Apremilast - Oral Lichen Planus Trial (APOLP)
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|ClinicalTrials.gov Identifier: NCT03836885|
Recruitment Status : Withdrawn (Study was terminated due to delay in enrollment.)
First Posted : February 11, 2019
Last Update Posted : June 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Oral Lichen Planus||Drug: Apremilast Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||November 21, 2019|
|Actual Primary Completion Date :||April 22, 2020|
|Actual Study Completion Date :||April 22, 2020|
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.
Other Name: Otezla
Placebo Comparator: 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.
- Assessing treatment success defined as Physician Global Assessment (PhGA) of 0 or 1 [ Time Frame: Baseline to 16 weeks ]The primary outcome will be assessing treatment success with Apremilast as compared to placebo defined as Physician Global Assessment (PhGA) of 0 or 1.
- Achieving complete remission defined as achieving a score of 0 on PhGA scale [ Time Frame: 12 weeks and 16 weeks ]Complete remission is defined as achieving a score of 0 on PhGA scale
- Physician Global Assessment (PhGA) [ Time Frame: Baseline to 16 weeks ]Physician Global Assessment (PhGA) grading score from 0 to 4. Score of 0 is clear, score of 1 is almost clear, score of 2 is mild disease, score of 3 is moderate disease, and a score of 4 is severe disease.
- Patient Assessment (PtA) [ Time Frame: Baseline to 16 weeks ]Patient Assessment (PtA) grading score from 0 to 4. Score of 0 is clear, score of 1 is almost clear, score of 2 is mild disease, score of 3 is moderate disease, and a score of 4 is severe disease.
- Achieving partial response [ Time Frame: Baseline to 12 weeks ]Percentage of patients who achieve partial response
- Visual Analogue Scale (VAS) [ Time Frame: Baseline to 16 weeks ]Patient assessment of pain score from 0 to 10. VAS is a scale demonstrated by a 10 cm horizontal line marked from 0-10 with the left end marked as no symptoms (0) and the right end marked as worst symptoms (10).
- Oral Health Impact Profile (OHIP-14) Scale [ Time Frame: Baseline to 16 weeks ]Patient assessment of overall disease impact on quality of life is a self-filled validated scale that focuses on seven domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Participants will be asked to respond according to frequency of impact on a 5-point scale coded: never (score 0), hardly ever (score 1), occasionally (score 2), fairly often (score 3) and very often (score 4).
- Modified Oral Mucositis Index (MOMI) Scale [ Time Frame: Baseline weeks to 16 weeks ]Physician assessment using a validated 20 item scale in OLP, is used to rate four types of mucosal changes (atrophy, edema, erythema, and ulceration) in nine anatomical areas of the oral cavity
- Safety and tolerability of Apremilast [ Time Frame: 6 weeks to 16 weeks ]Relationship of adverse events to study treatment. Difference in proportions between the two study arms for each AE at each time point will be assessed and changes in the incidence of treatment.
- Standardized steroid and anti-fungal rinses used [ Time Frame: 6 weeks to 16 weeks ]Differences in total dexamethasone and nystatin mouthwashes quantity used at each time point between the two study arms will be assessed
- Body Mass Index (BMI) [ Time Frame: Baseline to 16 weeks ]Differences in BMI scores at each time point between two study arms will be assessed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836885
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N3M5|
|Principal Investigator:||Hagen Klieb, HBSc, MSc, DMD, FRCD(C)||Sunnybrook Health Sciences Centre|