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Study of Safety, Tolerability, Preliminary Efficacy of Intra-articular LNA043 Injections in Patients With Articular Cartilage Lesions.

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ClinicalTrials.gov Identifier: NCT03275064
Recruitment Status : Recruiting
First Posted : September 7, 2017
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study is to assess the efficacy, safety and tolerability of multiple intra-articular (i.a.) injections of LNA043 over 4-weeks, in regenerating the articular surface in patients with cartilage lesions of the knee.

Condition or disease Intervention/treatment Phase
Wounds and Injuries Biological: LNA043 Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Patient and Investigator Blinded, Study Investigating the Safety, Tolerability and Preliminary Efficacy of Intra-articular LNA043 Injections in Regenerating the Articular Cartilage of the Knee in Patients With Articular Cartilage Lesions.
Actual Study Start Date : September 12, 2017
Estimated Primary Completion Date : September 16, 2019
Estimated Study Completion Date : September 16, 2019

Arm Intervention/treatment
Experimental: LNA043 Biological: LNA043
LNA043 intra-articular injection

Placebo Comparator: Placebo Other: Placebo
Placebo intra-articular injection




Primary Outcome Measures :
  1. Articular cartilage bi-layer collagen organisation evaluated with MRI [ Time Frame: Up to Week 28 ]
  2. Number of patients with any adverse events, serious adverse events and death [ Time Frame: Up to 31 weeks ]

Secondary Outcome Measures :
  1. Percentage (%) of cartilage defect filling evaluated with MRI [ Time Frame: Week 16, Week 28 ]
  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0 (pre-dose), 15 min, 60 min and 120 min post-dose Week 1, Week 2, Week 3, Week 4 ]
  3. Potential immunogenicity of LNA043 presence and characterisation of anti-LNA043 antibodies in serum [ Time Frame: Week 1, Week 3, Week 6, Week 16, Week 28 ]
  4. Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (AUClast) [ Time Frame: 0 (pre-dose), 15 min, 60 min and 120 min post-dose Week 1, Week 2, Week 3, Week 4 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Patient is ≥18 and ≤55 years old at time of screening.
  • Patient has a body mass index (BMI) <30 kg/m2 at screening, for patients with BMI >30 but ≤ 33kg/m2, eligibility will be decided by consultation with the sponsor.
  • Patient has a symptomatic, single, articular cartilage defect of one knee, grade II or IIIA according to the ICRS classification, localized to either the femoral condyles/femoral trochlea or to the patella, based on MRI or arthroscopy performed within 9 months before screening visit and confirmed by screening 3T MRI.
  • Patient has an onset of pain and impairment of function between two (2) months and two (2) years before screening.
  • Patient reports a KOOS (sports and recreational activities subscale) score of ≤ 60 at both screening and Day 1.

Exclusion criteria

  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 15 days after stopping of investigational drug.
  • Regular smokers (> 5 cigarettes/day). Urine cotinine levels will be measured during screening for all patients. Regular smokers will be defined as any patient who reports tobacco use of > 5 cigarettes/day and/or who has a urine cotinine ≥ 500 ng/mL.
  • Patient has radiologically apparent degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade ≥2 based on X-ray evaluation performed within 9 months from screening.
  • Patient has had surgical treatment of the target knee using mosaicplasty, microfracture, meniscectomy >50% (Note: prior diagnostic arthroscopy with debridement and lavage, <50% meniscectomy, lateral release, patellar realignment, medial patellofemoral ligament reconstruction are acceptable if performed at least 2 months prior to screening; anteriorcruciate ligament reconstrucion is acceptable if performed 12 months prior to screening, or less if restoration of joint function is evident, and agreed by the sponsor).
  • Patient has an unstable target knee joint or insufficiently reconstructed ligaments based on medical history and physical examination by the investigator.
  • Patients with patellofeoral dysplasia Dejour and patients with malalignment, X-ray requirement not limited to 9 months.
  • Patient has patellofemoral dysplasia Dejour Grade B-D based on X-ray evaluation performed within 9 months from screening.
  • Patient has malalignment (valgus- or varus-deformity) in the target knee ≥ 5° based on X-ray evaluation performed within 9 months from screening. In suspected cases, the mechanical axis must be established radiographically through complete leg imaging during standing and in postero-anterior (PA) projection.

Prohibited medication updated with reference to dosing (formerly screening).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275064


Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
United States, Arizona
Novartis Investigative Site Recruiting
Phoenix, Arizona, United States, 85053
United States, California
Novartis Investigative Site Recruiting
La Mesa, California, United States, 91942
United States, Florida
Novartis Investigative Site Recruiting
Longwood, Florida, United States, 32750
Novartis Investigative Site Recruiting
Miami Lakes, Florida, United States, 33014
United States, Illinois
Novartis Investigative Site Recruiting
Chicago, Illinois, United States, 60612
United States, Indiana
Novartis Investigative Site Recruiting
Greenwood, Indiana, United States, 46143
Czechia
Novartis Investigative Site Recruiting
Brno, Czech Republic, Czechia, 66250
Novartis Investigative Site Recruiting
Mlada Boleslav, Czech Republic, Czechia, 29301
Novartis Investigative Site Recruiting
Kladno, Czechia, 272 59
Novartis Investigative Site Recruiting
Pardubice, Czechia, 53002
Denmark
Novartis Investigative Site Recruiting
Aarhus C, Denmark, DK 8000
Novartis Investigative Site Recruiting
Hvidovre, Denmark, 2650
Sweden
Novartis Investigative Site Terminated
Kungsbacka, Sweden, 434 80
Sponsors and Collaborators
Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03275064     History of Changes
Other Study ID Numbers: CLNA043X2202
2016-004052-30 ( EudraCT Number )
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Articular cartilage, partial thickness cartilage lesion, knee, cartilage
regeneration

Additional relevant MeSH terms:
Wounds and Injuries