Maywood, Illinois 60153

  • host Disease

Purpose:

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).


Criteria:

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.


Study is Available At:


Original ID:

INCB 39110-309


NCT ID:

NCT03584516


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

Phase 2/Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Incyte Corporation


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

431


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Rodica Morariu-Zamfir, MD
Study Director
Incyte Corporation
Primary Contact:Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com
Backup Contact:Incyte Corporation Call Center (ex-US)
+800 00027423
globalmedinfo@incyte.com

Study Dates

Start Date:January 17, 2019
Completion Date:February 20, 2025
Completion Type:Anticipated
Primary Completion Date:January 12, 2024
Primary Completion Type:Anticipated
Verification Date:March 2021
Last Changed Date:March 24, 2021
First Received Date:June 29, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Part 1 : Dose Determination: Number of dose-limiting toxicities
Time Frame:28 days
Safety Issues:False
Description:To identify an appropriate dose of itacitinib in combination with corticosteroids as initial treatment for moderate or severe cGVHD.
Outcome Type:Primary Outcome
Measure:Part 2 : Response rate
Time Frame:Month 6
Safety Issues:False
Description:Defined as the proportion of participants demonstrating a complete response (CR) or partial response (PR) per National Institutes of Health (NIH) consensus guideline.
Outcome Type:Primary Outcome
Measure:Part 1 : Dose Expansion: Number of dose-limiting toxicities
Time Frame:28 days
Safety Issues:False
Description:To identify an appropriate dose of itacitinib in combination with corticosteroids as initial treatment for moderate or severe cGVHD.
Outcome Type:Secondary Outcome
Measure:Part 1, 1 expansion, and Part 2: Cmax of itacitinib when administered in combination with corticosteroids
Time Frame:Up to 28 days
Safety Issues:False
Description:Maximum observed concentration.
Outcome Type:Secondary Outcome
Measure:Part 1, 1 expansion, and Part 2: Cmin of itacitinib when administered in combination with corticosteroids
Time Frame:Up to 28 days
Safety Issues:False
Description:Minimum observed plasma or serum concentration over the dose interval.

Study Interventions

Intervention Type:Drug
Name:Prednisone
Description: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.
Arm Name:Part 1 : Dose determination of itacitinib
Other Name:Deltasone, Prednicot, predniSONE Intensol, Rayos,
Intervention Type:Drug
Name:Methylprednisolone
Description: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.
Arm Name:Part 1 : Dose determination of itacitinib
Other Name:Medrol, Medrol Dosepak, Solu-Medrol
Intervention Type:Drug
Name:Placebo
Description:In Part 2, participants will receive matching placebo.
Arm Name:Part 1 : Dose expansion of itacitinib
Intervention Type:Drug
Name:Itacitinib
Description: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.
Arm Name:Part 1 : Dose determination of itacitinib
Other Name:INCB039110

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Part 2 : itacitinib recommended dose from part 1
Description:itacitinib or placebo administered in combination with corticosteroids
Study Arm Type:Experimental
Arm Name:Part 1 : Dose expansion of itacitinib
Description:itacitinib administered in combination with corticosteroids or corticosteroids alone.
Study Arm Type:Experimental
Arm Name:Part 1 : Dose determination of itacitinib
Description:itacitinib administered in combination with corticosteroids.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Incyte Corporation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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