LEO 124249 Ointment in the Treatment of Alopecia Areata

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.

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).