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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05885555
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Primary Immune Thrombocytopenia (ITP)

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Ianalumab — BIOLOGICAL
    Intravenous infusion, prepared from concentrate solution

Study Details

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.

Key Dates

Start date
Aug 16, 2023
Status verified
Apr 2026
Primary completion
Feb 5, 2025
Completion
Mar 19, 2029

Study Design

Enrollment
41 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single-arm
    All eligible participants will receive ianalumab at the same dose.

Primary Outcome Measure

Confirmed response [ Time Frame: Between Week 1 Day 1 and Week 25 Day 1 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Med CenterBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-

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