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

Longbio Pharma

Status and phase: Not yet enrolling; Phase 2

Conditions: Complement-mediated Renal Diseases

Treatments: Biological: LP-005 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07363265

P10-LP005-06

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

LP-005

Experimental group

Description:

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

Treatment:

Biological: LP-005 Injection