Topical delgocitinib for facial vitiligo

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Gentofte Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

25 Mar 2026 → ongoing

Decision date (initial)

2026-01-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

This open-label proof-of-concept trial primarily aims to define whether delgocitinib cream is a potential treatment for patients with non-segmental vitiligo in the facial area.

Secondary objectives 1

1. The secondary objective is to understand the mechanisms of action of delgocitinib in vitiligo-affected skin and the pathophysiology of vitiligo

Conditions and MedDRA coding

Vitiligo

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Able to provide written informed consent
2. Age 18 years or above at screening
3. Ability to understand, speak, and read Danish, as assessed by the investigator
4. Have a clinical diagnosis of non-segmental vitiligo with facial involvement corresponding to at least 0.5% of total BSA
5. Agree not to use any other agent used to treat vitiligo from screening through the final visit (also please see Exclusion criteria 9─16)
6. Able and willing to follow trial procedures including application of trial medication to facial vitiligo lesions
7. A WOCBP must agree to use an acceptable method of birth control throughout the trial up until the last application of the trial treatment

Exclusion criteria 25

1. Disease duration of more than 10 years in the area chosen for treatment
2. Signs of follicular repigmentation in the area chosen for treatment
3. Concurrent skin diseases in the face
4. Other active skin diseases requiring medical treatment
5. Other forms of vitiligo (e.g., segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (e.g., piebaldism, pityriasis alba, leprosy, post inflammatory hypopigmentation, progressive macule hypomelanosis, idiopathic guttate hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor)
6. Patients who have no pigmented hair within any of the vitiligo areas on the face
7. Clinically significant bacterial, viral, or fungal skin infection in the face within one week before baseline
8. Known or suspected hypersensitivity to any components of the trial drug
9. Previous or current treatment with JAK inhibitors (including delgocitinib), systemic or topical
10. Treatment with any marketed biological therapy or investigational biologic agents within 12 weeks or 5-lives, whichever is longer, prior to baseline
11. Systemic treatment with immunosuppressive or immunomodulating drugs within 12 weeks prior to baseline
12. Use of tanning beds, phototherapy, or intentional UV exposure within 12 weeks prior to baseline
13. Cutaneous applied treatment with topical corticosteroids or other immunomodulators such as phosphodiesterase type 4 inhibitors or calcineurin inhibitors within four weeks prior to baseline
14. Any systemic or topical therapies that could increase the skin sensitivity to UV/visible light or impact skin pigmentation, that is, retinoids, tetracyclines within four weeks prior to baseline
15. Any depigmentation treatments for past treatment of vitiligo or other pigmented areas
16. Surgical or laser treatments in the facial area within 12 weeks prior to baseline
17. History of any known primary immunodeficiency disorder
18. Planned hospitalization during the trial period
19. History of cancer (for skin cancer in the facial area, the patient is NOT eligible; for skin cancer outside of the facial area, a patient is eligible if in remission and curative therapy has been completed ≥12 months prior to screening; for other malignancies, a patient is eligible if in remission and curative therapy has been completed ≥5 years prior to screening)
20. Any unstable disorder that could affect the safety of the patient throughout the trial or impede the patient’s ability to complete the trial
21. Any clinically abnormal finding observed during the screening period that could affect the safety of the patient or influence the ability to complete the trial
22. Any significant illness or medical, physical, or psychiatric condition that, in the opinion of the investigator, could hinder the participant’s ability to fully engage in the study—such as receiving the trial medication or attending scheduled visits—pose a notable risk to their health, or compromise the integrity of the trial data
23. Current participation in any other interventional clinical trial
24. Current or recent chronic alcohol or drug abuse, or any other condition associated with poor compliance as judged by the investigator
25. Women who are pregnant or breastfeeding, or women considering pregnancy during the period of their trial participation

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in F-VASI from baseline to Week 24

Secondary endpoints 22

1. Change in T-VASI from baseline to Week 24
2. Change in VESplus from baseline to Week 24
3. Change in VETF score from baseline to Week 24
4. Change in facial BSA from baseline to Week 24
5. Change in total BSA from baseline to Week 24
6. F-VASI50 at Week 24
7. F-VASI75 at Week 24
8. F-VASI90 at Week 24
9. Change in T-VASI at Weeks 4 and 12
10. Change in VESplus at Weeks 4 and 12
11. Change in VETF score at Weeks 4 and 12
12. F-VASI50 at Weeks 4 and 12
13. F-VASI75 at Weeks 4 and 12
14. F-VASI90 at Weeks 4 and 12
15. Change in DQOL from baseline to Week 24
16. Change in VitiQoL from baseline to Week 24
17. Change in WHO-5 from baseline to Week 24
18. Change in DQOL at Weeks 4 and 12
19. Change in VitiQoL at Weeks 4 and 12
20. Change in WHO-5 at Weeks 4 and 12
21. Frequency, duration, and severity of AEs
22. Changes in skin proteome and transcriptome from baseline to Weeks 4 and 24 (analyses will be performed if a change in F-VASI is shown)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gentofte Hospital

Sponsor organisation

Gentofte Hospital

Address

Gentofte Hospitalsvej 1

City

Hellerup

Postcode

2900

Country

Denmark

Scientific contact point

Organisation

Gentofte Hospital

Contact name

Lone Skov

Public contact point

Organisation

Gentofte Hospital

Contact name

Lone Skov

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications