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

June 12, 2025 updated by: Equillium

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Royal Adelaide Hospital
      • East Melbourne, Australia, 3002
        • Royal Melbourne Hospital
      • Heidelberg, Australia, 3084
        • Austin Health
      • Westmead, Australia, 2145
        • Westmead Hospital
  • Belgium
      • Anderlecht, Belgium, 1070
        • ULB - Institut Jules Bordet; department of Hematology
      • Antwerpen, Belgium, 2060
        • ZNA Stuivenberg
      • Brugge, Belgium, 8000
        • AZ Sint-Jan Brugge-Oostende AV
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc; Hematology Department
      • Leuven, Belgium, 3000
        • UZ Leuven - Campus Gasthuisberg - Department of Hematology
      • Liege, Belgium, 4000
        • CHU de Liege - Hematology Department
      • Roeselare, Belgium, 8800
        • AZ Delta
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Coastal Health Authority
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montréal, Quebec, Canada, H3G 1A4
        • McGill University Health Center - Research Institute
      • Québec, Quebec, Canada, G1R 2J6
        • CHU de Quebec - Universite Laval
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • University of Saskatchewan
  • France
      • Amiens, France, 80054
        • Chu Amiens Picardie - Hopital Sud
      • Caen, France, 14003
        • CHU de Caen - Hopital Femme-Enfant-Hematologie (FEH)
      • Grenoble Cedex 9, France, 38043
        • CHU de Grenoble Hôpital Michallon
      • Lille, France, 59000
        • CHU de Lille - Hôpital Claude Huriez
      • Lyon, France, 69003
        • CHU de Nantes - Hotel-Dieu
      • Marseille, France, 13009
        • Institut Paoli Calmettes - Hematology
      • Nice, France, 06200
        • CHU Nice, Hospital l'Archet
      • Paris, France, 75010
        • AP-HP Hopital Saint-Louis
      • Pessac, France, 33604
        • CHU Bordeaux - Hopital Haut-Leveque - Centre Francois Magendie
      • Pierre Bénite, France, 69495
        • HCL Centre Hospitalier Lyon Sud
      • Rennes Cedex 9, France, 35033
        • Chu de Rennes Hopital Pontchaillou
      • Toulouse, France, 31059
        • CHU Toulouse, Hematology
      • Villejuif, France, 94805
        • Institut Gustave Roussy - Hematology
  • Germany
      • Berlin, Germany, 13353
        • Charité Universitätsmedizin Berlin, Tumorimmunologie Campus Virchow-Klinikum
      • Duesseldorf, Germany, 40225
        • Universitaetsklinikum Duesseldorf
      • Halle, Germany, 06120
        • Martin Luther Universitat Halle-Wittenberg
      • Jena, Germany, 07747
        • Universitatsklinikum Jena
      • Köln, Germany, 50937
        • Universitaetsklinikum Koeln (AoeR)
      • Leipzig, Germany, 04103
        • Universitaetsklinikum Leipzig
      • Münster, Germany, 48149
        • Universitätsklinikum Münster
      • Ulm, Germany, 89081
        • Universitaetsklinikum Ulm
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg, Medizinische Klinik II
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center Ein Karem
      • Petach Tikva, Israel, 4941492
        • Bone Marrow Transplantation Unit Rabin MC
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
      • Tel HaShomer, Israel, 5265601
        • Chaim Sheba Medical Center
  • Italy
      • Catania, Italy, 95123
        • Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco- Presidio Ospedaliero Ferrarotto Alessi
      • Firenze, Italy, 50134
        • Azienda Ospedaliero-Universitaria Careggi
      • Milano, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Milano, Italy, 20132
        • Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
      • Monza, Italy, 20900
        • Fondazione IRCCS San Gerardo dei Tintori
      • Reggio Calabria, Italy, 89133
        • Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"
      • Rome, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
      • Rozzano, Italy, 20089
        • Istituto Clinico Humanitas
      • Torino, Italy, 10126
        • AOU Città della Salute e della Scienza di Torino - Ospedale Regina Margherita
      • Verona, Italy, 37134
        • Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
    • BO
      • Bologna, BO, Italy, 40138
        • Dipartimento Malattie oncologiche ed ematologiche - U.O. Ematologia - Programma dipartimentale Terapie cellulari avanzate
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Daegu, Korea, Republic of, 41944
        • Kyungpook National University Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
    • Jeollanam-do
      • Hwasun, Jeollanam-do, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
  • New Zealand
      • Auckland, New Zealand, 1023
        • Starship Children's Hospital
  • Portugal
      • Lisboa, Portugal, 1099-023
        • Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
      • Porto, Portugal, 4200-072
        • Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona
      • Barcelona, Spain, 8025
        • Hospital de La Santa Creu i Sant Pau
      • Barcelona, Spain, 08908
        • Institut Català d'Oncologia - L'Hospitalet
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain, 28046
        • Clinica Universidad de Navarra - Pamplona
      • Madrid, Spain, 28046
        • Hospital Universitario Marqués de Valdecilla
      • Málaga, Spain, 29010
        • Hospital Universitario Regional de Málaga
      • Salamanca, Spain, 37007
        • Hospital Clinico Universitario de Salamanca
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
    • Gipuzkoa
      • Donostia, Gipuzkoa, Spain, 20014
        • Hospital Universitario Donostia
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • La Jolla, California, United States, 92093
        • University of California, San Diego (UCSD) - Moores Cancer Center
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90059
        • University of California, Los Angeles (UCLA) - Medical Center
      • Stanford, California, United States, 94305
        • Stanford Cancer Center
    • Florida
      • Orlando, Florida, United States, 32804
        • AdventHealth Orlando
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medical Center (UCMC)
      • Maywood, Illinois, United States, 60153
        • Loyola University Chicago, performing research at Loyola University Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack UMC
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Cancer Institute of Nj
    • New York
      • Lake Success, New York, United States, 11042
        • Northwell Health
      • New York, New York, United States, 10065
        • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina (UNC)
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology in Cincinnati
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43201
        • The Ohio State University (OSU)
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University (OHSU)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Abramson Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute, LLC (SCRI)
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75246
        • Baylor Scott & White Research Institute
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: Day 29
Complete response at Day 29
Day 29

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Equillium

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biocon Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Chief Development Officer, Equillium, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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