A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)

Purpose

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

Conditions

  • Graft Versus Host Disease
  • GVHD
  • Acute-graft-versus-host Disease
  • Acute GVHD
  • aGVHD

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Itolizumab (EQ001) 		Itolizumab (EQ001) administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses.
  • Biological: Itolizumab
    Itolizumab [Bmab600]
    Other names:
    • EQ001
    • Bmab600
Placebo Comparator
EQ001 Placebo 		EQ001 Placebo administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses
  • Drug: EQ001 Placebo
    EQ001 Placebo

Recruiting Locations

Tulane University Medical Center
New Orleans, Louisiana 70112

More Details

Status
Recruiting
Sponsor
Equillium

Study Contact

Clinical Trial Manager
858-240-1200
clinicaltrials@equilliumbio.com

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.