NCT07363265

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
37mo left

Started Feb 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Feb 2026May 2029

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2028

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2029

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

January 15, 2026

Last Update Submit

January 15, 2026

Conditions

Complement-mediated Renal Diseases

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • 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

Study Arms (1)

LP-005

EXPERIMENTAL

Patients with complement-mediated renal diseases will be treated with predefined dose of LP-005 (1200 mg or 1500 mg).

Biological: LP-005 Injection

Interventions

LP-005 InjectionBIOLOGICAL

IV, Q4W

LP-005

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females aged 18 to 65 years at screening.
  • Body weight of ≥ 40 kg and a body mass index (BMI) within the range of 15 to 35 kg/m\^2 (inclusive).
  • Patients with complement-mediated renal disease.
  • 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.
  • 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.

You may not qualify if:

  • Pregnant or lactating female.
  • History of meningococcal infection.
  • Active, uncontrolled acute, chronic, or recurrent infection within 4 weeks prior to screening.
  • Other severe, poorly controlled comorbidities within 3 months prior to screening.
  • Patients with known hypersensitivity to any component of LP-005 or a history of atopic diathesis.
  • 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).
  • Prior use of any complement inhibitor within 3 months prior to screening or 5 half-lives of the drug, whichever is longer.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, China

Location

Study Officials

  • Minghui Zhao

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Yang

CONTACT

+86 021-58372390yangj@longbiopharma.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

August 2, 2028

Study Completion (Estimated)

May 2, 2029

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

CN(1)