Evaluating LP-10 in Subjects With OLP

A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-10 in Subjects With Symptomatic Oral Lichen Planus

This is a multicenter, dose-ranging study including adult male and female subjects (>= 18 years old) with symptomatic Oral Lichen Planus (OLP). A total of approximately 24 subjects will be enrolled at approximately eight (8) study sites in the United States. This study will evaluate the safety, tolerability and efficacy of LP-10 at 0.25 mg, 0.5 mg and 1.0 mg of tacrolimus.The study consists of screening, treatment and follow-up phases. The treatment phase includes 10 mL LP-10 oral rinse for 3 minutes twice a day for 4 weeks. The follow-up phase includes one post-treatment visit 2 weeks after the last oral LP-10 dose.

Study Overview

• Status: Active, not recruiting
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Drug: LP-10 (Liposomal Tacrolimus)

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Center for Dermatology
    • San Francisco, California, United States, 94143
      • UCSF School of Dentistry
  • Florida
    • Miami, Florida, United States, 33176
      • Miami Cancer Institue at Baptist Health, Inc
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • New York
    • Buffalo, New York, United States, 14215
      • Erie County Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Atrium Health Oral Medicine & Maxillofacial Surgery
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Co, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Provide written informed consent
• Male or female ≥ 18 years of age
• Oral biopsy performed within the last 10 years before the Screening Visit demonstrating OLP and/or oral lichenoid mucositis in the absence of cancer or dysplasia
• Moderate OLP based on an OLP Investigator Global Assessment (IGA) score of ≥ 3
• OLP Pain and Sensitivity Numerical Rating Scale (NRS) score of ≥ 3
• Patients taking prescription oral steroid or rinse treatment(s) at the time of the Screening Visit agree to stop treatment for the duration of the trial and to undergo a 4-week washout period
• Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the self-administered questionnaires
• Willing to avoid live vaccines while enrolled in the trial
• Patients of child-bearing potential must have a negative pregnancy test and agree to undergo pregnancy testing at each study visit. (unless patient has undergone a bilateral tubal ligation or hysterectomy and/or is post-menopausal as defined by the absence of menses for at least 12 months)
• Patients of child-bearing potential and male participants with a female partner of child-bearing potential, agree to use a reliable method of contraception (condoms and/or oral contraceptives) for the duration of the trial and for 10 days thereafter

Exclusion Criteria:

• Hyperkalemia
• Chronic kidney disease
• Long QT syndrome
• History of oral cavity or oropharyngeal cancers
• Active cancer
• Uncontrolled hypertension (i.e., > 145 mm/Hg systolic or > 95 mmHg diastolic)
• Patients who failed tacrolimus treatment for OLP in the past
• Patient who is currently or has previously participated in another oral cavity therapeutic or device study within 3 months of screening and has not returned to baseline
• History of oral cavity infection (bacterial, viral or fungal) within 3 months prior to screening
• Pregnant or lactating
• Active bleeding peptic ulcer disease
• Known allergy to liposomes and/or egg yolk and/or tacrolimus
• Evidence of renal impairment (creatinine > 2 × the upper limit of normal at Visit 1), hepatic impairment (AST or ALT > 3 × the upper limit of normal at Visit 1), clinically significant cardiovascular, respiratory, or psychiatric diseases per investigator's judgment
• Patients currently taking magnesium and aluminum-hydroxide antacids or metoclopramide
• Patients currently taking aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, and protease inhibitors
• The presence of any clinically significant systemic disease or condition that in the opinion of the investigator would make the patient unsuitable for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LP-10 0.25mg; 0.25mg LP-10 / 10 mL twice daily oral rinse	Drug: LP-10 (Liposomal Tacrolimus); Liposomal oral rinse formulation of Tacrolimus
Experimental: LP-10 0.5 mg; 0.5mg LP-10 / 10 mL twice daily oral rinse	Drug: LP-10 (Liposomal Tacrolimus); Liposomal oral rinse formulation of Tacrolimus
Experimental: LP-10 1.0 mg; 1.0mg LP-10 / 10 mL twice daily oral rinse	Drug: LP-10 (Liposomal Tacrolimus); Liposomal oral rinse formulation of Tacrolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety of LP-10 in patients with oral lichen Planus	Incidence and severity of treatment-emergent adverse events, changes in standard laboratory studies, whole-blood tacrolimus levels	over 4 weeks of treatment and 2 weeks of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus	Patient Global Response Assessment (GRA)	at 4 weeks after first dose
To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus	Change in the OLP Investigator Global Assessment (IGA) score	from baseline to 1 and 4 weeks after the first dose and 2 weeks after the last dose
To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus	Change in the OLP Reticulation, Erythema, and Ulceration (REU) score	from baseline to 1 and 4 weeks after the first dose and 2 weeks after the last dose
To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus	Changes in the Oral Lichen Planus Symptom Severity Measure (OLPSSM) score	from baseline to 1 and 4 weeks after the first dose and 2 weeks after the last dose
To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus	Change in the OLP Pain and Sensitivity Numerical Rating Scale (NRS)	from baseline to 1 and 4 weeks after the first dose and 2 weeks after the last dose

Collaborators and Investigators

• Sponsor: Lipella Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 27, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: OLP
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Lichen Planus, Oral; Lichen Planus; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: 310-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No