Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata.

Study Overview
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Brief Summary
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This clinical trial attempts to investigate the efficacy of LEO 124249 ointment in the treatment of alopecia areata on the eyebrows.

Official Title
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Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata.

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: LEO 124249
* Other: Ointment vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical unequivocal diagnosis of Alopecia Areata (patchy, univeralis and totalis), on both scalp and eyebrows as assessed by the investigator. Maximal disease duration of current episode of Alopecia Areata on the eyebrows of 3 years at screening. Maximal Alopecia Areata disease duration - defined as years of active disease - in other locations than eyebrows of 10 years at screening. Exclusion Criteria: Clinical diagnosis of diffuse type alopecia areata as assessed by the investigator. Any topical, intralesional therapy or procedure applied within 2 cm of the treatment area, within 4 weeks of randomisation, which in the opinion of the investigator, could interfere with the trial assessments. This includes, but is not limited to: corticosteroids, calcineurin inhibitors, calcipotriol, minoxidil, antimicrobials, prostaglandin analogs (e.g. bimatoprost), herbal extracts, topical immunotherapy with allergens or irritants and any laser or phototherapy, and eyebrow tattoo. Any systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), chloroquin derivatives, corticosteroids (including intralesional treatment outside the trial treatment area), or any other systemic therapy that in the opinion of the investigator could affect hair regrowth, within 4 weeks prior to randomisation. Any biologic medicinal product targeting the immune system within 5 half-lives and minimum 4 weeks prior to randomisation (e.g. anti-TNFα, anti-IL17, anti IL12/23, anti IL-4Rα targeting drugs). Systemic JAK inhibitor Ruxolitinib (Jakafi®/Jakavi®), Tofacitinib (Xeljanz®) at any time prior to randomisation.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEO 124249 ointment 30 mg/g<br>Ointment to be applied on the eyebrow twice daily. | Drug: LEO 124249<br>* Ointment containing LEO 124249<br>|
| Placebo Comparator: LEO 124249 ointment vehicle<br>Ointment to be applied on the eyebrow twice daily. | Other: Ointment vehicle<br>* Ointment without active ingredients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 12 of investigator evaluated overall area score (ASoverall L+R) of eyebrow hair growth. | The percentage area of the identified left and right eyebrow area and left and right region of interest (ROI) covered by hair growth will be scored according to the following: 1-10 % - 1 11-20 % - 2 21-30 % - 3 31-40 % - 4 41-50 % - 5 51-60 % - 6 61-70 % - 7 71-80 % - 8 81-90 % - 9 91-100 % - 10 | baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment emergent AEs (including AEs relating to local tolerability) |  | baseline to week 12 | 
| Degree of response in change from baseline to Week 12 for ASoverall L+R | Complete response - ≥ 8 Partial response - 4-<8 Minimal response - 1-<4 No response - <1 | baseline to Week 12 | 
| Investigator evaluation of cosmetic outcome at Week 12 as assessed by Cosmetic outcome Score | Is the appearance of the eyebrows cosmetically normal and acceptable? Yes - 1 No - due to insufficient regrowth area - 2 No - due to insufficient density - 3 No - due to uneven distribution - 4 No - due to other reason (explain, including combination of the above) - 5 | baseline to Week 12 |