About this trial
This study will evaluate the effect and safety of 626 in patients with SLE
Eligibility criteria
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
Treatments tested in this trial
- 626
- 626
- Placebo
Treatment groups
7
Treatment groupsSee each treatment group below.