Efficacy, safety, PK, PD, and immunogenicity of BP16 in post-menopausal osteoporosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Curateq Biologics Private Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

9 Jan 2024 → 12 Dec 2025

Decision date (initial)

2023-11-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Curateq Biologics Private Limited

External identifiers

EU CT number

2023-503790-37-00

WHO UTN

U1111-1289-3242

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Pharmacodynamic, Safety, Bioequivalence, Others, Efficacy

1. To demonstrate therapeutic and PD equivalence between BP16 and EU-Prolia in terms of change in BMD at Week 52.
2. To demonstrate therapeutic and PD equivalence between BP16 and EU-Prolia in terms of area under the effect curve (AUEC) in serum C-telopeptide (sCTX) up to Week 26

Secondary objectives 5

1. To assess and compare the PD between BP16 and EU-Prolia. 2. To assess and compare other efficacy parameters between BP16 and EU-Prolia. 3. To assess and compare the PK parameters between BP16 and EU-Prolia. 4. To assess and compare the safety between BP16 and EU-Prolia. 5. To assess and compare the immunogenicity between BP16 and EU-Prolia.
2. To assess and compare other efficacy parameters between BP16 and EU-Prolia.
3. To assess and compare the PK parameters between BP16 and EU-Prolia.
4. To assess and compare the safety between BP16 and EU-Prolia.
5. To assess and compare the immunogenicity between BP16 and EU-Prolia.

Conditions and MedDRA coding

Post-Menopausal Osteoporosis

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Signed and dated written informed consent prior to any study-specific procedures, ability to understand, and willingness to comply with the study procedures, restrictions, and requirements as judged and confirmed by the investigator.
2. Post-menopausal women with age between 55 and 80 years (both inclusive) at screening visit.
3. Evidence of osteoporosis as assessed by LS absolute BMD corresponding to T-score of -2.5 and -4.0 (both inclusive) at lumbar spine
4. Body weight: 50 to 90 kg (both inclusive).
5. At least 3 intact, nonfractured vertebrae in the L1-L4 region are evaluable by DXA (as assessed by central imaging center).

Exclusion criteria 4

1. Known history of hypersensitivity or allergic reactions to denosumab or any of its excipients.
2. Previous exposure to denosumab (Prolia, Xgeva, or biosimilar denosumab).
3. T-score of <-4.0 at either region of lumbar spine, total hip, or femoral neck.
4. Prior or ongoing use of any anti-osteoporotic treatment. For the rest of the exclusion criteria, please refer to the study protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Percent change from baseline (%CfB) in lumbar spine bone mineral density (LS-BMD) at Week 52
2. AUEC of sCTX from Week 0 up to Week 26 (AUEC0-26w).

Secondary endpoints 10

1. Percent change in bone turnover markers (sCTX and P1NP) at Week 26, Week 52, and Week 78.
2. %CfB in LS-BMD at Week 26 and Week 78.
3. %CfB in total hip and femoral neck BMD at Week 26, Week 52, and Week 78.
4. Incidence of fracture up to Week 52 and Week 78.
5. Ctrough: Serum trough concentration of denosumab at Week 26, Week 52, and Week 78.
6. Incidence, nature, and severity of adverse events (AE) including adverse drug reactions (ADRs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 as defined by TEAEs,SAEs, related TEAEs, and related SAEs.
7. Physical examination, vital signs, and 12-lead ECG.
8. Laboratory parameters (hematology, clinical chemistry, and urinalysis).
9. Incidence and titer of antidrug antibody to denosumab at Week 0, Week 12, Week 26, Week 52, and Week 78.
10. Incidence of neutralizing antibody in all the ADA-positive subjects.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Curateq Biologics Private Limited

Sponsor organisation

Curateq Biologics Private Limited

Address

Survey No. 77 And 78, Indrakaran Village, Kandi Mandal, Sangareddy Dist Indrakaran Village Kandi Mandal

City

Hyderabad

Postcode

502329

Country

India

Scientific contact point

Organisation

Curateq Biologics Private Limited

Contact name

Dr Arpitkumar Prajapati

Public contact point

Organisation

Curateq Biologics Private Limited

Contact name

Dr Arpitkumar Prajapati

Third parties 11

Locations

6 EU/EEA countries · 45 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 57 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

15 submissions — initial application plus substantial / non-substantial modifications