A Clinical Study of ACG102 Injection in Patients With Refractory Active Systemic Lupus Erythematosus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ACG102 Injection.
- Who it may be relevant to
- Registry conditions: Refractory Active Systemic Lupus Erythematosus. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Characteristics, and Preliminary Efficacy of ACG102 Injection in Patients With Refractory Active Systemic Lupus Erythematosus
Overview
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of ACG102 administered via intravenous injection in patients with refractory active systemic lupus erythematosus (SLE)
Detailed description
A first-in-human, open label study to evaluate safety and tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of multiple ascending dose ACG102 intravenously administered to adult participants with refractory active systemic lupus erythematosus (SLE)
Interventions
- Drug ACG102 Injection
All enrolled participants will receive multiple intravenous infusions of ACG102 at the dose level assigned to their cohort. Dose levels and dosing schedules may be adjusted based on emerging safety, tolerability, and PK/PD data.
Primary outcome measures
- Incidence of dose-limiting toxicities (DLTs) [Time frame: Within 21 days after first dose]
- Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time frame: From first dose through Week 52]
- Incidence of Treatment-Emergent Clinical Laboratory Abnormalities [Time frame: Up to 52 weeks post first dose]
Secondary outcome measures (12)
- Change from baseline in SLE disease activity scores [Time frame: baseline and up to Week 52 post first dose]
- Change from Baseline in BILAG-2004 Score [Time frame: pre-dose and up to 52 weeks post the first dose]
- Change from Baseline in Physician's Global Assessment (PGA) Score [Time frame: pre-dose and up to 52 weeks post first dose]
- Composite efficacy response rates [Time frame: baseline and up to Week 52 post first dose]
- Composite efficacy response rates [Time frame: baseline and up to Week 52 post first dose]
- Composite efficacy response rates [Time frame: Baseline and up to Week 52 post first dose]
- Change from baseline in SF-36 score [Time frame: baseline and up to Week 52 post first dose]
- Change from baseline in renal parameters [Time frame: Baseline and up to Week 52 post first dose]
- Change from baseline in renal parameters [Time frame: Baseline and up to Week 52 post first dose]
- Change from baseline in renal parameters [Time frame: baseline and up to Week 52 post first dose]
- Change from baseline in renal parameters [Time frame: Baseline and up to Week 52 post first dose]
- Pharmacokinetic profiling [Time frame: Baseline and up to 24 weeks post first dose]
Eligibility criteria
Inclusion criteria
- ≥18 years of age at time of informed consent.
- Diagnosis of systemic lupus erythematosus (SLE) fulfilling the 2019 EULAR/ACR classification criteria.
- Refractory active disease defined as inadequate response to, or relapse following, standard of care (SoC) therapy.
- Patients on a stable dose of SoC for at least 4 weeks prior to enrollment.
- Sufficient organ function as defined by the protocol.
Exclusion criteria
- Active severe infection, including tuberculosis.
- Severe hypogammaglobulinemia or IgA deficiency.
- Active hepatitis or history of severe liver disease.
- Severe cardiovascular diseases.
- History of cancer within the past 5 years (with exceptions per protocol).
- Receipt of B-cell-targeted therapies or other biologic therapies within the defined washout window prior to enrollment.
- History of organ transplantation, bone marrow transplantation, or hematopoietic stem cell transplantation.
- Known allergy to any active or inactive component of the study drug.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07749430 · ACG102-001