Expanded Access Program for Axatilimab in Chronic Graft Versus Host Disease (GVHD)

Chronic Graft Vs. Host Disease Clinical Trial

Official title:

Expanded Access Program for Axatilimab in Chronic Graft Versus Host Disease (GVHD)

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Bronchiolitis Obliterans Syndrome
• Chronic Graft Vs. Host Disease
• Graft vs Host Disease

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