Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis (EQUALISE)
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|ClinicalTrials.gov Identifier: NCT04128579|
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : April 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|Lupus Erythematosus Lupus Nephritis||Drug: Itolizumab [Bmab 600]||Phase 1|
The study will enroll approximately 55 subjects, with up to 5 dose escalating cohorts of 6 open-label subjects enrolled for Type A-SLE and a single dose cohort of approximately 20 open-label subjects enrolled for Type B-Lupus Nephritis.
Subjects will receive itolizumab administered subcutaneously every two weeks for a total of either 2 (Type A) or 13 (Type B) doses with 4 or 12 weeks of follow-up after the last dose of investigational product.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||cohort based escalation of 6 subjects (Type A) single dose cohort of 20 subjects (Type B)|
|Masking:||None (Open Label)|
|Masking Description:||Type A and Type B are open-label.|
|Official Title:||A Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||January 2023|
Experimental: EQ001 Type A cohort
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).
Drug: Itolizumab [Bmab 600]
Experimental: EQ001 for Type B cohort
EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg).
Drug: Itolizumab [Bmab 600]
- Incidence of Treatment Emergent Adverse Events [ Time Frame: Type A up to Day 57 or Type B up to Day 253 ]Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
- To characterize the PK of itolizumab [ Time Frame: Type A up to Day 57 or Type B up to Day 253 ]To characterize the pharmacokinetics of itolizumab
- CD6 receptor occupancy [ Time Frame: Type A up to Day 57 or Type B up to Day 253 ]the % levels of free versus EQ001-bound CD6 receptor on T cells
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128579
|Contact: Clinical Trial Manager||858 412 email@example.com|
|Principal Investigator:||Kenneth Kalunian, MD||UCSD|