Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCB028050 · 1 trial · 1 indication
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: participants' assessment of pain, participants' global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), participants' self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.
| Arm | Type | Description |
|---|---|---|
| INCB028050 4 mg QD | EXPERIMENTAL | INCB028050 4mg Once daily (QD) |
| INCB028050 7 mg QD | EXPERIMENTAL | INCB028050 7mg QD |
| INCB028050 10 mg QD | EXPERIMENTAL | INCB028050 10mg QD |
| Placebo | PLACEBO_COMPARATOR | Placebo group may 'cross-over' following 3 months of treatment to receive either active arm #2 (7mg QD) or active arm #3 (10mg QD) of INCB028050 capsules. |
| Name | Type | Description |
|---|---|---|
| INCB028050 | DRUG | 4 mg capsules QD |
| Placebo | DRUG | Placebo matching INCB028050 QD |
Inclusion Criteria: * Must have rheumatoid arthritis which has been inadequately controlled with at least one DMARD * For subjects receiving antimalarials, they must be treated with antimalarials for at least 6 months and receiving a stable daily dose * For subjects receiving sulfasalazine, they mu...
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INCB028050 is an investigational small molecule being studied for the treatment of rheumatoid arthritis. It was evaluated in a Phase 2 clinical trial in patients with active rheumatoid arthritis who had an inadequate response to disease-modifying anti-rheumatic drugs. The drug is not approved and remains in clinical development.
INCB028050 is a small molecule developed by Incyte Corporation. Its specific molecular target has not been disclosed in the available information. The drug is being investigated for its potential role in treating rheumatoid arthritis, an autoimmune condition.
INcyte Corporation (NASDAQ: INCY) is developing INCB028050. The company sponsored a Phase 2 clinical trial of the drug for rheumatoid arthritis. Incyte is a biopharmaceutical company focused on the discovery and development of novel small molecule drugs.
INCB028050 is in Phase 2 clinical development. A Phase 2 trial for rheumatoid arthritis has been completed. The drug is investigational and has not received FDA approval. Its development status beyond Phase 2 has not been disclosed.
INCB028050 has one completed clinical trial, NCT00902486. This Phase 2 study compared the drug to background therapy in 127 patients with active rheumatoid arthritis who had an inadequate response to disease-modifying anti-rheumatic drugs. The trial was randomized, double-blind, and placebo-controlled, conducted in the United States and Czechia.