NCT02561585 is a Phase 2 clinical trial of LEO 124249 in Alopecia Areata, sponsored by LEO Pharma.

Who is sponsoring NCT02561585?

NCT02561585 is sponsored by LEO Pharma.

What drugs are being tested in NCT02561585?

Interventions in NCT02561585: LEO 124249, Vehicle.

What condition does NCT02561585 study?

NCT02561585 studies Alopecia Areata.

Is NCT02561585 still recruiting?

NCT02561585 is currently completed. Last updated 21 February 2025.

Are results published for NCT02561585?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-02-21 · How we verify

NCT02561585

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 21 February 2025

What this trial tests

Phase 2 trial testing LEO 124249 in Alopecia Areata in 40 participants. Completed in 1 December 2016.

Timeline

1 January 2016

Primary endpoint
1 December 2016

1 December 2016

Quick facts

Lead sponsor	LEO Pharma
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	1 January 2016
Primary completion	1 December 2016
Estimated completion	1 December 2016
Sites	2 locations across United States

Drugs / interventions tested

LEO 124249
Vehicle

Conditions studied

Alopecia Areata — all drugs for Alopecia Areata →

Sponsor

LEO Pharma — full company profile →

Who can join

Adults 18 to 65, any sex, with Alopecia Areata. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in Severity of Alopecia Areata Tool (SALT) Score
Time frame: From baseline (Day 1) to Week 12 (Day 84)
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.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Emerging Topical and Systemic JAK Inhibitors in Dermatology.
Solimani F, Meier K, Ghoreschi K. · · 2019 · cited 199× · PMID 31849996 · DOI 10.3389/fimmu.2019.02847
Targeting the Janus Kinase Family in Autoimmune Skin Diseases.
Howell MD, Kuo FI, Smith PA. · · 2019 · cited 180× · PMID 31649667 · DOI 10.3389/fimmu.2019.02342
Tyrosine Kinases in Autoimmune and Inflammatory Skin Diseases.
Szilveszter KP, Németh T, Mócsai A. · · 2019 · cited 102× · PMID 31447854 · DOI 10.3389/fimmu.2019.01862
An overview of JAK/STAT pathways and JAK inhibition in alopecia areata.
Lensing M, Jabbari A. · · 2022 · cited 100× · PMID 36110853 · DOI 10.3389/fimmu.2022.955035
JAK Inhibitors for Treatment of Alopecia Areata.
Wang EHC, Sallee BN, Tejeda CI, Christiano AM. · · 2018 · cited 58× · PMID 30057345 · DOI 10.1016/j.jid.2018.05.027
Topical tofacitinib solution for the treatment of alopecia areata affecting eyelashes.
Craiglow BG. · · 2018 · cited 20× · PMID 30417059 · DOI 10.1016/j.jdcr.2018.07.018
Comparative efficacy and safety of JAK inhibitors in the treatment of moderate-to-severe alopecia areata: a systematic review and network meta-analysis.
Yan T, Wang T, Tang M, Liu N. · · 2024 · cited 19× · PMID 38659584 · DOI 10.3389/fphar.2024.1372810

Verify or expand the search:

Other trials of LEO 124249

Trials testing the same drug.

NCT03325296 — Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata. · Phase 2 · terminated

Other recruiting trials for Alopecia Areata

Currently open trials in the same condition.

NCT07242638 — Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome · Phase 2 · recruiting
NCT07311564 — A Study of LAD603 in Adults With Alopecia Areata · Phase 2 · recruiting
NCT07250997 — PALLAS Laser for Skin Diseases · NA · recruiting
NCT07205159 — A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata. · Phase 1 · recruiting
NCT06747611 — Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata · Phase 2 · recruiting

Other LEO Pharma trials

Trials by the same sponsor.

NCT07335588 — A 52-Week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream in Adult Participants With Lichen Sclerosus · Phase 3 · not yet recruiting
NCT07013201 — A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to · Phase 2 · recruiting
NCT06444867 — A Study to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of LEO 15896 · Phase 1 · completed
NCT06311682 — A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and · Phase 3 · recruiting
NCT05923099 — A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic De · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02561585 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by LEO Pharma
Last refreshed: 21 February 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02561585.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing