# GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease

> **NCT03139604** · PHASE3 · COMPLETED · sponsor: **Incyte Corporation** · enrollment: 439 (actual)

## Conditions studied

- Graft-versus-host Disease (GVHD)

## Interventions

- **DRUG:** Itacitinib
- **DRUG:** Placebo
- **DRUG:** Prednisone
- **DRUG:** Methylprednisolone

## Key facts

- **NCT ID:** NCT03139604
- **Lead sponsor:** Incyte Corporation
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2017-07-19
- **Primary completion:** 2019-05-02
- **Final completion:** 2020-07-13
- **Target enrollment:** 439 (ACTUAL)
- **Last updated:** 2025-09-02


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03139604

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03139604, "GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease". Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/clinical/NCT03139604. Licensed CC0.

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