ASKC200 for Knee Osteoarthritis Pain

NCT07742852 | Active Not Recruiting Phase 2

• 1 other identifier: ASKC200-LC-201
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II clinical trial designed to evaluate the efficacy and safety of ASKC200 Lotion in patients with knee osteoarthritis (KOA) pain. A total of 175 eligible patients will be randomly assigned to three groups at a 1:2:2:2 ratio: the experimental group1 (treated with 1% ASKC200 Lotion), the experimental group 2(treated with 5% ASKC200 Lotion), the active control group (treated with Diclofenac Diethylamine Emulgel), and the placebo group (treated with matching placebos).

Conditions

Osteoarthritis (OA) of the Knee; Pain

Outcome Measures

Primary Outcomes (1)

• Change in WAADPI (NRS) of the target knee from baseline

  The average amount of pain as reported by the subject using a 0 - 10 numerical rating scale (NRS). Higher scores indicate more pain.

  Day 34

Secondary Outcomes (4)

• Change in WAADPI (NRS) of the target knee from baseline

  Day 19, Day 64，Day 94

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score

  Day 19，Day 34，Day 64，Day 94

• Change in patient's clinical general impression (PGIC)

  Day 19，Day 34 ，Day 64，Day 94

• Days of first-aid medicine administration

  94days

Study Arms (4)

5% ASKC200

EXPERIMENTAL

Drug: 5% ASKC200; Drug: Placebo

1% Diclofenac Diethylamine Emulgel

ACTIVE COMPARATOR

Drug: 1% Diclofenac Diethylamine Emulgel; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Drug: Placebo

1% ASKC200

EXPERIMENTAL

Drug: Placebo; Drug: 1% ASKC200

Interventions

5% ASKC200 DRUG

A single dose will be topically applied to study knees for 60 minutes on Visit 1 on Day 1, Day 2, Day 3, and Day 4.

5% ASKC200

1% Diclofenac Diethylamine Emulgel DRUG

Day 5-18；Four times daily

1% Diclofenac Diethylamine Emulgel

Placebo DRUG

ASKC200 Placebo or Diclofenac Diethylamine Placebo

1% ASKC200; 1% Diclofenac Diethylamine Emulgel; 5% ASKC200; Placebo

1% ASKC200 DRUG

A single dose will be topically applied to study knees for 60 minutes on Visit 1 on Day 1, Day 2, Day 3, and Day 4.

1% ASKC200

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria:
• Provide signed informed consent before undergoing any examinations or assessments, and understand and comply with the study requirements;
• Aged 40 to 80 years (inclusive) at the time of signing the informed consent, male or female;
• Diagnosed with primary knee osteoarthritis based on clinical and radiological examinations;
• History of knee osteoarthritis pain lasting ≥ 6 months;
• Within 3 months prior to dosing, X-ray of the tibiofemoral joint shows Kellgren-Lawrence Grade II or III in the target knee, with the contralateral knee grade not higher than the target side;
• Before the first dose, the weekly average of the daily mean pain NRS score in the target knee is ≥ 4 and \< 8, and the weekly average of the daily mean pain NRS score in the contralateral knee is \< 4;
• Before the first dose, the WOMAC pain scale score for the target knee is ≥ 20, and the WOMAC pain scale score for the contralateral knee is \< 20;
• Willing to discontinue the use of non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and other analgesics, and to use only study-provided acetaminophen as rescue medication for knee osteoarthritis pain during the study period;
• Body Mass Index (BMI) ≤ 40.0 kg/m²;
• Male and female subjects of childbearing potential agree to voluntarily adopt effective contraceptive measures and have no plans for pregnancy, egg donation, or sperm donation from the screening period through 3 months after the last dose. Female subjects of childbearing potential must have a negative pregnancy test before the first use of the study drug.

You may not qualify if:

• Subjects will be excluded from the study if they meet any of the following criteria:
• Secondary arthritis due to other causes (e.g., psoriasis, ankylosing spondylitis, rheumatoid arthritis, systemic lupus erythematosus, etc.);
• The target knee has other conditions that may affect the function and pain assessment of the target knee (e.g., fractures, osteonecrosis, and chondrocalcinosis within 6 months prior to screening, etc.);
• Presence of other diseases causing pain in the target knee (e.g., hip pain, lumbar spinal stenosis, intermittent claudication, etc.) or pain in other areas that, in the investigator's judgment, may affect the assessment of knee osteoarthritis pain;
• Use of other medications for osteoarthritis within 1 week prior to the first dose, such as NSAIDs (except aspirin ≤ 325 mg/day for cardiac prophylaxis), analgesics (except rescue acetaminophen used continuously for ≤ 3 days), symptomatic slow-acting drugs for osteoarthritis (diacerein, glucosamine, chondroitin sulfate, etc.), anxiolytics (doxepin, amitriptyline, pregabalin, etc.), or traditional Chinese medicines (containing active ingredients such as artificial tiger bone powder, Psammosilene tunicoides, etc.), whether oral or topical;
• The target knee has pathological joint effusion requiring aspiration or has surgical indications;
• Presence of chronic pain in other body parts requiring long-term oral analgesic therapy, or need for concomitant systemic glucocorticoid therapy from 4 weeks prior to the first dose through the study period;
• Open knee injury or other knee surgeries (e.g., arthroscopy, arthroscopic debridement, knee replacement, etc.) on the target knee within 6 months prior to the first dose;
• Undergone any major surgical procedure within 3 months prior to the first dose;
• Received intra-articular injection therapy (e.g., corticosteroids or sodium hyaluronate, etc.) in the target knee within 3 months prior to the first dose;
• Received treatment with other investigational drugs or devices within 4 weeks prior to the first dose;
• Received physical therapy (e.g., electrotherapy, etc.) for knee osteoarthritis in the target knee within 3 months prior to the first dose;
• Patients who are unable to ambulate independently and require assistive devices for more than 50% of ambulation time within 4 weeks prior to the first dose;
• Applied any capsaicin-containing products or NSAIDs to the skin of the target knee within 2 weeks prior to the first dose;
• History of allergy, contraindication, or intolerance to any component of the investigational product ASKC200 liniment, the comparator diclofenac diethylamine emulgel, or the rescue medication acetaminophen, or to any other NSAIDs;

Sponsors & Collaborators

• Jiangsu Aosaikang Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Hospital

Beijing, China

Location

MeSH Terms

Conditions

Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: July 26, 2026
• First Posted: August 3, 2026
• Study Start: September 12, 2025
• Primary Completion: April 28, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)