Rheumatoid Arthritis, Sjögren's Disease, Systemic Lupus Erythematosus, Systemic Sclerosis
Conditions
Keywords
Autoimmune disease
Brief summary
This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020. The study will enroll healthy participants at low doses, followed by participants with moderate to severe autoimmune diseases with predominant B-cell involvement. Eligible participants include patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), Sjögren's disease (SjD), and rheumatoid arthritis (RA).
Interventions
DRUGHBM7020
Liquid formulation, administered through intravenous infusion
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria for Healthy Participants (Part 1) 1. Participants who are of non-childbearing potential or are using acceptable contraception. 2. Body mass index (BMI) and body weight within an acceptable range. 3. Good general health based on medical history, physical examination, electrocardiogram (ECG), and laboratory assessments. Key Disease-Agnostic Inclusion Criteria for Patient Participants (Part 1) 1. BMI and body weight within an acceptable range. 2. Adequate hematologic, renal, hepatic, immunologic, and lymphocyte parameters. Key Disease-Specific Inclusion Criteria for Patient Participants (Part 1) 1. Confirmed autoimmune disease with appropriate supporting autoantibody findings. 2. Stable background therapy prior to dosing. 3. Active moderate to severe disease consistent with protocol-defined disease activity criteria for: * Systemic lupus erythematosus (SLE) * Systemic sclerosis (SSc) * Rheumatoid arthritis (RA) * Sjögren's disease (SjD) Key Inclusion Criteria for Rescreening Participants (Part 2) 1. Meets Part 1 disease-agnostic inclusion criteria. 2. Stable background autoimmune therapy prior to dosing. 3. Ongoing active moderate to severe disease based on protocol-defined disease-specific criteria. Key
Exclusion criteria
for Parts 1 and 2 1. Pregnant or breastfeeding participants. 2. Recent vaccination within protocol-defined timelines. 3. Clinically significant medical history or abnormal physical examination findings. 4. Clinically significant cardiovascular abnormalities, including blood pressure, heart rate, syncope, or ECG findings. 5. Prior or recent therapies or conditions that may interfere with study participation or safety evaluations. 6. Severe pulmonary, renal, or cardiac disease, or clinically significant pulmonary hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Discontinuations Due to Adverse Events Through Week 48 | Up to Week 48 |
| Number of Participants With Signs Characteristic of Cytokine Release Syndrome (CRS), Immune Related Reaction (IRR), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Including Immunosuppression-Related Infection | Up to Week 24 |
| Number of Participants With Dose limiting AE Evaluation During Dose Escalation | Up to Day 15 |
| Number of Participants With Clinically Significant Changes in Vital Signs | Up to Week 24 |
| Number of Participants With Clinically Significant Changes in Physical Examination Findings | Up to Week 24 |
| Change From Baseline in Serum Interleukin-6 (IL-6) | Up to Week 20 |
| Change From Baseline in Serum Tumour Necrosis Factor-Alpha (TNF-α) | Up to Week 20 |
| Change From Baseline in Serum Interferon-Gamma (IFN-γ) | Up to Week 20 |
| Change From Baseline in Serum High Sensitivity C-Reactive Protein (hsCRP) | Up to Week 20 |
| Change From Baseline in Serum Erythrocyte Sedimentation Rate (ESR) | Up to Week 20 |
| Change From Baseline in Serum Ferritin | Up to Week 20 |
| Change From Baseline in Serum Immunoglobulin G (IgG) | Up to Week 20 |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the Concentration-Time Curve From Time Zero to Last Observable Concentration (AUCt) of HBM7020 | Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29) |
| Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC∞) of HBM7020 | Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29) |
| Maximum Observed Plasma Concentration (Cmax) of HBM7020 | Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29) |
| Time to Maximum Observed Plasma Concentration (tmax) of HBM7020 | Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29) |
| Number of Participants With Anti-Drug Antibodies (ADA) to HBM7020 | Up to Week 24 |
Contacts
CONTACTOtsuka Call Center
Outcome results
None listed