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

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results first posted: May 4, 2026 Secondary endpoints: details revised at 1 of 5 entriesv15 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 5 entries
  2. Enrollment target: estimated 90 to confirmed 94 Secondary endpoints: 7 to 5v14 Show 1 more changeShow less
    • Secondary endpoints: 7 to 5

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date changed from estimate of May 2026 to Sep 23, 2024v13
  4. Study sites: 38 to 40v12
  5. Trial status: Recruiting to Active, Not Recruiting Site details revised at 38 of 38 sitesv11 Show 1 more changeShow less
    • Site details revised at 38 of 38 sites
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 35 to 38 Study description expanded, about 50 wordsv10 Show 1 more changeShow less
    • Study description expanded, about 50 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 33 to 35v9
  3. Study sites: 32 to 33v8
  4. Study sites: 30 to 32v7
  5. Study sites: 28 to 30v6
  6. Study sites: 26 to 28v5
  7. Study sites: 25 to 26v4
  8. Study sites: 2 to 25 Study title expanded, about 1 wordv3 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  9. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Apr 2023 to Apr 27, 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Apr 2023 to Apr 27, 2023
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov