Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ponesimod dose range · 1 trial · 1 indication
Emax HR is defined as the maximum decrease from baseline in mean hourly HR.
Emax HR is defined as the maximum decrease from baseline in mean hourly HR.
HR nadir will be defined as the minimum of the mean hourly HR for each day and will be summarized by descriptive statistics.
HR nadir will be defined as the minimum of the mean hourly HR for each day and will be summarized by descriptive statistics.
| Arm | Type | Description |
|---|---|---|
| Treatment Period 1: Ponesimod (2 mg) | EXPERIMENTAL | Participants will receive a single dose ponesimod 2 milligram (mg) oral tablet under fed conditions on Day 1. Participants not fulfilling discontinuation criteria can continue to Treatment Period 2 after a washout period of at least 7 days and a maximum of 14 days. |
| Treatment Period 2:Ponesimod, Propranolol, Placebo Propranolol | EXPERIMENTAL | Participants who do not fulfill any of discontinuation criteria will be randomized to 1 of 2 Treatments (Treatment A or B) on Day 1. Treatment A: up-titration regimen of ponesimod (2mg-20mg) once daily from Day 5 to Day 19 plus placebo propranolol once daily from Day 1 to Day 19; Treatment B: up-titration regimen of ponesimod (2mg-20mg) once daily from Day 5 to Day 19 plus 80 mg propranolol once daily from Day 1 to Day 19. |
| Name | Type | Description |
|---|---|---|
| Ponesimod dose range (2 - 20 mg) | DRUG | Participants will receive ponesimod oral tablet at a dose of 2 mg in Treatment period 1 and as an up-titrating regimen (dose range: 2mg-20mg) in Treatments period 2. |
| Placebo Propranolol | DRUG | Participants will be administered placebo propranolol oral capsule from Day 1 to Day 19 in Treatment A of Treatment period 2. |
| Propranolol 80 mg | DRUG | Participants will receive propranolol 80 mg long acting oral capsule from Day 1 to Day 19 in Treatment B of Treatment period 2. |
Inclusion Criteria: * Systolic blood pressure (SBP) 90 to 140 millimeters of mercury (mmHg) and diastolic blood pressure (DBP) 50 to 90 mmHg measured on the right arm in supine position after at least 5 minutes rest in the supine position at screening, on Day 1 of the Treatment Period 1, and on Day...
Ponesimod dose range refers to the range of oral doses of ponesimod studied in clinical development, spanning 2 mg to 20 mg. Ponesimod is a small molecule being developed by Johnson & Johnson under the ticker JNJ. The dose range describes the different dose levels evaluated rather than a single fixed dose.
Ponesimod dose range targets sphingosine-1-phosphate receptor 1, or S1PR1. Ponesimod acts as an agonist at this receptor. S1PR1 is a G protein-coupled receptor involved in lymphocyte trafficking, and modulating it is the mechanism through which ponesimod exerts its pharmacological activity.
Johnson & Johnson, which trades under the ticker JNJ, is the developer of ponesimod dose range. The company is responsible for the clinical development program for ponesimod across its studied dose levels.
Ponesimod dose range is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA. The Phase 1 program has completed, with one completed trial and no active trials at this time.
Ponesimod dose range has been studied in one completed Phase 1 trial, NCT03882255, titled A Study of Ponesimod in Healthy Adult Participants Receiving Propranolol at Steady State. The trial enrolled 52 healthy adult participants in Belgium and was randomized, double-blind, and controlled.