Evaluating LP-10 in Subjects With OLP

Oral Lichen Planus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06233591
• Other study ID #: 310-001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 1, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: December 2023
• Source: Lipella Pharmaceuticals, Inc.
• Contact: Janet Okonski
• Phone: 412-894-1853
• Email: janet.okonski[@]lipella.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 five (5) 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: March 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Drug:
• LP-10 (Liposomal Tacrolimus)
Liposomal oral rinse formulation of Tacrolimus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lipella Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of this study is safety assessed by incidence of Treatment-Emergent Adverse Events	Safety data will be collected by ongoing monitoring of adverse events	through study completion, an average of 10 weeks
Secondary	Measure the objective effect of LP-10 on OLP by Focused Oral Examination including Intraoral Images	Investigator will conduct the oral exam with intraoral images	an average of 10 weeks
Secondary	Measure the objective effect of LP-10 on OLP by OLP Investigator Global Assessment (IGA)	Investigator will complete the OLP IGA score	An average of 10 weeks
Secondary	Measure the objective effect of LP-10 on OLP by Reticulation, erythema, and ulceration (REU) score	Investigator will complete the OLP REU score	an average of 10 weeks
Secondary	Measure the objective effect of LP-10 on OLP by Oral Lichen Planus Symptom Severity Measure (OLPSSM)	Patient will complete the OLPSSM	an average of 10 weeks
Secondary	Measure the objective effect of LP-10 on OLP by Patient Global Response assessment (GRA)	Patient will complete the GRA	At week 4 visit
Secondary	Measure the objective effect of LP-10 on OLP by Pain and sensitivity numerical rating scale (NRS)	Patient will complete the Numerical Rating Scale (NRS) a scale from 0 - 10, higher score is a worse outcome	an average of 10 weeks