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 groupSponsors and collaborators
Source ClinicalTrials.gov