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Also known as Milvexian, BMS-986177
JNJ-70033093 · 4 trials · 4 indications
Time to the first occurrence of composite endpoint of stroke and non-CNS systemic embolism will be reported.
Time to first occurrence of any component of MACE will be reported. MACE is a composite of cardiovascular (CV) death, myocardial infarction (MI), and ischemic stroke.
Time to first occurrence of ischemic stroke will be reported.
Total VTE was defined as the composite of clinical events committee (CEC)-adjudicated proximal and/or distal Deep Vein Thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death.
| Arm | Type | Description |
|---|---|---|
| Milvexian | EXPERIMENTAL | Participants will receive milvexian 100 milligrams (mg) orally, twice daily and placebo that matches apixaban beginning on Day 1 through end of treatment (EOT). Participants after the EOT visit may have an option to receive open-label apixaban at the appropriate dose (5 mg or 2.5 mg, twice daily), for which the sponsor provides a 30-day supply. |
| Apixaban | ACTIVE_COMPARATOR | Participants will receive a placebo that matches milvexian and a capsule containing apixaban 5 mg or 2.5 mg orally, twice daily. Participants after the EOT visit may have an option to receive open-label apixaban (5 mg or 2.5 mg, twice daily) at the appropriate dose, for which the sponsor provides a 30-day supply. |
| Placebo | PLACEBO_COMPARATOR | Participants enrolled within 7 days of an ACS, who have undergone cardiac catheterization with PCI or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (SAPT or DAPT) as determined by the investigator will receive placebo orally, twice daily. |
| Group A: JNJ-70033093 25 mg + Placebo BID | EXPERIMENTAL | Participants will receive JNJ-70033093 25 milligram (mg) (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days. |
| Group B: JNJ-70033093 50 mg BID | EXPERIMENTAL | Participants will receive JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days. |
| Group C: JNJ-70033093 100 mg + Placebo BID | EXPERIMENTAL | Participants will receive JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days. |
| Group D: JNJ-70033093 200 mg BID | EXPERIMENTAL | Participants will receive JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days. |
| Group E: JNJ-70033093 25 mg Once Daily + Placebo | EXPERIMENTAL | Participants will receive JNJ-70033093 25 mg (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days. |
| Group F: JNJ-70033093 200 mg Once Daily + Placebo | EXPERIMENTAL | Participants will receive JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days. |
| Group G: JNJ-70033093 50 mg once daily + Placebo | EXPERIMENTAL | Participants will receive JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days. |
| Group I: Enoxaparin 40 mg Once Daily | ACTIVE_COMPARATOR | Participants will receive enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days. |
| Name | Type | Description |
|---|---|---|
| Milvexian | DRUG | Milvexian will be administered orally. |
| Apixaban | DRUG | Apixaban will be administered orally. |
| Placebo | DRUG | Milvexian matching milvexian placebo will be administered orally. |
| Apixaban Placebo | DRUG | Apixaban matching apixaban placebo will be administered orally. |
| JNJ-70033093 25 mg | DRUG | 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. |
| JNJ-70033093 50 mg | DRUG | Participants will receive JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days. |
| JNJ-70033093 100 mg | DRUG | Participants will receive JNJ-70033093 100 mg (1\*100 mg capsule) BID, orally for 10 to 14 postoperative days. |
| JNJ-70033093 200 mg | DRUG | 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. |
| Enoxaparin 40 mg | DRUG | Participants will receive enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days. |
Inclusion Criteria: * Minimum age of 18 years * Medically stable and appropriate for chronic antithrombotic treatment * Atrial fibrillation eligible to receive anticoagulation * Participant must satisfy one or both of the following categories of risk factors (a or b): a) one or more of the followin...
JNJ-70033093 was studied for use in patients undergoing elective total knee replacement surgery, a procedure also called knee arthroplasty. The Phase 2 trial evaluated it in adults aged 50 years and older who were having this orthopedic surgery, a setting where anticoagulant therapy is used to prevent blood clots after the operation.
JNJ-70033093 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The compound was studied in a trial that also referenced the designation BMS-986177, indicating it was part of a collaboration between Johnson & Johnson and Bristol Myers Squibb.
JNJ-70033093 is in Phase 2 development. It is an investigational small molecule and has not been approved by the FDA. The Phase 2 study in patients undergoing elective total knee replacement surgery has been completed, and no trials of this asset are currently listed as active.
The Phase 2 trial for JNJ-70033093 is NCT03891524, titled a study of JNJ-70033093 (BMS-986177) versus subcutaneous enoxaparin in participants undergoing elective total knee replacement surgery. It was an active-controlled, randomized trial that enrolled 1,242 participants across the United States, Europe, Latin America, Asia, and South Africa, and it has been completed.
The Phase 2 trial NCT03891524 enrolled 1,242 participants. It was a randomized, active-controlled study comparing JNJ-70033093 with subcutaneous enoxaparin in patients undergoing elective total knee replacement surgery. Participants were 50 years of age or older, and the study has been completed.