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

PHASE3RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Is willing and able to provide written informed consent/assent and to comply with all protocol procedures and assessments required for the study.

Is age ≥12 years and >40kg at informed consent/assent.

Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis.

Has evidence of myeloid engraftment

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.

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

Evidence of morphological relapsed, progressive, persistent, or untreated malignancy, with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the breast.

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

Evidence of persistent molecular disease requiring treatment that was not specified prior to HSCT.

Evidence of cGVHD or overlap syndrome

Use of immunosuppressants other than corticosteroids for the treatment of aGVHD.

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.

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Eligibility

Age eligible for study : 12 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-04-29

Primary completion: 2024-12-01

Study completion finish: 2025-12-01

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT05263999

Intervention or treatment

BIOLOGICAL: Itolizumab

DRUG: EQ001 Placebo

Conditions

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

Image related to Graft Versus Host Disease

Condition: Graft Versus Host Disease, GVHD and more
BIOLOGICAL: Itolizumab and other drugs
Adelaide, Not Specified, Australia and more
Sponsor: Equillium

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Royal Adelaide Hospital

Research sites nearby

Select from list below to view details:

Royal Adelaide Hospital
Adelaide, Not Specified, Australia
Westmead Hospital
Westmead, Not Specified, Australia
Royal Melbourne Hospital
East Melbourne, Not Specified, Australia
Austin Health
Heidelberg, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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 \[Bmab600\]
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

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
The efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response.	Complete response at Day 29	Day 29

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Evaluate the durability of response to itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids.	Durable Complete Response rate from Day 29 through Day 99	Day 99
Assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures,	Overall Response Rates at Day 29	Day 29

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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