NCT03209362

SI-613 Study for Knee Osteoarthritis

Completed Phase 2 Results posted Last updated 4 November 2021

What this trial tests

Phase 2 trial testing SI-613 in Osteoarthritis, Knee in 80 participants. Completed in 13 November 2018.

Timeline

19 October 2017

Primary endpoint
17 August 2018

13 November 2018

Quick facts

Lead sponsor	Seikagaku Corporation
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	80
Start date	19 October 2017
Primary completion	17 August 2018
Estimated completion	13 November 2018
Sites	10 locations across United States

Drugs / interventions tested

• SI-613
• Placebo

Conditions studied

• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

Seikagaku Corporation — full company profile →

Who can join

Adults 40 to 75, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks Primary · Baseline over 12 weeks

Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline over 12 weeks was analyzed using a repeated measures Analysis of Covariance (ANCOVA) model.

Group	Value	95% CI
SI-613	-29.9	-36.7 – -23.1
Placebo	-27.0	-33.6 – -20.4

Change From Baseline in WOMAC Pain Subscore at Weeks 12 and 26 Secondary · Baseline, Weeks 12 and 26

Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.

Change at Week 12

Group	Value	95% CI
SI-613	-40.4	-48.5 – -32.3
Placebo	-36.9	-44.8 – -28.9

Change at Week 26

Group	Value	95% CI
SI-613	-41.7	-50.2 – -33.1
Placebo	-38.4	-46.7 – -30.1

Change From Baseline in WOMAC Physical Function Subscore at Weeks 12 and 26 Secondary · Baseline, Weeks 12 and 26

Observed VAS of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.

Change at Week 12

Group	Value	95% CI
SI-613	-39.2	-47.9 – -30.6
Placebo	-36.3	-44.8 – -27.8

Change at Week 26

Group	Value	95% CI
SI-613	-38.5	-47.4 – -29.5
Placebo	-36.7	-45.5 – -28.0

Change From Baseline in WOMAC Stiffness Subscore at Weeks 12 and 26 Secondary · Baseline, Weeks 12 and 26

Observed VAS of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.

Change at Week 12

Group	Value	95% CI
SI-613	-38.2	-47.0 – -29.4
Placebo	-37.3	-45.9 – -28.7

Change at Week 26

Group	Value	95% CI
SI-613	-41.4	-50.4 – -32.3
Placebo	-35.7	-44.6 – -26.9

Change From Baseline in WOMAC Total Score at Weeks 12 and 26 Secondary · Baseline, Weeks 12 and 26

WOMAC total score was the mean of WOMAC pain, physical function and stiffness subscores and ranges from 0 to 100 mm, where higher scores indicated worse response. Changes in WOMAC total score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.

Change at Week 12

Group	Value	95% CI
SI-613	-39.4	-47.9 – -30.9
Placebo	-36.4	-44.8 – -28.1

Change at Week 26

Group	Value	95% CI
SI-613	-39.4	-48.2 – -30.6
Placebo	-36.9	-45.5 – -28.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to Week 26. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SI-613

Serious: 1/39 (3%)

Deaths: 0/39

Placebo

Serious: 1/41 (2%)

Deaths: 0/41

Serious adverse events (3 terms)

Reaction	System	SI-613	Placebo
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—
Heat exhaustion	Injury, poisoning and procedural complications	—	—
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	SI-613	Placebo
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Injection site joint pain	General disorders	—	—

Most-reported serious reactions: Pneumonitis, Heat exhaustion, Plasma cell myeloma.

Data from ClinicalTrials.gov NCT03209362 adverse events section.

Sponsor's own description

The objective of the study is to evaluate the efficacy and safety of intra-articular injections of SI-613 compared with placebo for knee OA.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent advances in targeted drug delivery for treatment of osteoarthritis.
   Mehta S, He T, Bajpayee AG. · · 2021 · cited 67× · PMID 33229973 · DOI 10.1097/bor.0000000000000761
2. Overcoming barriers for intra-articular delivery of disease-modifying osteoarthritis drugs.
   Gao J, Xia Z, Mary HB, Joseph J, et al · · 2022 · cited 63× · PMID 35086691 · DOI 10.1016/j.tips.2021.12.004
3. Recent Advances in Clinical Translation of Intra-Articular Osteoarthritis Drug Delivery Systems.
   DeJulius CR, Gulati S, Hasty KA, Crofford LJ, et al · · 2021 · cited 30× · PMID 33709019 · DOI 10.1002/adtp.202000088
4. Composing On-Program Triggers and On-Demand Stimuli into Biosensor Drug Carriers in Drug Delivery Systems for Programmable Arthritis Therapy.
   Lim YY, Zaidi AMA, Miskon A. · · 2022 · cited 13× · PMID 36355502 · DOI 10.3390/ph15111330