Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoarthritis

NCT04333160 | Completed Phase 3

• 1 other identifier: 000014/BT
• Study Type: interventional
• Target: 746
• Locations: 7 countries
• Sites: 22

Brief Summary

Osteoarthritis is a degenerative, chronic, and progressive joint disease considered as the most common joint disorder worldwide. In healthy joints, there is a continuous process of natural breakdown and repair of cartilage. This process becomes disrupted in OA, leading to degeneration and loss of articular cartilage, along with other joint changes, including subchondral bone remodeling, osteophyte formation, thickening of the capsule and sometimes inflammation of the synovia. JTA-004 is a plasma protein solution supplemented with HA and clonidine developed as a single IA injection for the treatment of knee OA. Local administration of JTA-004 into the joint cavity is intended to relieve chronic pain in subjects suffering from knee OA and discomfort associated with the IA administration. The JTA-004 Phase III study is a placebo and active-controlled, randomized, double-blind study to evaluate the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee at 3 months compared to placebo or active comparator. The study is expected to enrol 742 patients with mild to moderate symptomatic knee osteoarthritis in 22 centres in 6 European countries and Hong Kong SAR.

Conditions

Symptomatic Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

• knee pain

  Difference between JTA-004 and placebo in mean change from baseline in knee pain at Month 3 using the Western Ontario McMaster University (WOMAC®) Visual Analogue 3.1 pain subscale (subscale A; score 0 (no-pain)-100 (worst imaginable pain) mm).

  3 months

Secondary Outcomes (7)

• knee pain

  6 months

• Knee pain

  3 months

• knee physical function

  3 months

• Patient Global assessment

  3 months

• physical function

  6 months

Study Arms (3)

JTA-004

EXPERIMENTAL

single knee intra-articular injection of JTA-004 solution (2ml)

Drug: JTA-004

placebo

PLACEBO COMPARATOR

single knee intra-articular injection of saline solution (2ml)

Other: placebo

Hylan G-F 20

ACTIVE COMPARATOR

single knee intra-articular injection of Hylan G-F 20 (6ml)

Device: Hylan G-F 20

Interventions

JTA-004 DRUG

Patients will undergo a single intra-articular injection of JTA-004 into the knee joint

JTA-004

Hylan G-F 20 DEVICE

Patients will undergo a single intra-articular injection of Hylan G-F 20 into the knee joint

Hylan G-F 20

placebo OTHER

Patients will undergo a single intra-articular injection of placebo into the knee joint

Also known as: saline solution

placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory (able to walk unassisted, the use of a crutch or a walking stick (only one) is allowed if already used at screening but should be avoided during the study up to the 6-month follow-up visit)
• Diagnosed with primary knee OA, fulfilling the following American College of Rheumatology (ACR) criteria at the target knee:
• Pain present for most days of the preceding month
• Morning stiffness \< 30 minutes
• Kellgren-Lawrence grade II or III (confirmed by appropriate X-rays taken within 6 months prior to screening visit)
• Target knee pain ≥ 200 mm and ≤ 400 mm out of 500 mm on the WOMAC® VA3.1 pain questionnaire (sum of 5 questions) at screening and baseline
• Insufficient/failed response or intolerance to analgesics and/or non-steroidal anti-inflammatory drugs (NSAIDs) as reported by the subject
• Willing and able to abstain from initiation of physical therapy and of use of knee braces at the target knee up to the 6-month follow-up visit (a subject undergoing physical therapy or using knee braces at a stable frequency for at least 2 weeks prior to screening is allowed to continue at same frequency (frequency increase is not allowed))
• Capable to understand and comply with study requirements and to provide a written, dated, and signed informed consent prior to any study procedure for participation in the study and transmission of personal "pseudo-anonymized" data

You may not qualify if:

• Concomitant inflammatory disease or other conditions affecting the joints (e.g., infectious arthritis, rheumatoid arthritis, psoriatic arthritis or spondyloarthropathy, Paget's disease, hemochromatosis…)
• Any target knee abnormality that could impact safety or efficacy assessment
• Microcrystalline arthropathies: chondrocalcinosis/calcium pyrophosphate dihydrate disease (pseudo-gout) or gout if believed likely to interfere with the study endpoints, in the opinion of the Investigator
• Clinically significant valgus/varus deformities at the Investigator's discretion
• Any musculoskeletal condition (such as symptomatic hip OA, amputation, neurologic disorder, chronic back pain with or without radiculopathy, sciatica) that would impede measurement of efficacy at target knee
• Contralateral knee pain equal to or exceeding the pain in the target knee (on the WOMAC® VA3.1 pain questionnaire) at screening and/or baseline
• Knee arthroplasty planned within 12 months after the screening visit Current or previous diagnoses, signs and/or symptoms
• Uncontrolled diabetes mellitus (hemoglobin A1c \[HbA1c\] \> 10% or \> 86 mmol/mol), end-stage hepatic or renal disease (severe and clinically significant abnormalities according to local laboratory ranges) documented in the subject's file
• Any relevant cardiovascular disease (severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease) or any clinically significant electrocardiogram (ECG) abnormality as judged by the Investigator
• Subject with neuropathic pain or chronic pain syndrome including fibromyalgia
• Current (or within the last 5 years prior to entering the study) history of solid or hematological neoplasia or bone marrow transplantation (except for basal cell carcinoma and completely excised squamous cell carcinoma)
• Other severe acute or chronic medical or psychiatric conditions or pre-dispositions or laboratory abnormalities, as judged by the Investigator
• Current or past history of coagulation disorders (according to local laboratory ranges), as judged by the Investigator
• Hypersensitivity to any components of hyaluronic acid (HA)-based injection products
• Hypersensitivity to human biological material including blood and blood-derived products, potential excipients and residues from manufacturing process, documented clinically or by laboratory tests

Sponsors & Collaborators

• Bone Therapeutics S.A: lead
• Nordic Bioscience A/S: collaborator

Study Sites (22)

Cliniques universitaires Saint-Luc (UCL)

Brussels, 1200, Belgium

Location

UZ Leuven University Hospitals Leuven

Leuven, 3000, Belgium

Location

CHU Liège

Liège, 4020, Belgium

Location

CHU Ambroise Paré

Mons, 7000, Belgium

Location

CCR Brno, s.r.o

Brno, 60200, Czechia

Location

CCR Czech, a.s

Pardubice, 53002, Czechia

Location

CCR Prague s.r.o

Prague, 13000, Czechia

Location

The Parker Institute

Frederiksberg, 2000, Denmark

Location

Sanos Clinic

Gandrup, Denmark

Location

Sanos Clinic

Herlev, 2730, Denmark

Location

Sanos Clinic

Vejle, 7100, Denmark

Location

Hong Kong Center for Clinical Research

Hong Kong, Hong Kong

Location

"Timofei Mosneaga" Republican Clinical Hospital, Sectia Reumatologie,

Chisinau, 2025, Moldova

Location

RTL SM SRL / Institutul de Cardiologie, sectia consultativa

Chisinau, 2025, Moldova

Location

PL35

Bytom, Poland

Location

PL37

Gdansk, Poland

Location

PL36

Katowice, Poland

Location

PL31

Nadarzyn, Poland

Location

PL32

Poznan, Poland

Location

PL33

Poznan, Poland

Location

PL34

Swidnica, Poland

Location

St Pancras Clinical Research

London, United Kingdom

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: March 10, 2020
• Primary Completion: March 31, 2021
• Study Completion: December 9, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-03

Locations

PL (7); HK (1); GB (1); BE (4); DK (4); MO (2); CZ (3)