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

NCT02566564 | Completed Phase 1 DMC

• 1 other identifier: MTX-071-P01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• pain relief response: overall and dose response

  up to 6 months

• duration of pain relief response: overall and dose response

  up to 6 months

• Acceptance of / satisfaction with treatment as stated by the patients and physicians. (VAS score)

  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)

  up to 6 months

Study Arms (1)

open label, single arm

EXPERIMENTAL

Open label, single arm, dose escalating

Drug: Lopain

Interventions

Lopain DRUG

intra-articular injection

Also known as: MTX-071

open label, single arm

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grünenthal GmbH: lead

Study Sites (1)

SGS Antwerpen

Antwerp, Belgium

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Steven Ramael

  SGS Antwerpen, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: October 2, 2015
• Study Start: April 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 16, 2021

Record last verified: 2021-07

Locations

BE (1)