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Clinical Trial Details
Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)
Complete Title: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study of ABSK021 to Assess the Efficacy and Safety in Patients with Tenosynovial Giant Cell Tumor
Trial Phase: III
Investigator: Michael Wagner
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. Complete the study procedures speficied in the protocol, which is guided by researchers.
Keywords:
- Giant Cell Tumors
- Synovitis, Pigmented Villonodular
- Giant Cell Tumour, Tenosynovial
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Adult
III
Michael Wagner
RG1123595
NCT05804045
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study of ABSK021 to Assess the Efficacy and Safety in Patients with Tenosynovial Giant Cell Tumor
Giant Cell Tumors
Synovitis, Pigmented Villonodular
Giant Cell Tumour, Tenosynovial