A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo

Vitiligo Clinical Trial

— Viti-Up  

Official title:

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects With Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06118411
• Other study ID #: M19-044
• Secondary ID: 2023-506195-27-0
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: December 19, 2023
• Est. completion date: February 5, 2028

Study information

• Verified date: March 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo (NSV). Adverse effects and change in disease activity will be assessed. Upadacitinib is an approved drug for various immune-mediated inflammatory diseases and is currently being investigated for the treatment of NSV. There will be 2 replicate studies running at the same time. In Period A, participants are placed in 1 of 2 groups called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will receive placebo and 2 in 3 chance participants will receive upadacitinib. In Period B, all participants will be in one treatment arm where they all receive upadacitinib. Approximately 270 adult and adolescent participants with NSV will be enrolled in each study (540 participants total) at approximately 90 sites worldwide. In Period A, participants will receive oral tablets of upadacitinib or placebo once a day for 48 weeks. In Period B, participants will receive oral tablets of upadacitinib 15 mg once a day for 112 weeks. Participants will be followed up for 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 540
• Est. completion date: February 5, 2028
• Est. primary completion date: February 23, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Documented clinical diagnosis of non-segmented vitiligo (NSV).
• At Screening and Baseline Visits, participants must satisfy at least 1 of the

following criteria:

• >= 0.5 F-VASI and 5 <= T-VASI < 50 AND have failed at least 1 topical corticosteroid and/or at least 1 topical calcineurin inhibitor for vitiligo; or
• >= 0.5 F-VASI and 5 <= T-VASI < 50 AND have a sign of actively progressing vitiligo; or
• >= 0.5 F-VASI and 10 <= T-VASI < 50.

Exclusion Criteria:

• Segmental or localized vitiligo.
• History of active skin disease other than vitiligo that could interfere with the assessment of vitiligo.
• >33% leukotrichia in areas of vitiligo on the face or > 33% leukotrichia in areas of vitiligo on the body (including the face).

