A Study of Obexelimab in Patients With Systemic Lupus Erythematosus
ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorZenas BioPharma (USA), LLC
About this trial
This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).
Eligibility criteria
Qualifiers
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.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Obexelimab
- Placebo
Treatment groups
190 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov