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Itolizumab

Phase 3

Lupus Erythematosus | Monoclonal antibody | Immunology |Equillium, Inc.|Trials Updated: Apr 18, 2025

Itolizumab development status

Highest phase Phase 3 (NCT05263999)
Phase scored for EQPhase 1
Registered trials 5 across 1 sponsor since Dec 2018

Itolizumab target and mechanism

Molecular targetCD6
Target classInhibitor
ModalityMonoclonal antibody

Also known as Itolizumab [Bmab 600], Bmab600, EQ001

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials3
Total Enrollment100

FDA Designations

No designations recorded

Itolizumab clinical trials

Itolizumab · 3 trials · 7 indications

Phase 1 3
NCT04128579Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative NephritisLupus Erythematosus
COMPLETED52 Analytics
NCT03763318A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHDAcute-graft-versus-host Disease
COMPLETED30 Analytics
NCT04007198A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled AsthmaAsthma
COMPLETED18 Analytics
PHASE1COMPLETED
Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
Lupus ErythematosusUnlock trial analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD
Acute-graft-versus-host DiseaseUnlock trial analytics
PHASE1COMPLETED
A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Treatment Emergent Adverse Events
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.

Overall Response Rate
Study Day 29

Overall Response Rate (ORR) is defined as the number of subjects with a partial response (PR), very good partial response (VGPR), or complete response (CR) who are alive at Day 29. Subjects must not have received new systemic therapy for aGVHD before the Day 29 Visit.

Secondary Endpoints

To Characterize the PK of Itolizumab
Type A up to Day 57 or Type B up to Day 253
CD6 Receptor Occupancy
Type A up to Day 57 or Type B up to Day 253
Time to Maximum EQ001serum Concentration, Tmax
Day 337
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EQ001 Type A cohortEXPERIMENTALEQ001 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).
EQ001 for Type B cohortEXPERIMENTALEQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg).
EQ001 Dose Escalation (Part A)EXPERIMENTALOpen label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses.
EQ001 (Part B)EXPERIMENTALEQ001 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.
EQ001 Placebo (Part B)PLACEBO_COMPARATORPlacebo administered in a blinded fashion by intravenous infusion every two weeks for a total of 5 doses.
EQ001EXPERIMENTALEQ001 administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses.
EQ001 PlaceboPLACEBO_COMPARATORPlacebo administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses.

Interventions

NameTypeDescription
Itolizumab [Bmab 600]DRUGEQ001
EQ001BIOLOGICALItolizumab \[Bmab 600\])
EQ001 PlaceboBIOLOGICALEQ001 Placebo
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites25

Type A Cohort Key Inclusion Criteria: 1. Is male or female, age ≥ 18 and ≤ 75 years 2. 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 3. Received at least 1 immun...

Countries:United StatesIndiaPolandAustraliaNew Zealand
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Frequently asked questions about Itolizumab

What is itolizumab?

Itolizumab is an investigational monoclonal antibody developed by Equillium, Inc. (ticker EQ) for lupus erythematosus. It is a CD6 inhibitor and is being studied in immunology. Itolizumab is also known as Bmab 600. It has been evaluated in a Phase 1 clinical trial in systemic lupus erythematosus with or without active proliferative nephritis.

What is itolizumab used for?

Itolizumab is being developed for lupus erythematosus, including systemic lupus erythematosus with or without active proliferative nephritis. It is an investigational therapy and is not approved for commercial use. Equillium, Inc. (ticker EQ) is the developer. The clinical program has focused on patients 18 years and older.

What does itolizumab target?

Itolizumab targets CD6, a cell surface receptor involved in T cell activation. Itolizumab is classified as a CD6 inhibitor. By binding CD6, itolizumab is designed to modulate T cell activity, which is relevant in autoimmune conditions such as lupus erythematosus. It is a monoclonal antibody being developed by Equillium, Inc. (ticker EQ).

Who makes itolizumab?

Itolizumab is developed by Equillium, Inc., which trades under the ticker EQ. Equillium is advancing itolizumab as an investigational monoclonal antibody for lupus erythematosus. The drug is also known as Bmab 600. Development has included a Phase 1 study in systemic lupus erythematosus with or without active proliferative nephritis.

What phase is itolizumab in?

Itolizumab is in Phase 1 clinical development. The completed Phase 1 trial, NCT04128579, enrolled 52 participants with systemic lupus erythematosus with or without active proliferative nephritis. Itolizumab is investigational and has not been approved by the FDA. Equillium, Inc. (ticker EQ) is the developer. No active trials are currently listed.

What clinical trials is itolizumab in?

Itolizumab has been studied in the Phase 1 trial NCT04128579, titled Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis. The trial enrolled 52 participants across the United States, India, and Poland and is completed. It was a controlled study in adults 18 years and older, and it was not randomized or double blinded.

Is itolizumab the same as Bmab 600?

Yes, itolizumab is also known as Bmab 600. Both names refer to the same monoclonal antibody developed by Equillium, Inc. (ticker EQ). Itolizumab is a CD6 inhibitor being studied in lupus erythematosus. The alternative name Bmab 600 may appear in scientific literature and trial records for the same investigational asset.