Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT05063110
Phase
PHASE2
Status
Completed

Conditions

  • Adults Patients Having Non Severe HLH

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Itacitinib — DRUG
    Administration of 300 mg of ITACITINIB per os every day for 30 days.

Study Details

This project aims to test the effectiveness of ITACITINIB in sporadic Hemophagocytosis Lymphohistiocytosis (HLHs)

Key Dates

Start date
May 3, 2022
Status verified
Oct 2025
Primary completion
Apr 3, 2025
Completion
Oct 1, 2025

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm
    300 mg of ITACITINIB will be administrated per os every day for 30 days, dose with reduction to 200 mg per safety is allowed if AEs are observed or if co-administered a strong CYP3A inhibitor

Primary Outcome Measure

Efficacy of ITACITINIB [ Time Frame: At day 15 ]