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Itolizumab

Phase 1

Lupus Erythematosus | Small molecule | Immunology |Equillium, Inc.|Last Updated: Apr 18, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

Itolizumab · 1 trial · 2 indications

Phase 1 1
NCT04128579Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative NephritisLupus Erythematosus
COMPLETED52 Analytics
PHASE1COMPLETED
Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
Lupus ErythematosusUnlock 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.

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
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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).

Interventions

NameTypeDescription
Itolizumab [Bmab 600]DRUGEQ001
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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 StatesIndiaPoland
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Frequently asked questions about Itolizumab

What is Itolizumab used for?

Itolizumab is an investigational small molecule being studied for the treatment of Lupus Erythematosus, including systemic lupus erythematosus with or without active proliferative nephritis. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does Itolizumab target?

Itolizumab is a small molecule that targets a specific molecular pathway involved in the immune response. It is being developed for the treatment of Lupus Erythematosus, a condition characterized by abnormal immune system activity.

Who makes Itolizumab?

Itolizumab is being developed by Equillium, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Lupus Erythematosus.

What phase is Itolizumab in?

Itolizumab is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is still being studied in clinical trials to assess its safety and potential therapeutic effects.

What clinical trials is Itolizumab in?

Itolizumab has been studied in one completed clinical trial, NCT04128579, which evaluated the drug in patients with systemic lupus erythematosus with or without active proliferative nephritis. The trial enrolled 52 participants and was conducted in the United States, India, and Poland.

Is Itolizumab the same as EQ001?

Yes, Itolizumab is also known as EQ001. The clinical trial NCT04128579, which studied the drug in systemic lupus erythematosus, refers to it as EQ001 (Itolizumab).