Related Conditions & MeSH terms

• Vitiligo

Intervention

Drug:
• Upadacitinib
Oral Tablets
• Placebo
Oral Tablets

Locations

Country	Name	City	State
Japan	Yamanashi Prefectural Central Hospital /ID# 260554	Kofu-shi	Yamanashi
Japan	Dermatology and Ophthalmology Kume Clinic /ID# 260555	Sakai-shi	Osaka
Japan	Tokyo Medical University Hospital /ID# 260552	Shinjuku-ku	Tokyo
Japan	Yamagata University Hospital /ID# 260553	Yamagata-shi	Yamagata
Puerto Rico	Dr. Samuel Sanchez PSC /ID# 260090	Caguas
Puerto Rico	Mindful Medical Research /ID# 260092	San Juan
United States	Oakland Hills Dermatology /ID# 260602	Auburn Hills	Michigan
United States	Bellaire Dermatology Associates /ID# 260044	Bellaire	Texas
United States	Skin Care Research - Boca Raton /ID# 260094	Boca Raton	Florida
United States	Apex Clinical Trials /ID# 260096	Brandon	Florida
United States	Hamzavi Dermatology - Canton /ID# 260545	Canton	Michigan
United States	DeNova Research /ID# 260611	Chicago	Illinois
United States	Michigan Center for Research Company /ID# 260069	Clarkston	Michigan
United States	ClinOhio Research Services /ID# 260300	Columbus	Ohio
United States	Florida Academic Dermatology Center /ID# 259919	Coral Gables	Florida
United States	Dermatology Treatment and Research Center /ID# 260078	Dallas	Texas
United States	Cleaver Medical Group /ID# 259925	Dawsonville	Georgia
United States	Private Practice - Dr. Joseph Raoof /ID# 260055	Encino	California
United States	Advanced Research Associates - Glendale /ID# 259915	Glendale	Arizona
United States	Encore Medical Research LLC /ID# 259963	Hollywood	Florida
United States	Skin Care Research - Hollywood /ID# 260101	Hollywood	Florida
United States	Dawes Fretzin, LLC /ID# 260068	Indianapolis	Indiana
United States	Dermatology Research Associates /ID# 260056	Los Angeles	California
United States	Vitiligo & Pigmentation Institute of Southern California /ID# 259970	Los Angeles	California
United States	GSI Clinical Research, LLC /ID# 259918	Margate	Florida
United States	Life Clinical Trials /ID# 260097	Margate	Florida
United States	Savin Medical Group, LLC /ID# 259968	Miami Lakes	Florida
United States	Minnesota Clinical Study Center /ID# 260154	New Brighton	Minnesota
United States	Alliance Dermatology and MOHs Center, PC /ID# 259926	Phoenix	Arizona
United States	Oregon Dermatology and Research Center /ID# 259917	Portland	Oregon
United States	Integrative Skin Science and Research /ID# 260060	Sacramento	California
United States	Derm Clin Res Ctr San Antonio /ID# 260047	San Antonio	Texas
United States	Progressive Clinical Research /ID# 260070	San Antonio	Texas
United States	DermResearchCenter of New York, Inc. /ID# 259906	Stony Brook	New York
United States	Advanced Clinical Research Institute /ID# 260058	Tampa	Florida
United States	Clinical Trials Research Institute /ID# 259910	Thousand Oaks	California
United States	Schweiger Dermatology, P.C. /ID# 260152	Verona	New York
United States	Encore Medical Research of Weston LLC /ID# 260542	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Japan,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (= 50% Improvement in T-VASI From Baseline)	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100.	Week 48
Primary	Percentage of Participants Achieving Facial-Vitiligo Area Scoring Index (F-VASI) 75 (= 75% Improvement in F-VASI From Baseline)	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.	Week 48
Secondary	Percentage of Participants Achieving F-VASI 50 (= 50% Improvement in F-VASI From Baseline)	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.	Week 48
Secondary	Percentage of Participants Achieving F-VASI 75 (= 75% Improvement in F-VASI From Baseline)	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.	Week 24
Secondary	Percent Change from Baseline in F-VASI	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.	Week 24
Secondary	Percent Change From Baseline in T-VASI	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100.	Week 48
Secondary	Percentage of Participants Achieving F-VASI 90 (= 90% Improvement in F-VASI From Baseline)	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.	Week 48
Secondary	Percentage of Participants Achieving T-VASI 75 (= 75% Improvement in T-VASI From Baseline)	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100.	Week 48
Secondary	Percentage of Participants Achieving Patient Global Impression of Noticeability (PGIN) Score of "Not Noticeable at All (0)" or "A Little Noticeable (1)" For Participants with a Score of "Moderately Noticeable (2)" or "Very Noticeable (3)" at Baseline	The PGIN is a single item questionnaire to measure the participant's impression of noticeability of their depigmented vitiligo skin that uses a 4-point rating scale scored from 0 to 3 points: "Not noticeable at all" (score = 0); "A little noticeable" (score = 1); "Moderately noticeable" (score = 2); and "Very noticeable" (score = 3). Higher scores indicate worse outcomes.	Week 48
Secondary	Percentage of Participants Achieving Patient Global Impression of Severity of Vitiligo Sun Sensitivity Score of "Not Sensitive at All (0)" or "Mildly Sensitive (1)" For Participants with a Score of "Moderately Sensitive (2)" or Higher at Baseline	The Patient Global Impression of Severity of Vitiligo Sun Sensitivity is a single item questionnaire that measures the participant's impression of sensitivity in their depigmented vitiligo skin in the sun. The measure uses a 5-point rating scale scored from 0 to 4 points: "Not sensitive at all" (score = 0); "Mildly sensitive" (score = 1); "Moderately sensitive" (score = 2); "Severely sensitive" (score = 3); and "Very severely sensitive" (score = 4). A score of 99 indicates the subject responded with "I was not in the sun over the past week." Higher scores indicate worse outcomes.	Week 48
Secondary	Percentage of Participants Achieving 3D Imaging Facial Vitiligo 40 (= 40% Reduction in Facial Vitiligo Area Measured by 3D Digital Imaging from Baseline) (Study 1 Only)	3D imaging will be used to objectively quantify the facial vitiligo area.	Week 48

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