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New lupus drug shows promise in early safety trial

NCT ID NCT04128579

Disease control Sponsor: Biocon Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tested a drug called itolizumab (EQ001) in 52 adults with lupus, some of whom also had active kidney inflammation. The main goal was to check safety and find the right dose. Researchers also looked at how the drug behaves in the body and how it affects immune cells. Results will help decide if larger studies are warranted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Itolizumab (EQ001), a drug that targets the immune system
What this could lead to
If successful, this could point toward a new treatment option for lupus that helps control the disease and reduce symptoms.
What could go wrong
This is an early Phase 1b trial with only 52 participants, focused on safety and dosing. It is too small and early to know if it will work or be safe for wider use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

52 people

The number who actually took part.

Started

Oct 2019

Finished

Jan 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 immunosuppressive or immunomodulatory treatment for SLE at any time in the past or currently 4. Has documented elevation of antinuclear antibodies (ANA) in the past or during Screening 5. Restricted SLE treatments are stable and/or washed out 6. During Screening, has adequate hematologic function Type B Cohort Key Inclusion Criteria: 1. Is male or female, age ≥ 18 and ≤ 75 years 2. Has a diagnosis of SLE 3. Kidney biopsy with a histologic diagnosis of LN Classes III or IV (+/- V) 4. Has a urine protein to creatinine ratio of \> 1000 mg/g 5. Requires induction treatment due to newly diagnosed LN or relapsing/flaring disease or has an incomplete response to current treatment 6. Has adequate hematologic function 7. Restricted SLE treatments are stable and/or washed out 8. Most recent eGFR ≥ 40 mL/min/1.73m2 9. Has evidence of serologic activity Key Exclusion Criteria: 1. Acute or chronic infections requiring systemic antibacterial, antifungal, or antiviral therapy 2. Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV 3. Active TB or a positive TB test

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Conditions

The condition(s) this trial relates to.

lupus erythematosus lupus nephritis systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lupus erythematosus Lupus nephritis

Contacts and locations

Locations

  • AKDHC Medical Research Services, LLC

    Sun City, Arizona, 85351, United States

  • Albert Einstein College of Medicine, Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • California Institute of Renal Research

    Chula Vista, California, 91910, United States

  • Centre for Rheumatology, Immunology and Arthritis

    Fort Lauderdale, Florida, 33309, United States

  • Clinical Research of West Florida - Clearwater

    Clearwater, Florida, 33765-2616, United States

  • Clinical Research of West Florida - Tampa

    Tampa, Florida, 33603, United States

  • Clinical Site Partners Leesburg, LLC

    Leesburg, Florida, 34748, United States

  • Columbia University Medical Center, Div of Nephrology

    New York, New York, 10032, United States

  • Dallas Renal Group

    Dallas, Texas, 75230, United States

  • Georgia Nephrology

    Lawrenceville, Georgia, 30046, United States

  • Hope Clinical Trials

    Miami, Florida, 33165, United States

  • Jawaharlal Nehru Institute of Postgraduate Medical Education and Research (JIPMER)

    Puducherry, India

  • MAX Super Specialty Hospital

    New Delhi, India

  • Medanta - The Medicity Hospital

    Gurugramam, India

  • Miedzyleski Szpital Specjalistyczny w Warszawie, Oddzial Nefrologiczny i Stacja Dializ

    Warsaw, 04-749, Poland

  • Northeast Clinical Research Center, LLC

    Bethlehem, Pennsylvania, 18017, United States

  • Northwell Health / Division of Rheumatology

    Great Neck, New York, 11021, United States

  • Omega Research Maitland, LLC

    Orlando, Florida, 32810, United States

  • Post Graduate Institute of Medical Education and Research (PGIMER)

    Chandigarh, India

  • Prolato Clinical Research Center (PCRC)

    Houston, Texas, 77054, United States

  • SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Klinika Nefrologii, Hipertensjologii

    Lodz, 92-213, Poland

  • SouthCoast Research Center Inc

    Miami, Florida, 33136, United States

  • University of California San Diego Perlman Ambulatory Clinic

    La Jolla, California, 92037, United States

  • University of Florida, Division of Rheumatology

    Gainesville, Florida, 32610, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

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