Lupus ErythematosusPhase 1EQUALISENCT04128579
Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
A Phase 1 study testing Itolizumab [Bmab 600] in people with Lupus Erythematosus and Lupus Nephritis, run by Biocon Limited at 25 sites in 3 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus Erythematosus, Lupus Nephritis
- What is being tested?
- Itolizumab [Bmab 600]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 25 sitesin 3 countries
- Study dates
- 1 Oct 2019to 18 Jan 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Acute or chronic infections requiring systemic antibacterial, antifungal, or antiviral therapy
- Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
- Active TB or a positive TB test
Trial locations and contacts
25 sites in 3 countries.
25 sites in 3 countries
United States19 sites
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, 18017
California Institute of Renal Research
Chula Vista, California, 91910
Clinical Research of West Florida - Clearwater
Clearwater, Florida, 33765-2616
Dallas Renal Group
Dallas, Texas, 75230
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, 33309
University of Florida, Division of Rheumatology
Gainesville, Florida, 32610
Northwell Health / Division of Rheumatology
Great Neck, New York, 11021
Prolato Clinical Research Center (PCRC)
Houston, Texas, 77054
University of California San Diego Perlman Ambulatory Clinic
La Jolla, California, 92037
Georgia Nephrology
Lawrenceville, Georgia, 30046
Clinical Site Partners Leesburg, LLC
Leesburg, Florida, 34748
SouthCoast Research Center Inc
Miami, Florida, 33136
Hope Clinical Trials
Miami, Florida, 33165
Columbia University Medical Center, Div of Nephrology
New York, New York, 10032
Omega Research Maitland, LLC
Orlando, Florida, 32810
AKDHC Medical Research Services, LLC
Sun City, Arizona, 85351
Clinical Research of West Florida - Tampa
Tampa, Florida, 33603
University of South Florida
Tampa, Florida, 33606
Albert Einstein College of Medicine, Montefiore Medical Center
The Bronx, New York, 10461
India4 sites
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh
Medanta - The Medicity Hospital
Gurugramam
MAX Super Specialty Hospital
New Delhi
Jawaharlal Nehru Institute of Postgraduate Medical Education and Research (JIPMER)
Puducherry
Poland2 sites
SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Klinika Nefrologii, Hipertensjologii
Lodz, 92-213
Miedzyleski Szpital Specjalistyczny w Warszawie, Oddzial Nefrologiczny i Stacja Dializ
Warsaw, 04-749
About this study
Official title: A Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis
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
Read the detailed description
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.
- Conditions
- Lupus Erythematosus, Lupus Nephritis
- Being tested
- Itolizumab [Bmab 600]
- Keywords
- Systemic Lupus Erythematosus, Active Proliferative Lupus Nephritis
- Medical subject headings
- Lupus Nephritis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itolizumab [Bmab 600]Drug
Also called Bmab600, Itolizumab
EQ001
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Itolizumab [Bmab 600] |
| 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). Receives: Drug: Itolizumab [Bmab 600] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Type A up to Day 57 or Type B up to Day 253
Secondary outcomes (2)
To Characterize the PK of Itolizumab
To characterize the pharmacokinetics of itolizumab
Measured: 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
Measured: Type A up to Day 57 or Type B up to Day 253
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 Oct 2019
- Primary completion16 Nov 2023
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- cohort based escalation of 6 subjects (Type A) single dose cohort of 20 subjects (Type B)
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocon Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Kalunian, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128579
- Sponsor's protocol ID
- EQ001-19-002
- Acronym
- EQUALISE
- Status last verified
- May 2026
- First submitted
- 30 Sep 2019
- Last updated
- 4 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis
- ClinicalTrials.gov ID
- NCT04128579
- Acronym / sponsor ID
- EQUALISE / EQ001-19-002
- Conditions
- Lupus Erythematosus, Lupus Nephritis
- Keywords
- Systemic Lupus Erythematosus, Active Proliferative Lupus Nephritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Biocon LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Posted 18 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cohort based escalation of 6 subjects (Type A) single dose cohort of 20 subjects (Type B)
| Arm | Type | Receives |
|---|---|---|
| EQ001 Type A cohort | Experimental | Drug: Itolizumab [Bmab 600]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 | Drug: Itolizumab [Bmab 600]EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Acute or chronic infections requiring systemic antibacterial, antifungal, or antiviral therapy
- Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
- Active TB or a positive TB test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Itolizumab [Bmab 600]Also: Bmab600, ItolizumabEQ001 | Drug | EQ001 Type A cohort, EQ001 for Type B cohort |
Primary outcome
Number 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.
2 secondary outcomes
To Characterize the PK of Itolizumab
Time frame: Type A up to Day 57 or Type B up to Day 253
CD6 Receptor Occupancy
Time frame: Type A up to Day 57 or Type B up to Day 253
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- company websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Kalunian, MD principal investigator
UCSD
25 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Itolizumab [Bmab 600] in people with Lupus Erythematosus and Lupus Nephritis, run by Biocon Limited at 25 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, India, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment Emergent Adverse Events (time frame: Type A up to Day 57 or Type B up to Day 253). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.