Clinical Trials in the USA / NCT07667569
Recruiting
Phase 2
A Study to Learn How Safe ACT-777991 is and How Well it Works in Adults With Non-segmental Vitiligo
NCT07667569 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Non-Segmental Vitiligo
Investigational drug(s) / intervention(s)
ACT-777991Placebo
ACT-777991: ACT-777991 tablets
Placebo: ACT-777991-matching placebo tablets
Study summary
The purpose of this clinical trial is to learn how well ACT-777991 works, how safe it is and how well it is tolerated by adults with non-segmental vitiligo.
The main question this clinical trial aims to answer is:
• Can ACT-777991 help return color to the skin of the face of adults with non-segmental vitiligo?
Researchers will compare ACT-777991 to placebo (a look-alike inactive treatment that contains no medicine) to see if ACT-777991 works to treat non-segmental vitiligo.
Trial participants will:
* Take the trial intervention (either ACT-777991 or placebo) daily for 24 weeks.
* Visit the clinic 7 times for check-up and tests.
Eligibility
Inclusion Criteria:
* Clinical diagnosis of either active or stable non segmental vitiligo for at least 3 months prior to Screening and meet all the following criteria:
* F-VASI score ≥ 0.3 based on BICR at Screening.
* T-VASI score ≥ 5 based on investigator assessment at Screening and Randomization.
* Total body surface area (BSA) involvement, including the face, ≤ 50% based on investigator assessment at Screening and Randomization.
* Participants must agree not to use therapeutic agents and procedures to treat vitiligo from Screening until Participant Last Visit.
Applicable only to EU: In addition to the above, participants must not have discontinued, reduced, or modified a vitiligo treatment/ procedure for the purpose of meeting trial eligibility criteria or a wash out requirement.
Exclusion Criteria:
* Clinical diagnosis of other forms of vitiligo (e.g., segmental) or other hypo- or depigmentation disorders (e.g., piebaldism, leukoderma, Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation).
* Any autoimmune disease, except adequately treated thyroid disease.
* History of systemic immunotherapy treatment, including JAK inhibitors, for any inflammatory disease in the 12 months prior to Randomization.
* History of topical JAK inhibitors for any inflammatory disease in the 6 weeks prior to Screening.
* Use of laser or light-based treatment (phototherapy), including tanning beds, in the 8 weeks prior to Screening.
* eGFR \< 90 mL/min/1.73 m\^2, defined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, at Screening.
Primary outcome measure(s)
- Main primary outcome measure: Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) based on Blinded Independent Central Reading (BICR) at Week 24 — Baseline; Week 24
The vitiligo area scoring index (VASI) is a validated clinician-reported outcome measure that scores both the extent (surface area) and degree (level of depigmentation) of vitiligo lesions over time. The F-VASI describes involvement of the face, with higher scores indicating more severe disease. Negative changes from baseline indicate improvement. - Supplementary primary outcome measure: Percentage change from baseline in F-VASI based on investigator assessment at Week 24 — Baseline; Week 24
- Supplementary primary outcome measure: Percentage change from baseline in F-VASI at Week 4, 8 and 16 — Baseline; Week 4, Week 8; Week 16
F-VASI will be assessed by the investigator and by BICR. - Supplementary primary outcome measure: Achievement of F-VASI50 at Week 4, 8, 16 and 24 — Baseline; Week 4; Week 8; Week 16; Week 24
Proportion of patients achieving at least a 50% improvement from baseline in F-VASI. - Supplementary primary outcome measure: Achievement of F-VASI75 at Week 4, 8, 16 and 24 — Baseline; Week 4; Week 8; Week 16; Week 24
Proportion of patients achieving at least a 75% improvement from baseline in F-VASI. - Supplementary primary outcome measure: Achievement of F-VASI90 at Week 4, 8, 16 and 24 — Baseline; Week 4; Week 8; Week 16; Week 24
Proportion of patients achieving at least a 90% improvement from baseline in F-VASI.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Vitiligo & Pigmentation Institute of Southern California | Los Angeles | California | Recruiting |
| Centrum Medyczne Angelius Provita | Katowice | Poland | Not Yet Recruiting |
| Medistica s.c. | Krakow | Poland | Not Yet Recruiting |
| Małopolskie Centrum Kliniczne | Krakow | Poland | Not Yet Recruiting |
| DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c. | Osielsko | Poland | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07667569 on ClinicalTrials.gov ↗ ← All trials in the USA