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A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

ConditionChronic Graft-versus-host-disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorIncyte Corporation

About this trial

This study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 12 years of age at the time of informed consent.

New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy.

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.

Adequate hematologic function with ANC ≥ 0.5 × 109/L independent of growth factors for at least 7 days prior to study entry.

Disqualifiers

Received more than 1 prior allo-HCT. Prior autologous HCT is allowed.

Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.

Received more than 7 days of systemic corticosteroid treatment for cGVHD or unable to begin a prednisone dose ≥ 1.0 mg/kg per day (or methylprednisolone equivalent) for cGVHD.

Received previous systemic treatment for cGVHD, including extracorporeal photopheresis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • INCA034176

    Drug

    IV infusion

  • Placebo

    Drug

    IV infusion

  • Corticosteroids

    Drug

    Oral/IV Infusion

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Axatilimab + CorticosteroidsExperimental treatment 2 interventions
Group B: Placebo + CorticosteroidsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Event Free Survival (EFS)

Defined from the date of randomization to the date of any predefined event, whichever occurs first.

Time frame
Up to 3 years

Secondary outcomes

1

Objective Response (OR)

Defined for each treatment group as CR or PR at 6 months Cycle 7 (28-day cycles), Day 1, in the absence of new systemic therapy for cGVHD. Responses defined by the 2014 NIH consensus criteria.

Time frame
6 months
2

Event Free Survival 2

Defined from the date of randomization to the date of any predefined event, whichever occurs first.

Time frame
Up to 3 years
3

Proportion of participants with a ≥ 7-point improvement in mLSS total score

Time frame
Up to 3 years
4

Overall Response

Defined as CR or PR at 12 months in the absence of new systemic therapy for cGVHD.

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Incyte Corporation

Lead sponsor

Source ClinicalTrials.gov
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