A study evaluating safety and efficacy of itacitinib and corticosteroids as initial treatment of chronic graft versus-host disease

Phase 1

• Conditions: Moderate or severe cGVHD; MedDRA version: 20.1Level: PTClassification code 10066261Term: Chronic graft versus host diseaseSystem Organ Class: 10021428 - Immune system disorders; MedDRA version: 20.1Level: PTClassification code 10072160Term: Chronic graft versus host disease in liverSystem Organ Class: 10021428 - Immune system disorders; MedDRA version: 20.1Level: PTClassification code 10072158Term: Chronic graft versus host disease in intestineSystem Organ Class: 10021428 - Immune system disorders; MedDRA version: 20.1Level: PTClassification code 10072159Term: Chronic graft versus host disease in skinSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-22
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 401

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 methylprednisolone or equivalent) ± 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, nonmyeloablative, or reduced intensity conditioning are eligible.
4. KPS score = 60%.
5. Evidence of myeloid and platelet engraftment, that is, ANC = 1.0 × 10E9/L and platelet count = 50 × 10E9/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 294
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 107

Exclusion Criteria

1. Has received more than 1 prior allo-HCT. Prior autologous HCT is allowed.

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. CNIs initiated before randomization may be continued at the same or lower dose; topical/inhaled steroids are acceptable.

4. Prior treatment with a JAK inhibitor within 8 weeks before randomization. Participants who received a JAK inhibitor for aGVHD are eligible only if they achieved CR or PR.

Study & Design

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