Complement-mediated Renal Diseases
Conditions
Brief summary
This is a multicenter, open-label, proof-of-concept, phase Ⅱ adaptive basket clinical trial designed to evaluate the efficacy, safety, and pharmacokinetic profile of LP-005 Injection as add-on therapy to standard treatment in patients with complement-mediated renal diseases.
Interventions
BIOLOGICALLP-005 Injection
IV, Q4W
Sponsors
Longbio Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females aged 18 to 65 years at screening. 2. Body weight of ≥ 40 kg and a body mass index (BMI) within the range of 15 to 35 kg/m\^2 (inclusive). 3. Patients with complement-mediated renal disease. 4. Females and males of childbearing potential (including the participants' partners) must agree to use effective contraceptive measures during the trial and for 3 months after the trial ends. 5. Willing to participate in this clinical trial and voluntarily sign the informed consent form; additionally, be assessed by the investigator as being able to fully understand and comply with all planned study procedures and other requirements.
Exclusion criteria
1. Pregnant or lactating female. 2. History of meningococcal infection. 3. Active, uncontrolled acute, chronic, or recurrent infection within 4 weeks prior to screening. 4. Other severe, poorly controlled comorbidities within 3 months prior to screening. 5. Patients with known hypersensitivity to any component of LP-005 or a history of atopic diathesis. 6. History of malignancy within 5 years prior to screening, except for resected cutaneous basal cell carcinoma, resected cutaneous squamous cell carcinoma, and completely resected carcinoma in situ without evidence of local recurrence or metastasis (e.g., cervical carcinoma in situ or breast carcinoma in situ). 7. Prior use of any complement inhibitor within 3 months prior to screening or 5 half-lives of the drug, whichever is longer. 8. Participation in another clinical trial with administration of investigational drug or medical device within 4 weeks prior to screening or 5 half-lives of the administered product, whichever applies. 9. Any condition that, in the investigator's judgment, may impede study participation, pose a safety risk to the participant, or confound the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in 24-hour urinary protein-to-creatinine ratio (UPCR) in Basket 1 cohort | Week 24 |
| Proportion of patients with a ≥25% reduction in serum creatinine (SCr) from baseline in Basket 2 cohort | Week 24 |
| Proportion of patients without dialysis requirement in Basket 3 cohort | Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in serum creatinine (SCr) | Up to approximately 64 weeks |
| Change from baseline in estimated glomerular filtration rate (eGFR) | Up to approximately 64 weeks |
| Incidence of AEs | Up to approximately 64 weeks |
| Serum concentrations of LP-005 | Up to approximately 64 weeks |
| Number of patients with anti-drug antibodies (ADA) | Up to approximately 64 weeks |
Countries
China
Contacts
CONTACTJie Yang
PRINCIPAL_INVESTIGATORMinghui Zhao
Peking University First Hospital
Outcome results
None listed