Clinical trial NCT06233591: Evaluating LP-10 in Subjects With OLP
Official title: A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-10 in Subjects With Symptomatic Oral Lichen Planus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Oral Lichen Planus
Keywords: OLP
Lead sponsor: Lipella Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the safety of LP-10 in patients with oral lichen Planus
timeFrame: over 4 weeks of treatment and 2 weeks of follow-up
Secondary outcomes:
measure: To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus
timeFrame: from baseline to 1 and 4 weeks after the first dose and 2 weeks after the last dose
measure: To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus
timeFrame: from baseline to 1 and 4 weeks after the first dose and 2 weeks after the last dose
measure: To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus
timeFrame: from baseline to 1 and 4 weeks after the first dose and 2 weeks after the last dose
measure: To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus
timeFrame: from baseline to 1 and 4 weeks after the first dose and 2 weeks after the last dose
measure: To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus
timeFrame: at 4 weeks after first dose
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Center for Dermatology
state: California
city: San Francisco
country: United States
facility: UCSF School of Dentistry
state: California
city: Miami
country: United States
facility: Miami Cancer Institue at Baptist Health, Inc
state: Florida
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: Charlotte
country: United States
facility: Atrium Health Oral Medicine & Maxillofacial Surgery
state: North Carolina
city: Philadelphia
country: United States
facility: Paddington Testing Co, Inc
state: Pennsylvania
Study officials:
References: