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The Purpose of This Study is to Evaluate the Efficacy and Safety of 626 in the Treatment of SLE

ConditionSystemic Lupus Erythematosus (SLE)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

About this trial

This study will evaluate the effect and safety of 626 in patients with SLE

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to understand protocol requirements and sign a written ICF.

Male or female subjects aged 18-70 years when signing the ICF.

Body weight between 40 and 90 kg.

Diagnosed with SLE at least 6 months before the Screening Visit by a qualified physician，confirmed according to the 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE.

Disqualifiers

Study participant has a mixed connective tissue disease, and/or overlap syndrome of systemic lupus erythematosus (SLE) with systemic sclerosis.

Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition

Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.

History of cancer.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 626

    Drug

    626 subcutaneous (SC) injection. Placebo subcutaneous (SC) injection.

  • 626

    Drug

    626 subcutaneous (SC) injection.

  • Placebo

    Drug

    Placebo subcutaneous (SC) injection.

Treatment groups

198 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Group M1Experimental treatment 2 interventions
Group B: Group M2Experimental treatment 2 interventions
Group C: Group M3Experimental treatment 2 interventions
Group D: Group M4Experimental treatment 2 interventions
Group E: 626 Dose AExperimental treatment 1 intervention
Group F: 626 Dose BExperimental treatment 1 intervention
Group G: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with Adverse Events

Incidence of adverse events will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments.

Time frame
During the 32- or 36-week study period

Secondary outcomes

1

SLE Responder Index (SRI-4)

Proportion of subjects achieving an SLE Responder Index (SRI-4) response

Time frame
During the 20- or 24-week treatment period
2

BILAG-based Combined Lupus Assessment (BICLA) Response

Proportion of patients achieving a BILAG-based Combined Lupus Assessment (BICLA) response

Time frame
During the 20- or 24-week treatment period

Other outcomes

1

Peak Plasma Concentration (Cmax)

Time frame
During the 32- or 36-week study period
2

Area under the Concentration-Time Curve up to the Last Measurable Concentration（AUC0-last）

Time frame
During the 32- or 36-week study period
3

Time to Peak Concentration（Tmax ）

Time frame
During the 32- or 36-week study period

Sponsors and contacts

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

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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