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This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational study drug to learn whether the delgocitinib 20 mg/g cream works in treating a specific disease. "Investigational" means that the delgocitinib 20 mg/g cream is being studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study drug | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delgocitinib | Drug | Everyone in this study receives the study drug (delgocitinib) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hairline measurements | Change in hairline measurements from baseline to Week 24. (ie, lateral canthus [right and left] to hairline, lower glabellar crease to hair line, top of frontalis muscle to hair line, and mid brow to hair line [right and left]) | from 0 to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frontal scalp haircounts | Change in frontal scalp hair counts in a tattooed target area by trichoscopy from baseline to Week 24 following topical application of delgocitinib cream 20 mg/g in subjects with FFA. | 0 to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial.
Subject has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1.
Subject has had excessive sun exposure or has used tanning booths within 4 weeks prior to Day 1 or is not willing to minimize natural and artificial sunlight exposure during the trial. Use of sunscreen products (except on treated areas for subjects in Cohort 1) and protective apparel are recommended when sun exposure cannot be avoided.
History of other scalp/hair disease including discoid lupus erythematosus and central centrifugal cicatricial alopecia. Note: Subjects with lichen planopilaris/FFA overlap are not to be excluded.
Presence of active dermatologic condition that might interfere with FFA diagnosis and/or interfere with the trial assessments such as seborrheic dermatitis, psoriasis, or telogen effluvium.
Subject who has undergone scalp reduction surgery or hair transplantation.
Use of adhesive wigs during the trial.
Subject is known to have immune deficiency or is immunocompromised.
Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded.
Subject had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the trial.
Subject has any clinically significant medical condition or physical/laboratory/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of trial results.
Subject has positive results for hepatitis B surface antigens (HBsAg), antibodies to hepatitis B core antigens (anti-HBc), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
Subject has used treatment with agents (including natural products or nutritional supplement such as Viviscal, Nutrafol, and/or biotin) that may affect hair regrowth in the last 4 weeks prior to Day 1. Patients who have been on oral minoxidil or oral spironolactone for 6 or more months may continue these medications at the same doses.
Subject has used intralesional scalp corticosteroids or platelet rich plasma injection in the last 4 weeks prior to Day 1.
Subject has used systemic treatment with immunosuppressive/modulating medication or medication that could affect FFA (eg, corticosteroids, methotrexate, hydroxychloroquine, retinoids, calcineurin inhibitor, tetracyclines, pioglitazone, oral JAK inhibitor, or 5-α-reductase-inhibitors) within 4 weeks prior to Day 1. Note: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed. Note: Standard doses of systemic antihistamines are allowed.
Subject has used any topical medicated treatment that could affect FFA within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, calcineurin inhibitors, phosphodiesterase-4 (PDE-4) inhibitors, topical JAK inhibitors.
Subject has received any ultraviolet (UV)-B phototherapy (including tanning beds), excimer laser, or any other phototherapy within 4 weeks prior to Day 1.
Subject has had psoralen-UV-A (PUVA) treatment within 4 weeks prior to Day 1.
Subject has a known or suspected allergy to delgocitinib or any component of the IMP.
Subject has a history of an allergic reaction or significant sensitivity to hypoallergenic ink.
Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.
Subject has prior use of delgocitinib cream as treatment for frontal fibrosing alopecia.
Subject has prior failure of adequate response of frontal fibrosing alopecia to a topical JAK inhibitor or oral JAK inhibitor.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maryanne Senna, MD | Contact | 7817441375 | Maryanne.M.Senna@lahey.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41101628 | Background | Martin A, Shokrian N, Kelley KJ, Correa da Rosa J, Del-Duca E, Bissonnette R, Sorensen OE, Nielsen AB, Guttman-Yassky E, Senna MM. Randomized Controlled Trial of the Topical Jak Inhibitor Delgocitinib Cream in Patients with Frontal Fibrosing Alopecia. J Invest Dermatol. 2026 May;146(5):1265-1270.e7. doi: 10.1016/j.jid.2025.09.375. Epub 2025 Oct 14. |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000621572 | delgocitinib |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |