Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04971200
Other study ID # 2021-04-373
Secondary ID
Status Active, not recruiting
Phase Early Phase 1
First received
Last updated
Start date September 16, 2021
Est. completion date April 2024

Study information

Verified date October 2023
Source Premier Specialists, Australia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Vitiligo is a common acquired depigmentation disorder affecting approximately 2% of the world population. The purpose of this pilot study is to evaluate the effect and the safety of Tildrakizumab in adult participants with vitiligo.


Description:

Tildrakizumab is a monoclonal antibody against interleukin (IL) 23, specifically anti-IL23p19. It is approved in the USA, Europe and Australia for psoriasis. The psoriasis dose is 100mg administered subcutaneously at weeks 0, 4 and every 12 weeks. Recent research has shown medications used to treat psoriasis may be effective in other immune mediated or autoimmune diseases such as vitiligo. With studies underway assessing the effect of Janus Kinase (JAK) inhibitors in psoriasis and vitiligo, this study seeks to determine if an IL-23 inhibitor is beneficial in halting disease progression and inducing repigmentation in vitiligo. There is some data to indicate that a higher dose of Tildrakizumab is effective for other autoimmune diseases such as psoriasis and hidradenitis suppurativa. For psoriasis, 200mg dosage was more effective than 100mg dosage. For hidradenitis suppurativa, a dosage of 200mg every 4 weeks was shown to be effective. Patients included in this study will start Tildrakizumab at a dosage of 200mg every 4 weeks for 6 months. There is a total of 8 visits involved in this study. Tildrakizumab is provided during visit 2, 3, 4, 5, 6, 7. Visit 1is a screening visit. At visit 1 and visit 8 no study drug will be provided.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 12
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age or older - Diagnosis of vitiligo - Clinically stable vitiligo: defined as no new vitiligo patches and no enlargement of existing patches in previous 3 months. - Able to provide voluntary, written, informed consent Exclusion Criteria: - Clinically active vitiligo: defined as new vitiligo patches or enlargement of existing patches in previous 3 months - Concurrent skin disease in the study area - Immunocompromise - Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 12 weeks after the last dose.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tildrakizumab
2 100mg subcutaneous injections Q4W

Locations

Country Name City State
Australia Premier Specialists Pty Ltd Sydney New South Wales

Sponsors (1)

Lead Sponsor Collaborator
Premier Specialists, Australia

Country where clinical trial is conducted

Australia, 

References & Publications (7)

Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x. — View Citation

Hamzavi I, Jain H, McLean D, Shapiro J, Zeng H, Lui H. Parametric modeling of narrowband UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. Arch Dermatol. 2004 Jun;140(6):677-83. doi: 10.1001/archderm.140.6.677. — View Citation

Hu Y, Qi X, Hu Y, Lu Y, Liu K, Han X, Mao Z, Wu Z, Zhou X. Effects of CO2 fractional laser therapy on peripheral blood cytokines in patients with vitiligo. Dermatol Ther. 2019 Jul;32(4):e12992. doi: 10.1111/dth.12992. Epub 2019 Jun 17. — View Citation

Jerjen R, Moodley A, Sinclair R. Repigmentation of acrofacial vitiligo with subcutaneous tildrakizumab. Australas J Dermatol. 2020 Nov;61(4):e446-e448. doi: 10.1111/ajd.13346. Epub 2020 May 21. No abstract available. — View Citation

Vaccaro M, Cannavo SP, Imbesi S, Cristani M, Barbuzza O, Tigano V, Gangemi S. Increased serum levels of interleukin-23 circulating in patients with non-segmental generalized vitiligo. Int J Dermatol. 2015 Jun;54(6):672-4. doi: 10.1111/ijd.12392. Epub 2014 Nov 27. — View Citation

van Geel N, Lommerts J, Bekkenk M, Wolkerstorfer A, Prinsen CAC, Eleftheriadou V, Taieb A, Picardo M, Ezzedine K, Speeckaert R. Development and Validation of the Vitiligo Extent Score (VES): an International Collaborative Initiative. J Invest Dermatol. 2016 May;136(5):978-984. doi: 10.1016/j.jid.2015.12.040. Epub 2016 Jan 28. — View Citation

