A study evaluating safety and efficacy of Itacitinib or Placebo in combination with corticosteroids as initial treatment of chronic graft versus-host disease

Phase 1

• Conditions: Moderate or severe cGVHD; MedDRA version: 20.1 Level: PT Classification code 10066261 Term: Chronic graft versus host disease System Organ Class: 10021428 - Immune system disorders; MedDRA version: 20.1 Level: PT Classification code 10072160 Term: Chronic graft versus host disease in liver System Organ Class: 10021428 - Immune system disorders; MedDRA version: 20.1 Level: PT Classification code 10072158 Term: Chronic graft versus host disease in intestine System Organ Class: 10021428 - Immune system disorders; MedDRA version: 20.1 Level: PT Classification code 10072159 Term: Chronic graft versus host disease in skin System Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-001606-29-FR
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-08
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 266

Inclusion Criteria

1. Male or female, aged 18 years or older inclusive at the time of signing the ICF.
2. Active, clinically diagnosed, moderate or severe cGVHD per NIH Consensus Criteria :
a. Moderate cGVHD: At least 1 organ (except lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1.
b. Severe cGVHD: At least 1 organ with a score of 3, or lung score of 2 or 3.
Note: Candidates who transition from active aGVHD to cGVHD without tapering off of corticosteroids (< 0.25 mg/kg per day) ± CNI are also eligible.
3. Underwent allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative or reduced intensity conditioning are eligible.
4. KPS score = 60%.
5. Evidence of myeloid and platelet engraftment, that is, ANC = 1.0 × 109/L and platelet count = 25 × 109/L. Note: Use of growth factor supplementation and transfusion support is allowed during the study; however, transfusion to reach a minimum platelet count for inclusion is not allowed within the 7 days before the screening laboratory assessment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 213
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 53

Exclusion Criteria

1. Has received more than 1 prior allo-HCT.
2. Has received more than 3 days/72 hours of systemic corticosteroid treatment for cGVHD.
3. Has received any other systemic treatment for cGVHD, including ECP. Prior and concomitant use of CNIs as well as topical/inhaled steroids is acceptable.
4. Prior treatment with a JAK inhibitor for aGVHD, unless the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks before randomization.
5. cGVHD occurring after a nonscheduled DLI administered for pre-emptive treatment of malignancy recurrence. Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified