Clinical trial NCT06559163: A Study of Obexelimab in Patients With Systemic Lupus Erythematosus
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
SLE
Lupus
Lead sponsor: Zenas BioPharma (USA), LLC
Sponsor class: INDUSTRY
First posted: 2024-08-19
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This study consists of a 24-week treatment period followed by a 12-week follow-up period. Patients must have a clinical diagnosis of SLE at least 24 weeks prior to screening and meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria. To enter the Screening Period (Day -28 to Day -1) patients will have active SLE as defined by having: a) hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) ≥ 6 and clinical hSLEDAI ≥ 4, and b) British Isles Lupus Assessment Group (BILAG)-2004 Grade A or B in ≥ 1 organ system. Patients must be treated with one or more of the following background nonbiologic lupus standard of care therapies: oral corticosteroid, antimalarial, and/or immunosuppressant.

On Day 1, patients will be randomized 1:1 to obexelimab or placebo subcutaneous (SC) injection once per week (QW) for 24 weeks. All patients will return to the study site for scheduled visits at Week 2, Week 4, and then every 4 weeks thereafter until study completion. During the study, patients will undergo assessments for efficacy, safety, PK, PD, and immunogenicity.

Including screening and follow-up, the maximum duration of participation in this study for an individual patient is approximately 40 weeks (i.e., up to a 28-day Screening Period, 24-week Treatment Period, and a 12-week follow-up).

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: 24 weeks
Secondary outcomes:
measure: Secondary Outcome Measures
timeFrame: 24 weeks
Other outcomes:
measure: Additional Outcome Measures
timeFrame: 24 weeks
Locations:
city: Fresno
country: United States
facility: Sierra Pacific Arthritis and Rheumatology Centers
state: California
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Lake Charles
country: United States
facility: Accurate Clinical Research
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Lansing
country: United States
facility: June DO, PC
state: Michigan
city: Lansing
country: United States
facility: Juno DO, PC
state: Michigan
city: Charlotte
country: United States
facility: DJL Clinical Research PLLC
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
city: Hershey
country: United States
facility: Penn State - Hershey Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Prolato Clinical Research Center (PCRC)
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research
state: Texas
city: Mansfield
country: United States
facility: Prime Clinical Research - Mansfield
state: Texas
city: Liege
country: Belgium
facility: CHU de Liege
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv"
city: Richmond
country: Canada
facility: Richmond Clinical Trials
state: British Columbia
city: Sydney
country: Canada
facility: Riverside Professional Centre
state: Nova Scotia
city: Hefei
country: China
facility: Anhui Provincial Hospital (The First Affiliated Hospital of USTC)
state: Anhui
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangx
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangx
city: Pudong
country: China
facility: Lanzhou University Second Hospital
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: München
country: Germany
facility: Medicover Munchen Ost MVZ
state: Bavaria
city: Cologne
country: Germany
facility: Uniklinik Koln
city: Chaidari
country: Greece
facility: Attikon University General Hospital
state: Athens
city: Voula
country: Greece
facility: General Hospital Asklepieio Voulas
state: Athens
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki ''Hippokration''
city: Verona
country: Italy
facility: Centro Ricerche Cliniche Di Verona S.r.l.
city: Nagoya-shi
country: Japan
facility: Hospital of Japan Community Health Care Organization Chukyo Hospital
state: Aichi
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health
state: Fukuoka
city: Naha-city
country: Japan
facility: Hospital of Shinkenko Clinic
state: Okinawa
city: Kita-Ku
country: Japan
facility: Hokkaido University Hospital
state: Sapporo Hokkaido
city: Mexico City
country: Mexico
facility: Clinstile, S.A. de C.V.
state: Cuidad de Mexico
city: Guadalajara
country: Mexico
facility: PanAmerican Clinical Research
state: Jalisco
city: Merida
country: Mexico
facility: Eme Red Hospitalaria
state: Yucatán
city: Merida
country: Mexico
facility: Kohler and Milsten Research
state: Yucatán
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
state: Malopolskie
city: Warsaw
country: Poland
facility: MICS Centrum Medyczne Warszawa
state: Mazowieckie
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska Prof Hab Med Pawel Hrycaj
state: Wielkopolskie
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
city: Lisboa
country: Portugal
facility: ULS de Santa Maria, EPE - Hospital de Santa Maria
city: Setúbal
country: Portugal
facility: ULS da Arrábida, E.P.E. - Hospital de São Bernardo
city: Caguas
country: Puerto Rico
facility: Centro Reumatologico de Caguas
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
city: Brasov
country: Romania
facility: Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL
city: Madrid
country: Spain
facility: FutureMeds DKF
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
References: