A Study to Learn How Safe ACT-777991 is and How Well it Works in Adults With Non-segmental Vitiligo
Key facts
- Where
- Prague and Praha 1, CzechiaSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07667569, who can take part
Where in Czechia
- Fakultni nemocnice BulovkaPrague, CzechiaNot yet recruiting
- Prof. MUDr. Petr Arenberger, DrSc.Praha 1, CzechiaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Idorsia Pharmaceuticals Ltd.
- Trial code
- NCT07667569EU 2025-524865-25-00
- Record updated
- 2 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 2a, Proof of Concept, Multicenter, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial to Assess the Efficacy and Safety of ACT-777991 in Adults With Non-segmental Vitiligo
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.
Inclusion: 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: 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; 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; eGFR < 90 mL/min/1.73 m\^2, defined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, at Screening.