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

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Equillium
• Collaborator: Biocon Limited

Criteria

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. Subjects <18 years may only enroll after the initial DMC data review, if locally permitted.

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, defined as an absolute neutrophil count ≥500/mm3 (or ≥0.5 × 10^9/L) achieved and sustained for 3 laboratory values obtained on different days. Laboratory values prior to Screening may be used.

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. Biopsies to confirm aGVHD should be obtained but are not required and should not delay entry into the study.

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. Has 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. Has an unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT.

3. Has evidence of persistent molecular disease requiring treatment (eg, standard chemotherapy or tyrosine kinase inhibitors) that was not specified prior to HSCT.

4. Has evidence of cGVHD or overlap syndrome, as defined by 2014 NIH Consensus Criteria.

5. Is using immunosuppressants other than corticosteroids for the treatment of aGVHD. Continued use of immunosuppressants as GVHD prophylaxis agents is permitted.

6. Has received 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. Systemic corticosteroids administered as premedication before blood product transfusions or IV medications to prevent infusion-related reactions are allowed.

7. Has a clinically active, uncontrolled bacterial, viral, or fungal infection, despite adequate treatment. No signs of progression of the infection can be present at Screening. Asymptomatic cytomegalovirus (CMV), Epstein-Barr virus (EBV), or human Herpesvirus 6 (HHV 6) viremia based on viral load or a viral load that is declining with treatment does not constitute a clinically active infection.

8. Has an active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

9. Has signs or symptoms of active tuberculosis (TB), as determined per local practice by the treating physician.

10. Has a known history of or has a positive test for human immunodeficiency virus (HIV) during Screening.