Not Yet RecruitingPhase 2

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

China100 participantsStarted 2026-05-01

Plain-language 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, and to investigate changes in biomarker levels.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in Gingival Index (GI)

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

Change from Baseline in Bleeding Index (BI)

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

Change from Baseline in Probing Pocket Depth (PD)

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

Change from Baseline in Clinical Attachment Loss (AL)

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

Change from Baseline in Plaque Index (PI)

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

Change from Baseline in Alveolar Bone Defect Height

Timeframe: Day 85, and Day 169

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Timeframe: Up to approximately 24 weeks

Trial details

NCT IDNCT07603713

SponsorLongbio Pharma (Suzhou) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-12

Contact for this trial

Jie Yang

+86 021-58372390 yangj@longbiopharma.com

View on ClinicalTrials.gov More Periodontitis trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

What they're measuring

Change from Baseline in Gingival Index (GI)

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

Change from Baseline in Bleeding Index (BI)

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

Change from Baseline in Probing Pocket Depth (PD)

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

Change from Baseline in Clinical Attachment Loss (AL)

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

Change from Baseline in Plaque Index (PI)

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

Change from Baseline in Alveolar Bone Defect Height

Timeframe: Day 85, and Day 169

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Timeframe: Up to approximately 24 weeks