Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP) (VAYHIT1)

Overview

About this study

The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥ 30 G/L in adult participants with primary ITP.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Signed informed consent prior to participation in the study.

- Male or female participants aged 18 years and older on the day of signing informed
consent

- Primary ITP diagnosed within 3 months before initiating first-line ITP therapy
(corticosteroids, IVIG)

- Platelet count below 30 G/L before starting any first-line ITP therapy
(corticosteroids, IVIG)

- Response (platelet count >=50 G/L) to corticosteroids (+/- IVIG) at any time prior to
randomization. Note: Platelet count measured within 7 days of platelet transfusion
will not be considered as response.

Key Exclusion Criteria:

- Evans syndrome or any other cytopenia

- Current life-threatening bleeding

- Previous ITP treatment, including splenectomy, except for corticosteroids and/or IVIG
initiated as first-line therapy for up to 28 days before randomization and rescue
corticosteroids and/or IVIG given prior to confirmed diagnosis of primary ITP .

- Prior use of B-cell depleting therapy (e.g., rituximab).

- Absolute neutrophil count below 1.0 G/L at randomization

- Participants with concurrent coagulation disorders and/or receiving anti-platelet or
anticoagulant medication with an exemption of low dose of acetylsalicylic acid

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/18/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Alexandra Wolanskyj-Spinner, M.D.

Open for enrollment

Contact information:

Department of Medicine (DOM) Research Hub

(507) 266-1944

DOMRESEARCHHUB@mayo.edu

More information

Publications

Publications are currently not available