Health TrialsbyHealthPanel

Study of YK012 in Moderate to Severe Systemic Lupus Erythematosus

ConditionSystemic Lupus Erythematosus (SLE)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorExcyte Biopharma Ltd

About this trial

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of YK012 in participants with Moderate to Severe Systemic Lupus Erythematosus (SLE).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 75 years (inclusive) at screening, regardless of sex

Meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE, with a confirmed SLE diagnosis for at least 24 weeks at screening

Positive for anti-dsDNA antibody and/or antinuclear antibody (ANA) and/or anti-Smith antibody at screening, as determined using the local laboratory's reference ranges at the study site

Medium to high disease activity at screening, defined as: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥7

Disqualifiers

Known allergy to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to the investigational drug or any of its components

Received any anti-CD19/CD20 therapy or any B-cell depleting agents within 6 months prior to enrollment, or B-cell stimulatory factor inhibitors within 3 months or 5 half-lives prior to enrollment

Received TNF inhibitors, interleukin receptor blockers, other small molecules or biologics within 3 months or 5 half-lives prior to enrollment

Received intravenous immunoglobulins or plasmapheresis within 3 months prior to enrollment

Trial design

Design model

Sequential

Treatments tested in this trial

  • YK012

    Drug

    YK012 is a bispecific antibody targeting CD19 and CD3.

Treatment groups

189 Participants
are divided into 1 treatment group
Group A: YK012Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ib dose escalation stage: Dose Limiting Toxicity (DLT)

Time frame
From the first infusion of YK012 to Day 28 post first infusion
2

Adverse Event (AE)

An AE is defined as any untoward medical event that occurs after a participant receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug.

Time frame
From the first infusion of YK012 to the end of trial at 48 weeks
3

Severe Adverse Event (SAE)

An SAE refers to any untoward medical occurrence after the participant receives the IMP that results in one or more of the following: death, life-threatening event, permanent or serious disability or loss of function, hospitalization or prolongation of hospitalization, congenital abnormalities or birth defects.

Time frame
From the first infusion of YK012 to the end of trial at 48 weeks
4

Ib dose expansion stage and phase II: SRI-4 (Systemic Lupus Erythematosus Responder Index-4) response rates

Time frame
From the first infusion of YK012 to the end of trial at 48 weeks

Secondary outcomes

1

Area Under the Curve (AUC0-t) of a serum concentration versus time profile

Time frame
From pre-dose of YK012 to the end of trial at 48 weeks
2

Area under the blood concentration-time curve from zero to infinity (AUC0-∞)

Time frame
From pre-dose of YK012 to the end of trial at 48 weeks
3

Maximum Concentration (Cmax) of YK012

Time frame
From pre-dose of YK012 to the end of trial at 48 weeks
4

Time to Reach Cmax (Tmax)

Time frame
From pre-dose of YK012 to the end of trial at 48 weeks

Other outcomes

Sponsors and contacts

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

Excyte Biopharma Ltd

Lead sponsor

Source ClinicalTrials.gov
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