RECRUITING

A Study of Obexelimab in Patients with Systemic Lupus Erythematosus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2024-09-17

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06559163

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Patient and Medical Information

CONTACT

833-269-4696

clinicaltrialsinfo@zenasbio.com

Study Locations (Sites)

Sierra Pacific Arthritis and Rheumatology Centers

Fresno, California, 93710

United States

Clinical Research of West Florida, Inc

Clearwater, Florida, 33765

United States

Clinical Research of West Florida, Inc.

Tampa, Florida, 33606

United States

Accurate Clinical Research

Lake Charles, Louisiana, 70605

United States

June DO, PC

Lansing, Michigan, 48911

United States

Juno DO, PC

Lansing, Michigan, 48911

United States

DJL Clinical Research PLLC

Charlotte, North Carolina, 28211

United States

Prolato Clinical Research Center (PCRC)

Houston, Texas, 77054

United States

Accurate Clinical Research

Houston, Texas, 77089

United States

Prime Clinical Research - Mansfield

Mansfield, Texas, 76063

United States

Collaborators and Investigators

Sponsor: Zenas BioPharma (USA), LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-17

Study Completion Date2026-03

Study Record Updates

Study Start Date2024-09-17

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

Systemic Lupus Erythematosus
SLE
Lupus

Additional Relevant MeSH Terms

Systemic Lupus Erythematosus