LEO 124249 Ointment in the Treatment of Alopecia Areata

Study Overview
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Brief Summary
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This clinical trial attempts to investigate the efficacy and safety of LEO 124249 ointment in the treatment of alopecia areata and the molecular disease mechanism and biomarkers.

Detailed Description
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The objectives of this clinical trial are to compare the efficacy of twice-daily topical LEO 124249 30 mg/g ointment with LEO 124249 ointment vehicle for 12 weeks in the treatment of hair loss in subjects with alopecia areata, to evaluate the safety of this treatment, to evaluate hair regrowth, to determine subject quality of life, and to explore disease mechanism and its biomarkers.

Official Title
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Efficacy of Twice Daily Applications of LEO 124249 Ointment 30mg/g for 12 Weeks to Subjects With Alopecia Areata

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: LEO 124249
* Other: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have signed and dated informed consent after receiving verbal and written information about the clinical trial. Subjects with unequivocal clinical diagnosis of moderate to severe scalp alopecia areata (patch type, totalis, universalis), as determined by the (sub) investigator, affecting a minimum of 30% scalp area at Visit 1 (Screening) and Visit 2 (Day 1, baseline). Minimum 6 month duration of hair loss at Visit 1 (Screening). No upper limit time limit. Subject must accept to not cut hair in the treated scalp areas during the trial. Exclusion Criteria: Females who are pregnant or are breast feeding. Current signs of spontaneous hair regrowth. Diffuse type alopecia areata. Co-existing moderate to severe androgenic alopecia (Norwood-Hamilton stage IV-VI and Ludwig stage II and III) Subjects with changed or expected changes in medication for thyroid disease within 6 month before Visit 1 (screening) or during the trial. Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), chloroquin derivatives, corticosteroids, or any other systemic therapy that in the opinion of the investigator could affect hair regrowth, within 6 weeks prior to randomization (inhaled or intra-nasal steroids corresponding to up to 1 mg prednisone for asthma or rhinitis may be used).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEO 124249<br>LEO 124249 ointment 30 mg/g twice daily | Drug: LEO 124249<br> <br> * Other names: LEO 124249 Ointment;|
| Placebo Comparator: Vehicle<br>LEO 124249 ointment vehicle twice daily | Other: Vehicle<br> <br> * Other names: LEO 124249 Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Severity of Alopecia Areata Tool (SALT) Score | The SALT score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss. | From baseline (Day 1) to Week 12 (Day 84) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Absolute SALT Score | The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. Summary of observed values of the absolute SALT score. | At baseline (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | 
| Summary of Change in SALT Score | The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss. | From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84) | 
| Summary of Relative Change in SALT Score | The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss. | From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84) | 
| Percentage of Patients Who Achieve 50% Improvement in the SALT Score | The event of having at least 50% reduction in SALT score at Week 12 (Day 84) as compared to baseline (Day 1) | At Week 12 (Day 84) | 
| Hair Length | Hair length measured in millimeters. | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | 
| Hair Growth Rate | Change in hair length measured in millimeters per day. | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | 
| Relative Hair Thickness | Thickness relative to participant's normal scalp hair. Relative assessment not applicable for participants with alopecia areata totalis and universalis. | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | 
| Hair Type | Hair type being either vellus hair or terminal hair. Hair type is not applicable for participants with alopecia areata totalis and universalis. | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | 
| Hair Color | Absolute color of hair. Hair color is not applicable for alopecia areata totalis and universalis. | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | 
| Global Assessment of Overall Hair Regrowth Compared to Baseline | Based on standardized photographs | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | 
| Participant's Global Assessment of Hair Regrowth | The participant will assess the hair regrowth before the investigator does any assessments of hair regrowth. | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | 
| Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | The scale includes 21 questions measuring the degree to which the patient was affected by the AA in the last month, scored from 1 (not affected at all) to 4 (highly affected). The AA-QLI transformed scores for each of the subcategories 'subjective symptoms', 'relationship' and 'objective signs' ranging from (min-max) 9-36, 9-36, and 3-12. Total score ranges from 0-84. Low score indicating that the participant was least affected by AA. | At baseline (Day 1) and at Week 12 (Day 84) | 
| Treatment Satisfaction Questionnaire for Medication Score | The Treatment Satisfaction Questionnaire for Medication (TSQM II) is a validated, general measure of treatment satisfaction for medication - accounting for effectiveness, side effects, convenience, and global satisfaction - that is comparable across medication types and patient conditions. The individual derived score for each of the 4 dimensions (effectiveness, side effects, convenience, and global satisfaction) of the TSQM II questionnaire ranged from 0-100, with a higher score indicating greater satisfaction to treatment. | At Week 12 (Day 84) |