Efficacy of twice daily application of LEO 124249 ointment 30 mg/g for 12weeks on eyebrow alopecia areata. Exploratory Phase 2a

Phase 1

Active, not recruiting

Conditions: Alopecia Areata
MedDRA version: 20.0Level: SOCClassification code 10040785Term: Skin and subcutaneous tissue disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2017-002720-24-DK

Lead Sponsor: EO Pharma A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

1. Signed and dated informed consent has been obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
2. Clinical unequivocal diagnosis of Alopecia Areata (patchy, univeralis and totalis, on both scalp and eyebrows as assessed by the investigator.
3. Maximal disease duration of current episode of Alopecia Areata on the eyebrows of 3 years at screening.
4. Maximal Alopecia Areata disease duration - defined as years of active disease - in other locations than eyebrows of 10 years at screening.
5. Male or female, age between 18 and 65 years at screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Clinical diagnosis of diffuse type alopecia areata as assessed by the investigator.
2. 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.
3. The following topical treatments are permitted elsewhere on the body: up to 25g per week of mild to moderate corticosteroids (WHO groups I-III), calcipotriol or calcineurin inhibitors for inflammatory skin conditions (e.g. atopic dermatitis or psoriasis).
4. 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.
5. The following inhaled medications are permitted: the equivalent to 1mg prednisolone used intranasaly or inhaled for rhinitis or asthma.
6. Systemic JAK inhibitor Ruxolitinib (Jakafi®/Jakavi®), Tofacitinib (Xeljanz®) at any time prior to randomisation.
7. Ongoing skin infection requiring systemic antimicrobials at randomisation.
8. Any skin condition, that in the opinion of the investigator, would interfere with the trial specified assessments.
9. Debute of thyroid disease or change in thyroid medication and/or dose within 6 months of screening.
10. Female subjects who are pregnant, breast feeding or intends to become pregnant or is of childbearing potential* and not using highly effective contraceptive methods** at trial entry and until end of follow-up visit.
*Female subjects are considered of child-bearing potential unless they have undergone hysterectomy, bilateral
salpingectomy or bilateral oophorectomy or have been post-menopausal for at least one year prior to screening.
** Highly effective contraception is defined as follows:
Sexual abstinence (when this is in line with the preferred and usual life style of the subject)
Vasectomized partner (given that the subject is monogamous)
Bilateral tubal occlusion
An intrauterine device (IUD)
Intrauterine hormone-releasing system (IUS)
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition
of ovulation (oral, intravaginal, transdermal)
Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable,
implantable)
Surgical sterilised (vasectomy/bilateral tubectomy, hysterectomy and bilateral ovariectomy)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of twice daily topical LEO 124249 ointment 30 mg/g compared with LEO 124249 ointment vehicle on hair growth in subjects with Alopecia Areata on eyebrows.;Primary end point(s): Investigator evaluated overall area score (AS overall L+R) of eyebrow hair growth;Timepoint(s) of evaluation of this end point: At 12 weeks;Secondary Objective: 1. To evaluate safety and tolerability of the treatment with topical LEO 124249 ointment 30 mg/g.<br>2. To evaluate the degree of response to treatment (i.e. complete, partial, minimal, none) with twice daily topical LEO 124249 ointment 30 mg/g compared to LEO 124249 ointment vehicle.<br>3. To evaluate cosmetic outcome of treatment with twice daily topical LEO 124249 ointment 30 mg/g compared to LEO 124249 ointment vehicle.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Treatment emergent AEs (including AEs relating to local tolerability)<br>2. Degree of response from baseline to treatment at Week 12<br>3. Investigator evaluation of cosmetic outcome at Week 12 as assessed by Cosmetic outcome Score;Timepoint(s) of evaluation of this end point: Ad 1. Treatment emergent AE's - at end of study<br>Ad 2+3. Other two endpoints - at 12 weeks