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

Conditions

• Vitiligo

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Upadacitinib — DRUG
  Oral Tablets
• Placebo — DRUG
  Oral Tablets
• NB-UVB (narrow-band ultraviolet B) Phototherapy — OTHER
  NB-UVB phototherapy is a commonly used treatment modality in participants with vitiligo and can be administered in an office setting or at home 2 times per week

Study Details

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 currently being investigated for the treatment of NSV. There will be 2 replicate studies running at the same time (Study 1 and Study 2 with periods A and B), an optional exploratory NB-UVB phototherapy study (Study 3), and a re-randomized dose-escalation study (Study 4). 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. In Period B, all participants will receive upadacitinib. Approximately 540 adult and adolescent participants with NSV will be enrolled between each main study at around 180 sites worldwide with an option for adult participants who completed Period A of either study and did not achieve T-VASI90 at week 48 while on study drug, to enter Study 3. Participants who failed to achieve T-VASI75 response at week 118 of Study 1 or 2 or at week 70 of Study 3 will be considered for entry into Study 4. In Studies 1 and 2: 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. Study 3 participants will receive upadacitinib monotherapy or upadacitinib with Narrow-Band Ultraviolet B (NB-UBV) phototherapy for at least 24 weeks followed by upadacitinib alone. In Study 4, participants will be re-randomized to receive oral tablets of upadacitinib 15 mg or 30 mg once a day for 56 weeks. 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.

Key Dates

Start date

Dec 19, 2023

Status verified

Jun 2026

Primary completion

Mar 31, 2028

Completion

Mar 31, 2028

Study Design

Enrollment

614 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Study 1, Period A: Group 1
  Participants will receive upadacitinib 15 mg once daily for 48 weeks.
• Placebo Comparator: Study 1, Period A: Group 2
  Participants will receive placebo once daily for 48 weeks.
• Experimental: Study 2, Period A: Group 1
  Participants will receive upadacitinib 15 mg once daily for 48 weeks.
• Placebo Comparator: Study 2, Period A: Group 2
  Participants will receive placebo once daily for 48 weeks.
• Experimental: Study 1, Period B: Group 1 Open-Label Extension Period
  Participants that were randomized to receive upadacitinib in Period A Group 1, will continue to receive upadacitinib 15 mg once daily for 112 weeks in Period B.
• Experimental: Study 1, Period B: Group 2 Open-Label Extension Period
  Participants that were randomized to receive placebo in Period A Group 2, will receive upadacitinib 15 mg once daily for 112 weeks in Period B.
• Experimental: Study 2, Period B: Group 1 Open-Label Extension Period
  Participants that were randomized to receive upadacitinib in Period A Group 1, will continue to receive upadacitinib 15 mg once daily for 112 weeks in Period B.
• Experimental: Study 2, Period B: Group 2 Open-Label Extension Period
  Participants that were randomized to receive placebo in Period A Group 2, will receive upadacitinib 15 mg once daily for 112 weeks in Period B.
• Experimental: (Optional) Study 3: Open Label Upadacitinib
  Participants will receive upadacitinib 15 mg once daily for 112 weeks.
• Experimental: (Optional) Study 3: Open Label Upadacitinib + NB-UVB
  Participants will receive 15 mg upadacitinib once daily for 112 weeks and Narrow-band ultraviolet B (NB-UVB) for up to 28 weeks.
• Experimental: Study 4: Upadacitinib 15 mg
  Eligible participants will be re-randomized to receive upadacitinib 15 mg once daily for 56 weeks.
• Experimental: Study 4: Upadacitinib 30 mg
  Eligible participants will be re-randomized to receive upadacitinib 30 mg once daily for 56 weeks.

Primary Outcome Measure

Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline) [ Time Frame: Week 48 ]

Locations (46)

Related coverage on Hipa.ai

• Upadacitinib Phase 3 Vitiligo Trial Reaches Primary Completion
  Upadacitinib · Sep 23, 2025 · ClinicalTrials.gov

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