van Geel N, Lommerts JE, Bekkenk MW, Prinsen CA, Eleftheriadou V, Taieb A, Picardo M, Ezzedine K, Wolkerstorfer A, Speeckaert R; international Vitiligo Score Working Group. Development and validation of a patient-reported outcome measure in vitiligo: The Self Assessment Vitiligo Extent Score (SA-VES). J Am Acad Dermatol. 2017 Mar;76(3):464-471. doi: 10.1016/j.jaad.2016.09.034. Epub 2016 Nov 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage repigmentation: Vitiligo Area Scoring Index (VASI) Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse Week 24
Primary Percentage repigmentation: Vitiligo Extent Score (VES) Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse Week 24
Primary Percentage repigmentation: Photographs Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline. Week 24
Secondary Percentage repigmentation: Vitiligo Area Scoring Index (VASI) Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse Week 12
Secondary Percentage repigmentation: Vitiligo Extent Score (VES) Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse Week 12
Secondary Percentage repigmentation: Photographs Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline. Week 12
Secondary Time to repigmentation through study treatment completion at 24-weeks
Secondary Change in Quality of Life score from baseline: Dermatology Life Quality Index (DLQI) Used to assess treatment response on subject's quality of life. Range 0-30. Higher score=larger effect on patient's life/worse Baseline through week 12 and through study treatment completion at 24-weeks
Secondary Change in Quality of Life score from baseline: Patient Global Impression of Change (PGIC) 1-tem questionnaire designed to assess a subject's impression of disease improvement. 7 point Likert scale ranging from "Very much better" to "Very much worse" with "no change" in the middle. Range[1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better/a definite improvement, 7-a great deal better]. Higher score=better impression of change/better Baseline through week 12 and through study treatment completion at 24-weeks
Secondary Change in Quality of Life score from baseline: Self-Assessment Vitiligo Extent Score (SA-VES) Validated patient reported outcome measurement to provide information about disease extent and repigmentation. Range 0-100. Higher score=greater depigmentation/worse. Baseline through week 12 and through study treatment completion at 24-weeks
Secondary Adverse events incidence and nature of any adverse events through study treatment completion at 24-weeks
See also
  Status Clinical Trial Phase
Completed NCT05298033 - Study of Efficacy, Safety and Tolerability of Crisaborole and PF-07038124 With and Without NBUVB in Vitiligo Phase 2
Recruiting NCT05872477 - Promoting Repigmentation After Epidermal Cell Suspension Grafting and preVENTing the Loss of Melanocytes Using Topical Ruxolitinib for Vitiligo in Resistant Areas Phase 2
Terminated NCT04374435 - Evaluating the Efficacy of the Melanocyte Keratinocyte Transplantation Procedure in the Treatment of Vitiligo N/A
Completed NCT04103060 - Safety and Tolerability Study of Cerdulatinib Gel, 0.37% in Adults With Vitiligo Phase 2
Terminated NCT04271501 - Feasibility Study to Evaluate RECELL and Melanocyte Keratinocyte Transplantation Procedure for Repigmentation of Stable Vitiligo Lesions N/A
Completed NCT04530344 - Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo Phase 3
Not yet recruiting NCT05008887 - Fractional CO2 Laser-assisted Cutaneous Delivery of Methotrexate Versus 5-fluorouracil in Stable Non-segmental Vitiligo Phase 4
Terminated NCT02191748 - Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo Phase 2/Phase 3
Terminated NCT01262547 - A New Micrografting Technique for Vitiligo Phase 2
Completed NCT01382589 - Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo Phase 2
Completed NCT04872257 - Oral Vitamin D Supplementation Combined With Phototherapy as a Treatment for Vitiligo N/A
Completed NCT04547998 - Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions N/A
Not yet recruiting NCT04039451 - Prevalence of Psoriasis and Vitiligo in Assiut Governorate, Egypt
Not yet recruiting NCT03611348 - Microneedling and Latanoprost in Acrofacial Vitiligo Phase 2/Phase 3
Recruiting NCT03199664 - Effectiveness of Narrow-band Ultraviolet B Combined With Topical Tacrolimus 0.03% in Treatment of Patients With Vitiligo Phase 4
Recruiting NCT03340155 - Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases N/A
Completed NCT03249064 - Response to Tregs in Innate Immunity Receptor LRP1 (CD91) and Tregs in Periferic Blood Mononuclear Cells in Patients With Non-segmentary Vitiligo N/A
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Recruiting NCT04246372 - Tofacitinib for Immune Skin Conditions in Down Syndrome Phase 2
Completed NCT02797574 - Stress Response Pathways in Vitiligo N/A