Efficacy and Safety of LP-005 Injection in Patients With Moderate-to-Severe Periodontitis

Официальное название

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅱ Study to Evaluate the Efficacy and Safety of LP-005 Injection in Patients With Moderate-to-Severe Periodontitis

Обзор

This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the clinical efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of multiple local injections of different doses of LP-005 injection in patients with moderate-to-severe periodontitis, and to investigate changes in biomarker levels.

Вмешательства

• Препарат LP-005 Injection
  LP-005 is a bifunctional antibody fusion protein consisting of an anti-human C5 monoclonal antibody and a human complement regulatory protein, formulated as a sterile injectable solution. Each vial contains 300 mg of LP-005 in 6 mL (50 mg/mL). The LP-005 is administered via interdental papilla injection.
• Препарат Placebo Injection
  Placebo is a sterile injectable solution matched to LP-005 for appearance, formulation, and administration, with 0 mg of active ingredient per 6 mL vial.

Первичные конечные точки

• Change from Baseline in Gingival Index (GI) [Срок оценки: Day 43, Day 85, Day 127, and Day 169]
• Change from Baseline in Bleeding Index (BI) [Срок оценки: Day 43, Day 85, Day 127, and Day 169]
• Change from Baseline in Probing Pocket Depth (PD) [Срок оценки: Day 43, Day 85, Day 127, and Day 169]
• Change from Baseline in Clinical Attachment Loss (AL) [Срок оценки: Day 43, Day 85, and Day 127, Day 169]
• Change from Baseline in Plaque Index (PI) [Срок оценки: Day 43, Day 85, Day 127, and Day 169]
• Change from Baseline in Alveolar Bone Defect Height [Срок оценки: Day 85, and Day 169]
• Incidence of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Up to approximately 24 weeks]
• Detect Pharmacokinetic (PK) Characteristics of LP-005 [Срок оценки: Up to approximately 24 weeks]
• Gingival Crevicular Fluid (GCF) Concentration of LP-005 [Срок оценки: Up to approximately 24 weeks]
• Detect Pharmacodynamics (PD) Characteristics of LP-005 [Срок оценки: Up to approximately 24 weeks]

Вторичные конечные точки (1)

• Change from Baseline in Gingival Crevicular Fluid (GCF) Biomarker Levels [Срок оценки: Up to approximately 24 weeks]

Критерии участия

Критерии включения

• Aged 18 to 70 years (inclusive), with no restriction on sex.
• Clinically diagnosed with moderate to severe (Stage II or III) periodontitis according to the 2018 International Classification of Periodontal and Peri-Implant Diseases. participants must have at least 2 non-adjacent natural teeth (excluding third molars) in the dentition with a Probing Depth (PD) of 5 to 8 mm (inclusive), and at least 1 site per tooth with a BI score > 2.
• Participants and their partners must agree to practice effective non-pharmacological contraception from the time of signing the Informed Consent Form (ICF) until 3 months after the study completion. For female participants of childbearing potential, a negative pregnancy test result is required within 7 days prior to the first dose.
• Voluntary participation in the trial and signed approval of the ICF.

Критерии исключения

• At the time of screening, the target tooth and/or adjacent teeth (as determined by the investigator to affect the target tooth) exhibit periapical periodontitis, pericoronitis, or combined pulp-periodontal lesions; or the participant has orthodontic appliances (including fixed lingual retainers, etc.);
• At screening, the target tooth and/or adjacent teeth (as determined by the investigator to affect the target tooth) are found by the investigator to have severe caries or caries requiring immediate treatment;
• At screening, the participant has a periodontal or dental abscess, or a tumor of the oral soft or hard tissues;
• Participants who have previously undergone periodontal surgery on the target teeth and/or adjacent teeth (as determined by the investigator to affect the target teeth), or who have undergone subgingival scaling and root planning (SRP) within 6 months prior to screening;
• Participants with a history of Neisseria meningitidis infection;
• Participants with a history of splenectomy or congenital asplenia;
• Participants with impaired immune function (e.g., HIV infection, neutropenia, complement deficiency, etc.);
• Participants with autoimmune diseases that the investigator determines may interfere with the evaluation of the study disease, such as Sjögren's syndrome, systemic lupus erythematosus, psoriasis, rheumatoid arthritis, etc.;
• Participants with poorly controlled blood pressure at screening, such as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg;
• Participants with glycated hemoglobin (HbA1c) >7.5% or severe diabetic complications at screening;
• Participants with severe or poorly controlled systemic diseases at screening, as determined by the investigator, such as respiratory, gastrointestinal, cardiovascular, hematological, urological, neurological, or psychiatric disorders;
• Participants who have continuously taken medications deemed by the investigator to interfere with the study within 1 month prior to screening, such as nifedipine, phenytoin, or anticoagulants (e.g., warfarin);
• Participants who have received systemic antibiotic therapy within 3 months prior to screening;
• Participants who have taken nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids on a long-term basis (≥3 times per week) prior to screening;
• Participants with any of the following laboratory test results at the time of screening:

• ALT or AST > 2.5 times the upper limit of normal (ULN) or serum total bilirubin > 1.5 times ULN;
• Serum creatinine > 1.5 times the upper ULN;
• International Normalized Ratio (INR) ≥ 1.5 times ULN, or activated partial thromboplastin time (APTT) ≥ 1.5 times ULN (excluding participants currently receiving anticoagulant therapy);
• Platelet count (PLT) < 100 × 10⁹/L;
• Participants who test positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab) at screening;
• Participants with a history of malignant tumors within 5 years prior to screening;
• Participants with a history of heavy smoking (≥10 cigarettes per day) within 12 months prior to screening;
• Participants with known allergies to any drugs or materials used during surgery;
• Pregnant or breastfeeding women;
• Participants who have participated in other clinical trials within 30 days prior to screening or who plan to participate in other clinical trials during the study period;
• Participants assessed by the investigator as having other conditions rendering them unsuitable for participation in the clinical study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University School and Hospital of Stomatology — Пекин

Идентификаторы

NCT: NCT07603713 · P10-LP005-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