A Study of SCTB35 in Patients with Systemic Lupus Erythematosus
ConditionSystem Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSinocelltech Ltd.
About this trial
This study is a multicenter Phase Ib/II clinical trial aimed at evaluating the safety, tolerability and efficacy of SCTB35 in patients with systemic lupus erythematosus (SLE).
Eligibility criteria
Qualifiers
Age 18-75 years；
Diagnosed with SLE for ≥12 weeks prior to screening (2019-ACR/EULAR criteria);
SLEDAI-2K ≥ 8 at screening, or ≥6 if there is hypocomplementemia or elevated anti-dsDNA antibody levels;
Positive for ANA (1:80) or positive for anti-dsDNA and/or anti-Sm antibodies within the last 12 months or at screening;
Disqualifiers
Severe active or unstable lupus-related neuropsychiatric disorders;
Other autoimmune diseases that may interfere with efficacy evaluation;
Catastrophic antiphospholipid syndrome;
Received live vaccines or attenuated vaccines within 28 days prior to baseline or screening;
Trial design
Treatments tested in this trial
- SCTB35 injection
Treatment groups
168 Participants
are divided into 1 treatment groupLocations
14Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Beijing China
Xuanwu Hospital, Capital Medical University Beijing China
Jilin Provincial People's Hospital Changchun China
Guangdong Provincial People's Hospital Guangzhou China
Sponsors and collaborators
Sinocelltech Ltd.
Lead sponsor
Source ClinicalTrials.gov