NCT06585774
Recruiting
Phase 3
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (AXemplify-357)
ConditionsChronic Graft-versus-host-disease
Overview
- Phase
- Phase 3
- Intervention
- INCA034176
- Conditions
- Chronic Graft-versus-host-disease
- Sponsor
- Incyte Corporation
- Enrollment
- 240
- Locations
- 206
- Primary Endpoint
- Event Free Survival (EFS)
- Status
- Recruiting
- Last Updated
- 26 days ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •≥ 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.
- •Willingness to avoid pregnancy or fathering children.
Exclusion Criteria
- •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.
- •Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D
- •Prior treatment with CSF-1R targeted therapies.
- •Active, uncontrolled bacterial, fungal, parasitic, or viral infection.
- •Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-HCT was performed, including DLIs for the treatment of molecular relapse.
- •History of acute or chronic pancreatitis.
- •Active symptomatic myositis.
Arms & Interventions
Axatilimab + Corticosteroids
Axatilimab and Corticosteroids at the protocol-defined dose.
Intervention: INCA034176
Placebo + Corticosteroids
Matching placebo and Corticosteroids at the protocol-defined dose.
Intervention: Placebo
Placebo + Corticosteroids
Matching placebo and Corticosteroids at the protocol-defined dose.
Intervention: Corticosteroids
Axatilimab + Corticosteroids
Axatilimab and Corticosteroids at the protocol-defined dose.
Intervention: Corticosteroids
Outcomes
Primary Outcomes
Event Free Survival (EFS)
Time Frame: Up to 3 years
Defined from the date of randomization to the date of any predefined event, whichever occurs first.
Secondary Outcomes
- Objective Response (OR)(6 months)
- Event Free Survival 2(Up to 3 years)
- Proportion of participants with a ≥ 7-point improvement in mLSS total score(Up to 3 years)
- Overall Response(12 Months)
- DOR (in responders only)(Up to 3 years)
- Best Overall Response (BOR)(Up to 3 years)
- Overall Survival (OS)(Up to 3 years)
- Nonrelapse mortality (NRM)(Up to 3 years)
- Failure-free survival (FFS)(Up to 3 years)
- Relapse of hematologic diseases(Up to 3 years)
- Time to primary hematologic disease relapse(Up to 3 years)
- Percent reduction in daily corticosteroid dose(6 months)
- Proportion of participants who tapered off all corticosteroids(6 months)
- Change from baseline in soluble markers for bone resorption and formation, including bone-specific alkaline phosphatase (BAP) and C-terminal telopeptide (CTX)(Up to 3 years and 30 days)
- Number of participants with Treatment-emergent Adverse Events (TEAEs)(Up to 3 years and 30 days)
- Change from baseline in circulating monocyte number and phenotype (CD14/16)(Up to 3 years and 30 days)
Study Sites (206)
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