NCT03355196

Brief Summary

This study is designed to evaluate, for the first time in humans, safety and tolerability of single ascending doses of intra-articular (i.a.) injections of LRX712 into the knee of patients with moderate osteoarthritis (OA), in order to support the further clinical development. This study will also allow establishment of the systemic and local pharmacokinetics (PK) of LRX712 and the exploration of biomarkers of cartilage breakdown and regeneration in OA patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

November 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2019

Completed
Last Updated

December 11, 2020

Status Verified

May 1, 2020

Enrollment Period

1.3 years

First QC Date

November 17, 2017

Last Update Submit

December 9, 2020

Conditions

Patients With Moderate Knee Osteoarthritis (30 - 65 Years)

Keywords

Osteoarthritic patientsCartilageSafety

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of LRX712 after a single intra-articular (i.a.) injection in Osteoarthritic (OA) patients

    To evaluate Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of LRX712 after a single i.a. injection in osteoarthritic patients

    Day 29

Secondary Outcomes (7)

  • Time to Reach the Maximum Plasma Concentration (Tmax)

    pre-dose to 29 days post-dose

  • Maximum Observed Plasma Concentration (Cmax)

    pre-dose to 29 days post-dose

  • Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (AUClast)

    pre-dose to 29 days post-dose

  • Area under the plasma concentration-time curve from time zero to infinity (AUCinf)

    pre-dose to 29 days post-dose

  • Half-life (T1/2)

    pre-dose to 29 days post-dose

  • +2 more secondary outcomes

Study Arms (2)

LRX712

EXPERIMENTAL

LRX712 given intra-articularly

Drug: LRX712

Placebo

PLACEBO COMPARATOR

Placebo given intra-articularly

Drug: Placebo

Interventions

LRX712DRUG

Ascending single dose on Day 1

LRX712
PlaceboDRUG

Ascending single dose on Day 1

Placebo

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients, 30 to 65 years of age inclusive, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
  • At screening, and at baseline vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three minutes, and again (when required) after three minutes in the standing position as outlined in the SOM.
  • Sitting vital signs should be guided by the following ranges:
  • body temperature between 35.0-37.5 °C
  • systolic blood pressure 90-139 mm Hg
  • diastolic blood pressure 50-89 mm Hg
  • pulse rate, 40 - 90 bpm • Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 32 kg/m2. BMI = Body weight (kg) / \[Height (m)\]

You may not qualify if:

  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
  • Pregnant or nursing (lactating) women
  • Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations
  • A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening and baseline
  • PR \> 200 msec
  • QRS complex \> 120 msec
  • QTcF \> 450 msec (males)
  • QTcF \> 460 msec (females)
  • Known family history or known presence of long QT syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Leiden, 2333 CL, Netherlands

Location

Related Links

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 28, 2017

Study Start

November 20, 2017

Primary Completion

March 26, 2019

Study Completion

March 26, 2019

Last Updated

December 11, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)