Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as INCB018424
Ruxolitinib IR · 3 trials · 2 indications
The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: subject's assessment of pain, Subject's global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), subject's self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.
INCB018424 concentration in plasma.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Treatment Group A | EXPERIMENTAL | INCB018424 15 mg twice daily (BID) or matching placebo |
| Cohort 2: Treatment Group B | EXPERIMENTAL | INCB018424 5 mg BID or matching placebo |
| Cohort 2: Treatment Group C | EXPERIMENTAL | INCB018424 25 mg BID or matching placebo |
| Cohort 2: Treatment Group D | EXPERIMENTAL | INCB018424 50 mg once daily (QD) or matching placebo |
| Placebo | PLACEBO_COMPARATOR | Matching placebo, oral |
| Period 1: Dose Treatment A | EXPERIMENTAL | Ruxolitinib IR will be administered at protocol defined dose. |
| Period 1: Dose Treatment B | EXPERIMENTAL | Ruxolitinib XR will be administered at protocol defined dose. |
| Period 2: Dose Treatment A | EXPERIMENTAL | Ruxolitinib IR will be administered at protocol defined dose. |
| Period 2: Dose Treatment B | EXPERIMENTAL | Ruxolitinib XR will be administered at protocol defined dose. |
| Cohort 1: Dose Treatment A | EXPERIMENTAL | Ruxolitinib IR will be administered at protocol defined dose. |
| Cohort 1: Dose Treatment B | EXPERIMENTAL | Ruxolitinib XR will be administered at protocol defined dose. |
| Cohort 2: Dose Treatment A | EXPERIMENTAL | Ruxolitinib IR will be administered at protocol defined dose. |
| Cohort 2: Dose Treatment B | EXPERIMENTAL | Ruxolitinib XR will be administered at protocol defined dose. |
| Name | Type | Description |
|---|---|---|
| INCB018424 | DRUG | - |
| Placebo | DRUG | - |
| Ruxolitinib IR | DRUG | Tablet |
| Ruxolitinib XR | DRUG | Tablet |
Inclusion Criteria: 1. Established diagnosis of rheumatoid arthritis 2. Patients receiving methotrexate must be treated with for at least 6 months and receiving a stable weekly dose between 10 and 25 mg for at least 8 consecutive weeks prior to study entry. Exclusion Criteria: 1. Patients who hav...
Ruxolitinib IR is an immediate-release tablet formulation of ruxolitinib, a small molecule JAK inhibitor developed by Incyte Corporation. It has been studied in Phase 1 clinical trials in healthy participants, including bioequivalence and relative bioavailability studies comparing it with an extended-release (XR) tablet formulation.
Ruxolitinib IR targets JAK1, TYK2, JAK2, and JAK3. It is an inhibitor of these Janus kinase enzymes. By inhibiting JAK1, TYK2, JAK2, and JAK3, the drug interferes with JAK-mediated signaling pathways.
Ruxolitinib IR is developed by Incyte Corporation, which trades under the ticker INCY. Incyte is the sponsor of the clinical trials evaluating this immediate-release formulation.
Ruxolitinib IR is in Phase 1 clinical development. Both of its recorded trials are Phase 1 studies that have been completed. The trials enrolled healthy participants rather than patients with a specific disease.
Ruxolitinib IR has been evaluated in two completed Phase 1 trials. NCT06555081 was a bioequivalence study of ruxolitinib extended-release tablets versus immediate-release tablets in 168 healthy participants. NCT06310304 was a relative bioavailability study comparing the two formulations in 24 healthy participants. Both were conducted in the United States.
Ruxolitinib IR is the immediate-release tablet form of ruxolitinib. It is distinct from ruxolitinib extended-release (XR) tablets, which are a separate formulation. The Phase 1 trials for Ruxolitinib IR directly compared the immediate-release and extended-release tablets.