Graft Versus Host Disease, GVHD, Acute-graft-versus-host Disease, Acute GVHD, aGVHD
Conditions
Brief summary
This is a multi-center study to compare the efficacy and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids
Detailed description
This study will enroll 200 subjects at approximately 125 sites globally. Subjects will be randomized in a 1:1 ratio to active or placebo and will receive a total of 7 doses administered intravenously approximately every 2 weeks. The study follows the patients for a total of approximately 365 days.
Interventions
BIOLOGICALItolizumab
Itolizumab \[Bmab600\]
DRUGEQ001 Placebo
EQ001 Placebo
Sponsors
Biocon Limited
Equillium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Is willing and able to provide written informed consent/assent and to comply with all protocol procedures and assessments required for the study. 2. Is age ≥12 years and \>40kg at informed consent/assent. 3. Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis. 4. Has evidence of myeloid engraftment 5. Has a clinical diagnosis of aGVHD Grades III-IV or Grade II with LGI involvement based on Mount Sinai Acute GVHD International Consortium (MAGIC) grading criteria. 6. Began systemic corticosteroid treatment for aGVHD ≤72 hours prior to the start of study drug dosing AND must receive 2 mg/kg/day methylprednisolone or equivalent on Day 1.
Exclusion criteria
1. Evidence of morphological relapsed, progressive, persistent, or untreated malignancy, with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the breast. 2. An unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT. 3. Evidence of persistent molecular disease requiring treatment that was not specified prior to HSCT. 4. Evidence of cGVHD or overlap syndrome 5. Use of immunosuppressants other than corticosteroids for the treatment of aGVHD. 6. Use of any systemic corticosteroids of \>0.5 mg/kg/day methylprednisolone or equivalent for any indication other than aGVHD within 7 days before the onset of aGVHD.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response. | Day 29 | Complete response at Day 29 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the durability of response to itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids. | Day 99 | Durable Complete Response rate from Day 29 through Day 99 |
| Assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures, | Day 29 | Overall Response Rates at Day 29 |
Countries
Australia, Belgium, Canada, France, Germany, Israel, Italy, New Zealand, Portugal, South Korea, Spain, United States
Outcome results
None listed