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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
APG-2575
DrugTake orally once daily (QD) for 12 weeks.
Placebo
Other interventionTake orally once daily (QD) for 12 weeks.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: APG-2575Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
According to CTCAE v5.0, the number and frequency of adverse events of test drug were assessed.
Time frame
Up to 1 yearSecondary outcomes
1
Peak Plasma Concentration (Cmax) of APG-2575 in SLE patients.
To evaluate the metabolic characteristics of APG-2575 in SLE patients
Time frame
At Day1 and Day 28 since the first dose of study drug.2
Area under the plasma concentration versus time curve (AUC) of APG-2575 in SLE patients.
To evaluate the metabolic characteristics of APG-2575 in SLE patients
Time frame
At Day1 and Day 28 since the first dose of study drug.3
Time to Peak (Tmax) of APG-2575 in SLE patients.
To evaluate the metabolic characteristics of APG-2575 in SLE patients
Time frame
At Day1 and Day 28 since the first dose of study drug.4
Assessment of SLE disease activity using SLEDAI（Systemic Lupus Erythematosus Disease Activity Index）-2000.
To evaluate the patients' efficacy.
Time frame
Up to 1 yearOther outcomes
1
Change in the number and percentages of immune cells clusters.
The changes of immune cell clusters from baseline.
Time frame
Up to 1 year2
Change in the number and percentages of cytokines.
The changes of cytokines from baseline.
Time frame
Up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ascentage Pharma Group Inc.
Lead sponsor
Suzhou Yasheng Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov