A Study to Evaluate Efficacy and Safety of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms

NCT06693648 | Completed Phase 3 FDA Drug

• 2 other identifiers: AMZ001-0072024-517404-11
• Study Type: interventional
• Target: 549
• Locations: 5 countries
• Sites: 11

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, 6-week trial of a formulation of AMZ001 once daily versus placebo once daily.

Conditions

Osteoarthritis of Knee; Osteoarthritis, Knee

Keywords

AMZ001; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the WOMAC pain sub-score in the target knee at week 2.

  WOMAC: Western Ontario and McMasters University Osteoarthritis Index Scale: 0-100, 100 being the worse

  Baseline and Week 2

Secondary Outcomes (9)

• Change from baseline in the WOMAC pain sub-score at week 1, in the target knee

  Baseline and Week 1

• Change from baseline in daily pain at Day 8 using an 11-point Numeric Rating Scale (NRS)

  Baseline and Day 8

• Change from baseline in daily pain at Day 7 using an 11-point Numeric Rating Scale (NRS)

  Baseline and Day 7

• Change from baseline in daily pain at Day 6 using an 11-point Numeric Rating Scale (NRS)

  Baseline and Day 6

• Change from baseline in daily pain at Day 5 using an 11-point Numeric Rating Scale (NRS)

  Baseline and Day 5

Study Arms (2)

AMZ001 diclofenac gel

EXPERIMENTAL

Drug: AMZ001 Diclofenac gel

Placebo gel

PLACEBO COMPARATOR

Drug: Placebo gel

Interventions

AMZ001 Diclofenac gel DRUG

Diclofenac gel applied once daily

AMZ001 diclofenac gel

Placebo gel DRUG

Matching placebo gel applied once daily

Placebo gel

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is able to read and understand the language and content of the study material, understand the requirements for study visits, and is willing to provide information at the scheduled evaluations and appropriate written informed consent has been obtained.
• Femorotibial osteoarthritis (OA) of the knee, according to the American College of Rheumatology (ACR) clinical and radiographic criteria (Altman et al. 1986)
• Radiological OA grade 2, or 3 of the target knee, using the Kellgren-Lawrence method (Kellgren \& Lawrence 1957) as graded by central, independent reading of X-ray obtained during screening, or on a recent (within 6 months) X-ray image which fulfils the specifications for central reading.
• Pain score rated on an 11-point numerical rating scale of the target knee of ≥20 and ≤45 out of 50 in response to the WOMAC pain sub-score (5 questions), at the time of screening and baseline.
• The WOMAC pain sub-score on the target knee must exceed the one on the contralateral knee, regardless of the eligibility of the contralateral knee.
• At screening Visit 1a, participants report that their typical OA knee pain in one or both knees when not using medication is ≥4 out of 10.
• Daily OA knee pain diary average numerical rating scale (NRS) score of ≥4 and ≤9 in the target knee, for the 7 days immediately preceding baseline (Day 1). The average calculation is based on the recorded scores during this entire period with a requirement of at least 4 days of data recorded.
• Women of child-bearing potential must use at least an acceptably effective method of contraception (progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) from enrolment up to at least 3 months after the study end. Postmenopausal status is defined as being amenorrheic for at least 1 year prior to screening. Sexually active men with a female partner of childbearing potential must agree to use condom from enrolment up to at least 3 months after the study end.
• Knee pain in the target knee for at least 14 days of the preceding month (periarticular knee pain due to OA and not due to non-OA conditions such as bursitis, tendonitis, etc.) based on participant report.
• Except for OA, the participant is in reasonably good health as determined by the Investigator.

You may not qualify if:

• Known or suspected hypersensitivity to or previous hypersensitivity reactions to diclofenac or of the excipients in either of the investigational products.
• Patients in whom asthma, angioedema, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• Any physical impediment to gel application on the target knee.
• Intra-articular delivery of corticosteroids or hyaluronic acid in the target knee within 6 months of screening or into any other joint within 30 days of screening.
• High dose (equivalent to \> 10 mg of prednisone/day) systemic corticosteroid treatment of more than 14 days during the past 6 months prior to screening.
• Major surgery/ arthroscopy of the target knee within the previous year prior to screening or aspiration of effusion of the target knee within 12 weeks prior to enrollment.
• Planned surgery of the target knee within the next 12 months.
• Use of a currently unapproved investigational drug, device or biologic within 3 months prior to screening.
• Presence of concomitant non-osteoarthritic disease affecting either knee, such as rheumatoid arthritis, psoriasis, gout or clinically relevant pseudogout, if there is reason to believe that the disease(s) may significantly interfere with the interpretation of the clinical response to the study drug.
• Perioperative period in the setting of coronary artery bypass graft surgery.
• Current malignancy or treatment for malignancy within the past five years, with the exception of non-melanoma skin cancer, unless affecting the target knee area, or carcinoma in situ events.
• Any other abnormal laboratory results or significant medical conditions that the Investigator believes should preclude the participant's participation in the trial.
• Secondary OA of the target knee, previous procedures or trauma affecting joint homeostasis including total meniscectomy or septic arthritis, or any other serious condition leading to secondary OA of the target knee.
• Reported incidence of any of the following diseases: known OA of the hip(s) if pain in either or both hip(s) exceeds that of the target knee using the WOMAC hip pain subscore, or presence of significant radicular back pain.
• Presence of severe pain in either knee, defined as \> 45 out of 50 in response to the WOMAC pain sub-score (5 questions), at the time of screening and baseline, regardless of the eligibility of the contralateral knee.

Sponsors & Collaborators

• Amzell: lead
• NBCD A/S: collaborator

Study Sites (11)

Millennium Clinical Trials

Thousand Oaks, California, 91360, United States

Location

Eastern Research Inc

Hialeah, Florida, 33013, United States

Location

Future Medical Research

Longwood, Florida, 32750, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

DelRicht Research

Rockville, Maryland, 20852, United States

Location

Oakland Medical Research

Troy, Michigan, 48085, United States

Location

West Clinical Research

Morehead City, North Carolina, 28557, United States

Location

hong Kong Center for Clinical Research

Hong Kong, China

Location

Charles University

Prague, Czechia

Location

Sanos Clinic

Herlev, Denmark

Location

Medyczne Centrum Hetmanska Piotr Leszczynski

Poznan, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

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

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: February 18, 2025
• Primary Completion: December 22, 2025
• Study Completion: April 13, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

CZ (1); CN (1); PL (1); US (7); DK (1)