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

Graft Versus Host Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05263999
• Other study ID #: EQ-100-02
• Status: Recruiting
• Phase: Phase 3
• Start date: April 29, 2022
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: Equillium
• Contact: Clinical Trial Manager
• Phone: 858-240-1200
• Email: clinicaltrials[@]equilliumbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute GVHD
• Acute-graft-versus-host Disease
• aGVHD
• Graft Versus Host Disease
• Graft vs Host Disease
• GVHD

Intervention

Biological:
• Itolizumab
Itolizumab [Bmab600]

Drug:
• EQ001 Placebo
EQ001 Placebo

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	Royal Melbourne Hospital	East Melbourne
Australia	Austin Health	Heidelberg
Australia	Westmead Hospital	Westmead
Belgium	ZNA Stuivenberg	Antwerpen
Belgium	AZ Sint-Jan Brugge-Oostende AV	Brugge
Belgium	UZ Leuven - Campus Gasthuisberg - Department of Hematology	Leuven
Belgium	CHU de Liege - Hematology Department	Liege
Belgium	AZ Delta	Roeselare
Canada	McGill University Health Center - Research Institute	Montréal	Quebec
Canada	CHU de Québec - Université Laval	Québec	Quebec
Canada	University of Saskatchewan	Saskatoon	Saskatchewan
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Vancouver Coastal Health Authority	Vancouver	British Columbia
France	CHU Amiens Picardie - Hopital Sud	Amiens
France	CHU de Caen - Hopital Femme-Enfant-Hematologie (FEH)	Caen
France	CHU de Grenoble Hôpital Michallon	Grenoble Cedex 9
France	CHU de Lille - Hopital Claude Huriez	Lille
France	CHU de Nantes - Hôtel-Dieu	Lyon
France	Institut Paoli Calmettes - Hematology	Marseille
France	CHU Nice, Hospital l'Archet	Nice
France	AP-HP Hopital Saint-Louis	Paris
France	CHU Bordeaux - Hopital Haut-Leveque - Centre François Magendie	Pessac
France	HCL Centre Hospitalier Lyon Sud	Pierre Bénite
France	CHU de Rennes Hôpital Pontchaillou	Rennes Cedex 9
France	CHU Toulouse, Hematology	Toulouse
Germany	Universitaetsklinikum Duesseldorf	Duesseldorf
Germany	Martin Luther Universitat Halle-Wittenberg	Halle
Germany	Universitätsklinikum Jena	Jena
Germany	Universitaetsklinikum Koeln (AoeR)	Köln
Germany	Universitaetsklinikum Leipzig	Leipzig
Germany	Universitätsklinikum Münster	Münster
Germany	Universitaetsklinikum Ulm	Ulm
Israel	Rambam Health Care Campus	Haifa
Israel	Hadassah Medical Center Ein Karem	Jerusalem
Israel	Bone Marrow Transplantation Unit Rabin MC	Petach Tikva
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	Chaim Sheba Medical Center	Tel HaShomer
Italy	Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco- Presidio Ospedaliero Ferrarotto Alessi	Catania
Italy	Azienda Ospedaliero-Universitaria Careggi	Firenze
Italy	Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII	Milano
Italy	IRCCS Ospedale San Raffaele	Milano
Italy	Fondazione IRCCS San Gerardo dei Tintori	Monza
Italy	Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"	Reggio Calabria
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore	Rome
Italy	Istituto Clinico Humanitas	Rozzano
Italy	AOU Citta della Salute e della Scienza di Torino - Ospedale Regina Margherita	Torino
Italy	Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma	Verona
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Jeollanam-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
New Zealand	Starship Children's Hospital	Auckland
Portugal	Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.	Lisboa
Portugal	Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.	Porto
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Institut Catala d'Oncologia - L'Hospitalet	Barcelona
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Clinica Universidad de Navarra - Pamplona	Madrid
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Marques de Valdecilla	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitario Regional de Málaga	Málaga
Spain	Hospital Clinico Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitari i Politecnic La Fe	Valencia
United States	Emory University	Atlanta	Georgia
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of North Carolina (UNC)	Chapel Hill	North Carolina
United States	The University of Chicago Medical Center (UCMC)	Chicago	Illinois
United States	Oncology Hematology in Cincinnati	Cincinnati	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	The Ohio State University (OSU)	Columbus	Ohio
United States	Baylor Scott & White Research Institute	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	City of Hope	Duarte	California
United States	Spectrum Health	Grand Rapids	Michigan
United States	John Theurer Cancer Center At Hackensack UMC	Hackensack	New Jersey
United States	University of Iowa	Iowa City	Iowa
United States	University of California, San Diego (UCSD) - Moores Cancer Center	La Jolla	California
United States	Northwell Health	Lake Success	New York
United States	University of California, Los Angeles (UCLA) - Medical Center	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Sarah Cannon Research Institute, LLC (SCRI)	Nashville	Tennessee
United States	Rutgers Cancer Institute of NJ	New Brunswick	New Jersey
United States	Tulane University Medical Center	New Orleans	Louisiana
United States	David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center	New York	New York
United States	AdventHealth Orlando	Orlando	Florida
United States	University of Pennsylvania Abramson Cancer Center	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University (OHSU)	Portland	Oregon
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Stanford Cancer Center	Stanford	California
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Moffitt Cancer Center	Tampa	Florida
United States	Wake Forest	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Equillium	Biocon Limited

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Israel,  Italy,  Korea, Republic of,  New Zealand,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures,	Overall Response Rates at Day 29	Day 29

External Links

•   Company website