First-in-human Single Ascending Dose Study of LNA043 in Patients Scheduled for Total Knee Replacement

Novartis

Status and phase

Completed

Phase 1

Conditions

Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery

Treatments

Drug: LNA043

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02491281

CLNA043X2101

Details and patient eligibility

About

This study is designed to evaluate the safety and tolerability of ascending single doses of LNA043 given intra-articularly into the human knee joint prior to its removal at total knee replacement surgery. In addition, this will help to establish the presence of LNA043 within the articular cartilage, assess pharmacokinetics and immunogenicity, and will allow exploration of biomarkers of hyaline cartilage repair.

Enrollment

28 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Male and female patients age 50 to 75 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
Patients diagnosed with primary osteoarthritis of the knee assessed locally for whom a total knee replacement is planned
General health status acceptable for total knee replacement surgery in the opinion of the investigator
Stable medications within 3 months prior to enrollment (such as appropriate pain medication, antibiotics prophylaxis) and standard of care

Key Exclusion Criteria:

Presence of inflammatory arthropathy (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout), active acute or chronic infection, or systemic cartilage disorder
Prior cartilage repair surgery, e.g. microfracture, autologous cartilage implantation (ACI) or else, at the same knee
Any surgical therapy or local treatment i.a. into the knee (viscosupplementation) to the knee within 2 months prior to enrollment
BMI > 40; presence of uncontrolled diabetes or hyperthyroidism
Large effusion in the knee to be replaced, more than (>)1 cm fluid in the suprapatellar space at the midline
Corticosteroid use by any route except topical and nasal in the 3 months prior to enrollment
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
Pregnant or nursing (lactating) women
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant