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

Primary Purpose

Graft Versus Host Disease, GVHD, Acute-graft-versus-host Disease

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Itolizumab
EQ001 Placebo
Sponsored by
Equillium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft Versus Host Disease

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • City of HopeRecruiting
  • University of California, San Diego (UCSD) - Moores Cancer CenterRecruiting
  • University of Southern CaliforniaRecruiting
  • University of California, Los Angeles (UCLA) - Medical CenterRecruiting
  • Stanford Cancer CenterRecruiting
  • AdventHealth OrlandoRecruiting
  • Moffitt Cancer CenterRecruiting
  • Emory UniversityRecruiting
  • The University of Chicago Medical Center (UCMC)Recruiting
  • University of IowaRecruiting
  • Tulane University Medical CenterRecruiting
  • University of Maryland Medical CenterRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Dana-Farber Cancer InstituteRecruiting
  • Henry Ford HospitalRecruiting
  • Spectrum HealthRecruiting
  • Mayo Clinic - RochesterRecruiting
  • John Theurer Cancer Center At Hackensack UMCRecruiting
  • Northwell HealthRecruiting
  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterRecruiting
  • Stony Brook University Medical CenterRecruiting
  • University of North Carolina (UNC)Recruiting
  • Wake ForestRecruiting
  • Oncology Hematology in CincinnatiRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • The Ohio State University (OSU)Recruiting
  • Oregon Health & Science University (OHSU)Recruiting
  • University of Pennsylvania Abramson Cancer CenterRecruiting
  • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer CenterRecruiting
  • Sarah Cannon Research Institute, LLC (SCRI)Recruiting
  • Baylor Scott & White Research InstituteRecruiting
  • Fred Hutchinson Cancer Research CenterRecruiting
  • Royal Adelaide HospitalRecruiting
  • Royal Melbourne HospitalRecruiting
  • Austin HealthRecruiting
  • Westmead HospitalRecruiting
  • ZNA StuivenbergRecruiting
  • AZ Sint-Jan Brugge-Oostende AVRecruiting
  • CHU de Liege - Hematology DepartmentRecruiting
  • AZ DeltaRecruiting
  • Vancouver Coastal Health AuthorityRecruiting
  • Princess Margaret HospitalRecruiting
  • McGill University Health Center - Research InstituteRecruiting
  • CHU de Québec - Université LavalRecruiting
  • University of SaskatchewanRecruiting
  • CHU Amiens Picardie - Hopital SudRecruiting
  • CHU de Caen - Hopital Femme-Enfant-Hematologie (FEH)Recruiting
  • CHU de Lille - Hopital Claude HuriezRecruiting
  • CHU de Nantes - Hôtel-DieuRecruiting
  • AP-HP Hopital Saint-LouisRecruiting
  • CHU Bordeaux - Hopital Haut-Leveque - Centre François MagendieRecruiting
  • HCL Centre Hospitalier Lyon SudRecruiting
  • Universitaetsklinikum DuesseldorfRecruiting
  • Martin Luther Universitat Halle-WittenbergRecruiting
  • Universitaetsklinikum Koeln (AoeR)Recruiting
  • Universitaetsklinikum LeipzigRecruiting
  • Universitaetsklinikum UlmRecruiting
  • Rambam Health Care CampusRecruiting
  • Hadassah Medical Center Ein KaremRecruiting
  • Tel Aviv Sourasky Medical CenterRecruiting
  • Chaim Sheba Medical CenterRecruiting
  • Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco- Presidio Ospedaliero Ferrarotto AlessiRecruiting
  • Azienda Ospedaliero-Universitaria CareggiRecruiting
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIRecruiting
  • IRCCS Ospedale San RaffaeleRecruiting
  • Fondazione IRCCS San Gerardo dei TintoriRecruiting
  • Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"Recruiting
  • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro CuoreRecruiting
  • Istituto Clinico HumanitasRecruiting
  • AOU Citta della Salute e della Scienza di Torino - Ospedale Regina MargheritaRecruiting
  • Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo RomaRecruiting
  • Pusan National University HospitalRecruiting
  • Kyungpook National University HospitalRecruiting
  • Chonnam National University Hwasun HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Hospital Clinic BarcelonaRecruiting
  • Institut Catala d'Oncologia - L'HospitaletRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital Universitario Virgen de las NievesRecruiting
  • Hospital General Universitario Gregorio MaranonRecruiting
  • Hospital Universitario Ramon y CajalRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Clinica Universidad de Navarra - PamplonaRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Universitario Marques de ValdecillaRecruiting
  • Hospital Clinico Universitario de SalamancaRecruiting
  • Hospital Universitario Virgen del RocioRecruiting
  • Hospital Universitari i Politecnic La FeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Itolizumab (EQ001)

