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Clinical Trials in Ireland / NCT06821542
Active, not recruiting Phase 3

A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy

NCT06821542 · tracked via the Priya Life Science Ireland tracker
Sponsor
Incyte Corporation
Phase
Phase 3
Started
2025-06-04
Last updated
2026-08-25

Condition(s) studied

Chronic Graft-versus-host-disease

Investigational drug(s) / intervention(s)

INCA034176Best Available Therapy (BAT)

INCA034176: IV infusion

Best Available Therapy (BAT): Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.

Study summary

This study will be conducted to compare Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 12 years at the time of signing the ICF. * Active, moderate to severe cGVHD, requiring systemic immune suppression. * Participants with refractory or recurrent cGVHD who have received at least 2 lines of systemic therapy, including corticosteroids and ruxolitinib. * Concomitant use of systemic corticosteroids is allowed. Participants on systemic corticosteroids must be on a stable dose of corticosteroids for at least 2 weeks prior to C1D1. Topical and inhaled corticosteroid agents are allowed. * Participants must accept to be treated with one of the following BAT options on C1D1: CNI (cyclosporine or tacrolimus), ECP, MMF, an mTOR inhibitor (everolimus or sirolimus), rituximab, pentostatin, proteasome inhibitors, imatinib, or ibrutinib. * History of 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. Exclusion Criteria: * Receipt of more than 1 prior allo-HCT. Prior autologous HCT is allowed. * Evidence of relapse of hematologic disease or treatment for relapse after the allo-SCT was performed, including DLI for the treatment of molecular relapse. Note: Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible. * Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1. * Severe renal impairment, that is, estimated creatinine clearance \< 30 mL/min measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or end-stage renal disease on dialysis. * Impaired liver function, defined as total bilirubin \> 1.5 × ULN and/or ALT and AST \> 3 × ULN in participants with no evidence of liver cGVHD. * History of acute or chronic pancreatitis. * Active, symptomatic myositis. * Pregnant or breastfeeding. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Primary outcome measure(s)

Trial sites (130)

FacilityCityRegionStatus
Medical University of Graz Graz Austria
Medizinische Universitaet Innsbruck - Universitaetsklinik Fuer Innere Medizin Iii Innsbruck Austria
Krankenhaus Der Elisabethinen Linz Gmbh Linz Austria
Medizinische Universitat Wien, Universitatsklinik Fur Innere Medizin I Vienna Austria
St. Anna Childrens Hospital Vienna Austria
Az Sint-Jan Brugge Av Bruges Belgium
Chu Ucl Namur Site Godinne Godinne-mont Belgium
Universitair Ziekenhuis Leuven Leuven Belgium
Chu Liege -Centre Hospitalier Universitaire Sart Tilman Liège Belgium
Algemeen Ziekenhuis Delta Roeselare Belgium
Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
Fakultni Nemocnice Hradec Kralove Hradec Králové Czechia
Fakultni Nemocnice Ostrava Ostrava-poruba Czechia
Ustav Hematologie A Krevni Transfuze (Uhkt), the Institute of Hematology and Blood Transfusion (Ihbt Prague Czechia
Helsinki University Central Hospital Helsinki Finland
New Children'S Hospital, University of Helsinki and Helsinki University Hospital Helsinki Finland
Turku University Hospital Turku Finland
Chu D'Amiens-Picardie - Hopital Sud Amiens France
CHU CAEN Caen France
Centre Hospitalier Regional Universitaire (Chru) de Lille - Hopital Claude Huriez Lille France
Institut Paoli Calmettes Marseille France
Chu de Nantes Nantes France
Centre Hospitalier Universitaire de Nice,Hopital L Archet Nice France
Hospital Saint-Louis - Aphp Paris France
Hopital Universitaire Robert Debre Paris France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque Pessac France
Centre Hospitalier Lyon Sud Pierre-Bénite France
Centre Henri Becquerel Rouen France
Institut Claudius Regaud Cancer Comprehensive Center - Iuct Oncopole Toulouse France
Chru Nancy Vandœuvre-lès-Nancy France
Gustave Roussy Cancer Campus Grand Paris- (Institut de Cancerologie Gustave-Roussy) Villejuif France
Uniklinik Rwth Aachen Medizinische Klinik Iv Aachen Germany
Charite - Universitaetsmedizin Berlin Berlin Germany
Universitaetsklinikum Koeln Cologne Germany
University Hospital Carl Gustav Carus Dresden Germany
Universitatsklinikum Erlangen Erlangen Germany
Klinikum Der Johann Wolfgang Goethe-Universitaet Frankfurt am Main Germany
Universitaetsklinikum Freiburg Freiburg im Breisgau Germany
Universitaetsmedizin Goettingen Göttingen Germany
Universitaetsklinikum Halle Halle Germany

+ 90 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06821542 on ClinicalTrials.gov ↗ ← All trials in Ireland