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NCT07667569
A Study to Learn How Safe ACT-777991 is and How Well it Works in Adults With Non-segmental Vitiligo
Conditions: Non-Segmental Vitiligo
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 30
Sponsor: Idorsia Pharmaceuticals Ltd.
Location: Vitiligo & Pigmentation Institute of Southern California Los Angeles California
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07667569). StuddyBuddy aggregates publicly available trial information.