A Study of GR1803 in Systemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorGenrix (Shanghai) Biopharmaceutical Co., Ltd.
About this trial
to evaluate the safety and efficacy of GR1803 in the treatment of patients with systemic lupus erythematosus
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
comfirmed diagnosis of systemic lupus erythematosus
SLEDAI-2K≥6分
written informed consent and ability to comply with protocol requirements
have received adequate dose of glucocorticoids, antimalarials, immunosuppressants for 3 months
Disqualifiers
with unstable acute and chronic diseases
active infection
history of malignant tumor within 5 years
Trial design
Design model
Sequential
Treatments tested in this trial
GR1803 injection
Biological/Vaccinestep-up dosing, Dose and frequency according to the protocol
Treatment groups
44 Participants
are divided into 4 treatment groupsGroup A: GR1803 injection dose 1Experimental treatment 1 intervention
Group B: GR1803 injection dose 2Experimental treatment 1 intervention
Group C: GR1803 injection dose 3Experimental treatment 1 intervention
Group D: GR1803 injection dose 4Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
incidence of adverse event
incidence of adverse event
Time frame
52 weekSecondary outcomes
1
efficacy of GR1803
clinical response of SLE
Time frame
52 weekSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov