GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease. The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD). GRAVITAS-309: A phase 2/3 study of itacitinib and corticosteroids as initial treatment for chronic graft-versus-host disease: Part 2. GRAVITAS-309 (NCT03584516) is a 2-part phase 3 study of itacitinib or placebo in combination with CS as initial treatment for cGVHD. Masks are required in our facilities. GRAVITAS-309 (NCT03584516) is a randomized, double-blind, placebo-controlled pivotal Phase 3 study evaluating itacitinib or placebo in combination with corticosteroids as a first-line treatment for patients with chronic graft-versus-host disease (cGVHD). They must cover your nose and mouth. GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD). Itacitinib still has a shot at chronic GVHD, where it is being studied in the Gravitas-309 trial, though Kadmon’s KD025 is looking especially strong in this setting. The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft … Purpose. GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease. Results from GRAVITAS-309, which is testing itacitinib in chronic GvHD, aren't expected for years. incb 39110-309 (gravitas) A phase 3 study of Itacitinib or Placebo in combination with corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease Study Treatments Wearing masks helps us keep each other safe. Nearer on the horizon is a Food and Drug Administration decision on pemigatinib, a liver cancer drug Incyte submitted for approval late last year. National Clinical Trial Number: NCT03584516 Evercore ISI analysts yesterday went as far as to suggest that Incyte, capitalised at $19bn, now risked being bought and asset-stripped purely for the Jakafi cash flow. The company will do a six-month futility analysis to gauge the trial's likelihood of success, however. GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease Sponsors Lead Sponsor: Incyte Corporation If you cannot wear a mask, contact your care team before you visit to … About GRAVITAS-309. GRAVITAS-309 (NCT03584516) is a randomized, double-blind, placebo-controlled pivotal Phase 3 study evaluating itacitinib or placebo in combination with corticosteroids as a first-line treatment for patients with chronic graft-versus-host disease (cGVHD). Official Title. Print.