A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.
ConditionSLE
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorAscentage Pharma Group Inc.
About this trial
To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).
Eligibility criteria
Qualifiers
1. Diagnosis of systemic lupus erythematosus for at least 6 months.
2. On stable treatment for systemic lupus erythematosus before first dose at least 28 days.
3. SLEDIA-2000 score: 4-12
4.Other than systemic lupus erythematosus, subject should be in general good health.
Disqualifiers
1. Severe systemic lupus erythematosus.
2. Significant autoimmune disease other than lupus.
3. Significant, uncontrolled or unstable disease in any organ.
Trial design
Treatments tested in this trial
- APG-2575
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ascentage Pharma Group Inc.
Lead sponsor
Suzhou Yasheng Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov