Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis

Phase 2

Active, not recruiting

• Conditions: Osteoarthritis
• Interventions: Drug: LNA043 Dosing Regimen A; Drug: LNA043 Dosing Regimen B; Drug: LNA043 Dosing Regimen C; Drug: LNA043 Dosing Regimen D; Drug: Placebo

• Registration Number: NCT04864392
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The study will determine the optimal dosing regimen of LNA043 in patients with knee osteoarthritis (OA).

Detailed Description

This study is a 2-period, multicenter, randomized, parallel-group, double-blind, placebo-controlled study consisting of a 2-year Core period, followed by a 3 year extension period. The primary objective of this study is to assess the efficacy of LNA043 compared to placebo at Week 104 as measured by the mean change from baseline in cartilage thickness using qMRI of the target knee

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-28
• Study Start: 2021-05-31
• Primary Completion: 2024-09-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Study Completion: 2027-10-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 585

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LNA043 Dosing Regimen A	LNA043 Dosing Regimen A	LNA043 injection to the knee with dosing regimen A
LNA043 Dosing Regimen B	LNA043 Dosing Regimen B	LNA04 injection to the knee with dosing regimen B
LNA043 Dosing Regimen C	LNA043 Dosing Regimen C	LNA043 injection to the knee with dosing regimen C
LNA043 Dosing Regimen D	LNA043 Dosing Regimen D	LNA043 injection to the knee with dosing regimen D
Placebo	Placebo	Injection to the knee

Primary Outcome Measures

Name	Time	Method
Change from baseline in the cartilage thickness of the medial compartment of the knee as assessed by imaging.	Week 0 to Week 104	To evaluate cartilage thickness changes

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index pain scale. The scale (5 questions) ranges from 0 to 50. Higher score indicates a worse outcome.	Week 0 to Week 104	To evaluate changes from baseline in OA pain
Change from baseline in the Osteoarthritis Research Society International physical performance-based assessment of 40-meter (4×10m) fast-paced walk test	Week 0 to Week 104	To evaluate changes from baseline in physical function
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index function scale. The scale (17 questions) ranges from 0 to 170. Higher scores indicates a worse outcome.	Week 0 to Week 104	To evaluate changes from baseline in physical function
Change from baseline in the cartilage thickness of the knee as assessed by imaging.	Week 0 to Week 104	To evaluate changes from baseline the cartilage structure
Change from baseline in the Osteoarthritis Research Society International physical performance-based assessments 30-second chair stand test	Week 0 to Week 104	To evaluate changes from baseline in physical function
Change from baseline in the Osteoarthritis Research Society International physical performance-based assessment of 6-minute walking test	Weeek 0 to Week 104	To evaluate changes from baseline in physical function
Proportion of participants demonstrating structural progression	Week 0 to Week 104	To evaluate structural progression
Assessing percentage of participants with adverse events and serious adverse events	Week 0 to Week 104	To evaluate safety and tolerability of the various LNA043 regimens

Trial Locations

Locations (24)

Elite Clinical Studies; 🇺🇸 Phoenix, Arizona, United States

Tucson Orthopedic Institute PC; 🇺🇸 Tucson, Arizona, United States

Clinical Trials Research; 🇺🇸 Lincoln, California, United States

Stamford Therapeutics Consortium LLC; 🇺🇸 Stamford, Connecticut, United States

Clinical Research of West Florida Inc; 🇺🇸 Tampa, Florida, United States

The Center for Rheumatology and Bone Research; 🇺🇸 Wheaton, Maryland, United States

New Orleans Center For Clinical Research-Knoxville; 🇺🇸 Knoxville, Tennessee, United States

Metroplex Clinical Research; 🇺🇸 Dallas, Texas, United States

Pioneer Research Solutions; 🇺🇸 Sugar Land, Texas, United States

Charlottesville Medical Research; 🇺🇸 Charlottesville, Virginia, United States

Sharps Hospital Grossmont; 🇺🇸 La Mesa, California, United States

Long Beach Clinical Trials; 🇺🇸 Long Beach, California, United States

Artemis Institute Clinical Research; 🇺🇸 Riverside, California, United States

Northern California Research; 🇺🇸 Sacramento, California, United States

Arthemis Clinical Research; 🇺🇸 San Diego, California, United States

Sensible Healthcare; 🇺🇸 Ocoee, Florida, United States

Conquest Research; 🇺🇸 Winter Park, Florida, United States

Chicago Clinical Research Inst; 🇺🇸 Chicago, Illinois, United States

Tandem clinical research; 🇺🇸 Marrero, Louisiana, United States

Center For Pharmaceutical Research; 🇺🇸 Kansas City, Missouri, United States

Drug Trials America; 🇺🇸 Hartsdale, New York, United States

Annapolis Rheumatology LLC; 🇺🇸 Fairfax, Virginia, United States

Virginia Ispine Physicians PC; 🇺🇸 Richmond, Virginia, United States

Novartis Investigative Site; 🇬🇧 Norwich, United Kingdom