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This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EQ001 Type A cohort | Experimental | 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). |
|
| EQ001 for Type B cohort | Experimental | EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itolizumab [Bmab 600] | Drug | EQ001 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events | Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | Type A up to Day 57 or Type B up to Day 253 |
| Measure | Description | Time Frame |
|---|---|---|
| To Characterize the PK of Itolizumab | To characterize the pharmacokinetics of itolizumab | Type A up to Day 57 or Type B up to Day 253 |
| CD6 Receptor Occupancy | the % levels of free versus EQ001-bound CD6 receptor on T cells |
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Type A Cohort Key Inclusion Criteria:
Type B Cohort Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Kalunian, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKDHC Medical Research Services, LLC | Sun City | Arizona | 85351 | United States | ||
| California Institute of Renal Research |
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| Label | URL |
|---|---|
| company website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | EQ001 Type A Cohort (0.4mg/kg) | EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 0.4mg/kg. Itolizumab [Bmab 600]: EQ001 |
| FG001 | EQ001 for Type B Cohort |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 3, 2022 | Mar 6, 2025 |
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cohort based escalation of 6 subjects (Type A) single dose cohort of 20 subjects (Type B)
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Type A and Type B are open-label.
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| Type A up to Day 57 or Type B up to Day 253 |
| Chula Vista |
| California |
| 91910 |
| United States |
| University of California San Diego Perlman Ambulatory Clinic | La Jolla | California | 92037 | United States |
| Clinical Research of West Florida - Clearwater | Clearwater | Florida | 33765-2616 | United States |
| Centre for Rheumatology, Immunology and Arthritis | Fort Lauderdale | Florida | 33309 | United States |
| University of Florida, Division of Rheumatology | Gainesville | Florida | 32610 | United States |
| Clinical Site Partners Leesburg, LLC | Leesburg | Florida | 34748 | United States |
| SouthCoast Research Center Inc | Miami | Florida | 33136 | United States |
| Hope Clinical Trials | Miami | Florida | 33165 | United States |
| Omega Research Maitland, LLC | Orlando | Florida | 32810 | United States |
| Clinical Research of West Florida - Tampa | Tampa | Florida | 33603 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Georgia Nephrology | Lawrenceville | Georgia | 30046 | United States |
| Northwell Health / Division of Rheumatology | Great Neck | New York | 11021 | United States |
| Columbia University Medical Center, Div of Nephrology | New York | New York | 10032 | United States |
| Albert Einstein College of Medicine, Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Northeast Clinical Research Center, LLC | Bethlehem | Pennsylvania | 18017 | United States |
| Dallas Renal Group | Dallas | Texas | 75230 | United States |
| Prolato Clinical Research Center (PCRC) | Houston | Texas | 77054 | United States |
| Post Graduate Institute of Medical Education and Research (PGIMER) | Chandigarh | India |
| Medanta - The Medicity Hospital | Gurugramam | India |
| MAX Super Specialty Hospital | New Delhi | India |
| Jawaharlal Nehru Institute of Postgraduate Medical Education and Research (JIPMER) | Puducherry | India |
| SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Klinika Nefrologii, Hipertensjologii | Lodz | 92-213 | Poland |
| Miedzyleski Szpital Specjalistyczny w Warszawie, Oddzial Nefrologiczny i Stacja Dializ | Warsaw | 04-749 | Poland |
EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg). Itolizumab [Bmab 600]: EQ001 |
| FG002 | EQ001 Type A Cohort (0.8mg/kg) | EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 0.8mg/kg. Itolizumab [Bmab 600]: EQ001 |
| FG003 | EQ001 Type A Cohort (1.6mg/kg) | EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 1.6mg/kg. Itolizumab [Bmab 600]: EQ001 |
| FG004 | EQ001 Type A Cohort (2.4mg/kg) | EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 2.4mg/kg. Itolizumab [Bmab 600]: EQ001 |
| FG005 | EQ001 Type A Cohort (3.2mg/kg) | EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 3.2mg/kg. Itolizumab [Bmab 600]: EQ001 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | EQ001 Type A Cohort (0.4mg/kg) | EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 0.4mg/kg. Itolizumab [Bmab 600]: EQ001 |
| BG001 | 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). Itolizumab [Bmab 600]: EQ001 |
| BG002 | EQ001 Type A Cohort (0.8mg/kg) | EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 0.8mg/kg. Itolizumab [Bmab 600]: EQ001 |
| BG003 | EQ001 Type A Cohort (1.6mg/kg) | EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 1.6mg/kg. Itolizumab [Bmab 600]: EQ001 |
