Clinical Trial

Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to assess the efficacy and safety of Pimicotinib (ABSK021) in patients with Tenosynovial Giant Cell Tumor (TGCT). The main questions it aims to answer are: * Whether the Pimicotinib(ABSK021) works well in patients with TGCT. * Whether the Pimicotinib(ABSK021) is safe in patients with TGCT. Participants will be asked to complete the study procedures: * Receive the administration of Pimicotinib(ABSK021) or placebo (a placebo is a look-alike substance that contains no active drug) about 24 weeks in study part 1. * Receive the administration of Pimicotinib(ABSK021) about 24 weeks in study part 2. * Receive the administration of Pimicotinib(ABSK021) till study end in study part 3. * Complete the study procedures speficied in the protocol, which is guided by researchers.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2023-04-05; most recent amendment 2026-04-30.
Status change: Recruiting → Active, Not Recruiting 2024-04-10
Status change: Not Yet Recruiting → Recruiting 2023-05-17
Trial Details
NCT Number NCT05804045
Lead Sponsor Abbisko Therapeutics Co, Ltd
Conditions Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath
Enrollment 94 participants
Start Date 2023-04-27
Primary Completion 2024-09-23 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-04