Clinical Trials/NCT06388564

NCT06388564

Recruiting

Phase 2

A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

Incyte Corporation131 sites in 6 countries120 target enrollmentOctober 11, 2024

ConditionsChronic Graft-versus-host-disease

InterventionsAxatilimab Ruxolitinib Corticosteroids

DrugsAxatilimab Ruxolitinib Corticosteroids

Overview

Phase: Phase 2
Intervention: Axatilimab
Conditions: Chronic Graft-versus-host-disease
Sponsor: Incyte Corporation
Enrollment: 120
Locations: 131
Primary Endpoint: Objective Response Rate
Status: Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief Summary

This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.

Registry

clinicaltrials.gov

Start Date

October 11, 2024

End Date

December 1, 2029

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Incyte Corporation

Responsible Party

Sponsor

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 1 allo-SCT (any type of stem cell donor, any conditioning regimen, and source of hematopoietic stem cells).
•Adequate hematologic function independent of platelet transfusion and growth factors for at least 7 days prior to study entry: ANC ≥ 0.75 × 109/L and platelet count ≥ 20 × 109/L.
•Willingness to avoid pregnancy or fathering children.

Exclusion Criteria

•Received more than 1 prior allo-SCT. Prior autologous HCT is allowed.
•Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.
•Received previous systemic treatment for cGVHD, including systemic corticosteroids and extracorporeal photopheresis.
•Received systemic corticosteroids within 2 weeks prior to C1D1, regardless of indication.
•Initiated systemic treatment with CNIs or mTOR inhibitors within 2 weeks prior to C1D
•Prior treatment with a JAK inhibitor within 8 weeks before randomization. Participants who received a JAK inhibitor for the treatment of aGVHD are eligible only if they achieved a response (CR or PR) to JAK inhibitor treatment and did not discontinue due to toxicity.
•Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-SCT was performed, including DLIs for the treatment of molecular relapse.
•History of acute or chronic pancreatitis.
•History of thromboembolic events (such as deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction) in the 6 months prior to study entry.
•Active symptomatic myositis.

Arms & Interventions

Treatment Group A

Axatilimab will be administered at a protocol defined starting dose plus ruxolitinib at a protocol defined starting dose.

Intervention: Axatilimab

Treatment Group A

Axatilimab will be administered at a protocol defined starting dose plus ruxolitinib at a protocol defined starting dose.

Intervention: Ruxolitinib

Treatment Group B

Ruxolitinib will be administered at a protocol defined starting dose.

Intervention: Ruxolitinib

Treatment Group C

Corticosteroids alone will be administered at a protocol defined starting dose.

Intervention: Corticosteroids

Outcomes

Primary Outcomes

Objective Response Rate

Time Frame: 6 months

Defined as Complete Response (CR) or Partial Response (PR) at 6 months in the absence of new systemic therapy for cGVHD. Response assessment will be based on the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD.

Secondary Outcomes

Best overall response in the first 6 months(Up to 6 months)
Duration of Response(Up to 2 years)
Proportion of participants who remain corticosteroid-free(4 weeks, 8 weeks and 6 months)
Axatilimab pharmacokinetic (PK) in Plasma(Up to 2 years and 30 days)
Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score(Up to 2 years)
OR at 12 months, defined as CR or PR at 12 months (C14D1) in the absence of new systemic therapy for cGVHD.(12 months)
Failure-free Survival (FFS)(Up to 2 years and 30 days)
Ruxolitinib PK in Plasma(Up to 2 years and 30 days)
Organ-specific response in the first 6 cycles and on study, based on the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD.(Up to 2 years)
Number of participants with Treatment-emergent Adverse Events (TEAEs)(Up to 2 years and 30 days)