Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05804045 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis, sponsored by Abbisko Therapeutics Co.

Active
Registry status
Phase 3
Development phase
90
Enrollment target
20
Study locations

NCT05804045 is a Phase 3 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis that is active but no longer recruiting, run by Abbisko Therapeutics Co. The registered enrollment target is 90 participants, below the 107-participant average among 8 other Tenosynovial Giant Cell Tumor trials with a reported enrollment target (16% lower). The trial reports 20 study locations across 14 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05804045, a Phase 3 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis, is active but no longer recruiting, sponsored by Abbisko Therapeutics Co.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
90 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Tenosynovial Giant Cell Tumor Pigmented Villonodular Synovitis Giant Cell Tumor of Tendon Sheath

Interventions

  • DRUG Placebo
  • DRUG Pimicotinib(ABSK021)

Study Locations (20)

Guangdong

  • Guangdong Provincial People's Hospital - Guangzhou
  • The First Affiliated Hospital of Jinan University - Guangzhou
  • The First Affiliated Hospital, Sun Yat-sen University - Guangzhou

California

  • Precision NextGen Oncology - Beverly Hills
  • Duke University Medical Center - Durham

Ohio

  • The Cleveland Clinic Foundation - Cleveland
  • The Ohio State University - Columbus

Other

  • McGill University Health Center - Montreal
  • Princess Margaret Cancer Center - Toronto

Hubei

  • The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture - Enshi
  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology - Wuhan

Michigan

  • Henry Ford Health System - Detroit

New York

  • Roswell Park Comprehensive Cancer Center - Buffalo

Texas

  • The University of Texas M.D. Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2023-04-27
Est. Completion 2028-06
Phase Phase 3

Sponsor

Abbisko Therapeutics Co

6 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05804045

The ClinicalTrials.gov registry entry for NCT05804045 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 107-participant average among 8 other Tenosynovial Giant Cell Tumor trials with a reported enrollment target (16% lower). The listed sponsor is Abbisko Therapeutics Co, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Tenosynovial Giant Cell Tumor appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05804045 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Guangdong, California, Ohio.

Frequently Asked Questions

What is clinical trial NCT05804045 about?

NCT05804045 is a clinical study titled "Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)". 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 s...

What is the current status of trial NCT05804045?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2023-04-27. Estimated completion is 2028-06.

What conditions does trial NCT05804045 study?

This clinical trial studies the following conditions: Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath.

What interventions are being tested in trial NCT05804045?

The interventions under investigation include: Placebo (DRUG), Pimicotinib(ABSK021) (DRUG).

Who is sponsoring clinical trial NCT05804045?

This trial is sponsored by Abbisko Therapeutics Co, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05804045 being conducted?

This trial has 20 study locations across California, Michigan, New York, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Tenosynovial Giant Cell Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Tenosynovial Giant Cell Tumor

All registered trials for this condition

Pigmented Villonodular Synovitis

All registered trials for this condition

California

All trials with a study site in California

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.