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Graft Versus Host DiseasePhase 3NCT05263999

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

A Phase 3 study testing Itolizumab in people with Graft Versus Host Disease and GVHD, run by Equillium at 118 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
Itolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
158 participants
Where
118 sitesin 12 countries
Study dates
29 Apr 2022to 12 May 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

118 sites in 12 countries.

118 sites in 12 countries

United States38 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30322

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of North Carolina (UNC)

    Chapel Hill, North Carolina, 27514

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • The University of Chicago Medical Center (UCMC)

    Chicago, Illinois, 60637

  • Oncology Hematology in Cincinnati

    Cincinnati, Ohio, 45242

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • The Ohio State University (OSU)

    Columbus, Ohio, 43201

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75246

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope

    Duarte, California, 91010

  • Spectrum Health

    Grand Rapids, Michigan, 49503

  • John Theurer Cancer Center At Hackensack UMC

    Hackensack, New Jersey, 07601

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of California, San Diego (UCSD) - Moores Cancer Center

    La Jolla, California, 92093

  • Northwell Health

    Lake Success, New York, 11042

  • University of Southern California

    Los Angeles, California, 90033

  • University of California, Los Angeles (UCLA) - Medical Center

    Los Angeles, California, 90059

  • Loyola University Chicago, performing research at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Sarah Cannon Research Institute, LLC (SCRI)

    Nashville, Tennessee, 37203

  • Rutgers Cancer Institute of NJ

    New Brunswick, New Jersey, 08901

  • Tulane University Medical Center

    New Orleans, Louisiana, 70112

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • AdventHealth Orlando

    Orlando, Florida, 32804

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health & Science University (OHSU)

    Portland, Oregon, 97239

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Stanford Cancer Center

    Stanford, California, 94305

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Wake Forest

    Winston-Salem, North Carolina, 27157

Other trials in United States

Spain16 sites

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Institut Catala d'Oncologia - L'Hospitalet

    Barcelona, 08908

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8025

  • Hospital Universitario Donostia

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Clinica Universidad de Navarra - Pamplona

    Madrid, 28046

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Marques de Valdecilla

    Madrid, 28046

  • Hospital Universitario Regional de Málaga

    Málaga, 29010

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

France13 sites

  • CHU Amiens Picardie - Hopital Sud

    Amiens, 80054

  • CHU de Caen - Hopital Femme-Enfant-Hematologie (FEH)

    Caen, 14003

  • CHU de Grenoble Hôpital Michallon

    Grenoble, 38043

  • CHU de Lille - Hopital Claude Huriez

    Lille, 59000

  • CHU de Nantes - Hôtel-Dieu

    Lyon, 69003

  • Institut Paoli Calmettes - Hematology

    Marseille, 13009

  • CHU Nice, Hospital l'Archet

    Nice, 06200

  • AP-HP Hopital Saint-Louis

    Paris, 75010

  • CHU Bordeaux - Hopital Haut-Leveque - Centre François Magendie

    Pessac, 33604

  • HCL Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Rennes Hôpital Pontchaillou

    Rennes, 35033

  • CHU Toulouse, Hematology

    Toulouse, 31059

  • Institut Gustave Roussy - Hematology

    Villejuif, 94805

Other trials in France

Italy11 sites

  • Dipartimento Malattie oncologiche ed ematologiche - U.O. Ematologia - Programma dipartimentale Terapie cellulari avanzate

    Bologna, BO, 40138

  • Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco- Presidio Ospedaliero Ferrarotto Alessi

    Catania, 95123

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Milan, 20132

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, 20900

  • Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"

    Reggio Calabria, 89133

  • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

    Rome, 00168

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • AOU Citta della Salute e della Scienza di Torino - Ospedale Regina Margherita

    Torino, 10126

  • Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma

    Verona, 37134

Other trials in Italy

Germany9 sites

  • Charité Universitätsmedizin Berlin, Tumorimmunologie Campus Virchow-Klinikum

    Berlin, 13353

  • Universitaetsklinikum Koeln (AoeR)

    Cologne, 50937

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225

  • Martin Luther Universitat Halle-Wittenberg

    Halle, 06120

  • Universitätsklinikum Jena

    Jena, 07747

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

  • Universitätsklinikum Münster

    Münster, 48149

  • Universitaetsklinikum Ulm

    Ulm, 89081

  • Universitätsklinikum Würzburg, Medizinische Klinik II

    Würzburg, 97080

Other trials in Germany

Belgium7 sites

  • ULB - Institut Jules Bordet; department of Hematology

    Anderlecht, 1070

  • ZNA Stuivenberg

    Antwerp, 2060

  • AZ Sint-Jan Brugge-Oostende AV

    Bruges, 8000

  • Cliniques Universitaires Saint-Luc; Hematology Department

    Brussels, 1200

  • UZ Leuven - Campus Gasthuisberg - Department of Hematology

    Leuven, 3000

  • CHU de Liege - Hematology Department

    Liège, 4000

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

South Korea7 sites

  • Pusan National University Hospital

    Busan, 49241

  • Kyungpook National University Hospital

    Daegu, 41944

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Canada5 sites

  • McGill University Health Center - Research Institute

    Montreal, Quebec, H3G 1A4

  • CHU de Québec - Université Laval

    Québec, Quebec, G1R 2J6

  • University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 4H4

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Vancouver Coastal Health Authority

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Israel5 sites

  • Rambam Health Care Campus

    Haifa, 3109601

  • Hadassah Medical Center Ein Karem

    Jerusalem, 9112001

  • Bone Marrow Transplantation Unit Rabin MC

    Petah Tikva, 4941492

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

  • Chaim Sheba Medical Center

    Tel HaShomer, 5265601

Other trials in Israel

Australia4 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Royal Melbourne Hospital

    East Melbourne, 3002

  • Austin Health

    Heidelberg, 3084

  • Westmead Hospital

    Westmead, 2145

Other trials in Australia

Portugal2 sites

  • Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

    Lisbon, 1099-023

  • Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.

    Porto, 4200-072

Other trials in Portugal

New Zealand1 site

  • Starship Children's Hospital

    Auckland, 1023

Other trials in New Zealand

About this study

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

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

Read the 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.

Being tested
Itolizumab, EQ001 Placebo
Medical subject headings
Graft vs Host Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ItolizumabBiological

    Also called EQ001, Bmab600

    Itolizumab [Bmab600]

  • EQ001 PlaceboDrug

    EQ001 Placebo

Study groups in NCT05263999
Study groupRoleWhat they receive
Itolizumab (EQ001)ExperimentalItolizumab (EQ001) administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses.
Receives: Biological: Itolizumab
EQ001 PlaceboPlacebo comparatorEQ001 Placebo administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses
Receives: Drug: EQ001 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 29

Secondary outcomes (2)

  1. 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

    Measured: Day 99

  2. Assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures,

    Overall Response Rates at Day 29

    Measured: Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2022
  2. Study start29 Apr 2022
  3. Primary completion22 Apr 2025
  4. Study completion12 May 2025

Why it stopped: The FDA declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway based on the EQUATOR study data.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05263999
Sponsor's protocol ID
EQ-100-02
Status last verified
Jun 2025
First submitted
1 Oct 2021
Last updated
17 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Itolizumab in people with Graft Versus Host Disease and GVHD, run by Equillium at 118 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, Spain, France, Italy, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The FDA declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway based on the EQUATOR study data.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response. (time frame: Day 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05263999.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.

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