| BG004 | EQ001 Type A Cohort (2.4mg/kg) | EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 2.4mg/kg. Itolizumab [Bmab 600]: EQ001 |
| BG005 | EQ001 Type A Cohort (3.2mg/kg) | EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 3.2mg/kg. Itolizumab [Bmab 600]: EQ001 |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Treatment Emergent Adverse Events | Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | Posted | Count of Participants | Participants | Type A up to Day 57 or Type B up to Day 253 |
|
|
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | To Characterize the PK of Itolizumab | To characterize the pharmacokinetics of itolizumab | Not Posted | Type A up to Day 57 or Type B up to Day 253 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CD6 Receptor Occupancy | the % levels of free versus EQ001-bound CD6 receptor on T cells | Not Posted | Type A up to Day 57 or Type B up to Day 253 | Participants |
The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EQ001 Type A Cohort (0.4mg/kg) | EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 0.4mg/kg. Itolizumab [Bmab 600]: EQ001 | 0 | 6 | 0 | 6 | 0 | 6 |
| EG001 | 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). Itolizumab [Bmab 600]: EQ001 | 0 | 17 | 2 | 17 | 17 | 17 |
| EG002 | EQ001 Type A Cohort (0.8mg/kg) | EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 0.8mg/kg. Itolizumab [Bmab 600]: EQ001 | 0 | 7 | 0 | 7 | 2 | 7 |
| EG003 | EQ001 Type A Cohort (1.6mg/kg) | EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 1.6mg/kg. Itolizumab [Bmab 600]: EQ001 | 0 | 7 | 0 | 7 | 4 | 7 |
| EG004 | EQ001 Type A Cohort (2.4mg/kg) | EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 2.4mg/kg. Itolizumab [Bmab 600]: EQ001 | 0 | 6 | 0 | 6 | 3 | 6 |
| EG005 | EQ001 Type A Cohort (3.2mg/kg) | EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses - 3.2mg/kg. Itolizumab [Bmab 600]: EQ001 | 0 | 9 | 1 | 9 | 8 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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| Renal Deterioration | Renal and urinary disorders | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| Myocarditis | Cardiac disorders | Systematic Assessment |
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| Diffuse alveolar hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Abscess on the proximal aspect of left thigh | Infections and infestations | Systematic Assessment |
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| Right elbow septic arthritis | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | Systematic Assessment |
| ||
| Injection site pruritus | General disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Oedema peripheral | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Herpes Zoster | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cushingoid | Endocrine disorders | Systematic Assessment |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Generalised oedema | General disorders | Systematic Assessment |
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| Injection site pain | General disorders | Systematic Assessment |
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| Mucosal inflammation | General disorders | Systematic Assessment |
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| Mucosal ulceration | General disorders | Systematic Assessment |
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| Oedema | General disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Abcess limb | Infections and infestations | Systematic Assessment |
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| Arthritis bacterial | Infections and infestations | Systematic Assessment |
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| Bacteraemia | Infections and infestations | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash erythematosus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Palor | Vascular disorders | Systematic Assessment |
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| Myocarditis | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Steroid diabetes | Metabolism and nutrition disorders | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | Systematic Assessment |
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| Renal impairement | Renal and urinary disorders | Systematic Assessment |
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| Renal mass | Renal and urinary disorders | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pleurisy | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Presyncope | Nervous system disorders | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Liver function test increased | Investigations | Systematic Assessment |
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| Injection site reaction | General disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Diverticulitis | Infections and infestations | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Equillium, Inc. | 8582401200 | clinicaltrials@equilliumbio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 17, 2024 | Mar 6, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000597346 | itolizumab |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
|
| India |
|