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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05395091
Other study ID # AVT03-GL-C01
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date August 23, 2022
Est. completion date October 25, 2024

Study information

Verified date May 2024
Source Alvotech Swiss AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of AVT03 and US-Prolia in postmenopausal women with osteoporosis.


Description:

After the screening activities, eligible subjects were randomized to receive either AVT03 60 mg or Prolia® 60 mg, administered as a subcutaneous (s.c.) injection At Month 12, subjects in AVT03 treatment group will receive a third dose of AVT03 60 mg administered s.c. while subjects in Prolia® treatment group will be re-randomized to receive either Prolia 60 mg or AVT03 60 mg administered as a subcutaneous injection. Afterwards, the subjects will be followed until the End of Study (EoS) Visit.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 532
Est. completion date October 25, 2024
Est. primary completion date May 7, 2024
Accepts healthy volunteers No
Gender Female
Age group 50 Years and older
Eligibility 1. Postmenopausal women with osteoporosis willing to sign an informed consent form (ICF)and able to undergo protocol related procedures. 2. A baseline dual-energy x-ray absorptiometry (DXA) scan with a T score =-2.5 and - 4.0 at the LS (L1 to L4)and/or, total hip, and/or femoral neck. 3. Age: =50 years. 4. Female subject is postmenopausal according to 1 of the following criteria: 1. Spontaneous amenorrhea for =12 consecutive months 2. Biochemical criteria of menopause, follicle-stimulating hormone, >40 IU/L except surgically sterile 3. Having had bilateral oophorectomy =6 weeks prior to Screening 5. Willing to receive calcium plus vitamin D supplements. 6. At least 2 consecutive evaluable lumbar vertebrae and at least 1 evaluable hip. Exclusion Criteria 1. Evidence of clinically relevant pathology, especially prior diagnosis of bone disease, or any uncontrolled condition that will affect bone metabolism 2. History and/or presence of 1 severe or more than 1 moderate vertebral fractures confirmed by x-ray. 3. History of hip fracture 4. Presence of active healing fractures 5. Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures 6. Evidence of hypo/hypercalcemia at Screening 7. Known vitamin D deficiency 8. Known intolerance to calcium and vitamin D supplement.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
AVT03
AVT03 (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL to be administered as a subcutaneous injection. Subjects in this arm will receive AVT03 60mg administered s.c. At Month 12, subjects in the AVT03 arm will receive a third dose of AVT03 60 mg.
Denosumab
Prolia (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL developed to be administered as a subcutaneous injection. Subjects will receive 60mg of commercially available US-Prolia, administered s.c At Month 12, subjects in the Prolia treatment group will be re-randomized in a 1:1 ratio to receive either: Group 2a: Subjects will receive AVT03 60 mg administered s.c. on Day365. Group 2b: Subjects will receive Prolia 60 mg administered s.c. on Day365.

Locations

Country Name City State
Bulgaria Investigational Site 3501 Plovdiv
Bulgaria Investigational Site 3503 Plovdiv
Bulgaria Investigational Site 3502 Stara Zagora
Czechia Investigational Site 4201 Praha
Czechia Investigational Site 4202 Uherské Hradište
Georgia Investigational Site 9901 Tbilisi
Georgia Investigational Site 9902 Tbilisi
Georgia Investigational Site 9903 Tbilisi
Georgia Investigational Site 9904 Tbilisi
Georgia Investigational Site 9905 Tbilisi
Georgia Investigational Site 9906 Tbilisi
Poland Investigational Site 4803 Bialystok
Poland Investigational Site 4804 Bialystok
Poland Investigational Site 4802 Kraków
Poland Investigational Site 4807 Kraków
Poland Investigational Site 4806 Lódz
Poland Investigational Site 4811 Lublin
Poland Investigational Site 4812 Poznan
Poland Investigational Site 4801 Skierniewice
Poland Investigational Site 4805 Swidnik
Poland Investigational Site 4809 Warsaw
Poland Investigational Site 4810 Zamosc
South Africa Investigational Site 2705 Bloemfontein
South Africa Investigational Site 2714 Cape Town
South Africa Investigational Site 2707 Centurion
South Africa Investigational Site 2708 Centurion
South Africa Investigational Site 2710 Groenkloof
South Africa Investigational Site 2712 Johannesburg
South Africa Investigational Site 2702 Kwadukuza
South Africa Investigational Site 2711 Parow
South Africa Investigational Site 2701 Port Elizabeth
South Africa Investigational Site 2706 Pretoria
South Africa Investigational Site 2713 Pretoria
South Africa Investigational Site 2703 Worcester

Sponsors (1)

Lead Sponsor Collaborator
Alvotech Swiss AG

Countries where clinical trial is conducted

Bulgaria,  Czechia,  Georgia,  Poland,  South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary To demonstrate clinical similarity of AVT03 and Prolia® in terms of change in Bone Mineral Density (BMD). Change in BMD Month 12
Primary To demonstrate clinical similarity of AVT03 and Prolia in terms of area under the percent change from Baseline in serum C-telopeptide of type 1 collagen (AUEC of %Cfb sCTX-1) Month 6
Secondary Percent change from Baseline in LS BMD Percent change from Baseline in LS BMD at 6 and 18 months Month 18
Secondary Percent change from Baseline in hip and femoral neck BMD Percent change from Baseline in hip and femoral neck BMD at Month 6, 12 and 18 months Month 6, Month 12, Month 18
Secondary Incidence of new morphometric vertebral fractures Incidence of new morphometric vertebral fractures at 12 and 18 months Month 12 and 18
Secondary Percent change from Baseline in sCTX-1 Percent change from Baseline in sCTX-1 at 3, 6, 9, 12 and 18 months Month 3, Month 6, Month 9, Month 12 and Month 18
Secondary Incidence, nature and severity of adverse events including adverse drug reactions Month 18
Secondary Frequency and severity of injection site reactions Month 12
Secondary Frequency and severity of findings in routine safety parameters Month 18
Secondary Frequency and titer of anti-drug antibodies and frequency of neutralizing antibodies against AVT03 and Prolia Month 18
Secondary Serum trough concentration of AVT03 and Prolia Month 18
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