Clinical Trials Logo

Clinical Trial Details — Status: Available

Administrative data

NCT number NCT05544032
Other study ID # INCA 34176-MA-GD-301
Secondary ID INCA 34176-MA-GD
Status Available
Phase
First received
Last updated

Study information

Verified date March 2024
Source Incyte Corporation
Contact Incyte Corporation Medical Information Call Center (US)
Phone 1.855.463.3463
Email medinfo@incyte.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

To provide axatilimab through an expanded access program for the treatment of graft-versus-host disease (GVHD) in United States to patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored clinical studies for axatilimab in the treatment of GVHD.


Recruitment information / eligibility

Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 6 Years and older
Eligibility Inclusion Criteria: - Must be 6 years of age or older. - Allogeneic HSCT recipients with active cGVHD. - Has refractory or recurrent active cGVHD despite at least 2 lines of systemic therapy. - Be willing to avoid pregnancy or fathering children. - Able to provide written informed consent and/or assent from the patient, parent, or guardian. Exclusion Criteria: - Eligible to participate in any actively enrolling axatilimab clinical trial for the treatment of cGVHD. - History of acute or chronic pancreatitis. - Has active symptomatic myositis. - Has known HIV seropositive status. - Has active, uncontrolled systemic bacterial, fungal, parasitic, or viral infection. - Has active HBV or HCV. - Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
axatilimab
Treatment with axatilimab includes receiving intravenous (IV) doses of axatilimab every 2 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Incyte Corporation
See also
  Status Clinical Trial Phase
Recruiting NCT00092235 - Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease
Terminated NCT02322190 - Biomarkers in Acute Graft-Versus-Host Disease and Extracorporeal Photopheresis Added to Investigator Chosen Therapies of Steroid Refractory Acute GVHD Phase 2