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Investigator-initiated Phase 2 clinical study of S-005151 in patients with osteoarthritis of the knee

Investigator-initiated Phase 2 clinical study of S-005151 in patients with osteoarthritis of the knee

Ishibashi Yasuyuki

Hirosaki University Hospital

53 Honcho, Hirosaki, Aomori

seikei@hirosaki-u.ac.jp

Ishibashi Yasuyuki

Hirosaki University Hospital

53, Honcho, Hirosaki, Aomori

+81-172-39-5083

seikei@hirosaki-u.ac.jp

Complete

Dec. 24, 2020

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

[At the time of informed consent]
1) Patients with the ability to understand the study and comply with such as the requirements of the study, and to obtain written consent prior to screening.
2) Male or female patients aged >=20 and <70 at the time of consent acquisition.
3) Patients with medial knee osteoarthritis scheduled for high tibial osteotomy and arthroscopic microfracture.
4) (Only women) Patients who can be consent to the contraceptive methods during the period from consent acquisition to 3 months after the last administration .

[Before surgery]
5) Patient with Medial knee osteoarthritis condition meeting the following for knee joints undergoing surgery.
-Kellgren-Lawrence grade is 2 or 3
-Exposure of subchondral bone is seen partially or the whole articular surface
-Area of the cartilage defect is 2 ~ 9 cm^2
-The mean of each subscale of Knee Injury and Osteoarthritis Outcome Score (KOOS) < 70
-Body Mass Index (BMI) <= 30 kg/m^2

[At Registration]
6) Patients undergoing surgery as specified in this study who are able to initiate drug administration by the day after surgery.

[At the time of informed consent]
1) Patients with the following diseases in the knee joint of the surgical treatment side specified in this study.
A) Anterior cruciate ligament dysfunction, Posterior cruciate ligament dysfunction
B) Arthritis of the knee (purulent arthritis, gouty arthritis)
C) Lateral tibiofemoral arthropathy, patellofemoral arthropathy, and neuropathic arthropathy (Charcot's joint)
D) Medial femoral condyle osteonecrosis
E) Intra-articular fracture of the knee articular with residual sequelae during or after treatment
F) Fractures of the femur or tibia under treatment.
2) Patients with concomitant systemic inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, various types of vasculitis).
3) Diabetics with poor control (HbA1C more than 8% in laboratory tests of pre-test 1).
4) Patients who cannot undergo MRI.
5) Patients with active malignancies (including a history of cancer within 5 years of disease-free period).
6) Patients with severe cardiovascular disease, renal disease, liver disease, respiratory disease, or hematologic disease.
7) Patients with a history of severe drug allergy (shock, anaphylaxis, angioedema) and patients with or with a history of severe allergic disease.
8) Female patients who wish to become pregnant during pregnancy or the study period, and female patients who are breastfeeding.
9) Patients who are scheduled to use prohibited concomitant medications or to receive prohibited concomitant therapy during the study period.
10) Patients who have received regenerative medicine in the past.
11) Patients who have previously received S-005151.
12) Patients who have received with other investigational products within 90 days prior to acquisition of consent.
13) Patients judged inappropriate for the study by the investigator or sub-investigator.

[Before surgery]
14) Patients requiring at least 15 degrees correction of the tibia alone for the knee joint performing the surgery.
15) Patients found to meet exclusion criteria 1) to 13).

[At Registration]
16) Patients found to meet exclusion criteria 1) to 14).

Both

Osteoarthritis of the knee

-Screening: After obtaining consent, check the eligibility of the subject (pre-test 1). After performing the surgery specified in this study (high tibial osteotomy and arthroscopic microfracture), check the eligibility of the subject again (pre-test 2) and enroll this trial when it is judged to be eligible.
-Treatment phase (4-week): Randomized 1:1 to either S-005151 group or the placebo group, and start administering investigational drugs under the blind.
-Follow-up phase (Until 52 weeks after start of administration): Plate removal after high tibial osteotomy will be performed, and safety and efficacy will be evaluated after completion of administration of the investigational drug.

[Safety endpoints]
-Presence or absence and incidence of adverse events, vital signs, ECG, clinical laboratory test

[Efficacy endpoints]
<Morphological evaluation (assessed for knee joints subjected to surgery)>
-Histological evaluation by biopsy
-MRI evaluation
-Whole ORgan Magnetic resonance imaging Score (WORMS)
-Kellgren-Lawrence classification
-International Cartilage Repair Society (ICRS) Grade

<Functional evaluation>
Knee assessments will be performed using the following tools
-Lysholm knee scoring scale
-Knee Injury & Osteoarthritis Outcome Score (KOOS)
-Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
-EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

+81-172-39-5295

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