Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02185040 | A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus. | PHASE2 | COMPLETED | 42 | — | — | Sep 16, 2014 | Sep 25, 2018 | Mar 19, 2020 | 35 | United States |
A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP up to 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.
A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP through 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.
| Arm | Type | Description |
|---|---|---|
| CC-220 0.3mg Every Other Day (QOD) | EXPERIMENTAL | Part 1: CC-220 0.3mg capsules by mouth every other day (QOD) |
| CC-220 0.3mg Every Day (QD) | EXPERIMENTAL | * Part 1: CC-220 0.3mg capsules by mouth every day (QD) * ATEP: CC-220 0.3 mg capsules by mouth every day (QD) |
| CC-220 0.6mg/0.3mg alternating dose QD | EXPERIMENTAL | * Part 1: CC-220 0.6 mg and 0.3mg capsules PO on alternating days * ATEP:CC-220 0.6 mg and 0.3 mg capsules PO on alternating days |
| CC-220 0.6mg QD | EXPERIMENTAL | Part 1: CC-220 0.6mg capsules by mouth QD |
| Placebo QD | PLACEBO_COMPARATOR | Part 1: Identically matching placebo capsules PO QD |
| Name | Type | Description |
|---|---|---|
| CC-220 | DRUG | 0.3 mg oral capsules once every other day with or without food |
| Placebo | DRUG | Matching oral placebo daily |
Inclusion Criteria: Part 1 * The subject has an established diagnosis of systemic lupus erythematosus (SLE) as defined by the 1997 Update of the 1982 ACR Revised Criteria for Classification of SLE at screening. The diagnosis is fulfilled provided that at least 4 criteria are met. * Disease history...