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AMG 557/MEDI5872 · 1 trial · 1 indication
The European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of 12 organ-specific domains (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, and biological). Each domain is assessed for activity level in 3 or 4 levels (i.e., no, low, moderate, high) according to their severity (no disease activity equals to 0 and for high disease activity the domain score equals 3 or 4). Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A higher score indicates worsening of the disease. Adjusted mean change and standard error are presented.
| Arm | Type | Description |
|---|---|---|
| MEDI5872 210 mg | EXPERIMENTAL | Participants will receive a fixed SC dose of 210 mg MEDI5872 every week (QW) from Days 1 to 15 and then every 2 weeks (Q2W) from Days 29 to 85 in double-blind period. In open-label period, participants will continue dosing of MEDI5872 210mg Q2W from Days 99 to 183 and will receive an additional dose of blinded placebo on Day 106. |
| Placebo/MEDI5872 210 mg | PLACEBO_COMPARATOR | Participants will receive a SC dose of placebo matching with MEDI5872 QW on Days 1, 8, and 15 and then Q2W from Days 29 to 85 in double-blind period. In open-label period, participants will receive a fixed SC dose of 210 mg MEDI5872 QW (Days 99 to 113) and Q2W (Days 127 to 183) in open-label period. |
| Name | Type | Description |
|---|---|---|
| AMG 557/MEDI5872 | BIOLOGICAL | Participants will receive a fixed SC dose of 210 mg MEDI5872 (AMG 557/MEDI5872) QW for 3 weeks (Days 1 to 15) and then Q2W for 9 weeks (Days 29 to 85) in double-blind period of the study. In open-label period, all participants from double-blind period will receive a fixed SC dose of 210 mg MEDI5872 from Day 99 to Day 183 (QW from Days 99 to 113 for participants from Placebo arm and on Days 99 and 113 for participants from MEDI5872 210 mg arm; and Q2W from Days 127 to 183 for participants from both arms). |
| Placebo | OTHER | The SC dose of placebo every week for 3 weeks (Days 1 to 15) and then every 2 weeks for 9 weeks (Days 29 to 85) in double-blind period of the study. In open-label period, an additional dose of blinded placebo will be administered on Day 106 for participants who will receive MEDI5872 210mg in double-blinded period. |
Inclusion Criteria: * Age 18 through 75 years at the time of signing the ICF. * Fulfill American-European Consensus Group (AECG) criteria for pSS * ESSDAI score ≥ 6. * Positive anti-SS-A and/or anti-SS-B autoantibodies and at least IgG \> 13 g/L or RF level \> upper limit of normal (ULN) or positiv...
AMG 557/MEDI5872 is an investigational monoclonal antibody being studied for the treatment of Primary Sjögren's Syndrome, an autoimmune condition that affects moisture-producing glands. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
AMG 557/MEDI5872 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AZN. The drug is in Phase 2 clinical development for Primary Sjögren's Syndrome.
AMG 557/MEDI5872 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials for safety and efficacy in patients with Primary Sjögren's Syndrome.
AMG 557/MEDI5872 has one completed Phase 2a clinical trial, identified as NCT02334306. This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of the drug in 32 participants with Primary Sjögren's Syndrome across the United States, France, Sweden, and the United Kingdom.
Yes, AMG 557 and MEDI5872 are the same drug. The compound is referred to by both names in clinical development, with the trial NCT02334306 using the combined designation AMG 557/MEDI5872. It is being developed by AstraZeneca for Primary Sjögren's Syndrome.