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Monoclonal Antibodies

Itolizumab for Lupus (EQUALISE Trial)

Phase 1
Waitlist Available
Led By Kenneth Kalunian, MD
Research Sponsored by Equillium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Type A Cohort: Has previously been documented to have met or currently meets Systemic Lupus International Collaborating Clinics (SLICC) and/or American College of Rheumatology (ACR) criteria for SLE
Type A Cohort: Received at least 1 immunosuppressive or immunomodulatory treatment for SLE at any time in the past or currently
Timeline
Screening 3 weeks
Treatment Varies
Follow Up type a up to day 57 or type b up to day 253
Awards & highlights

EQUALISE Trial Summary

This trial will test a new drug for Lupus called itolizumab to see if it is safe and effective.

Eligible Conditions
  • Lupus Nephritis
  • Lupus

EQUALISE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with or currently have symptoms that meet the criteria for systemic lupus erythematosus (SLE) according to specific guidelines.
Select...
You have taken medications to suppress or change your immune system for lupus in the past or are currently taking them.
Select...
You have been diagnosed with systemic lupus erythematosus (SLE).
Select...
You need initial treatment because you have newly diagnosed or recurring/active disease, or your current treatment hasn't worked well enough.
Select...
If you are in the Type B group, your treatments for SLE must be stable or stopped before joining the study.

EQUALISE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~type a up to day 57 or type b up to day 253
This trial's timeline: 3 weeks for screening, Varies for treatment, and type a up to day 57 or type b up to day 253 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment Emergent Adverse Events
Secondary outcome measures
CD6 receptor occupancy
To characterize the PK of itolizumab

EQUALISE Trial Design

2Treatment groups
Experimental Treatment
Group I: EQ001 for Type B cohortExperimental Treatment1 Intervention
EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg).
Group II: EQ001 Type A cohortExperimental Treatment1 Intervention
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses (up to 5 cohorts with dosing to be determined in the range of 0.4 -- 3.2 mg/kg).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itolizumab [Bmab 600]
2019
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

Biocon LimitedIndustry Sponsor
13 Previous Clinical Trials
837 Total Patients Enrolled
EquilliumLead Sponsor
6 Previous Clinical Trials
278 Total Patients Enrolled
Kenneth Kalunian, MDPrincipal InvestigatorUCSD
3 Previous Clinical Trials
638 Total Patients Enrolled

Media Library

Itolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04128579 — Phase 1
Lupus Nephritis Research Study Groups: EQ001 Type A cohort, EQ001 for Type B cohort
Lupus Nephritis Clinical Trial 2023: Itolizumab Highlights & Side Effects. Trial Name: NCT04128579 — Phase 1
Itolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04128579 — Phase 1

Frequently Asked Questions

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

Are there any remaining vacancies for enrollees in this trial?

"Affirmative, according to clinicaltrials.gov this medical experiment is still open for recruitment and was first shared on 10th October 2019. The latest update was made on April 19th 2022 and a total of 55 participants across 17 sites are needed in order to conduct the trial."

Answered by AI

How many healthcare facilities are actively participating in this clinical experiment?

"At the moment, 17 medical centres are running this clinical trial. The sites can be located in Sun City, La Jolla and Dallas in addition to 14 other locations across America. It is advised that patients pick an establishment which is nearby their residential location to reduce travelling demands if they decide to take part."

Answered by AI

How many test subjects have been recruited for this experiment?

"To proceed with the trial, a total of 55 eligible participants are needed. Biocon Limited will oversee this endeavor from multiple locations including AKDHC Medical Research Services in Sun City, Arizona and University of California San Diego Perlman Ambulatory Clinic in La Jolla, California."

Answered by AI

Are there any other exploratory investigations involving Itolizumab [Bmab 600]?

"Itolizumab [Bmab 600] was initially investigated at Froedtert & the Medical College of Wisconsin's hospital in 2019. Subsequently, 2 studies have been fulfilled and there are currently two active trials being conducted; many sites for these experiments are located in Sun City, Arizona."

Answered by AI

Does this trial accommodate individuals aged sixty or over?

"Eligibility criteria for this study necessitates that participants are under 75 years old and of legal age or older."

Answered by AI

Who would meet the criteria to be an appropriate candidate for this medical experiment?

"This clinical trial requires that those who possess lupus nephritis, and are aged between 18-75 to be eligible. A total of 55 participants need to be enrolled in this study."

Answered by AI

Does this clinical experiment represent a new approach in its field?

"Research involving the drug Itolizumab [Bmab 600] began in 2019, with a sponsored trial of 100 patients. After Phase 1 & 2 approval was granted due to these results, two active trials have been launched across 32 cities and 3 countries."

Answered by AI

What safety risks have been identified with the use of Itolizumab [Bmab 600]?

"The safety of Itolizumab [Bmab 600] was rated a 1 on our scale due to its Phase 1 status, which indicates limited evidence supporting both efficacy and security."

Answered by AI
~10 spots leftby Mar 2025