NCT03584516

GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Chronic Graft-versus-host Disease

Interventions

Type	Name	Description
DRUG	Itacitinib	In Part 1dose determination participants will receive itacitinib administered orally once daily at the protocol-defined dose according to cohort enrollment. In Part 1 expansion, participants will receive either itacitinib administered orally either once daily or twice a day or corticosteroid alone based on the assigned treatment regimen according to cohort enrollment. In Part 2, participants will receive the recommended dose from Part 1 expansion.
DRUG	Placebo	In Part 2, participants will receive matching placebo.
DRUG	Methylprednisolone	Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
DRUG	Prednisone	Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.

Timeline

• Start date: 2019-01-17
• Primary completion: 2023-11-03
• Completion: 2023-11-03
• First posted: 2018-07-12
• Last updated: 2025-10-20
• Results posted: 2025-01-27

Locations

133 sites across 16 countries: United States, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Israel, Italy, Poland, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study