TreatMent Of Knee osTeoarthritis wIth chONdroitin Sulfate - the OA MOTION Study

NCT05632783 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 22US-Ct04
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this phase III study is to evaluate the efficacy, safety, and tolerability of chondroitin sulfate 800 mg oral tablets versus placebo in the treatment of subjects with pain due to knee OA (osteoarthritis). The further aims of the study are to evaluate the durability of the treatment effect (up to week 36) and to gain further long-term safety and efficacy data (up to 48 weeks). The primary outcome of interest will be the effect of chondroitin sulfate on pain in the index knee at week 24 compared to placebo. The effect of chondroitin sulfate in the index knee functionality and the patient global impression of changes at 24 weeks compared to placebo are included as key-secondary endpoints. An additional key secondary endpoint will assess the durability of the effect on pain compared to placebo at week 36. Several additional secondary endpoints are included to further support the beneficial effect of the treatment and the improvements in patient's quality of life (i.e., Western Ontario and McMaster Universities Arthritis Index -WOMAC- subscales and total scores at each study visits, changes in patient's quality of life, use of rescue medication etc.) other than the safety of the product.

Conditions

Knee Osteoarthritis

Keywords

osteoarthritis; Pain

Outcome Measures

Primary Outcomes (2)

• Efficacy of once daily treatment-Change in pain (baseline to week-24) in target knee

  Change from Baseline to Week 24 in the weekly mean of the average daily pain in the index knee as measured by the numerical rating scale (NRS) (0 10 points where 0 is "no pain" and 10 "the worst pain imaginable")

  Week 24

• Safety of the long term treatment-Primary outcome of Safety Follow-up Period from Weeks 36 and 48 with Continued Double-blind Treatment

  Number of subjects with any AEs, TEAEs, ADRs, and SAEs in Safety Follow-up Period from Weeks 36 and 48 with Continued Double-blind Treatment

  48 weeks

Secondary Outcomes (4)

• Key secondary endpoint of the Double-blind Treatment Period until Week 36. Efficacy of once daily treatment-Change (baseline to week 24) in target knee function

  Week 24

• Key secondary endpoint of the Double-blind Treatment Period until Week 36. Subject's global evaluation

  Week 24

• Key secondary endpoint of the Double-blind Treatment Period until Week 36. Durability of the effect (up to week 36)

  Week 36

• Safety and tolerability-Double-blind Treatment Period until Week 36.

  week 24

Study Arms (2)

chondroitin sulfate 800 mg tablets

EXPERIMENTAL

oral chondroitin sulfate 800 mg tablet

Drug: Chondroitin Sulfate Sodium

placebo

PLACEBO COMPARATOR

oral placebo tablets matching the IP tablets

Other: Placebo

Interventions

Chondroitin Sulfate Sodium DRUG

Chondroitin sulfate 800 mg tablets

Also known as: chondroitin sulfate 800 mg

chondroitin sulfate 800 mg tablets

Placebo OTHER

Placebo tablets

placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided written informed consent for participation in the clinical study.
• Subject is outpatient of either sex, aged ≥50 years.
• Subjects with a diagnosis of OA (osteoarthritis) according to the ACR (American College of Rheumatology) criteria.
• Subject has a radiographic diagnosis (confirmed by a central reader) of knee OA classified Kellgren-Lawrence Grade of 2 or 3 on standing anterior-posterior X-ray of the index knee based on an x ray assessment of both knees available \<6 months from Screening or performed during Screening.
• Subject has a history of knee OA for \>6 months (including regular pain and functional impairment) as confirmed by the investigator, based on available written documentation and/or subject reporting.
• Subject meets the following requirements:
• Has a mean score of ≥5 to ≤9 on the 24-hour average daily pain score in the index knee (0-10 Numerical Rating Scale-NRS), where the mean is calculated over all values that are available in the 7 days prior to randomization (Day 1), and it is required that at least 5 pain score values will be available during that period.
• Subject has an individual index knee 24-hour average daily pain score ≥1 and ≤9 for all values that are available in the 7 days prior to randomization (Day 1).
• Subject has rated the pain in the non index knee consistently lower than the pain in the index knee at both the Screening and Baseline Visits in case of bilateral knee OA.
• Subject, if of childbearing potential, is nonlactating and nonpregnant (has negative serum pregnancy test results at Screening and negative urine pregnancy test result at the start of IP administration prior to dosing).
• Subject, if female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile \[bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\]) or practicing 1 of the following medically acceptable methods of birth control:
• Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the subject's usual menstrual cycle period) before IP administration.
• Agrees to abstain from heterosexual intercourse during study participation and to use a highly effective contraceptive (as described above) as backup if they become sexually active during the study. Abstinence is only acceptable if this is the subject's usual lifestyle. Periodic abstinence (calendar, symptothermal, postovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception.
• Intrauterine device.
• Double barrier method (condoms, sponge, diaphragm, with spermicidal jellies, or cream).

You may not qualify if:

• Subject with an allergy or hypersensitivity to the active substance or to any other ingredient of the IP (i.e., chondroitin sulfate tablets or placebo) or has a vegan lifestyle.
• Subject presenting with lactose intolerance.
• Subject with ≥1 pain score reported as 10 on the NRS during the 7 days prior to randomization (Day 1).
• Subject with New York Heart Association Grade III-IV with an ongoing treatment.
• Subject with severe renal or hepatic impairment (Child-Pugh Stage C) with renal and liver function assessment based on laboratory results.
• Subject with any other clinically severe or significant uncontrolled concurrent illness.
• Subject with any other concurrent illness requiring chronic use of analgesics/NSAIDs (nonsteroidal anti-inflammatory drug).
• Subject has a body mass index ≥40 kg/m2.
• Subject has predominantly patellofemoral osteoarthritis based on clinical diagnosis and/or x-ray.
• Subject had surgery of the index knee in the past 6 months (for arthroscopic surgery) or 12 months (for osteotomy or other surgery) or significant injuries in the past 6 months prior to Screening, or has planned knee surgery during the study.
• Subject with presence of clinical effusion of the knee requiring arthrocentesis or active infection of the index knee.
• Subject has any important genu varum or valgum \>8°(physiological angle including) or any other axial disorder justifying an osteotomy as assessed by central reading.
• Subject had viscosupplementation, tidal lavage, platelet-rich plasma, or stem cell injection within the last 6 months before Screening.
• Subject has systemic inflammatory arthropathies (rheumatic disease, inflammatory, infective, or metabolic joint diseases; recurrent clinical chondrocalcinosis; crystal arthropathies; osteo-articular pathologies differing from arthrosis; ochronosis; acromegaly; heritable disorders; or collagen gene mutations), metabolic arthropathies, or Paget's illness.
• History of acquired or congenital immunodeficiency diseases or positive test results for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus current infection at Screening.

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Interventions

Chondroitin Sulfates

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chondroitin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind study. Matching placebo tablets, indistinguishable from the test drug 800 mg chondroitin sulfate tablets
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, Randomized, Double-blind

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 1, 2022
• Study Start: December 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 5, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share