Efficacy and Safety of LP-005 Injection in Patients With Complement-Mediated Kidney Disease

A Multicenter, Open-label Phase Ⅱ Study to Evaluate the Efficacy and Safety of LP-005 Injection in Patients With Complement-Mediated Kidney Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Complement-mediated Renal Diseases
• Intervention / Treatment: Biological: LP-005 Injection

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jie Yang; Phone Number: +86 021-58372390; Email: yangj@longbiopharma.com

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital
    • Contact: Minghui Zhao; Phone Number: 86-010-83572388; Email: mhzhao@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LP-005; Patients with complement-mediated renal diseases will be treated with predefined dose of LP-005 (1200 mg or 1500 mg).	Biological: LP-005 Injection; IV, Q4W

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Longbio Pharma
• Investigators: Principal Investigator: Minghui Zhao, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 2, 2026
• Primary Completion (Estimated): August 2, 2028
• Study Completion (Estimated): May 2, 2029

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: P10-LP005-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No