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

NCT ID: NCT02566564

Last Updated: 2021-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-06-30

Brief Summary

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.

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

open label, single arm

Open label, single arm, dose escalating

Group Type: EXPERIMENTAL

Lopain

Intervention Type: DRUG

intra-articular injection

Interventions

Lopain

intra-articular injection

Intervention Type: DRUG

Other Intervention Names

MTX-071

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grünenthal GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Ramael

Role: PRINCIPAL_INVESTIGATOR

SGS Antwerpen, Belgium

Locations

SGS Antwerpen

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

MTX-071-P01

Identifier Type: -

Identifier Source: org_study_id