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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up type a up to day 57 or type b up to day 253
Awards & highlights
Summary
This trial is testing an injectable medication called itolizumab in patients with specific types of lupus. The medication aims to calm the immune system to reduce inflammation and prevent tissue damage.
Eligible Conditions
- Lupus Nephritis
- Lupus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ type a up to day 57 or type b up to day 253
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~type a up to day 57 or type b up to day 253
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment Emergent Adverse Events
Secondary study objectives
CD6 receptor occupancy
To characterize the PK of itolizumab
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
284 Total Patients Enrolled
Kenneth Kalunian, MDPrincipal InvestigatorUCSD
3 Previous Clinical Trials
638 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an infection that requires strong medication to treat.You have taken medications to suppress or change your immune system for lupus in the past or are currently taking them.You have been diagnosed with or currently have symptoms that meet the criteria for systemic lupus erythematosus (SLE) according to specific guidelines.You have been diagnosed with systemic lupus erythematosus (SLE).You have a history of high levels of antinuclear antibodies (ANA).You need initial treatment because you have newly diagnosed or recurring/active disease, or your current treatment hasn't worked well enough.Your blood works as it should.Your blood is working properly.Your most recent kidney function test result (eGFR) is above 40 mL/min/1.73m2.You show signs of immune system activity.If you are in the Type B group, your treatments for SLE must be stable or stopped before joining the study.You have kidney biopsy results showing certain types of lupus nephritis.Your urine has a lot of protein compared to creatinine.You have tested positive for hepatitis B, hepatitis C, or HIV.You currently have tuberculosis or a positive test for tuberculosis.
Research Study Groups:
This trial has the following groups:- Group 1: EQ001 Type A cohort
- Group 2: EQ001 for Type B cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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