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A phase 1b, parallel-group, observer-blind, 2-arm, 2-dose study to investigate the safety and tolerability of intravenous S-151128 compared with placebo in male and female participants aged 40 to 75 with knee osteoarthritis

A phase 1b study of S-151128 in participants with knee osteoarthritis

76

The mean age (SD) of the participants was 63.4 (8.3) years in the S-151128 group and 61.3 (7.6) years in the placebo group. The proportion of male participants was 39.5% in the S-151128 group and 28.9% in the placebo group.

A total of 76 participants were randomized and received the investigational intervention (38 in the S-151128 group and 38 in the placebo group). Of them, 3 participants in the S-151128 group and 1 participant in the placebo group discontinued the study. All 76 participants (38 in the S-151128 group and 38 in the placebo group) were included in the safety analysis population and the modified intent-to-treat (mITT) (efficacy analysis) population.

No adverse events (AEs) with an outcome of death, serious AEs, or AEs leading to discontinuation of the investigational intervention were reported in either the S-151128 group or the placebo group. Adverse events were reported in 21 of 38 participants (55.3%) in the S-151128 group, and in 5 of 38 participants (13.2%) in the placebo group. Treatment-related AEs were reported in 4 of 38 participants (10.5%) in the S-151128 group, while no treatment-related AEs were reported in the placebo group. The most common treatment-related AE (>=5%) was injection site reaction (5.3% in the S-151128 group and, 0% in the placebo group).

The details of AEs are presented in the "Adverse events" section. Although the incidences of AEs and treatment-related AEs in the S-151128 group were higher than those in the placebo group, there were no serious or significant findings related to S-151128. No clinically significant abnormal findings were observed in laboratory tests, vital signs, electrocardiography, or imaging assessment of the knee joint. These results indicate S-151128 has a favorable safety and tolerability. In the evaluation of efficacy as a secondary endpoint, the analgesic effect of S-151128 was not confirmed in participants with osteoarthritis of the knee.

There were no concerns regarding the safety and tolerability of S-151128 when administered intravenously as multiple doses to participants with osteoarthritis of the knee in this study.

Sept. 20, 2025

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031230458

Juan Carlos Gomez

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

shionogiclintrials-admin@shionogi.co.jp

Corporate Communications Department

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

Complete

Nov. 28, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Participant aged 40 to 75 years, inclusive, at the time of signing the informed consent.
Participants with knee osteoarthritis who meet the American College of Rheumatology classification criteria for idiopathic knee osteoarthritis and have the disease duration of >=3 months

Current serious or medically unstable cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders, or clinically significant abnormal laboratory test results or electrocardiogram findings, capable of constituting a risk when taking the investigational intervention; or interfering with the interpretation of data.
Concurrent malignant tumor requiring treatment or a history of malignant tumor within the past 5 years.
Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
Previously exposure to S-151128.

Both

patients with knee osteoarthritis

intravenous administration of S-151128 or placebo

AEs, laboratory tests, vital signs, 12-lead ECG, and Imaging assessment of the knee

+81-3-5396-4530

Nov. 09, 2023

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