Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Obexelimab

    Drug

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

  • Placebo

    Drug

    Placebo

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: ObexelimabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary Outcome Measure

Proportion of patients who achieve a response according to the BILAG-Based Composite Lupus Assessment (BICLA) Response

Time frame
24 weeks

Secondary outcomes

1

Secondary Outcome Measures

Proportion of patients who achieve response according to the Systemic Lupus Erythematosus Responder Index 4 (SRI-4).

Time frame
24 weeks

Other outcomes

1

Additional Outcome Measures

Number of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and injection site reactions.

Time frame
24 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zenas BioPharma (USA), LLC

Lead sponsor

Source ClinicalTrials.gov
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