A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)
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|ClinicalTrials.gov Identifier: NCT05263999|
Recruitment Status : Recruiting
First Posted : March 3, 2022
Last Update Posted : March 8, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease GVHD Acute-graft-versus-host Disease Acute GVHD aGVHD||Biological: Itolizumab Drug: EQ001 Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination With Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease|
|Actual Study Start Date :||April 29, 2022|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||November 2024|
Experimental: Itolizumab (EQ001)
Itolizumab (EQ001) administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses.
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
- The efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response. [ Time Frame: Day 29 ]Complete response at Day 29
- Evaluate the durability of response to itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids. [ Time Frame: 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, [ Time Frame: Day 29 ]Overall Response Rates at Day 29
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|Ages Eligible for Study:||12 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05263999
|Contact: Clinical Trial Managerfirstname.lastname@example.org|
|Study Director:||Maple Fung, MD||Equillium, Inc.|
|Other Study ID Numbers:||
|First Posted:||March 3, 2022 Key Record Dates|
|Last Update Posted:||March 8, 2023|
|Last Verified:||March 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Graft vs Host Disease
Immune System Diseases