A study to test if SRSD107 prevents venous thromboembolism events and how safe it is

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sirius Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

7 Aug 2025 → ongoing

Decision date (initial)

2025-07-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others, Safety, Pharmacodynamic, Pharmacokinetic

To evaluate the efficacy of SRSD107 in subjects undergoing elective, primary, unilateral total knee arthroplasty (TKA) comparing SRSD107 to enoxaparin

Secondary objectives 2

1. To evaluate the safety of SRSD107 in subjects undergoing elective, primary, unilateral TKA comparing SRSD107 to enoxaparin
2. To evaluate the efficacy of SRSD107 in subjects undergoing elective, primary, unilateral TKA comparing SRSD107 to enoxaparin

Conditions and MedDRA coding

venous thromboembolism

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1. Able to provide written informed consent before any study assessment is performed.
2. 2. Male and female subjects, of any race, between 60 and 80 years of age, inclusive. Female subjects should not be of child-bearing potential.An interim analysis of safety data will be conducted by the SSC after 50 subjects complete 12 weeks of follow-up; pending SSC approval following this analysis, enrollment of subjects between 81 and 85 years of age (inclusive) will be allowed
3. 3. Body mass index between 18.0 and 38.0 kg/m2, inclusive.
4. 4. Eligible to undergo elective primary unilateral TKA under general anesthesia.
5. 5. Willing to comply with study requirements including taking study drug at least 28 days prior to TKA, clinic visits, and venography at 10-14 days post TKA
6. 6. Activated partial thromboplastin time (aPTT), prothrombin time (PT), and international normalized ratio (INR) within the normal reference range at screening.
7. 7. Males will agree to use contraception.

Exclusion criteria 11

1. 1. Active bleeding requiring medical or surgical intervention within 4 weeks prior to screening.
2. 2. Known bleeding disorder, history of increased bleeding tendency (e.g., history of bleeding diathesis, known active gastrointestinal lesions such as angiodysplasia or an endoscopically verified gastrointestinal ulcer or a history of gastrointestinal bleeding within the past year) or any other condition that in the opinion of the investigator contraindicates prophylactic anticoagulation.
3. 3. History of intracranial, intraspinal, or intraocular bleeding.
4. 4. Evidence of active cancer, or a history of malignancy, within 2 years prior to screening. Nonmelanoma skin cancer, curatively treated localized breast or prostate cancer, or other carcinoma in situ are not exclusionary, providing that they did not require systemic chemotherapy (hormonal therapy allowed) and are considered cured.
5. 5. Myocardial infarction, stroke (hemorrhagic, ischemic or mixed), transient ischemic attack, systemic embolism, valvular thrombosis, or splanchnic thrombosis in the 6 months prior to screening, or any lifetime history of DVT or PE.
6. 6. Uncontrolled blood pressure as defined by a systolic blood pressure ≥ 180 mmHg and/or a diastolic blood pressure ≥ 110 mmHg at the time of screening.
7. 7. Estimated (by Modification of Diet in Renal Disease [MDRD]) glomerular filtration rate (eGFR) < 45 mL/min/1.73m2.
8. 8. Liver dysfunction (alanine aminotransaminase or aspartate aminotransferase >1.5× upper limit of normal [ULN] or total bilirubin > ULN), liver cirrhosis (Child-Pugh class B and C excluded; Child-Pugh A allowed), history of hepatic encephalopathy, esophageal varices, or portocaval shunt. Subjects with Gilbert’s syndrome are allowed to participate.
9. 9. Clinically significant anemia (hemoglobin <10 g/dL) at screening.
10. 10. Platelet count < 100,000/m3 at screening or a history of heparin-induced thrombocytopenia.
11. 11. Positive test for human immunodeficiency virus (HIV) (CD4+>200/mm3 can be included), positive hepatitis B surface antigen, and/or active hepatitis C (by HCV RNA testing) at screening.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of total venous thromboembolism (VTE) events, defined as deep vein thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), non-fatal and fatal PE, and unexplained death for which PE cannot be excluded, from the date of surgery through the venography visit. Venography will be performed 12±2 days after surgery

Secondary endpoints 8

1. Incidence of composite of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) from the Pre-surgical Period through the venography visit
2. Incidence of composite of MB, CRNMB, and any bleeding (including minor bleeding events) from the Pre-surgical Period through the venography visit, Day 64, and Day 169, respectively
3. Incidence of MB from the Pre-surgical Period through the venography visit
4. Incidence of CRNMB from the Pre-surgical Period through the venography visit
5. Incidence of adverse events (AEs) and other safety parameters throughout the study
6. Incidence of major VTE, defined as objectively confirmed symptomatic DVT and PE, asymptomatic proximal DVT, fatal PE, and unexplained death for which PE cannot be excluded, from the date of surgery through the venography visit and Day 64, respectively
7. Incidence of total VTE events, defined as symptomatic DVT, asymptomatic DVT , non-fatal and fatal PE, and unexplained death for which PE cannot be excluded, from the date of surgery through Day 64
8. Incidence of total VTE events for each individual dosing cohort of SRSD107 compared to enoxaparin from the date of surgery through the venography visit

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sirius Therapeutics Inc.

Sponsor organisation

Sirius Therapeutics Inc.

Address

1209 North Orange Street

City

Wilmington

Postcode

19801-1120

Country

United States

Scientific contact point

Organisation

Sirius Therapeutics Inc.

Contact name

Regulatory Affairs

Public contact point

Organisation

Sirius Therapeutics Inc.

Contact name

Regulatory Affairs

Third parties 12

Locations

6 EU/EEA countries · 25 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 53 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications