Study of efficacy, safety, and tolerability of LNA043 in patients with knee osteoarthritis

Phase 1

Conditions: osteoarthritis
MedDRA version: 21.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2020-004897-22-CZ

Lead Sponsor: ovartis Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 550

Inclusion Criteria

-Males and females between 40 and 75 years of age
-Body mass index (BMI) < 40 kg/m2
-Diagnosis of primary tibiofemoral knee OA by standard American College of Rheumatology clinical and radiographic criteria
-and other criteria as specified by the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

-Participants with radiographic knee OA K-L grade = 4 on the non-target knee
-Arthroscopy of the target knee within the 6 months prior to Screening
-Hemoglobin < 8.5 g/dL (85 g/L) or platelet count < 100,000/µL
-and other criteria as specified by the protocol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate knee structure changes;Secondary Objective: - To evaluate changes from baseline in OA pain<br>- To evaluate changes from baseline in physical function<br>- To evaluate changes from baseline the cartilage structure<br>- To evaluate changes from baseline in physical function<br>- To evaluate structural progression<br>- To evaluate safety and tolerability of the various LNA043 regimens<br><br>;Primary end point(s): Change from baseline in the knee structure;Timepoint(s) of evaluation of this end point: Week 0 to Week 104

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain<br>-Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function<br>- Change from baseline in cartilage structure<br>- Change from baseline in physical function<br>- Proportion of participants demonstrating structural progression<br>- Assessing adverse events and serious adverse events;Timepoint(s) of evaluation of this end point: - Week 0 to Week 104<br>- Week 0 to Week 104<br>- Week 0 to Week 104<br>- Week 0 to Week 104<br>- Week 0 to Week 104<br>- Week 0 to Week 104