Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA
Completed
Aclaris Therapeutics, Inc.
Phase 2
This is a Phase 2 study to investigate the safety, tolerability, PK, and PD of ATI-450 plus
methotrexate versus methotrexate alone in patients with moderate to severe RA.
A Trial of Aclaris Therapeutics, Inc. (ATI)-450 in Patients With Moderate-severe Novel Coronavirus Disease 2019 (COVID-19)
Completed
University of Kansas Medical Center
Phase 2
COVID-19 morbidity and mortality has been associated with Cytokine Release Syndrome (CRS) and
Acute Respiratory Distress Syndrome (ARDS).
ATI-450 is an oral small molecule MAPKAPK2 (MK2) inhibitor that potently inhibits multiple
inflammatory cytokines.
The investigator hypothesizes that MK2 pathway blockade during active COVID-19 infection in
hospitalized participants will result in improvement in respiratory-failure free survival.
Study of ATI-450 in Patients With Cryopyrin-Associated Periodic Syndrome (CAPS)
Terminated
Aclaris Therapeutics, Inc.
Phase 2
This is a Phase 2 study to investigate the safety and efficacy of ATI-450 for the Maintenance
of Remission in Patients with Cryopyrin-Associated Periodic Syndrome (CAPS) Previously
Managed with Anti-IL-1 Therapy.
ATI-450 in Combination With Paclitaxel or Capecitabine in Patients With Hormone Receptor-positive and HER2 Negative Metastatic Breast Cancer With Bone Metastasis
Not yet recruiting
Aclaris Therapeutics, Inc.
Phase 1/Phase 2
This is a dose-escalating phase I using a rolling 6 design and randomized phase II study of
ATI-450 in combination with chemotherapy testing the hypothesis that the combination of
chemotherapy (paclitaxel or capecitabine) and ATI-450 will improve progression-free survival
and reduce bone turnover, improve patient bone density, improve patient quality of life, and
improve clinical efficacy.
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