Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Medi-546 · 3 trials · 2 indications
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 |
| 4 | OTHER | MEDI-546 |
| 5 | OTHER | MEDI-546 |
| 6 | OTHER | MEDI-546 |
| 7 | OTHER | MEDI-546 |
| 8 | OTHER | MEDI-546 |
| 9 | OTHER | MEDI-546 |
| 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...
Top 20 of 32 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Biogen Inc. | BIIB | 5 | PHASE3 | Litifilimab |
| Bristol-Myers Squibb Company | BMY | 7 | PHASE3 | Deucravacitinib |
| Viatris, Inc. | VTRS | 5 | PHASE3 | Cenerimod |
| Novartis AG Sponsored ADR | NVS | 7 | PHASE3 | Ianalumab |
| AstraZeneca PLC | AZN | 21 | PHASE3 | Medi-546 |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Nipocalimab |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Upadacitinib |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Belimumab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | SAR441344 |
| Zenas BioPharma, Inc. | ZBIO | 1 | PHASE2 | Obexelimab |
| Alumis Inc. | ALMS | 1 | PHASE2 | Envudeucitinib |
| Immunovant Inc | IMVT | 1 | PHASE2 | IMVT-1402 |
| Amgen Inc. | AMGN | 1 | PHASE2 | Inebilizumab, Blinatumomab |
| Fate Therapeutics, Inc. | FATE | 2 | PHASE2 | FT819 |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY4298445 |
| Cartesian Therapeutics, Inc. | RNAC | 2 | PHASE2 | Descartes-08 |
| Merck & Co., Inc. | MRK | 1 | PHASE1 | MK-1045 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE1 | KITE-363, Fludarabine, Cyclophosphamide |
| Artiva Biotherapeutics, Inc. | ARTV | 2 | PHASE1 | AB-101, Cyclophosphamide, Fludarabine, Rituximab, Obinutuzumab |
| Cullinan Therapeutics, Inc. | CGEM | 1 | PHASE1 | CLN-978 |
MEDI-546 is an investigational drug being studied for scleroderma and systemic lupus erythematosus. It is in clinical development for these autoimmune conditions, with trials evaluating its safety and tolerability in adult patients.
MEDI-546 is being developed by AstraZeneca PLC, a biopharmaceutical company. AstraZeneca is conducting clinical trials to evaluate the drug's safety and efficacy in patients with scleroderma and systemic lupus erythematosus.
MEDI-546 is in clinical development, with trials ranging from Phase 1 to Phase 3. It is not approved by regulatory authorities and remains investigational. The most advanced trial is a Phase 3 study in systemic lupus erythematosus.
MEDI-546 has been studied in several clinical trials. NCT00930683 evaluated multiple doses in scleroderma patients, NCT01559090 assessed safety in Japanese patients with systemic lupus erythematosus, and NCT04877691 is a Phase 3 study of subcutaneous anifrolumab in systemic lupus erythematosus.
Yes, MEDI-546 is also known as anifrolumab. Clinical trial NCT04877691 refers to subcutaneous anifrolumab in patients with systemic lupus erythematosus, indicating that MEDI-546 and anifrolumab are the same drug.