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

• Status: Completed
• Trial end date: 2018-03-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

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