NCT03836885

Apremilast - Oral Lichen Planus Trial

The APOLP Trial: A Single-Center, Randomized, 16 Weeks, Explanatory, Parallel-Group, Superiority, Blinded, Placebo-Controlled, Clinical Trial of Apremilast Use in Oral Lichen Planus

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Apremilast for the management of oral lichen planus.

Detailed description

Oral lichen planus (OLP) affects approximately 1.27% of the general population. Inflammatory responses constitute a major component of OLP pathogenesis where targeted therapies play an important role in managing this condition. Apremilast is a new well-tolerated and relatively safe anti-inflammatory therapy that has been approved for managing psoriasis and psoriatic arthritis. Given its safer profile, Apremilast may ameliorate inflammatory responses in clinically active OLP without the experience of serious adverse events associated with other systemic immunosuppressive therapies used to treat OLP. The plan is to conduct a single-center, explanatory, randomized, 16 weeks, parallel group, superiority, blinded, placebo-controlled, clinical trial. The main objective is treatment success assessment. Other objectives include exploring the efficacy of Apremilast in clinically active OLP adult patients considered for systemic treatment and failed topical corticosteroid therapy. It is hypothesized that Apremilast will induce more treatment success as compared to placebo in patients who failed the standard treatment of topical corticosteroids.

Conditions

• Oral Lichen Planus

Interventions

Type	Name	Description
DRUG	Apremilast	Apremilast tablets. Titration will occur in the initial five days of treatment as per dosing in psoriasis as follows: Day 1: 10 mg; Day 2: 20 mg; Day 3: 30 mg; Day 4: 40 mg; Day 5: 50 mg. Day 6 and thereafter patients will be dosed at 60 mg for a total of 12 weeks.
DRUG	Placebo	Placebo Oral tablets. Patients randomized to the control arm will receive color, taste, shape and odour matched oral placebo. The number of tablets and the days taken is analogous to the intervention arm had they been randomized to the intervention arm.

Timeline

• Start date: 2019-11-21
• Primary completion: 2020-04-22
• Completion: 2020-04-22
• First posted: 2019-02-11
• Last updated: 2020-06-25

Locations

1 site across 1 country: Canada