EQ001 Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures,
Overall Response Rates at Day 29

Full Information

First Posted
October 1, 2021
Last Updated
October 2, 2023
Sponsor
Equillium
Collaborators
Biocon Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05263999
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Equillium
Collaborators
Biocon Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease, GVHD, Acute-graft-versus-host Disease, Acute GVHD, aGVHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Itolizumab (EQ001)
Arm Type
Experimental
Arm Description
Itolizumab (EQ001) administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses.
Arm Title
EQ001 Placebo
Arm Type
Placebo Comparator
Arm Description
EQ001 Placebo administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses
Intervention Type
Biological
Intervention Name(s)
Itolizumab
Other Intervention Name(s)
EQ001, Bmab600
Intervention Description
Itolizumab [Bmab600]
Intervention Type
Drug
Intervention Name(s)
EQ001 Placebo
Intervention Description
EQ001 Placebo
Primary Outcome Measure Information:
Title
The efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response.
Description
Complete response at Day 29
Time Frame
Day 29
Secondary Outcome Measure Information:
Title
Evaluate the durability of response to itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids.
Description
Durable Complete Response rate from Day 29 through Day 99
Time Frame
Day 99
Title
Assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures,
Description
Overall Response Rates at Day 29
Time Frame
Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Manager
Phone
858-240-1200
Email
clinicaltrials@equilliumbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maple Fung, MD
Organizational Affiliation
Equillium, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, San Diego (UCSD) - Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, Los Angeles (UCLA) - Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Chicago Medical Center (UCMC)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Tulane University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
John Theurer Cancer Center At Hackensack UMC
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwell Health
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Name
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Name
University of North Carolina (UNC)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Hematology in Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University (OSU)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43201
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health & Science University (OHSU)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute, LLC (SCRI)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Baylor Scott & White Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Melbourne Hospital
City
East Melbourne
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Name
Austin Health
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Westmead Hospital
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
ZNA Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Sint-Jan Brugge-Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU de Liege - Hematology Department
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Vancouver Coastal Health Authority
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
McGill University Health Center - Research Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHU de Québec - Université Laval
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Individual Site Status
Recruiting
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHU Amiens Picardie - Hopital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Caen - Hopital Femme-Enfant-Hematologie (FEH)
City
Caen
ZIP/Postal Code
14003
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Lille - Hopital Claude Huriez
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nantes - Hôtel-Dieu
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Name
AP-HP Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Bordeaux - Hopital Haut-Leveque - Centre François Magendie
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
HCL Centre Hospitalier Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Duesseldorf
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Name
Martin Luther Universitat Halle-Wittenberg
City
Halle
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Koeln (AoeR)
City
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Center Ein Karem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Chaim Sheba Medical Center
City
Tel HaShomer
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco- Presidio Ospedaliero Ferrarotto Alessi
City
Catania
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero-Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS San Gerardo dei Tintori
City
Monza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Name
Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"
City
Reggio Calabria
ZIP/Postal Code
89133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU Citta della Salute e della Scienza di Torino - Ospedale Regina Margherita
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hwasun Hospital
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Catala d'Oncologia - L'Hospitalet
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
8025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra - Pamplona
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Marques de Valdecilla
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Links:
URL
https://equilliumbio.com/
Description
Company website

Learn more about this trial

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

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