A randomized, placebo controlled, investigator and participant-blinded study, investigating safety, tolerability and efficacy of RHH646 in participants with knee osteoarthritis

Phase 1

Recruiting

• Conditions: Knee Osteoarthritis; MedDRA version: 21.1Level: LLTClassification code: 10023476Term: Knee osteoarthritis Class: 10028395; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: CTIS2022-502821-16-00
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-03
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Participant is >/= 35 and lateral Joint Space Narrowing (latJSN) in the target knee evaluated by X-Ray by the Central Reader at screening, Symptomatic disease, defined as having pain in the knee at least 3 days per week during the last 3 months from screening that is relieved by analgesic therapy (e.g., APAP or NSAIDs), according to the investigator’s evaluation and judgement of patient’s history

Exclusion Criteria

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, Inability to undergo MRI (e.g. claustrophobia, body size, leg not fitting in the coil) or contraindications to MRI (e.g. non-MRI compatible metallic implants, metallic foreign bodies, pacemaker, defibrillator), Arthroscopy of the target knee within the 6 months prior to screening or planned arthroscopy during the study, Previous surgical treatment of the target knee using mosaicplasty, microfracture, meniscectomy >50% or osteotomy; planned surgery for either knee during the study, Unstable target knee joint or insufficiently reconstructed ligaments based on medical history and/or physical examination by the investigator, Participant has severe malalignment (valgus or varus deformity) in the target knee >7.5° based on X-Ray evaluation by the Central Reader at screening, K&L grade 4 OA in either knee, Presence of severe hip OA that either (i) alters lower limb function to a degree that increases or abnormally changes the mechanical forces in the knee while walking according to the investigator’s evaluation or (ii) currently requires or is likely to require specific medical or surgical management during the study period, Other pathologies affecting the knee, including subchondral insufficiency fractures, bone fracture (acute or subacute within the 6 months prior to screening) or bone bruise, osteonecrosis, malignant bone marrow infiltration, solid tumors and/or patellofemoral dysplasia bbased on clinical assessment or imaging, Known autoimmune disease with inflammatory arthritis, crystal-induced arthritides (gout or pseudogout arthritis), active acute or chronic infection of the knee joint, Lyme disease involving the knee, reactive arthritis, systemic cartilage disorders, moderate to severe fibromyalgia, a known systemic connective tissue disease or a widespread pain index >4

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1.To evaluate the articular cartilage-regenerating capacity of RHH646 in the knee following 1 year of treatment<br>2.To evaluate the safety and tolerability of RHH646 following 1 year of treatment;Secondary Objective: To evaluate the pharmacokinetics of RHH646 in patients with knee OA;Primary end point(s): Change from baseline in cartilage volume in the index region of the target knee by MRI at Week 52, Adverse Events (AEs) Electrocardiograms (ECGs) Vital signs Hematology, blood chemistry, urinalysis

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):RHH646 plasma concentrations, Cmin,ss at Week4 and any other PK parameter as appropriate