Intra-articular Lopain (MTX-071) Phase I/IIa Study in Chronic Osteoarthritic Knee Joint Pain

An Open Label, Single Dose, Dose-escalating Phase I/IIa Study to Determine the Safety and Clinical Effects of Intra-articular Injections of Lopain (MTX-071) in Patients With Chronic Osteoarthritic Knee Joint Pain

Phase I/IIa study to determine the safety and clinical effects of intra-articular injections of MTX-071 (Lopain) in patients with chronic osteoarthritic knee-joint pain.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: Lopain

Detailed Description

Open label, single-dose, dose-escalating phase I/IIa study to determine the safety and clinical effects of intra-articular injections of MTX-071 (Lopain) in patients with chronic osteoarthritic knee-joint pain.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium
    • SGS Antwerpen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent
• Written informed consent
• Men or women aged between 40 and 70 years
• At least 40 mm on motion and at least 10 mm at rest on the 100 mm-VAS (Visual Analog Scale) for average arthritic joint pain in the knee to be studied during the last 2 days, with or without pain medication.
• Previously documented radiography showing a Kellgren Lawrence Grade 2 - 4 severity.
• Female patients of childbearing potential or female partners of childbearing potential of male patients must agree to use a reliable contraceptive method for at least one month after the injection of MTX-071.
• Subject is highly likely to comply with the protocol and complete the study.

Exclusion Criteria:

• Knee surgery within 6 months before study start or planned for any time during the next 6 months.
• Any injection into the knee to be studied within the preceding 7 days or trauma to the knee not yet healed.
• History of any clinically significant cardiac, renal, and/or other relevant disease or malignancy.
• History of severe allergic or anaphylactic reactions.
• Pregnancy.
• Major bleeding disorder.
• Clinically significant deviation from the normal laboratory values.
• Clinically significant abnormal ECG
• History of clinically relevant drug/chemical/ substance/alcohol abuse within the past 2 years prior to screening.
• Symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within the past 2 weeks prior to study medication administration.
• Patients positive for human immunodeficiency virus (HIV) antibody, hepatitis C antibody, or for hepatitis B virus surface antigen (HBsAg), tuberculosis.
• Patients who had a corticosteroid injection in the knee to be studied within 3 months prior to baseline or are planned to get a corticosteroid injection within 4 weeks following the injection of MTX-071.
• Vaccination within 60 days prior to study medication administration.
• Systemic immunosuppressant agent within 6 months prior to study medication administration
• Experimental agent within 30 days or ten half-lives, whichever is longer, prior to study medication administration.
• Any other condition, which in the opinion of the investigator, precludes the subject's participation in the trial.
• Patients who are dependent on the sponsor or investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: open label, single arm; Open label, single arm, dose escalating	Drug: Lopain; intra-articular injection; Other Names: MTX-071

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity and severity of AES/SAEs potentially causally related with the study medication	overall and per dose level (descriptive statistics) incidence, intensity and severity of AES/SAEs potentially causally related with the study medication	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain relief response: overall and dose response	overall and per dose level percentage of patients overall percentage of patients with pain relief response to single intraarticular administration of Lopain (MTX-071) defined as more than a 20% decrease from baseline in mm on the VAS for pain on motion without increase in pain medication	up to 6 months
duration of pain relief response: overall and dose response	overall and per dose level intra-patients maintenance at 7 days, 1, 3 and 6 months of the pain relief response defined as more than a 20% decrease from baseline in mm on the VAS for pain on motion without increase in pain medication	up to 6 months
Acceptance of / satisfaction with treatment as stated by the patients and physicians. (VAS score)	per dose level VAS score on acceptance of / satisfaction with treatment as stated by the patients and physicians.	up to 6 months
Influence of treatment on functionality of the knee joint and patients' general feeling of health and estimation of daily life conditions (VAS scores)	per dose level VAS scores on functionality of the knee joint and patients' general feeling of health and estimation of daily life conditions	up to 6 months

Collaborators and Investigators

• Sponsor: Grünenthal GmbH
• Investigators: Principal Investigator: Steven Ramael, SGS Antwerpen, Belgium

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: September 22, 2015
• First Submitted That Met QC Criteria: October 1, 2015
• First Posted (Estimate): October 2, 2015

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Arthralgia; Osteoarthritis, Knee
• Other Study ID Numbers: MTX-071-P01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided