Safety and Efficacy of RHH646 for Knee Osteoarthritis (NCT05816395) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of RHH646 for Knee Osteoarthritis
United States, Argentina82 participantsStarted 2023-05-31
Plain-language summary
The purpose of this study was to evaluate the articular cartilage-regenerating capacity of RHH646 in the knee as well as to assess safety and tolerability in participants with knee osteoarthritis.
Who can participate
Age range35 Years – 75 Years
SexALL
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Inclusion Criteria:
* Participant is ≥35 and ≤75 years old, at time of screening
* Participants must weigh at least 50 kg to participate in the study and must have a body mass index (BMI) ≤35 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2
* Diagnosis of tibiofemoral OA in at least one knee by standard American College of Rheumatology clinical and radiographic criteria (Altman et al 1986) at screening
* K\&L grade 2 to 3 OA in the target knee evaluated with X-Ray by the Central Reader at screening
* Predominantly medial tibiofemoral compartment involvement defined as medial Joint Space Narrowing (medJSN) 1-2 (Altman et al 1995; Altman, Gold 2007) and medJSN \> lateral Joint Space Narrowing (latJSN) in the target knee evaluated with X-Ray by the Central Reader at screening
* Symptomatic disease, defined as having pain in the target knee at least 3 days per week during the last 3 months from screening that is relieved by analgesic therapy (e.g. acetaminophen or non-steroidal anti-inflammatory drugs), according to the investigator's evaluation and judgment of the patient's history
Exclusion Criteria:
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception. In EEA countries, women of child-bearing potential will be excluded from participation in this trial, irrespective of the use of highly effective methods of contraception.
* Arthroscopy of the target knee within th…
What they're measuring
1
Change From Baseline in Cartilage Volume in the Index Region of the Target Knee by MRI
Timeframe: Baseline, Week 52
2
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 56 weeks.