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

Phase

N/A

Condition

N/A

Treatment

axatilimab

INCA34176

Clinical Study ID

NCT05544032

INCA 34176-MA-GD-301

Ages > 6
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 systemictherapy.
Be willing to avoid pregnancy or fathering children.
Able to provide written informed consent and/or assent from the patient, parent, orguardian.

Exclusion

Exclusion Criteria:

Eligible to participate in any actively enrolling axatilimab clinical trial for thetreatment 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 beforestarting therapy.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Design

axatilimab