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

Incyte

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Chronic Graft-versus-host Disease

Treatments: Drug: Placebo; Drug: Itacitinib; Drug: Methylprednisolone; Drug: Prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT03584516

INCB 39110-309

2018-001606-29 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active, clinically diagnosed, moderate or severe cGVHD per NIH Consensus Criteria
• Underwent allogeneic stem cell transplantation (allo-HCT)
• Karnofsky Performance Status score ≥ 60%.
• Evidence of myeloid and platelet engraftment.
• Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.

Exclusion criteria

• Has received more than 3 days/72 hours of systemic corticosteroid treatment for cGVHD.
• Has received any other systemic treatment for cGVHD, including extracorporeal photopheresis (ECP).
• Prior treatment with a Janus kinase (JAK) inhibitor for acute GVHD, unless the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks before randomization.
• cGVHD occurring after a nonscheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence.
• Evidence of relapsed primary malignancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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155 participants in 3 patient groups, including a placebo group

Part 1 : Dose determination of itacitinib

Experimental group

Description:

itacitinib administered in combination with corticosteroids.

Treatment:

Drug: Prednisone

Drug: Methylprednisolone

Drug: Itacitinib

Part 1 : Dose expansion of itacitinib

Experimental group

Description:

itacitinib administered in combination with corticosteroids or corticosteroids alone.

Treatment:

Drug: Prednisone

Drug: Methylprednisolone

Drug: Placebo

Drug: Itacitinib

Part 2 : itacitinib recommended dose from part 1

Placebo Comparator group

Description:

itacitinib or placebo administered in combination with corticosteroids

Treatment:

Drug: Prednisone

Drug: Methylprednisolone

Drug: Itacitinib