NCT03891524

A Study of JNJ-70033093 (BMS-986177) Versus Subcutaneous Enoxaparin in Participants Undergoing Elective Total Knee Replacement Surgery

A Randomized, Open-Label, Study Drug-Dose Blind, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-70033093 (BMS-986177), an Oral Factor XIa Inhibitor, Versus Subcutaneous Enoxaparin in Subjects Undergoing Elective Total Knee Replacement Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,242 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy of JNJ-70033093 in preventing total venous thromboembolism (VTE) events (proximal and/or distal deep vein thrombosis \[DVT\] \[asymptomatic confirmed by venography assessment or objectively confirmed symptomatic\], nonfatal pulmonary embolism \[PE\], or any death) during the treatment period.

Detailed description

JNJ-70033093 is an oral anticoagulant for prevention and treatment of thromboembolic events (for example, VTE) that binds and inhibits activated form of human coagulation Factor XI (FXIa) with high affinity and selectivity. The study will consist of 3 phases: up to 30-day screening phase before total knee replacement (TKR) surgery, 10 to14 day postoperative dosing phase, and 4-week follow-up phase. The hypothesis of this study is JNJ-70033093 reduces risk of total VTE during treatment period. The total duration of participation following randomization will be approximately 6 weeks. Efficacy evaluations include unilateral venography assessment of operated leg and assessments of symptomatic DVT, PE, or death. Safety evaluation includes adverse events, clinical laboratory tests, and physical examinations. The safety and efficacy will be monitored throughout the study.

Conditions

• Arthroplasty, Replacement, Knee

Interventions

Type	Name	Description
DRUG	JNJ-70033093 25 mg	Participants will receive JNJ-70033093 25 mg (1\*25 mg capsule) BID (in Group A) or once daily (in Group E), orally for 10 to 14 postoperative days.
DRUG	JNJ-70033093 50 mg	Participants will receive JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.
DRUG	JNJ-70033093 100 mg	Participants will receive JNJ-70033093 100 mg (1\*100 mg capsule) BID, orally for 10 to 14 postoperative days.
DRUG	JNJ-70033093 200 mg	Participants will receive JNJ-70033093 200 mg (2\*100 mg capsules) BID (in Group D) or once daily (in Group F), orally for 10 to 14 postoperative days.
DRUG	Placebo	Participants will receive placebo matching to JNJ-70033093, orally.
DRUG	Enoxaparin 40 mg	Participants will receive enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.

Timeline

• Start date: 2019-06-17
• Primary completion: 2021-04-06
• Completion: 2021-04-06
• First posted: 2019-03-27
• Last updated: 2025-03-30
• Results posted: 2022-07-15

Locations

117 sites across 18 countries: United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Greece, Hungary, Israel, Italy, Japan, Poland, Portugal, Russia, South Africa, Spain, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study