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PeriodontitisPhase 2NCT07603713

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

A Phase 2 study testing LP-005 Injection in people with Periodontitis, run by Longbio Pharma (Suzhou) Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Periodontitis
What is being tested?
LP-005 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteChina
Study dates
1 May 2026to 23 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Peking University School and Hospital of Stomatology

    Beijing, Beijing Municipality

    Hong Hua, 86-13671355702, honghua1968@aliyun.com

Other trials in China

About this study

Official title: 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

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.

Conditions
Periodontitis
Being tested
LP-005 Injection, Placebo Injection
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LP-005 InjectionDrug

    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.

  • Placebo InjectionDrug

    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.

Study groups in NCT07603713
Study groupRoleWhat they receive
LP-005 Low-dose cohortExperimentalParticipants in this arm will receive LP-005 injection at a dose of 2.5 mg per injection site, with 2 injection sites per treated tooth, administered at a volume of 150 μL per site, once every 4 weeks for a total of 3 doses.
Receives: Drug: LP-005 Injection
LP-005 Medium-dose cohortExperimentalParticipants in this arm will receive LP-005 injection at a dose of 5.0 mg per injection site, with 2 injection sites per treated tooth, administered at a volume of 150 μL per site, once every 4 weeks for a total of 3 doses.
Receives: Drug: LP-005 Injection
LP-005 High-dose cohortExperimentalParticipants in this arm will receive LP-005 injection at a dose of 7.5 mg per injection site, with 2 injection sites per treated tooth, administered at a volume of 150 μL per site, once every 4 weeks for a total of 3 doses.
Receives: Drug: LP-005 Injection
Placebo cohortPlacebo comparatorParticipants in this arm will receive placebo injection at a dose of 0 mg per injection site, with 2 injection sites per treated tooth, administered at a volume of 150 μL per site, once every 4 weeks for a total of 3 doses.
Receives: Drug: Placebo Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Gingival Index (GI)

    GI is measured using the Löe-Silness scale (range: 0-3), where higher scores indicate more severe gingival inflammation (worse outcome). Changes from baseline in gingival index (GI) scores are measured at Day 43, Day 85, Day 127, and Day 169 after the first administration of LP-005 injection.

    Measured: Day 43, Day 85, Day 127, and Day 169

  2. Change from Baseline in Bleeding Index (BI)

    BI is measured using the Caton-Paton scale (range: 0-4), where higher scores indicate more severe gingival bleeding (worse outcome). Changes from baseline in BI scores are measured at Day 43, Day 85, Day 127, and Day 169 after the first administration of LP-005 injection.

    Measured: Day 43, Day 85, Day 127, and Day 169

  3. Change from Baseline in Probing Pocket Depth (PD)

    Changes from baseline in probing pocket depth (PD) are measured at Day 43, Day 85, Day 127, and Day 169 after the first administration of LP-005 injection.

    Measured: Day 43, Day 85, Day 127, and Day 169

  4. Change from Baseline in Clinical Attachment Loss (AL)

    Clinical AL is evaluated by standardized periodontal probing: after measuring probing depth, the probe tip is withdrawn along the root surface to identify the cemento-enamel junction (CEJ). The distance from the CEJ to the gingival margin (GM) is recorded. AL is calculated by subtracting this distance from the probing depth. A result of zero or an undetectable CEJ indicates no attachment loss. In cases of gingival recession where the gingival margin is apical to the CEJ, AL is determined by summing the two measurements. Six sites per tooth are examined, and AL values are recorded at all measured sites, with units expressed in millimeters (mm); larger values represent more severe periodontal attachment destruction. Changes from baseline in AL are measured at Day 43, Day 85, Day 127, and Day 169 after the first administration of LP-005 injection.

    Measured: Day 43, Day 85, and Day 127, Day 169

  5. Change from Baseline in Plaque Index (PI)

    PI is measured using the Silness-Löe scale (range: 0-3), higher scores indicate thicker dental plaque accumulation and more severe periodontal plaque condition. Changes from baseline in plaque index (PI) scores are measured at Day 43, Day 85, Day 127, and Day 169 after the first administration of LP-005 injection.

    Measured: Day 43, Day 85, Day 127, and Day 169

  6. Change from Baseline in Alveolar Bone Defect Height

    Changes from baseline in alveolar bone defect height are measured at Day 85 and Day 169 after the first administration of LP-005 injection, assessed via cone-beam computed tomography (CBCT).

    Measured: Day 85, and Day 169

  7. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Incidence and severity of TEAEs from first dose to end of study are recorded.

    Measured: Up to approximately 24 weeks

  8. Detect Pharmacokinetic (PK) Characteristics of LP-005

    Assess detectable serum concentration of LP-005 after local administration; if sufficient systemic exposure is detected, evaluate the systemic plasma PK characteristics of LP-005.

    Measured: Up to approximately 24 weeks

  9. Gingival Crevicular Fluid (GCF) Concentration of LP-005

    GCF samples to evaluate changes in LP-005 concentration in participants' GCF after local administration.

    Measured: Up to approximately 24 weeks

  10. Detect Pharmacodynamics (PD) Characteristics of LP-005

    Collect systemic venous blood samples to evaluate changes in participants' serum complement hemolytic activity (CH50), free C5 level, and C3b deposition after local administration of LP-005.

    Measured: Up to approximately 24 weeks

  11. Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) Assessment

    Collect systemic venous blood samples to evaluate the positivity rate of ADA in participants, the titer of ADA-positive samples, and further detect NAb in ADA-positive samples.

    Measured: Up to approximately 24 weeks

Secondary outcomes (1)
  1. Change from Baseline in Gingival Crevicular Fluid (GCF) Biomarker Levels

    GCF samples will be collected in participants' GCF after local administration of LP-005 to assess changes from baseline in a predefined panel of inflammatory and tissue-degrading biomarkers, including C3b, C5a, IL-1β, IL-6, TNF-α, MMP-8, and MMP-9. All biomarkers are quantified in standardized protein concentration units within GCF, and individual biomarker changes will be reported separately without aggregation.

    Measured: Up to approximately 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion12 Nov 2026 (estimated)
  4. Study completion23 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07603713
Sponsor's protocol ID
P10-LP005-03
Status last verified
May 2026
First submitted
23 Apr 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LP-005 Injection in people with Periodontitis, run by Longbio Pharma (Suzhou) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jie Yang (+86 021-58372390, yangj@longbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Gingival Index (GI) (time frame: Day 43, Day 85, Day 127, and Day 169). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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