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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05263999




Registration number
NCT05263999
Ethics application status
Date submitted
1/10/2021
Date registered
3/03/2022
Date last updated
3/10/2024

Titles & IDs
Public title
A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)
Scientific 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
Secondary ID [1] 0 0
EQ-100-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Graft Versus Host Disease 0 0
GVHD 0 0
Acute-graft-versus-host Disease 0 0
Acute GVHD 0 0
aGVHD 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Itolizumab
Treatment: Drugs - EQ001 Placebo

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

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


Treatment: Other: Itolizumab
Itolizumab \[Bmab600\]

Treatment: Drugs: EQ001 Placebo
EQ001 Placebo
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response.
Timepoint [1] 0 0
Day 29
Secondary outcome [1] 0 0
Evaluate the durability of response to itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids.
Timepoint [1] 0 0
Day 99
Secondary outcome [2] 0 0
Assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures,
Timepoint [2] 0 0
Day 29

Eligibility
Key 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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - East Melbourne
Recruitment hospital [3] 0 0
Austin Health - Heidelberg
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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Florida
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Georgia
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Illinois
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Iowa
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United States of America
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Louisiana
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United States of America
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Maryland
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Massachusetts
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Michigan
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Minnesota
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Tennessee
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Texas
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United States of America
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Washington
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Belgium
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Anderlecht
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Belgium
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Antwerpen
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Belgium
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Brugge
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Belgium
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Brussels
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Leuven
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Liege
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Belgium
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Roeselare
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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France
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Amiens
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France
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Caen
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France
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Grenoble Cedex 9
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France
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Lille
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Lyon
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Marseille
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Paris
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Pessac
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Pierre Bénite
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Rennes Cedex 9
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France
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Toulouse
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France
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Villejuif
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Germany
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Berlin
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Germany
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Duesseldorf
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Germany
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Halle
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Jena
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Köln
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Leipzig
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Münster
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Ulm
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Germany
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Würzburg
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petach Tikva
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Israel
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Tel Aviv
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Israel
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Tel HaShomer
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Italy
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BO
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Italy
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Catania
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Italy
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Firenze
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Milano
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Monza
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Reggio Calabria
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Rome
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Rozzano
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Torino
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Italy
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Verona
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Korea, Republic of
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Jeollanam-do
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Korea, Republic of
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Busan
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Daegu
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Seoul
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New Zealand
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Auckland
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Portugal
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Lisboa
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Portugal
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Porto
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Gipuzkoa
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Spain
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Barcelona
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Spain
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Granada
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Salamanca
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Spain
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Sevilla
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Spain
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Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Equillium
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Biocon Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT05263999
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Maple Fung, MD
Address 0 0
Equillium, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trial Manager
Address 0 0
Country 0 0
Phone 0 0
858-240-1200
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05263999