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

Last Update: May 03, 2024

A Phase 2 Study to Evaluate the Efficacy and Safety of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least a Corticosteroid and a Thrombopoietin Receptor Agonist (TPO-RA)

ClinicalTrials.gov Identifier:

NCT05885555

Novartis Reference Number:CVAY736Q12201

See if you Pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

This is a phase 2, open-label, single-arm study to evaluate the efficacy, safety and tolerability of ianalumab in participants with primary ITP (platelet count <30 G/L at screening) previously treated with at least a corticosteroid and a TPO-RA.

The study consists of the screening period, the primary endpoint assessment period, the follow-up period. The screening period will last for up to 14 days prior to the first dose of ianalumab. All eligible participants will be treated with the same dose of ianalumab and will complete the primary endpoint assessment period. After completion of the primary endpoint assessment period, all participants will continue in safety monitoring and those with a platelet count ≥30 G/L in absence of a new line of ITP therapy and rescue therapy will also continue in efficacy monitoring. The trial includes an option to offer a second course of ianalumab treatment to participants who achieved confirmed response during the initial course of ianalumab and later lost response to explore the benefit of the second course of treatment. The study will end once all participants have completed 24 months of safety follow-up since their last dose of ianalumab (including the optional second course of ianalumab treatment),or discontinued the study earlier.

Condition

Primary Immune Thrombocytopenia (ITP)

Phase

Phase 2

Overall Status

Recruiting

Number of Participants

Start Date

Aug 16, 2023

Completion Date

Mar 19, 2029

Gender

All

Age(s)

18 Years - (Adult, Older Adult)

Interventions

Biological

Ianalumab

Intravenous infusion, prepared from concentrate solution

Eligibility Criteria

Inclusion Criteria:

Signed informed consent obtained prior to participation in the study.
Male or female participants aged 18 years and older on the day of signing informed consent.

Confirmed diagnosis of primary ITP.

Prior treatment with at least a corticosteroid (±IVIG) and a TPO-RA:
Prior additional therapies are allowed; the corticosteroid or the TPO-RA do not need to be the last treatment.
Prior response to IVIG/anti-D or a corticosteroid (platelet count ≥50 G/L) that was not maintained.
At last ITP treatment, loss of response, insufficient response, no response or intolerance.
Platelet count <30 G/L and assessed as needing treatment (per physician's discretion) at screening. If concomitant ITP medication is clinically indicated, the platelet assessment showing a value <30 G/L must be performed after at least 14 days on a stable dose of a corticosteroid or/and a TPO-RA (less than 10% variation from current dose) and continue stable thereafter.

Key exclusion criteria:

Diagnosis of secondary thrombocytopenia.
Platelet or whole blood transfusion, plasmapheresis, or use of any other rescue medications within 14 days before first ianalumab infusion.

Participants with the following conditions at screening:

Neutrophils <1000/mm3.
Immunoglobulin G (IgG) <5 g/L
Treatment with a B-cell depleting therapy (e.g., rituximab) or anti-B-cell Activating Factor of the TNF Family (BAFF) (e.g., belimumab) within 12 weeks prior to the first administration of ianalumab.
Immunosuppressant drugs other than corticosteroids within 5 times the elimination half-life of the drug or 14 days before first ianalumab infusion, whichever is longer.
Prior splenectomy.

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

Phone: +41613241111

Email:

Novartis Pharmaceuticals

Phone: 1-888-669-6682

Email: [email protected]

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

Study Description

Interventions

Ianalumab

Eligibility Criteria

Study Location

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Beth Israel Deaconess Medical Cente

Georgetown University Lombardi Cancer Center Dept. of Pharmacy Research 4

Massachusetts General Hospital .

University of Pennsylvania IDS Central

New York Oncology Hematology Saratoga NYOH

Virginia Oncology Associates .

Worldwide Contacts

Novartis Pharmaceuticals

Novartis Pharmaceuticals

AddToAny buttons

Printable Links Block (Content)