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

NCT05263999 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: EQ-100-02
• Study Type: interventional
• Target: 158
• Locations: 12 countries
• Sites: 118

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (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

  Day 29

Secondary Outcomes (2)

• Evaluate the durability of response to itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids.

  Day 99

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

  Day 29

Study Arms (2)

Itolizumab (EQ001)

EXPERIMENTAL

Itolizumab (EQ001) administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses.

Biological: Itolizumab

EQ001 Placebo

PLACEBO COMPARATOR

EQ001 Placebo administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses

Drug: EQ001 Placebo

Interventions

Itolizumab BIOLOGICAL

Itolizumab \[Bmab600\]

Also known as: EQ001, Bmab600

Itolizumab (EQ001)

EQ001 Placebo DRUG

EQ001 Placebo

EQ001 Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Equillium: lead
• Biocon Limited: collaborator

Study Sites (118)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

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

La Jolla, California, 92093, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

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

Los Angeles, California, 90059, United States

Location

Stanford Cancer Center

Stanford, California, 94305, United States

Location

AdventHealth Orlando

Orlando, Florida, 32804, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

The University of Chicago Medical Center (UCMC)

Chicago, Illinois, 60637, United States

Location

Loyola University Chicago, performing research at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

John Theurer Cancer Center At Hackensack UMC

Hackensack, New Jersey, 07601, United States

Location

Rutgers Cancer Institute of NJ

New Brunswick, New Jersey, 08901, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

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

New York, New York, 10065, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

University of North Carolina (UNC)

Chapel Hill, North Carolina, 27514, United States

Location

Wake Forest

Winston-Salem, North Carolina, 27157, United States

Location

Oncology Hematology in Cincinnati

Cincinnati, Ohio, 45242, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

The Ohio State University (OSU)

Columbus, Ohio, 43201, United States

Location

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

Location

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

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

Pittsburgh, Pennsylvania, 15232, United States

Location

Sarah Cannon Research Institute, LLC (SCRI)

Nashville, Tennessee, 37203, United States

Location

Baylor Scott & White Research Institute

Dallas, Texas, 75246, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

Royal Melbourne Hospital

East Melbourne, 3002, Australia

Location

Austin Health

Heidelberg, 3084, Australia

Location

Westmead Hospital

Westmead, 2145, Australia

Location

ULB - Institut Jules Bordet; department of Hematology

Anderlecht, 1070, Belgium

Location

ZNA Stuivenberg

Antwerp, 2060, Belgium

Location

AZ Sint-Jan Brugge-Oostende AV

Bruges, 8000, Belgium

Location

Cliniques Universitaires Saint-Luc; Hematology Department

Brussels, 1200, Belgium

Location

UZ Leuven - Campus Gasthuisberg - Department of Hematology

Leuven, 3000, Belgium

Location

CHU de Liege - Hematology Department

Liège, 4000, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

Vancouver Coastal Health Authority

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Health Center - Research Institute

Montreal, Quebec, H3G 1A4, Canada

Location

CHU de Québec - Université Laval

Québec, Quebec, G1R 2J6, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

CHU Amiens Picardie - Hopital Sud

Amiens, 80054, France

Location

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

Caen, 14003, France

Location

CHU de Grenoble Hôpital Michallon

Grenoble, 38043, France

Location

CHU de Lille - Hopital Claude Huriez

Lille, 59000, France

Location

CHU de Nantes - Hôtel-Dieu

Lyon, 69003, France

Location

Institut Paoli Calmettes - Hematology

Marseille, 13009, France

Location

CHU Nice, Hospital l'Archet

Nice, 06200, France

Location

AP-HP Hopital Saint-Louis

Paris, 75010, France

Location

CHU Bordeaux - Hopital Haut-Leveque - Centre François Magendie

Pessac, 33604, France

Location

HCL Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU de Rennes Hôpital Pontchaillou

Rennes, 35033, France

Location

CHU Toulouse, Hematology

Toulouse, 31059, France

Location

Institut Gustave Roussy - Hematology

Villejuif, 94805, France

Location

Charité Universitätsmedizin Berlin, Tumorimmunologie Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Universitaetsklinikum Koeln (AoeR)

Cologne, 50937, Germany

Location

Universitaetsklinikum Duesseldorf

Düsseldorf, 40225, Germany

Location

Martin Luther Universitat Halle-Wittenberg

Halle, 06120, Germany

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Universitaetsklinikum Ulm

Ulm, 89081, Germany

Location

Universitätsklinikum Würzburg, Medizinische Klinik II

Würzburg, 97080, Germany

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Hadassah Medical Center Ein Karem

Jerusalem, 9112001, Israel

Location

Bone Marrow Transplantation Unit Rabin MC

Petah Tikva, 4941492, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Chaim Sheba Medical Center

Tel Litwinsky, 5265601, Israel

Location

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

Bologna, BO, 40138, Italy

Location

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

Catania, 95123, Italy

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy

Location

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Milan, 20132, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Fondazione IRCCS San Gerardo dei Tintori

Monza, 20900, Italy

Location

Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"

Reggio Calabria, 89133, Italy

Location

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

Rome, 00168, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

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

Torino, 10126, Italy

Location

Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma

Verona, 37134, Italy

Location

Starship Children's Hospital

Auckland, 1023, New Zealand

Location

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

Lisbon, 1099-023, Portugal

Location

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

Porto, 4200-072, Portugal

Location

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital Universitario Donostia

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Institut Catala d'Oncologia - L'Hospitalet

Barcelona, 08908, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 8025, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Clinica Universidad de Navarra - Pamplona

Madrid, 28046, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Marques de Valdecilla

Madrid, 28046, Spain

Location

Hospital Universitario Regional de Málaga

Málaga, 29010, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Related Links

• Company website

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

itolizumab

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Chief Development Officer

  Equillium, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: March 3, 2022
• Study Start: April 29, 2022
• Primary Completion: April 22, 2025
• Study Completion: May 12, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

US (38); FR (13); AU (4); DE (9); BE (7); PT (2); KR (7); NZ (1); ES (16); IT (11); IL (5); CA (5)