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NCT07108283

A Study of Zasocitinib in Adults With Nonsegmental Vitiligo

StatusActive, Not Recruiting
PhasePhase 2
SponsorTakeda
Primary completion (estimated)
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Record History

All 18 versions: 17 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Primary completion moved earlier from Oct 12, 2027 to Mar 26, 2027
    • Enrollment target: estimated 200 to confirmed 207
    • Site details revised at 1 of 67 sites
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 69 to 67
  3. Study sites: 70 to 69
  4. Eligibility criteria expanded, about 41 words
    • Primary endpoints: details revised at 1 of 1 entry
    • Secondary endpoints: details revised at 4 of 4 entries
    • Site details revised at 10 of 70 sites
  5. Site details revised at 6 of 70 sitesv14
Show 11 earlier versionsHide 11 earlier versions
  1. Site details revised at 7 of 70 sitesv13
  2. Site details revised at 7 of 70 sitesv12
  3. Site details revised at 3 of 70 sitesv11
  4. Site details revised at 68 of 70 sitesv10
  5. Study sites revised (70)v9
  6. Eligibility criteria expanded, about 46 wordsv8
  7. Study sites revised (70)v7
  8. Site details revised at 29 of 70 sitesv6
  9. Site details revised at 1 of 70 sitesv4
  10. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 14, 2025 to Nov 3, 2025
    • Site details revised at 70 of 70 sites
    v3
  11. Study Status, Referencesv2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percentage of Participants Achieving >= 75% Improvement From Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24
Timeframe: Baseline, Week 24

Secondary (4)

Percent Change From Baseline in the F-VASI at Week 24
Percent Change From Baseline in the Total- Vitiligo Area Scoring Index (T-VASI) at Week 24
Percentage of Participants Achieving F-VASI 50 at Week 24
Percentage of Participants Achieving T-VASI 50 at Week 24

Arms and interventions

Zasocitinib Low DoseExperimental

Participants will receive Zasocitinib capsules, low dose, orally, up to Week 52.

Zasocitinib Medium DoseExperimental

Participants will receive Zasocitinib capsules, medium dose, orally, up to Week 52.

Zasocitinib High DoseExperimental

Participants will receive Zasocitinib capsules, high dose, orally, up to Week 52.

Placebo Group 1/ Zasocitinib Medium DoseExperimental

Participants will receive Placebo Group 1 orally, up to Week 24 followed by Zasocitinib capsules, medium dose, orally, up to Week 52.

Placebo Group 2/ Zasocitinib High DoseExperimental

Participants will receive Placebo Group 2, orally, up to Week 24 followed by Zasocitinib capsules, high dose, orally, up to Week 52.

Drugs: Zasocitinib

Other: Placebo

Sites

67 sites in 9 countries

United States 21, Canada 8, Poland 8, France 6, Spain 6, China 5, Italy 5, Japan 5, Mexico 3