Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for TLC599 in OA Patients

NCT03005873 | Completed Phase 2 Results DMC

• 1 other identifier: TLC599A2003
• Study Type: interventional
• Target: 76
• Locations: 2 countries
• Sites: 13

Brief Summary

This trial is a Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritis of the knee; TLC599; Dexamethasone; DSP

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in WOMAC Pain Subscale at Week 12

  The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale consist of five items, each ranging from 0 to 4, making the total Pain subscore 0 to 20. The total score of the pain subscale for each patient is normalized and expressed on a 0 to 4 scale. Higher scores represent higher levels of pain (worse outcome), whereas lower scores represent lower levels of pain (better outcome). Missing data were imputed.

  Baseline, Week 12

Study Arms (3)

TLC599 LD group

EXPERIMENTAL

12 mg DSP with 100 µmol PL (1.0 mL)

Drug: TLC599 LD group

TLC599 HD group

EXPERIMENTAL

18 mg DSP with 150 µmol PL (1.5 mL)

Drug: TLC599 HD group

Placebo group

PLACEBO COMPARATOR

1.5 mL normal saline

Drug: Normal Saline

Interventions

TLC599 LD group DRUG

Single dose via intra-articular injection

Also known as: 12 mg DSP with 100 µmol PL (1.0 mL)

TLC599 LD group

Normal Saline DRUG

Single dose via intra-articular injection

Also known as: Placebo

Placebo group

TLC599 HD group DRUG

Single dose via intra-articular injection

Also known as: 18 mg DSP with 150 µmol PL (1.5 mL)

TLC599 HD group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, at least 50 years of age.
• Documented diagnosis of OA of the knee for at least 6 months
• The study knee has OA with Grade 2 to 3 severity based on the Kellgren Lawrence grades
• Patients with patient related visual analogue scale (VAS) score of 5.0 to 9.0 at baseline.
• Willing and able to comply with study procedures and provide written informed consent.

You may not qualify if:

• Patients who received systemic corticosteroids within the last 30 days prior to dosing.
• Patients who use prohibited medications within 7 days prior to study drug administration or any pain control medication including acetaminophen within 48 hours prior to study drug administration.
• Patients who use prohibited medications other than acetaminophen and oral NSAIDs from screening visit to 7 days prior to study drug administration.
• Documented history and confirmed autoimmune disease
• History of post-traumatic knee arthritis, or evidence of intra articular bleeding of the study knee
• History of infective arthritis
• Unstable study knee joint
• Use of IA corticosteroid, hyaluronic acid, or other IA injection in the study knee within 3 months prior to the screening visit.
• A history of treated malignancy which is disease free for ≤ 5 years prior to the screening visit
• Uncontrolled and unstable concurrent medical or psychiatric illness, that will jeopardize the safety of the patient
• Use of any chemotherapeutic or systemic immunosuppressant agents for inflammatory diseases within 6 months prior to the screening visit.
• Current use of anticoagulants, including warfarin, heparin, low molecular weight heparin, or dabigatran.
• hemoglobin \< 8 g/dL;
• total white blood cell count \< 4000/ µL;
• serum bilirubin/ alanine aminotransferase/ aspartate aminotransferase \> 2 times upper limit of normal (ULN) for the laboratory reference ranges;

Sponsors & Collaborators

• Taiwan Liposome Company: lead

Study Sites (13)

Genesis Research Services Pty Limited

Broadmeadow, Australia

Location

Pendlebury Clinic Private Hospital

Cardiff, 2285, Australia

Location

Footscray Hospital- Western Health

Footscray, Australia

Location

Linear Clinical Research Limited

Nedlands, Australia

Location

Royal North Shore Hospital

Sydney, Australia

Location

Show Chwan Memorial Hospital

Changhua, Taiwan

Location

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Location

Chung Shan Medical University Hosptial

Taichung, 402, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Cheng Hsin General Hospital

Taipei, Taiwan

Location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Taipei Medical Universtiy Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Hunter DJ, Chang CC, Wei JC, Lin HY, Brown C, Tai TT, Wu CF, Chuang WC, Shih SF. TLC599 in patients with osteoarthritis of the knee: a phase IIa, randomized, placebo-controlled, dose-finding study. Arthritis Res Ther. 2022 Feb 21;24(1):52. doi: 10.1186/s13075-022-02739-4.

  PMID: 35189943 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Carl Brown
• Organization: Taiwan Liposome Company

tlc_clinicaltrials@tlcbio.com

886-2-2655-7377

Study Officials

• Yvonne Shih, PhD

  Taiwan Liposome Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 29, 2016
• Study Start: March 16, 2017
• Primary Completion: July 4, 2018
• Study Completion: July 4, 2018
• Last Updated: April 22, 2024
• Results First Posted: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (8); AU (5)