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Monoclonal Antibodies

EQ001 for Graft-versus-Host Disease (EQUATE Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Equillium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subject at least 18 years of age for Part A, and at least 12 years of age for Part B.
Recipients of allogeneic hematopoietic stem cell transplantation (alloHSCT) using myeloablative or non myeloablative conditioning regimens.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study day 337
Awards & highlights

EQUATE Trial Summary

This trial is testing a new drug to treat aGVHD, a condition where the transplanted donor cells attack the patient's cells. They will be testing how safe and well tolerated the drug is, how it works in the body, and how effective it is at treating aGVHD.

Eligible Conditions
  • Graft-versus-Host Disease
  • Acute Graft-versus-Host Disease

EQUATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

EQUATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study day 337
This trial's timeline: 3 weeks for screening, Varies for treatment, and study day 337 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in aGVHD organ stages and overall clinical grading, aGVHD-AI
Incidence of Treatment Emergent Adverse Events
Secondary outcome measures
CD6 receptor expression levels
Clearance, Cl
Half life of EQ001, t1/2
+6 more

EQUATE Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: EQ001 Dose Escalation (Part A)Experimental Treatment1 Intervention
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses.
Group II: EQ001 (Part B)Experimental Treatment1 Intervention
EQ001 administered in a blinded fashion using the optimal dose selected from Part A by intravenous infusion every two weeks for a total of 5 doses.
Group III: EQ001 Placebo (Part B)Placebo Group1 Intervention
Placebo administered in a blinded fashion by intravenous infusion every two weeks for a total of 5 doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itolizumab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Biocon LimitedIndustry Sponsor
13 Previous Clinical Trials
862 Total Patients Enrolled
EquilliumLead Sponsor
6 Previous Clinical Trials
303 Total Patients Enrolled
Joel RothmanStudy DirectorEquillium

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other research initiatives exist related to EQ001?

"Currently, two medical studies are underway examining the potential of EQ001. Neither is in Phase 3 yet. Bronx, New york serves as the hub for these trials with 45 separate locations running them."

Answered by AI

What is the current cohort size for this research endeavor?

"To successfully complete the trial, 100 qualified individuals need to enroll. These volunteers can select from two centers of excellence, Washington University and Barnes Jewish Heart & Vascular Center in Saint Louis or Dana-Farber Cancer Institute located in Boston."

Answered by AI

Is this an inaugural trial for its kind?

"EQ001 has been subject to clinical investigations since 2019, with the earliest trial conducted by Biocon Limited. After its successful Phase 1 & 2 approval in 2019 following a study involving 100 patients, there are currently two active trials for EQ001 spread across 32 cities and 3 countries."

Answered by AI

Are there various locations conducting this research in the city?

"Washington University and Barnes Jewish Heart & Vascular Center, Dana-Farber Cancer Institute, TriStar Centennial Medical Centre (SCRI), as well as 15 other centres in the United States of America are all participating sites for this clinical trial."

Answered by AI

Are there any vacancies available for participants in this clinical experiment?

"Affirmative. Information present on clinicaltrials.gov reveals that this research study is actively enrolling candidates as of now; it was initially advertised on July 15th, 2019 and the most recent update happened October 1st 2021. The trial requires 100 participants to be recruited from 15 medical centres."

Answered by AI

What are the primary aims of this medical investigation?

"The primary endpoint of the research is to assess the Treatment Emergent Adverse Events by Day 337. Secondary objectives involve measuring half-life, total exposure, area under curve (AUC) and maximum serum drug concentration for EQ001."

Answered by AI
~5 spots leftby Mar 2025