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NCT03826901
Delgocitinib Cream for the Treatment of Moderate to Severe Atopic Dermatitis During 8 Weeks in Adults, Adolescents, and Children
Phase 1 trial testing delgocitinib in Atopic Dermatitis in 46 participants. Completed in 29 October 2021.
29 October 2021
Quick facts
| Lead sponsor | LEO Pharma |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 20 February 2019 |
| Primary completion | 29 October 2021 |
| Estimated completion | 29 October 2021 |
| Sites | 16 locations across Canada, United States |
Drugs / interventions tested
- delgocitinib (DELGOCITINIB) — full drug profile →
Conditions studied
- Atopic Dermatitis — all drugs for Atopic Dermatitis →
Sponsor
LEO Pharma — full company profile →
Who can join
2 and older, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multi-center, open-label trial to evaluate safety and pharmacokinetics of topical delgocitinib cream applied to pediatric subjects (2-17 years) and adult subjects (18 years and above) with atopic dermatitis.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
A Comprehensive Overview of Globally Approved JAK Inhibitors.
Shawky AM, Almalki FA, Abdalla AN, Abdelazeem AH, et al · · 2022 · cited 222× · PMID 35631587 · DOI 10.3390/pharmaceutics14051001 -
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 -
A Review on the Safety of Using JAK Inhibitors in Dermatology: Clinical and Laboratory Monitoring.
Samuel C, Cornman H, Kambala A, Kwatra SG. · · 2023 · cited 141× · PMID 36790724 · DOI 10.1007/s13555-023-00892-5 -
Selectivity, efficacy and safety of JAKinibs: new evidence for a still evolving story.
Bonelli M, Kerschbaumer A, Kastrati K, Ghoreschi K, et al · · 2024 · cited 95× · PMID 37923366 · DOI 10.1136/ard-2023-223850 -
JAK-STAT signaling in human disease: From genetic syndromes to clinical inhibition.
Luo Y, Alexander M, Gadina M, O'Shea JJ, et al · · 2021 · cited 92× · PMID 34625141 · DOI 10.1016/j.jaci.2021.08.004 -
A Decade of JAK Inhibitors: What Have We Learned and What May Be the Future?
Liu C, Kieltyka J, Fleischmann R, Gadina M, et al · · 2021 · cited 49× · PMID 34180156 · DOI 10.1002/art.41906 -
Jakinibs of All Trades: Inhibiting Cytokine Signaling in Immune-Mediated Pathologies.
Alexander M, Luo Y, Raimondi G, O'Shea JJ, et al · · 2021 · cited 27× · PMID 35056105 · DOI 10.3390/ph15010048
Verify or expand the search:
- PubMed search for NCT03826901
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Atopic Dermatitis
Currently open trials in the same condition.
- NCT07262983 — Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopi · Phase 1 · recruiting
- NCT07445919 — A Clinical Study to Evaluate SM17 for Atopic Dermatitis · Phase 2 · recruiting
- NCT07488065 — A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants · Phase 1 · recruiting
- NCT07467564 — The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatit · recruiting
- NCT07358156 — A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and E · Phase 1 · 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)
- Trial protocol + status: ClinicalTrials.gov NCT03826901 (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: 24 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/NCT03826901.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing