Drugs / Dazodalibep
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02780388 | May 2016 → May 2018 | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT02151110 | May 2014 → May 2016 | — | MedImmune LLC | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT05306353 | Jul 2023 → Jul 2025 | rheumatoid arthritis | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05201469 | Dec 2022 → Jun 2028 expected | lupus nephritis | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 2 | NCT04174677 | Dec 2019 → Dec 2021 | anti-HLA hyperimmunization | Amgen | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04129164 | Dec 2019 → Sep 2022 | Sjogren syndrome | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT04163991 | Dec 2019 → Dec 2021 | rheumatoid arthritis | Amgen | Completed | Met primary |
| Phase 2 | NCT04046549 | Oct 2019 → Jul 2022 | transplant rejection | Amgen | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06747949 | Feb 2025 → Dec 2029 expected | Sjogren syndrome | Amgen | Recruiting | No outcome recorded |
| Phase 3 | NCT06245408 | Apr 2024 → Oct 2026 expected | Sjogren syndrome | Amgen | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06104124 | Jan 2024 → Jul 2026 | Sjogren syndrome | Amgen | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-09-22 | Amgen | Results AMGEN ANNOUNCES POSITIVE TOPLINE PHASE 3 RESULTS FOR DAZODALIBEP IN MODERATE-TO-SEVERE SYSTEMIC SJÖGREN'S DISEASE amgen.com ↗
Amgen (NASDAQ:AMGN) today announced positive topline results from the Phase 3 OASIZ 301 study evaluating dazodalibep in adults with Sjögren's disease and moderate-to-severe systemic disease activity. |
| 2024-06-12 | Amgen | Results AMGEN TO PRESENT INNOVATIVE RHEUMATOLOGY RESEARCH AT EULAR 2024 amgen.com ↗
Key presentations include the first findings showing dazodalibep improved major biomarkers in Sjögren's disease, as well as data on treatment outcomes for uncontrolled gout based on a post-hoc analysis of the MIRROR trial for KRYSTEXXA ® (pegloticase) with methotrexate. |
| 2023-11-07 | Amgen | Results AMGEN PRESENTS NEW DATA FROM PHASE 2 TRIAL OF DAZODALIBEP IN SJÖGREN'S SYNDROME AT ACR 2023 amgen.com ↗
Amgen (NASDAQ:AMGN) today announced new data from its Phase 2 study evaluating dazodalibep, an investigational medicine, for the treatment of Sjögren's. |
All press releases naming this drug 3 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dazodalibep | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06104124 ↗ |
| Known as | MEDI4920 | “The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920 (formerly MEDI4920) in adult participants with Sjögren's Syndrome (SS).” NCT04129164 ↗ |
| Known as | VIB4920 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05201469 ↗ |
| Action | Inhibit | “Dose-dependent decreases in rheumatoid factor autoantibodies and Vectra DA biomarker score provide additional evidence that VIB4920 effectively blocked the CD40/CD40L pathway.” PMID 31019027 ↗ Apr 20191“CD40 ligand antagonist” CHEMBL4594331 ↗ |
| Modality | Protein / enzyme biologic | “Here, we report the generation and clinical results of a CD40L binding protein, VIB4920, which lacks an Fc domain” PMID 31019027 ↗ Apr 2019 |
| Route | Intravenous | “single IV dose” NCT02151110 ↗ |
| Target | CD40LG | “CD40 ligand antagonist” CHEMBL4594331 ↗ |