Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT06559163

A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

Led by Zenas BioPharma (USA), LLC · Updated on 2025-07-30

190

Participants Needed

82

Research Sites

102 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).

CONDITIONS

Official Title

A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females aged 18 to 70 years
  • Diagnosed with systemic lupus erythematosus (SLE) at least 24 weeks prior to screening and meeting 2019 EULAR/ACR classification criteria
  • Active SLE with hSLEDAI score ≥ 6 and clinical hSLEDAI ≥ 4 at screening and Day 1
  • BILAG-2004 Grade A or B in one or more organ systems at screening and Day 1
  • Treated with one or more background nonbiologic lupus standard of care therapies: oral corticosteroid, antimalarial, and/or immunosuppressant
Not Eligible

You will not qualify if you...

  • Active lupus nephritis requiring additional or non-permitted therapy
  • History of thrombosis or embolism in the past 6 months, or in past 12 months associated with antiphospholipid syndrome or similar conditions
  • Active skin conditions other than cutaneous lupus erythematosus that could interfere with study assessments
  • Active severe neuropsychiatric or central nervous system lupus
  • Current inflammatory diseases other than SLE that might affect lupus symptom assessment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 82 locations

1

Sierra Pacific Arthritis and Rheumatology Centers

Fresno, California, United States, 93710

Actively Recruiting

2

California Research Institute

Huntington Park, California, United States, 90255

Actively Recruiting

3

University of California, San Diego

La Jolla, California, United States, 92037

Actively Recruiting

4

Clinical Research of West Florida, Inc

Clearwater, Florida, United States, 33765

Actively Recruiting

5

Clinical Research of West Florida, Inc.

Tampa, Florida, United States, 33606

Actively Recruiting

6

Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

7

Accurate Clinical Research

Lake Charles, Louisiana, United States, 70605

Actively Recruiting

8

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Actively Recruiting

9

June DO, PC

Lansing, Michigan, United States, 48911

Actively Recruiting

10

Juno DO, PC

Lansing, Michigan, United States, 48911

Actively Recruiting

11

DJL Clinical Research PLLC

Charlotte, North Carolina, United States, 28211

Actively Recruiting

12

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States, 73104-5005

Actively Recruiting

13

Penn State - Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

14

Prolato Clinical Research Center (PCRC)

Houston, Texas, United States, 77054

Actively Recruiting

15

Accurate Clinical Research

Houston, Texas, United States, 77089

Actively Recruiting

16

Prime Clinical Research - Mansfield

Mansfield, Texas, United States, 76063

Actively Recruiting

17

CHU de Liege

Liège, Belgium

Actively Recruiting

18

Medical Center Medtech Services EOOD

Haskovo, Bulgaria, 6304

Actively Recruiting

19

University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv"

Plovdiv, Bulgaria, 4004

Actively Recruiting

20

Richmond Clinical Trials

Richmond, British Columbia, Canada, V6V 2L1

Actively Recruiting

21

Riverside Professional Centre

Sydney, Nova Scotia, Canada, B1S 3N1

Actively Recruiting

22

Anhui Provincial Hospital (The First Affiliated Hospital of USTC)

Hefei, Anhui, China, 230001

Actively Recruiting

23

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

24

Peking University People's Hospital

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

25

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Actively Recruiting

26

Shenzhen People's Hospital

Shenzhen, Guangdong, China, 518020

Actively Recruiting

27

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China, 050005

Actively Recruiting

28

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangx, China, 330008

Actively Recruiting

29

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangx, China, 330008

Actively Recruiting

30

Lanzhou University Second Hospital

Pudong, Shanghai Municipality, China, 200127

Actively Recruiting

31

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China, 200001

Actively Recruiting

32

The Second Affiliated Hospital of Soochow University

Suzhou, China, 215025

Actively Recruiting

33

Shanxi Bethune Hospital

Taiyuan, China, 030032

Actively Recruiting

34

The First Affiliated Hospital of Ziamen University

Xiamen, China, 361003

Actively Recruiting

35

Sjaellands Universitetshospital, Koge

Køge, Denmark, 4600

Actively Recruiting

36

Medicover Munchen Ost MVZ

München, Bavaria, Germany, 81667

Actively Recruiting

37

Uniklinik Koln

Cologne, Germany

Actively Recruiting

38

Attikon University General Hospital

Chaïdári, Athens, Greece, 12462

Actively Recruiting

39

General Hospital Asklepieio Voulas

Voula, Athens, Greece, 16673

Actively Recruiting

40

University General Hospital of Heraklion

Heraklion, Greece, 71500

Actively Recruiting

41

Olympion General Clinic

Pátrai, Greece, 26443

Actively Recruiting

42

Kianous Stavros

Thessaloniki, Greece, 54636

Actively Recruiting

43

General Hospital of Thessaloniki ''Hippokration''

Thessaloniki, Greece, 54642

Actively Recruiting

44

Policlinico Universitario Campus Biomedico Di Roma

Roma, Italy, 00128

Actively Recruiting

45

Centro Ricerche Cliniche Di Verona S.r.l.

