 years and older at the time of signing consent

Hemoglobin concentration at screening <10 g/dL, associated with presence of symptoms related to anemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization to end of study (up to 39 months after randomization of last patient)

Awards & highlights

VAYHIA Trial Summary

"This trial aims to test if ianalumab is effective and safe for patients with warm autoimmune hemolytic anemia who have not responded to previous treatments."

Who is the study for?

This trial is for adults with warm autoimmune hemolytic anemia (wAIHA) who haven't had success with at least one previous treatment. They should have symptoms related to anemia and a hemoglobin level below 10 g/dL. Participants must not have changed their supportive care dose in the last four weeks.Check my eligibility

What is being tested?

The study is testing Ianalumab against a placebo in patients with wAIHA who didn't respond well to past treatments. The goal is to see if Ianalumab is more effective and safe compared to not receiving the active drug.See study design

What are the potential side effects?

While specific side effects of Ianalumab are not listed, common ones may include reactions at the injection site, increased risk of infections, potential liver issues, or other immune-related conditions.

VAYHIA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

My hemoglobin is below 10 g/dL and I feel tired or weak.

Select...

My hemoglobin levels are between 5 and 10 g/dL, and I feel symptoms of anemia.

Select...

I am 18 years old or older.

VAYHIA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization to end of study (up to 39 months after randomization of last patient)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization to end of study (up to 39 months after randomization of last patient)

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to end of study (up to 39 months after randomization of last patient) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Binary variable indicating whether a patient achieves a durable response

Secondary outcome measures

Change from baseline in immunoglobulin levels

Change from baseline in the 8 domain scores and in the summary scores (PCS, MCS) of SF-36 questionnaire

Change from baseline in the T-score of PROMIS Fatigue-13a questionnaire

+17 more

VAYHIA Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Ianalumab low doseExperimental Treatment1 Intervention

Participants will receive low dose ianalumab intravenously

Group II: Ianalumab high doseExperimental Treatment1 Intervention

Participants will receive high dose ianalumab intravenously

Group III: PlaceboPlacebo Group1 Intervention

Participants will receive placebo intravenously

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,860 Previous Clinical Trials

4,198,219 Total Patients Enrolled

Frequently Asked Questions

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

What is the current number of patients being recruited for participation in this medical study?

"A minimum of 90 eligible participants are required for this clinical investigation to proceed. Novartis Pharmaceuticals, the trial sponsor, will oversee operations at multiple locations such as University of Minnesota Med Center in Isehara and AV and Napa Research in Avellino, Chiba."

Answered by AI

Are there any available vacancies for participants in this clinical trial?

"Indeed, the details on clinicaltrials.gov indicate that recruitment is ongoing for this particular study. Originally shared on December 30th, 2022, and last revised on February 2nd, 2024. The aim is to enroll a total of 90 participants from a network of 68 sites."

Answered by AI

What is the safety profile of low-dose Ianalumab in patients?

"Ianalumab at a low dose is deemed to have the highest safety rating of 3, according to our team at Power. This assessment stems from its Phase 3 trial status, indicating existing efficacy data and robust safety information gathered over multiple evaluations."

Answered by AI

Are there several locations in the city conducting this research study?

"This research is conducted at the University of Minnesota Medical Center in Isehara, AV, Napa Research in Avellino, Chiba, and Inspira Medical Center Mullica Hill in Selangor, Hyogo. Additionally, it is being carried out at 68 other sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia

2022. "A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05648968.