Apremilast - Oral Lichen Planus Trial

Sponsor
Sunnybrook Health Sciences Centre
Study ID
NCT03836885
Phase
PHASE2
Status
Withdrawn

Conditions

  • Oral Lichen Planus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apremilast — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

Apremilast for the management of oral lichen planus.

Key Dates

First listed
Feb 11, 2019
Start date
Nov 21, 2019
Status verified
Jun 2020
Primary completion
Apr 22, 2020
Completion
Apr 22, 2020

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apremilast
    Oral tablet
  • Placebo Comparator: Placebo
    Oral tablet

Primary Outcome Measure

Assessing treatment success defined as Physician Global Assessment (PhGA) of 0 or 1 [ Time Frame: Baseline to 16 weeks ]