Verona, Italy, 37134

Actively Recruiting

46

Hospital of Japan Community Health Care Organization Chukyo Hospital

Nagoya, Aichi-ken, Japan, 457-8510

Actively Recruiting

47

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, Fukuoka, Japan, 807-8556

Actively Recruiting

48

Hospital of Shinkenko Clinic

Naha, Okinawa, Japan, 900-001

Actively Recruiting

49

Hokkaido University Hospital

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

Actively Recruiting

50

Juntendo University Hospital

Bunkyō City, Japan, 113843

Actively Recruiting

51

Clinstile, S.A. de C.V.

Mexico City, Cuidad de Mexico, Mexico

Actively Recruiting

52

PanAmerican Clinical Research

Guadalajara, Jalisco, Mexico

Actively Recruiting

53

Eme Red Hospitalaria

Mérida, Yucatán, Mexico

Actively Recruiting

54

Kohler and Milsten Research

Mérida, Yucatán, Mexico

Actively Recruiting

55

Oaxaca Site Management Organization

Oaxaca City, Mexico, 68000

Actively Recruiting

56

Prywatna Praktyka Lekarska Prof Hab Med Pawel Hrycaj

Poznan, Greater Poland Voivodeship, Poland, 61-397

Actively Recruiting

57

Centrum Medyczne Plejady

Krakow, Lesser Poland Voivodeship, Poland, 30-363

Actively Recruiting

58

MICS Centrum Medyczne Warszawa

Warsaw, Masovian Voivodeship, Poland, 00-874

Actively Recruiting

59

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, Poland, 85090

Actively Recruiting

60

Krakowskie Centrum Medyczne

Krakow, Poland, 31501

Actively Recruiting

61

SOMED CR

Lodz, Poland, 05260

Actively Recruiting

62

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

Lodz, Poland, 90153

Actively Recruiting

63

Pracownia Badan Klinicznych Salus

Wroclaw, Poland, 50570

Actively Recruiting

64

Hospital Egas Moniz

Lisbon, Portugal, 1349019

Actively Recruiting

65

ULS de Santa Maria, EPE - Hospital de Santa Maria

Lisbon, Portugal, 1649-035

Actively Recruiting

66

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

Setúbal, Portugal, 2910-446

Actively Recruiting

67

Centro Reumatologico de Caguas

Caguas, Puerto Rico, Puerto Rico, 00725

Actively Recruiting

68

Latin Clinical Trial Center

San Juan, Puerto Rico, Puerto Rico, 00909

Actively Recruiting

69

Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL

Brasov, Romania, 500283

Actively Recruiting

70

Dr I Cantacuzino Clinical Hospital

Bucharest, Romania, 030167

Actively Recruiting

71

FARMOVS

Bloemfontein, South Africa, 9301

Actively Recruiting

72

Panorama Medical Centre

Cape Town, South Africa, 7500

Actively Recruiting

73

FutureMeds DKF

Madrid, Spain, 28002

Actively Recruiting

74

Hospital Universitario Ramón y Cajal

Madrid, Spain, 28034

Actively Recruiting

75

Hospital Universitario La Paz

Madrid, Spain, 28046

Actively Recruiting

76

Hospital Universitario Virgen del Rocío

Seville, Spain, 41013

Actively Recruiting

77

Buddhist Tzu Chi General Hospital

Chiayi City, Taiwan, 622

Actively Recruiting

78

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan, 81362

Actively Recruiting

79

Chung Shan Medical University Hospital

Taichung, Taiwan, 402

Actively Recruiting

80

Taipei Medical University Hospital

Taipei, Taiwan, 110

Actively Recruiting

81

Taipei Veterans General Hospital

Taipei, Taiwan, 1121

Actively Recruiting

82

Chang Gung Memorial Hospital

Taoyuan, Taiwan, 333

Actively Recruiting

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Research Team

P

Patient and Medical Information

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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A Study of Obexelimab in Patients With Systemic Lupus Erythematosus | DecenTrialz