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

Overview

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).

Interventions

• Drug Obexelimab
  Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcyRllb, resulting in down regulation of B cell activity.
• Drug Placebo
  Placebo

Primary outcome measures

• Primary Outcome Measure [Time frame: 24 weeks]

Secondary outcome measures (1)

• Secondary Outcome Measures [Time frame: 24 weeks]

Eligibility criteria

Inclusion criteria

• Males and females, ≥ 18 to ≤ 70 years of age
• Diagnosed with SLE at least 24 weeks prior to screening and meets the 2019 EULAR/ACR classification criteria.
• Patient has all 3 of the following based on features active on the day of the visits:

• hSLEDAI ≥ 6 and clinical hSLEDAI ≥ 4 at screening, and clinical hSLEDAI ≥ 4 at Day 1 Note: Clinical points exclude laboratory tests, except proteinuria.
• BILAG-2004 Grade A or B in ≥ 1 organ system at screening and Day 1.
• 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.
• 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

• 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.
• 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.
• 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.
• Active severe neuropsychiatric or central nervous system SLE.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 16 centers

• Sierra Pacific Arthritis and Rheumatology Centers — Fresno
• California Research Institute — Huntington Park
• University of California, San Diego — La Jolla
• Clinical Research of West Florida, Inc — Clearwater
• Clinical Research of West Florida, Inc. — Tampa
• Emory University — Atlanta
• Accurate Clinical Research — Lake Charles
• Henry Ford Hospital — Detroit
• … and 8 more centers

China · 13 centers

• Anhui Provincial Hospital (The First Affiliated Hospital of USTC) — Hefei
• Beijing Friendship Hospital, Capital Medical University — Beijing
• Peking University People's Hospital — Beijing
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou
• Shenzhen People's Hospital — Shenzhen
• The Second Hospital of Hebei Medical University — Shijiazhuang
• The Second Affiliated Hospital of Nanchang University — Nanchang
• The Second Affiliated Hospital of Nanchang University — Nanchang
• … and 5 more centers

Poland · 8 centers

• Prywatna Praktyka Lekarska Prof Hab Med Pawel Hrycaj — Poznan
• Centrum Medyczne Plejady — Krakow
• MICS Centrum Medyczne Warszawa — Warsaw
• MICS Centrum Medyczne Bydgoszcz — Bydgoszcz
• Krakowskie Centrum Medyczne — Krakow
• SOMED CR — Lodz
• SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego — Lodz
• Pracownia Badan Klinicznych Salus — Wroclaw

Greece · 6 centers

• Attikon University General Hospital — Chaïdári
• General Hospital Asklepieio Voulas — Voula
• University General Hospital of Heraklion — Heraklion
• Olympion General Clinic — Pátrai
• Kianous Stavros — Thessaloniki
• General Hospital of Thessaloniki ''Hippokration'' — Thessaloniki

Taiwan · 6 centers

• Buddhist Tzu Chi General Hospital — Chiayi City
• Kaohsiung Veterans General Hospital — Kaohsiung City
• Chung Shan Medical University Hospital — Taichung
• Taipei Medical University Hospital — Taipei
• … and 2 more centers

Japan · 5 centers

• Hospital of Japan Community Health Care Organization Chukyo Hospital — Nagoya
• Hospital of the University of Occupational and Environmental Health — Kitakyushu-shi
• Hospital of Shinkenko Clinic — Naha
• Hokkaido University Hospital — Kita-ku
• Juntendo University Hospital — Bunkyō City

Mexico · 5 centers

• Clinstile, S.A. de C.V. — Mexico City
• PanAmerican Clinical Research — Guadalajara
• Eme Red Hospitalaria — Mérida
• Kohler and Milsten Research — Mérida
• Oaxaca Site Management Organization — Oaxaca City

Spain · 4 centers

• FutureMeds DKF — Madrid
• Hospital Universitario Ramón y Cajal — Madrid
• Hospital Universitario La Paz — Madrid
• Hospital Universitario Virgen del Rocío — Seville

Portugal · 3 centers

• Hospital Egas Moniz — Lisbon
• ULS de Santa Maria, EPE - Hospital de Santa Maria — Lisbon
• ULS da Arrábida, E.P.E. - Hospital de São Bernardo — Setúbal

Bulgaria · 2 centers

• Medical Center Medtech Services EOOD — Haskovo
• University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv" — Plovdiv

Canada · 2 centers

• Richmond Clinical Trials — Richmond
• Riverside Professional Centre — Sydney

Germany · 2 centers

• Medicover Munchen Ost MVZ — München
• Uniklinik Koln — Cologne

Italy · 2 centers

• Policlinico Universitario Campus Biomedico Di Roma — Roma
• Centro Ricerche Cliniche Di Verona S.r.l. — Verona

Puerto Rico · 2 centers

• Centro Reumatologico de Caguas — Caguas
• Latin Clinical Trial Center — San Juan

Romania · 2 centers

• Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL — Brasov
• Dr I Cantacuzino Clinical Hospital — Bucharest

South Africa · 2 centers

• FARMOVS — Bloemfontein
• Panorama Medical Centre — Cape Town

Belgium · 1 center

• CHU de Liege — Liège

Denmark · 1 center

• Sjaellands Universitetshospital, Koge — Køge

Identifiers

NCT: NCT06559163 · ZB012-02-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