Evaluating LP-10 in Subjects With OLP

L

Lipella Pharmaceuticals

Status and phase

Not yet enrolling
Phase 2

Conditions

Oral Lichen Planus

Treatments

Drug: LP-10 (Liposomal Tacrolimus)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06233591
310-001

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

24 participants in 3 patient groups

LP-10 0.25mg
Experimental group
Description:
0.25mg LP-10 / 10 mL twice daily oral rinse
Treatment:
Drug: LP-10 (Liposomal Tacrolimus)
LP-10 0.5 mg
Experimental group
Description:
0.5mg LP-10 / 10 mL twice daily oral rinse
Treatment:
Drug: LP-10 (Liposomal Tacrolimus)
LP-10 1.0 mg
Experimental group
Description:
1.0mg LP-10 / 10 mL twice daily oral rinse
Treatment:
Drug: LP-10 (Liposomal Tacrolimus)

Trial contacts and locations

0

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Central trial contact

Janet Okonski; Michele Gruber

Data sourced from clinicaltrials.gov

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