New drug shows promise for controlling rare immune disorder
NCT ID NCT05063110
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested the drug ITACITINIB in 35 adults with a mild form of a rare immune disease called HLH. The goal was to see if the drug could control the disease by improving symptoms within 15 days. The trial is now complete, and results will show how well the drug works for this condition.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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35 people
The number who actually took part.
- Started
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May 2022
- Finished
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Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients age \> 18 years, * Patient is willing to provide written informed consent prior to enrolment and agrees to follow the protocol * Patient known to have systemic juvenile idiopathic arthritis are classified as having HLH * Negative pregnancy test for woman of childbearing potential, woman of childbearing potential should have reliable contraception for the duration of the study * Be either affiliated to, or a beneficiary of, a social security category Exclusion Criteria: * Organ failure: confusion, organic kidney failure KDIGO 2 criteria, liver failure (Factor V \< 50%), heart failure, respiratory failure. * Fibrinogen \< 0.50 g/l, platelets \<20G/L * Indication to intensive care unit transfer on an organ failure requiring assistance (dialysis, Ventilation (assisted or VNI), shock regardless of the origin. * Breastfeeding women * Patient participating in another investigational therapeutic study * Women with a positive pregnancy test or not willing to take contraceptive measures * Known allergies, hypersensitivity, or intolerance to any of the ITACITINIB or excipients, or similar compounds * Current or history of recurrent infections, including HBV, HCV * Participants with active HBV or HCV infection that requires treatment or who are at risk for HBV reactivation (ie Positive HBs Ag serology) * Candidates positive for HCV antibody and positive PCR RNA HCV * HIV infection with positive viral charge * Protected adults (including individual under guardianship by court order) * Vulnerable adults, under a safeguard of justice measure * Adults deprived of their liberty by judicial or administrative decision * Persons under psychiatric care without their consent * Persons admitted to social institution for purposes other this research * Adults under legal protection (guardianship or curatorship) * Persons unable to express their consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hôpital Avicenne
Bobigny, Bobigny, 93000, France
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Other studies related to the condition(s) this trial covers.
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