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

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

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

Study Overview

• Status: Recruiting
• Conditions: Graft Versus Host Disease; GVHD; aGVHD; Acute-graft-versus-host Disease; Acute GVHD
• Intervention / Treatment: Biological: Itolizumab; Drug: EQ001 Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trial Manager; Phone Number: 858-240-1200; Email: clinicaltrials@equilliumbio.com

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Recruiting
    • Royal Adelaide Hospital
  • East Melbourne, Australia, 3002
    • Recruiting
    • Royal Melbourne Hospital
  • Heidelberg, Australia, 3084
    • Recruiting
    • Austin Health
  • Westmead, Australia, 2145
    • Recruiting
    • Westmead Hospital
• Belgium
  • Antwerpen, Belgium, 2060
    • Recruiting
    • ZNA Stuivenberg
  • Brugge, Belgium, 8000
    • Recruiting
    • AZ Sint-Jan Brugge-Oostende AV
  • Liege, Belgium, 4000
    • Recruiting
    • CHU de Liege - Hematology Department
  • Roeselare, Belgium, 8800
    • Recruiting
    • AZ Delta
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Recruiting
      • Vancouver Coastal Health Authority
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Hospital
  • Quebec
    • Montréal, Quebec, Canada, H3G 1A4
      • Recruiting
      • McGill University Health Center - Research Institute
    • Québec, Quebec, Canada, G1R 2J6
      • Recruiting
      • CHU de Québec - Université Laval
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Recruiting
      • University of Saskatchewan
• France
  • Amiens, France, 80054
    • Recruiting
    • CHU Amiens Picardie - Hopital Sud
  • Caen, France, 14003
    • Recruiting
    • CHU de Caen - Hopital Femme-Enfant-Hematologie (FEH)
  • Lille, France, 59000
    • Recruiting
    • CHU de Lille - Hopital Claude Huriez
  • Lyon, France, 69003
    • Recruiting
    • CHU de Nantes - Hôtel-Dieu
  • Paris, France, 75010
    • Recruiting
    • AP-HP Hopital Saint-Louis
  • Pessac, France, 33604
    • Recruiting
    • CHU Bordeaux - Hopital Haut-Leveque - Centre François Magendie
  • Pierre Bénite, France, 69495
    • Recruiting
    • HCL Centre Hospitalier Lyon Sud
  • Toulouse, France, 31059
    • Recruiting
    • CHU Toulouse, Hematology
• Germany
  • Duesseldorf, Germany, 40225
    • Recruiting
    • Universitaetsklinikum Duesseldorf
  • Halle, Germany, 06120
    • Recruiting
    • Martin Luther Universitat Halle-Wittenberg
  • Jena, Germany, 07747
    • Recruiting
    • Universitätsklinikum Jena
  • Köln, Germany, 50937
    • Recruiting
    • Universitaetsklinikum Koeln (AoeR)
  • Leipzig, Germany, 04103
    • Recruiting
    • Universitaetsklinikum Leipzig
  • Ulm, Germany, 89081
    • Recruiting
    • Universitaetsklinikum Ulm
• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Health Care Campus
  • Jerusalem, Israel, 9112001
    • Recruiting
    • Hadassah Medical Center Ein Karem
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Tel Aviv Sourasky Medical Center
  • Tel HaShomer, Israel, 5265601
    • Recruiting
    • Chaim Sheba Medical Center
• Italy
  • Catania, Italy, 95123
    • Recruiting
    • Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco- Presidio Ospedaliero Ferrarotto Alessi
  • Firenze, Italy, 50134
    • Recruiting
    • Azienda Ospedaliero-Universitaria Careggi
  • Milano, Italy, 20132
    • Recruiting
    • IRCCS Ospedale San Raffaele
  • Milano, Italy, 20132
    • Recruiting
    • Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
  • Monza, Italy, 20900
    • Recruiting
    • Fondazione IRCCS San Gerardo dei Tintori
  • Reggio Calabria, Italy, 89133
    • Recruiting
    • Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
  • Rozzano, Italy, 20089
    • Recruiting
    • Istituto Clinico Humanitas
  • Torino, Italy, 10126
    • Recruiting
    • AOU Citta della Salute e della Scienza di Torino - Ospedale Regina Margherita
  • Verona, Italy, 37134
    • Recruiting
    • Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Recruiting
    • Pusan National University Hospital
  • Daegu, Korea, Republic of, 41944
    • Recruiting
    • Kyungpook National University Hospital
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
  • Jeollanam-do
    • Hwasun, Jeollanam-do, Korea, Republic of, 58128
      • Recruiting
      • Chonnam National University Hwasun Hospital
• Portugal
  • Lisboa, Portugal, 1099-023
    • Recruiting
    • Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
  • Porto, Portugal, 4200-072
    • Recruiting
    • Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.
• Spain
  • Barcelona, Spain, 08908
    • Recruiting
    • Institut Català d'Oncologia - L'Hospitalet
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic Barcelona
  • Barcelona, Spain, 8025
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
  • Granada, Spain, 18014
    • Recruiting
    • Hospital Universitario Virgen de las Nieves
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramon Y Cajal
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28046
    • Recruiting
    • Clinica Universidad de Navarra - Pamplona
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario Marqués de Valdecilla
  • Salamanca, Spain, 37007
    • Recruiting
    • Hospital Clinico Universitario de Salamanca
  • Sevilla, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen Del Rocio
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitari I Politecnic La Fe
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama At Birmingham
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California, San Diego (UCSD) - Moores Cancer Center
    • Los Angeles, California, United States, 90033
      • Recruiting
      • University of Southern California
    • Los Angeles, California, United States, 90059
      • Recruiting
      • University of California, Los Angeles (UCLA) - Medical Center
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford Cancer Center
  • Florida
    • Orlando, Florida, United States, 32804
      • Recruiting
      • AdventHealth Orlando
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • The University of Chicago Medical Center (UCMC)
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • Tulane University Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • Spectrum Health
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic - Rochester
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • John Theurer Cancer Center at Hackensack UMC
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers Cancer Institute of Nj
  • New York
    • Lake Success, New York, United States, 11042
      • Recruiting
      • Northwell Health
    • New York, New York, United States, 10065
      • Recruiting
      • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Recruiting
      • University of North Carolina (UNC)
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Recruiting
      • Oncology Hematology in Cincinnati
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
    • Columbus, Ohio, United States, 43201
      • Recruiting
      • The Ohio State University (OSU)
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University (OHSU)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania Abramson Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Sarah Cannon Research Institute, LLC (SCRI)
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor Scott & White Research Institute
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutchinson Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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]; Other Names: Bmab600; EQ001
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 Measures

Outcome Measure	Measure Description	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 Measures

Outcome Measure	Measure Description	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

Collaborators and Investigators

• Sponsor: Equillium
• Collaborators: Biocon Limited
• Investigators: Study Director: Maple Fung, MD, Equillium, Inc.

Publications and helpful links

Helpful Links

• Company website

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: EQ-100-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No