NCT04200365

A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD)

A Pilot Study of INCB039110 (Itacitinib) for the Treatment of Steroid Refractory Chronic Graft-Versus-Host Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done in patients who have been receiving corticosteroids or other immunosuppressive therapies for the treatment of cGVHD for at least 6 months. The purpose of this study is to find out if itacitinib in combination with corticosteroids or other immunosuppressive therapies is safe and effective in people with cGVHD.

Detailed description

Graft versus host disease remains a major hurdle to improve allogeneic hematopoietic stem cell transplantation outcome, with cGVHD being associated with decreased quality of life. Suppression of the immune system with corticosteroids forms the basis of first-line therapy for management of GVHD, but sustained responses are usually seen in less than 50 percent of patients and there is no standard second- or third-line treatment for steroid refractory cGVHD. Identification of novel therapeutic targets are needed to improve outcomes. Therapeutic potential has been shown by a JAK inhibitor in the treatment of steroid refractory GVHD. Itacitinib is a novel, selective inhibitor of the JAK family of protein tyrosine kinases and will be studied here in patients with steroid refractory cGVHD.

Conditions

• Chronic Graft-versus-host-disease

Interventions

Type	Name	Description
DRUG	Itacitinib	Itacitinib will be administered orally once daily for up to 24 months.

Timeline

• Start date: 2020-06-05
• Primary completion: 2023-09-07
• Completion: 2023-09-07
• First posted: 2019-12-16
• Last updated: 2024-11-06
• Results posted: 2024-11-06

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study