New lupus drug shows promise in early safety trial

NCT ID NCT04128579

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

First seen Jun 06, 2026 · Last updated Jun 23, 2026 · Updated 4 times

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.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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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

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.

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