Clinical trial NCT05263999: A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Graft Versus Host Disease
GVHD
Acute-graft-versus-host Disease
Acute GVHD
aGVHD
Lead sponsor: Equillium
Sponsor class: INDUSTRY
Collaborators: name: Biocon Limited
First posted: 2022-03-03
Enrollment: 158
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response.
timeFrame: Day 29
Secondary outcomes:
measure: Evaluate the durability of response to itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids.
timeFrame: Day 99
measure: Assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures,
timeFrame: Day 29
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Duarte
country: United States
facility: City of Hope
state: California
city: La Jolla
country: United States
facility: University of California, San Diego (UCSD) - Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles (UCLA) - Medical Center
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center (UCMC)
state: Illinois
city: Maywood
country: United States
facility: Loyola University Chicago, performing research at Loyola University Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Hackensack
country: United States
facility: John Theurer Cancer Center At Hackensack UMC
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of NJ
state: New Jersey
city: Lake Success
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina (UNC)
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology in Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University (OSU)
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU)
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Abramson Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute, LLC (SCRI)
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: East Melbourne
country: Australia
facility: Royal Melbourne Hospital
city: Heidelberg
country: Australia
facility: Austin Health
city: Westmead
country: Australia
facility: Westmead Hospital
city: Anderlecht
country: Belgium
facility: ULB - Institut Jules Bordet; department of Hematology
city: Antwerpen
country: Belgium
facility: ZNA Stuivenberg
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende AV
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc; Hematology Department
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg - Department of Hematology
city: Liege
country: Belgium
facility: CHU de Liege - Hematology Department
city: Roeselare
country: Belgium
facility: AZ Delta
city: Vancouver
country: Canada
facility: Vancouver Coastal Health Authority
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Center - Research Institute
state: Quebec
city: Québec
country: Canada
facility: CHU de Québec - Université Laval
state: Quebec
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
city: Amiens
country: France
facility: CHU Amiens Picardie - Hopital Sud
city: Caen
country: France
facility: CHU de Caen - Hopital Femme-Enfant-Hematologie (FEH)
city: Grenoble Cedex 9
country: France
facility: CHU de Grenoble Hôpital Michallon
city: Lille
country: France
facility: CHU de Lille - Hopital Claude Huriez
city: Lyon
country: France
facility: CHU de Nantes - Hôtel-Dieu
city: Marseille
country: France
facility: Institut Paoli Calmettes - Hematology
city: Nice
country: France
facility: CHU Nice, Hospital l'Archet
city: Paris
country: France
facility: AP-HP Hopital Saint-Louis
city: Pessac
country: France
facility: CHU Bordeaux - Hopital Haut-Leveque - Centre François Magendie
city: Pierre Bénite
country: France
facility: HCL Centre Hospitalier Lyon Sud
city: Rennes Cedex 9
country: France
facility: CHU de Rennes Hôpital Pontchaillou
city: Toulouse
country: France
facility: CHU Toulouse, Hematology
city: Villejuif
country: France
facility: Institut Gustave Roussy - Hematology
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin, Tumorimmunologie Campus Virchow-Klinikum
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf
city: Halle
country: Germany
facility: Martin Luther Universitat Halle-Wittenberg
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Köln
country: Germany
facility: Universitaetsklinikum Koeln (AoeR)
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg, Medizinische Klinik II
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Medical Center Ein Karem
city: Petach Tikva
country: Israel
facility: Bone Marrow Transplantation Unit Rabin MC
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tel HaShomer
country: Israel
facility: Chaim Sheba Medical Center
city: Bologna
country: Italy
facility: Dipartimento Malattie oncologiche ed ematologiche - U.O. Ematologia - Programma dipartimentale Terapie cellulari avanzate
state: BO
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco- Presidio Ospedaliero Ferrarotto Alessi
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Torino
country: Italy
facility: AOU Citta della Salute e della Scienza di Torino - Ospedale Regina Margherita
city: Verona
country: Italy
facility: Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Auckland
country: New Zealand
facility: Starship Children's Hospital
city: Lisboa
country: Portugal
facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.
city: Donostia
country: Spain
facility: Hospital Universitario Donostia
state: Gipuzkoa
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Barcelona
country: Spain
facility: Institut Catala d'Oncologia - L'Hospitalet
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra - Pamplona
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Málaga
country: Spain
facility: Hospital Universitario Regional de Málaga
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
Study officials:
affiliation: Equillium, Inc.
name: Chief Development Officer
role: STUDY_DIRECTOR
References: