WHO ICTRP trial
Comparative efficacy, safety, pharmacokinetic, and immunogenicity study of…
EUCTR2022-002312-23-CZ · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2022-002312-23-CZ |
|---|---|
| Public title | Comparative efficacy, safety, pharmacokinetic, and immunogenicity study of LY06006 and EU-Prolia in postmenopausal women with osteoporosis. |
| Scientific title | A randomized, double-blind, parallel-group, active-controlled comparative study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of LY06006 compared with EU-Prolia in postmenopausal women with osteoporosis |
| Primary sponsor | Shandong Boan Biotechnology Co., Ltd. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Czech Republic;United States;Czechia;Japan;Poland;Bulgaria |
| Conditions | Postmenopausal osteoporosis MedDRA version: 20.0 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G]… |
| Interventions | Product Name: LY06006, proposed denosumab biosimilar Product Code: LY06006 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Denosumab CAS Number: 615258-40-7 Current Sponsor code: LY06006 Other… |
| Registration date | Jan 24, 2023 |
| Target size | 524 |
| Secondary IDs | LY06006/MRCT-301;2022-002312-23-BG |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: