AMGEN20160283

A Phase 1b/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 592 in Adult Subjects With Steroid Refractory Chronic Graft versus Host Disease

Study treatments

AMG 592 SC 

Fase 1b: either weekly or biweekly AMG 592 plus protocol permitted background therapy for up to 52 weeks 

Fase 2: the recommended phase 2 dose of AMG 592 for up to 52 plus protocol permitted background therapy for cGVHD 

Inclusion criteria

• Moderate to severe steroid-refractory cGVHD
• No more than 3 previous treatments for cGVHD, excluding topical agents. - Stable dose of ≤ 1 mg/kg/day of systemic prednisone or equivalent 
• On a stable dose of non-corticosteroid immunosuppressants
• Adequate pulmonary function - Adequate cardiac function
• Adequate bone marrow function 

Exclusion criteria

• Receiving treatment with calcineurin-inhibitor plus sirolimus 
• Received ibrutinib or the following therapies considered, investigational for treatment of cGVHD including     imatinib, bortezomib, ruxolitnib, or entospletinib, within 4 weeks prior to starting AMG 592 or is currently   receiving treatment in another investigational drug or device study.
• Received treatment with T-cell depleting, B-cell depleting or IL-2 signaling targeted medication within 12        weeks prior to starting AMG 592.
• Received treatment with T regulatory cell expanding therapies within 4 weeks prior to starting AMG 592 
• Received a donor lymphocyte infusion within 12 weeks prior to starting dose of AMG 592

Participating sites

• University Hospital Leuven Gasthuisberg