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A Study to Evaluate the Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone
Sponsor: Shanghai JMT-Bio Inc.
Summary
This is a phase Ⅲ, multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of narlumosbart (JMT103) in patients with unresectable or surgically difficult giant cell tumor of bone (GCTB). This clinical trial study hypothesizes narlumosbart administration groups are not inferior to active control administration groups.
Official title: A Multi-center, Randomized, Double-blind, Active-controlled, Phase Ⅲ Study to Evaluate Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
146
Start Date
2023-04
Completion Date
2028-09
Last Updated
2023-04-19
Healthy Volunteers
No
Conditions
Interventions
Narlumosbart
Administered by subcutaneous injection. Dietary Supplement: Calcium/Vitamin D. All patients should be adequately supplemented with calcium and vitamin D (at least 500 mg of calcium and 400 IU of vitamin D), except in the case of pre-existing hypercalcemia.
Denosumab
Administered by subcutaneous injection. Dietary Supplement: Calcium/Vitamin D. All patients should be adequately supplemented with calcium and vitamin D (at least 500 mg of calcium and 400 IU of vitamin D), except in the case of pre-existing hypercalcemia.
Locations (1)
Beijing Ji Shui Tan Hospital
Beijing, Beijing Municipality, China