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Can a B-Cell blocker tame lupus?

NCT ID NCT06559163

Disease control Sponsor: Zenas BioPharma (USA), LLC 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether an experimental drug called obexelimab can safely reduce disease activity in people with systemic lupus erythematosus (SLE). The study enrolls about 190 adults aged 18 to 70 with active lupus. Participants are randomly assigned to receive either obexelimab or a placebo, and researchers will measure how many achieve a meaningful reduction in lupus symptoms using a standard response index.

What this could mean

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

Active substance
obexelimab, an experimental monoclonal antibody that targets B cells to reduce their activity
What this could lead to
If successful, obexelimab could offer a new treatment option for people with systemic lupus erythematosus, potentially reducing disease flares and improving quality of life.
What could go wrong
This is an early-stage trial, so the drug may not prove more effective than placebo. Possible risks include side effects from suppressing the immune system, and results may not apply to all lupus patients.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

190 people

The number who actually took part.

Started

Sep 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

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 70 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.

Inclusion Criteria: 1. Males and females, ≥ 18 to ≤ 70 years of age 2. Diagnosed with SLE at least 24 weeks prior to screening and meets the 2019 EULAR/ACR classification criteria. 3. Patient has all 3 of the following based on features active on the day of the visits: 1. hSLEDAI ≥ 6 and clinical hSLEDAI ≥ 4 at screening, and clinical hSLEDAI ≥ 4 at Day 1 Note: Clinical points exclude laboratory tests, except proteinuria. 2. BILAG-2004 Grade A or B in ≥ 1 organ system at screening and Day 1. 3. In the opinion of the investigator and the central adjudicator, there is sufficient disease activity to warrant enrollment into a clinical study with an investigational agent. 4. Patients must be treated with one or more of the following background nonbiologic lupus standard of care therapies: oral corticosteroid, antimalarial, and/or immunosuppressant. Exclusion Criteria: 1. Active lupus nephritis for which, in the opinion of the investigator or the central adjudicator, current medications are insufficient for patient's safety or additional therapy that is not permitted in the protocol is needed. 2. A history of thrombosis or embolism in the previous 6 months before the Screening visit, or previous 12 months associated with antiphospholipid syndrome (APS) or another relevant hypercoagulable state. 3. Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as, but not limited to, psoriasis, dermatomyositis, and systemic sclerosis. 4. Active severe neuropsychiatric or central nervous system SLE. 5. Current inflammatory disease other than SLE (including, but not limited to, rheumatoid arthritis, psoriatic arthritis, spondyloarthropathy, reactive arthritis, scleroderma, dermatomyositis) that may interfere with the assessment of lupus signs and symptoms in the opinion of the investigator or central adjudicator.

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

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

Systemic lupus erythematosus

Contacts and locations

Locations

  • AARA Clinical Research - Chicago Arthritis & Regenerative Medicine

    Chicago, Illinois, 60661, United States

  • AARA Clinical Research - Rheumatology Specialty Center

    Willow Grove, Pennsylvania, 19090, United States

  • Accurate Clinical Research

    Lake Charles, Louisiana, 70605, United States

  • Accurate Clinical Research

    Houston, Texas, 77089, United States

  • Anhui Provincial Hospital (The First Affiliated Hospital of USTC)

    Hefei, Anhui, 230001, China

  • Attikon University General Hospital

    Chaïdári, Athens, 12462, Greece

  • Axon Clinical Research

    Baltimore, Maryland, 21237, United States

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124, Italy

  • Azienda Ospedaliero Universitaria di Ferrara

    Ferrara, 44124, Italy

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100044, China

  • Buddhist Tzu Chi General Hospital

    Chiayi City, 622, Taiwan

  • CHU de Liege

    Liège, 4000, Belgium

  • California Research Institute

    Huntington Park, California, 90255, United States

  • Centro Reumatologico de Caguas

    Caguas, 00725, Puerto Rico

  • Centro Ricerche Cliniche Di Verona S.r.l.

    Verona, 37134, Italy

  • Centro de Estudios de Investigacion Basica Y Clinica SC

    Guadalajara, 44690, Mexico

  • Centro de Investigacion y Tratamiento Reumatologico S.C.

    Mexico City, 11850, Mexico

  • Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL

    Brasov, 500283, Romania

  • Centrum Medyczne Plejady

    Krakow, Lesser Poland Voivodeship, 30-363, Poland

  • Chang Gung Memorial Hospital

    Taoyuan, 333, Taiwan

  • Chung Shan Medical University Hospital

    Taichung, 402, Taiwan

  • Clinical Research of West Florida, Inc

    Clearwater, Florida, 33765, United States

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33606, United States

  • Clinstile, S.A. de C.V.

