A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
ConditionNonsegmental Vitiligo
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTakeda
About this trial
Vitiligo is a long-term autoimmune condition that causes the skin to lose its color. The body's germ-fighting system (immune system) mistakenly attacks the skin cells (melanocytes) which produce the pigment that gives the skin color (melanin). This leads to the formation of patches of skin with less or no pigment (depigmentation). These patches can occur anywhere on the body. In the nonsegmental form of vitiligo, similar patches occur on both sides of the body (symmetrical patches).
The main aim of this study is to learn how safe zasocitinib is, how well it works and how well it is tolerated by adults with nonsegmental vitiligo.
The participants will receive the study treatment (either zasocitinib or placebo) for up to 1 year (52 weeks). The placebo looks like the zasocitinib capsule but does not have any medicine in it. Participants who receive placebo at the beginning will change to zasocitinib after about 6 months.
During the study, participants will visit their study clinic 11 times.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator.
Participant has provided written informed consent and any required privacy authorization before the initiation of any trial procedures.
Participants must have a clinical diagnosis of nonsegmental vitiligo: F-VASI greater than or equal to (>=) 0.5 and a T-VASI >= 5 and less than or equal to (<=) 50 at screening and Day 1.
Participant is aged >=18 years to <=75 years old at the time of consent.
Disqualifiers
Participant has segmental vitiligo (including mixed vitiligo) or any other congenital or acquired cause of hypopigmentation or depigmentation that could interfere with the diagnosis or assessment of nonsegmental vitiligo.
Participant has >50 percent (%) leukotrichia on the face or >50% leukotrichia of the body (includes the face), within the skin affected by vitiligo.
Participant requires immunomodulatory or immunosuppressive systemic treatment, other than nonsteroidal anti-inflammatory drugs, during the trial period for an immune-related disease (for example, inflammatory bowel disease).
Participant has a history of phototherapy (including, but not limited to, broadband Ultra-Violet [UV]-B, narrowband UV-B, psoralen and UV-A, excimer or other laser therapy, or tanning booth use) within 8 weeks before Day 1. Use of sunscreen products and protective apparel is recommended when sun exposure cannot be avoided.
Trial design
Design model
Parallel
Treatments tested in this trial
Zasocitinib
DrugZasocitinib capsules.
Placebo
Other interventionZasocitinib matching placebo capsules.
Treatment groups
200 Participants
are divided into 5 treatment groupsGroup A: Zasocitinib Low DoseExperimental treatment 1 intervention
Group B: Zasocitinib Medium DoseExperimental treatment 1 intervention
Group C: Zasocitinib High DoseExperimental treatment 1 intervention
Group D: Placebo Group 1/ Zasocitinib Medium DoseExperimental treatment 2 interventions
Group E: Placebo Group 2/ Zasocitinib High DoseExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Percentage of Participants Achieving >= 75% Improvement From Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24
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 3.5, with higher scores indicating more severe disease. Negative changes from baseline indicate improvement. This is recorded as either Yes (achieved \>= 75% improvement) or No (did not achieve).
Time frame
Baseline, Week 24Secondary outcomes
1
Percent Change From Baseline in the F-VASI at Week 24
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 3.5, with higher scores indicating more severe disease. Negative changes from baseline indicate improvement.
Time frame
Baseline, Week 242
Percent Change From Baseline in the Total- Vitiligo Area Scoring Index (T-VASI) at Week 24
The VASI is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100, with higher scores indicating more severe disease.
Time frame
Baseline, Week 243
Percentage of Participants Achieving F-VASI 50 at Week 24
F-VASI 50 is defined as \>=50% improvement from baseline.
Time frame
At Week 244
Percentage of Participants Achieving T-VASI 50 at Week 24
T-VASI 50 is defined as \>=50% improvement from baseline.
Time frame
At Week 24 Source ClinicalTrials.gov