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

NCT ID: NCT02491281

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-16

Study Completion Date

2018-03-06

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery

Keywords

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Primary Osteoarthritis, Total Knee Replacement, cartilage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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LNA043

LNA043 given intra-articularly

Group Type EXPERIMENTAL

LNA043

Intervention Type DRUG

ascending single dose on Day 1; 1 to 4 week(s) prior total knee replacement surgery

Placebo

Placebo given intra-articularly

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

ascending single dose on Day 1; 1 to 4 week(s) prior total knee replacement surgery

Interventions

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LNA043

ascending single dose on Day 1; 1 to 4 week(s) prior total knee replacement surgery

Intervention Type DRUG

Placebo

ascending single dose on Day 1; 1 to 4 week(s) prior total knee replacement surgery

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Phoenix, Arizona, United States

Site Status

Countries

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United States

References

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Gerwin N, Scotti C, Halleux C, Fornaro M, Elliott J, Zhang Y, Johnson K, Shi J, Walter S, Li Y, Jacobi C, Laplanche N, Belaud M, Paul J, Glowacki G, Peters T, Wharton KA Jr, Vostiar I, Polus F, Kramer I, Guth S, Seroutou A, Choudhury S, Laurent D, Gimbel J, Goldhahn J, Schieker M, Brachat S, Roubenoff R, Kneissel M. Angiopoietin-like 3-derivative LNA043 for cartilage regeneration in osteoarthritis: a randomized phase 1 trial. Nat Med. 2022 Dec;28(12):2633-2645. doi: 10.1038/s41591-022-02059-9. Epub 2022 Dec 1.

Reference Type DERIVED
PMID: 36456835 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=454

A Plain Language Trial Summary is available on novartisclinicatrials.com

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17358

Results for CLNA043X2101 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CLNA043X2101

Identifier Type: -

Identifier Source: org_study_id