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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01845740 | Phase Ib Study of SC Milatuzumab in SLE | PHASE1 | COMPLETED | 22 | — | — | Jan 1, 2007 | Jun 1, 2009 | Aug 19, 2021 | 1 | United States |
Will be assessed using laboratory and clinical data comparing baseline lab results and clinical condition to the lab results and clinical condition/adverse events during treatment and follow-up timepoints up to 2 years.
Will be assessed using the BILAG scoring model for lupus disease activity and symptoms by comparing baseline BILAG measurements against the BILAG measurements obtained during treatment and during follow-up for up to 2 years.
| Arm | Type | Description |
|---|---|---|
| Milatuzumab SC 250 mg | EXPERIMENTAL | Milatuzumab 250 mg will be administered subcutaneously once weekly for 4 weeks. |
| Milatuzumab 150 mg SC | EXPERIMENTAL | Milatuzumab 150 mg will be administered subcutaneously once weekly for 4 weeks. |
| Placebo SC | PLACEBO_COMPARATOR | Placebo will be administered subcutaneously once weekly for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| milatuzumab | DRUG | Milatuzumab has been used in clinical trials for multiple myeloma, non-Hodgkin's lymphoma and leukemia in the intravenous dosing form. In this study, milatuzumab is being given subcutaneously in patients with lupus. |
| Placebo | DRUG | Placebo will be administered subcutaneously once weekly for 4 weeks. |
Inclusion Criteria: * Male or female ≥ 18 years old * Signed written informed consent before study entry * Diagnosis of SLE by American College of Rheumatology revised criteria (meets ≥ 4 criteria) * Positive ANA (titer ≥ 1:80) at study entry * At least 1 BILAG A or 2 BILAG B scores in any organ/bo...