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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04877691 | Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus | PHASE3 | ACTIVE NOT_RECRUITING | 367 | — | — | Jun 8, 2021 | Nov 6, 2026 | May 22, 2026 | 140 | United States, Argentina +13 |
| NCT01559090 | Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus. | PHASE2 | COMPLETED | 17 | — | — | Apr 20, 2012 | Feb 21, 2017 | Mar 13, 2019 | 6 | Japan |
BICLA response is a composite binary endpoint whereby responders are defined by meeting all of the following criteria: * Improvement from baseline in disease activity as measured by BILAG-2004. Improvement is defined as a reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D and no BILAG-2004 worsening in other organ systems, where worsening is defined as ≥ 1 new BILAG-2004 A or ≥ 2 new BILAG 2004 B. * No worsening from baseline in SLEDAI-2K, where worsening is defined as an increase from baseline of \> 0 points in SLEDAI-2K. * No worsening from baseline in the patient's lupus disease activity, where worsening is defined as an increase ≥ 0.30 points on a 3-point PGA VAS.
| Arm | Type | Description |
|---|---|---|
| Anifrolumab | EXPERIMENTAL | Solution for injection in aPFS |
| Placebo | PLACEBO_COMPARATOR | Solution for injection in aPFS |
| 1 | EXPERIMENTAL | MEDI-546 100 mg IV |
| 2 | EXPERIMENTAL | MEDI-546 300 mg IV |
| 3 | EXPERIMENTAL | MEDI-546 1000 mg IV |
| Name | Type | Description |
|---|---|---|
| Medi-546 | DRUG | Patients will have IP administered or will self-administer IP under supervision by site staff at Week 0 and Week 1 and, for patients participating in the OLE period, at Week 52. For weekly doses coinciding with subsequent on-site visits, patients will also have IP administered or will self-administer IP under supervision by site staff, and in addition will receive a set of kits (including back-up kits) for at-home administration. |
| Placebo | DRUG | Solution for injection in aPFS |
Inclusion Criteria: 1. Patients who have a diagnosis of pediatric or adult SLE according to the ACR 1997 revised criteria for ≥ 24 weeks prior to signing the ICF 2. To be eligible a patient must have SLEDAI-2K ≥ 6 points and "Clinical" SLEDAI-2K score ≥4 points at screening 3. BILAG2004 with at lea...