    Mexico City, Cuidad de Mexico, 06700, Mexico

  • Cross Creek Medical Clinic

    Fayetteville, North Carolina, 28304, United States

  • DJL Clinical Research PLLC

    Charlotte, North Carolina, 28211, United States

  • Diagnostic Consultative Center Convex EOOD

    Sofia, 1404, Bulgaria

  • Dr A Naidoo

    Umhlanga, 4319, South Africa

  • Dr I Cantacuzino Clinical Hospital

    Bucharest, 030167, Romania

  • Eme Red Hospitalaria

    Mérida, Yucatán, 97000, Mexico

  • Emory University

    Atlanta, Georgia, 30322, United States

  • FARMOVS

    Bloemfontein, 9301, South Africa

  • FuturMeds Madrid - Santa Elena

    Madrid, 28003, Spain

  • FutureMeds DKF

    Madrid, 28002, Spain

  • General Hospital Asklepieio Voulas

    Voula, Athens, 16673, Greece

  • General Hospital of Thessaloniki ''Hippokration''

    Thessaloniki, 54642, Greece

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hokkaido University Hospital

    Kita-ku, Sapporo Hokkaido, 060-8648, Japan

  • Hospital Egas Moniz

    Lisbon, 1349019, Portugal

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital for Special Surgery

    New York, New York, 10021, United States

  • Hospital of Japan Community Health Care Organization Chukyo Hospital

    Nagoya, Aichi-ken, 457-8510, Japan

  • Hospital of Shinkenko Clinic

    Naha, Okinawa, 900-001, Japan

  • Hospital of the University of Occupational and Environmental Health

    Kitakyushu-shi, Fukuoka, 807-8556, Japan

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubrian

    Mexico City, 14080, Mexico

  • Juno DO, PC

    Lansing, Michigan, 48911, United States

  • Juntendo University Hospital

    Bunkyō City, 113843, Japan

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362, Taiwan

  • Kianous Stavros

    Thessaloniki, 54636, Greece

  • Kohler and Milsten Research

    Mérida, Yucatán, 97070, Mexico

  • Krakowskie Centrum Medyczne

    Krakow, 31501, Poland

  • Lanzhou University Second Hospital

    Pudong, Shanghai Municipality, 200127, China

  • Latin Clinical Trial Center

    San Juan, 00909, Puerto Rico

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz, 85090, Poland

  • MICS Centrum Medyczne Warszawa

    Warsaw, Masovian Voivodeship, 00-874, Poland

  • Medical Center Medtech Services EOOD

    Haskovo, 6304, Bulgaria

  • Medicover Munchen Ost MVZ

    München, Bavaria, 81667, Germany

  • Oaxaca Site Management Organization

    Oaxaca City, 68000, Mexico

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104-5005, United States

  • Olympion General Clinic

    Pátrai, 26443, Greece

  • Onsite Clinical Solutions

    Salisbury, North Carolina, 28144, United States

  • Onyx Clinical Research

    Peoria, Arizona, 85381, United States

  • Orthoillinois

    Rockford, Illinois, 61114, United States

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132, Italy

  • Ospedale San Giovanni Bosco

    Torino, 10154, Italy

  • PanAmerican Clinical Research

    Guadalajara, Jalisco, 44670, Mexico

  • Panorama Medical Centre

    Cape Town, 7500, South Africa

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044, China

  • Penn State - Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Policlinico Universitario Campus Biomedico Di Roma

    Roma, 00128, Italy

  • Pracownia Badan Klinicznych Salus

    Wroclaw, 50570, Poland

  • Prime Clinical Research - Lewisville

    Lewisville, Texas, 75067, United States

  • Prime Clinical Research - Mansfield

    Mansfield, Texas, 76063, United States

  • Prolato Clinical Research Center (PCRC)

    Houston, Texas, 77054, United States

  • Prywatna Praktyka Lekarska Prof Hab Med Pawel Hrycaj

    Poznan, Greater Poland Voivodeship, 61-397, Poland

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200001, China

  • Revive Research Institute - Sterling Heights

    Sterling Heights, Michigan, 48313, United States

  • Richmond Clinical Trials

    Richmond, British Columbia, V6V 2L1, Canada

  • Riverside Professional Centre

    Sydney, Nova Scotia, B1S 3N1, Canada

  • SOMED CR

    Lodz, 05260, Poland

  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

    Lodz, 90153, Poland

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Shanxi Bethune Hospital

    Taiyuan, 030032, China

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020, China

  • Sierra Pacific Arthritis and Rheumatology Centers

    Fresno, California, 93710, United States

  • Sjaellands Universitetshospital, Koge

    Køge, 4600, Denmark

  • Solace Clinical Research

    Tustin, California, 92780, United States

  • Taipei Medical University Hospital

    Taipei, 110, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 1121, Taiwan

  • The First Affiliated Hospital of Ziamen University

    Xiamen, 361003, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510060, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangx, 330008, China

  • The Second Affiliated Hospital of Soochow University

    Suzhou, 215025, China

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050005, China

  • ULS da Arrábida, E.P.E. - Hospital de São Bernardo

    Setúbal, 2910-446, Portugal

  • ULS de Santa Maria, EPE - Hospital de Santa Maria

    Lisbon, 1649-035, Portugal

  • UMass Chan Medical School

    Worcester, Massachusetts, 01655, United States

  • UZ Leuven

    Leuven, 3000, Belgium

  • Uniklinik Koln

    Cologne, 50937, Germany

  • University General Hospital of Heraklion

    Heraklion, 71500, Greece

  • University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv"

    Plovdiv, 4004, Bulgaria

  • University of California, Los Angeles

    Los Angeles, California, 90024, United States

  • University of California, San Diego

    La Jolla, California, 92037, United States

  • Velocity Clinical Research

    St Louis, Missouri, 63131, United States

  • Willow Rheumatology and Wellness

    Willowbrook, Illinois, 60527, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.