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A Study to Learn How Safe ACT-777991 is and How Well it Works in Adults With Non-segmental Vitiligo

24. juni 2026 opdateret af: Idorsia Pharmaceuticals Ltd.

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The trial includes three trial periods:

Following a Screening period, during which it will be checked if participants are eligible to take part, eligible participants will be randomized in a 2:1 ratio to receive either ACT-777991 or placebo for 24 weeks (Trial intervention period). On completion of treatment, participants will be followed for 30 (+7) days (Follow-up period).

Trial participation will end with a Follow-up visit (Participant Last Visit) at the end of the Follow-up period.

The maximum trial duration for an individual participant is approximately 33 weeks including a screening period of up to 28 days, a treatment period of 24 weeks, and a follow-up period of up to 37 days.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

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 m2, defined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, at Screening.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: ACT-777991
Participants will receive ACT-777991 tablets orally for 24 weeks.
Medicin: ACT-777991
ACT-777991 tablets
Placebo komparator: Placebo
Participants will receive placebo tablets orally for 24 weeks.
Medicin: Placebo
ACT-777991-matching placebo tablets

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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.
Baseline; Week 24
Supplementary primary outcome measure: Percentage change from baseline in F-VASI based on investigator assessment at Week 24
Tidsramme: Baseline; Week 24
Baseline; Week 24
Supplementary primary outcome measure: Percentage change from baseline in F-VASI at Week 4, 8 and 16
Tidsramme: Baseline; Week 4, Week 8; Week 16
F-VASI will be assessed by the investigator and by BICR.
Baseline; Week 4, Week 8; Week 16
Supplementary primary outcome measure: Achievement of F-VASI50 at Week 4, 8, 16 and 24
Tidsramme: Baseline; Week 4; Week 8; Week 16; Week 24
Proportion of patients achieving at least a 50% improvement from baseline in F-VASI.
Baseline; Week 4; Week 8; Week 16; Week 24
Supplementary primary outcome measure: Achievement of F-VASI75 at Week 4, 8, 16 and 24
Tidsramme: Baseline; Week 4; Week 8; Week 16; Week 24
Proportion of patients achieving at least a 75% improvement from baseline in F-VASI.
Baseline; Week 4; Week 8; Week 16; Week 24
Supplementary primary outcome measure: Achievement of F-VASI90 at Week 4, 8, 16 and 24
Tidsramme: Baseline; Week 4; Week 8; Week 16; Week 24
Proportion of patients achieving at least a 90% improvement from baseline in F-VASI.
Baseline; Week 4; Week 8; Week 16; Week 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage change from baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 4, 8, 16 and 24
Tidsramme: Baseline; Week 24
The T-VASI is calculated using a formula that includes contributions from all body regions, with higher scores indicating more severe disease. The F-VASI is used as the score for the 'face' component , i.e., the face is not be scored again. Negative changes from baseline indicate improvement. T-VASI will be assessed by the investigator.
Baseline; Week 24
Achievement of T-VASI50 at Week 4, 8, 16 and 24
Tidsramme: Baseline; Week 4; Week 8; Week 16; Week 24
Proportion of patients achieving at least a 50% improvement from baseline in T-VASI.
Baseline; Week 4; Week 8; Week 16; Week 24
Adverse events (AEs) leading to premature discontinuation of trial intervention
Tidsramme: From start of trial intervention to last dose of trial intervention, assessed up to Week 24
From start of trial intervention to last dose of trial intervention, assessed up to Week 24
Treatment-emergent AEs and serious AEs (SAEs)
Tidsramme: From start of trial intervention up to 37 days after last dose of trial intervention (Follow-up visit)
Treatment-emergent events are AEs and SAEs reported for the first time or as worsening of a pre-existing event after first dose of trial intervention up to 37 days after last dose of trial intervention (Follow-up visit).
From start of trial intervention up to 37 days after last dose of trial intervention (Follow-up visit)
Treatment-emergent AEs of special interest (AESI)
Tidsramme: From start of trial intervention up to 37 days after last dose of trial intervention (Follow-up visit)
From start of trial intervention up to 37 days after last dose of trial intervention (Follow-up visit)
Change from baseline in vital signs: systolic and diastolic blood pressure
Tidsramme: Baseline to all pre-defined time points, up to 37 days after last dose of trial intervention (Follow-up visit)
Baseline to all pre-defined time points, up to 37 days after last dose of trial intervention (Follow-up visit)
Change from baseline in vital signs: pulse rate
Tidsramme: Baseline to all pre-defined time points, up to 37 days after last dose of trial intervention (Follow-up visit)
Baseline to all pre-defined time points, up to 37 days after last dose of trial intervention (Follow-up visit)
Change from baseline in hematology variables
Tidsramme: Baseline to all pre-defined time points, up to 37 days after last dose of trial intervention (Follow-up visit)
The concentration of hematology variables will be measured and the change from baseline summarized.
Baseline to all pre-defined time points, up to 37 days after last dose of trial intervention (Follow-up visit)
Change from baseline in blood chemistry variables
Tidsramme: Baseline to all pre-defined time points, up to 37 days after last dose of trial intervention (Follow-up visit)
The concentration of blood chemistry variables will be measured and the change from baseline summarized.
Baseline to all pre-defined time points, up to 37 days after last dose of trial intervention (Follow-up visit)
Change from baseline in ECG parameters: PR interval, QRS duration, QTcF Value
Tidsramme: Baseline to all pre-defined time points, up to 37 days after last dose of trial intervention (Follow-up visit)
Baseline to all pre-defined time points, up to 37 days after last dose of trial intervention (Follow-up visit)
Change from baseline in ECG parameters: Heart rate
Tidsramme: Baseline to all pre-defined time points, up to 37 days after last dose of trial intervention (Follow-up visit)
Baseline to all pre-defined time points, up to 37 days after last dose of trial intervention (Follow-up visit)
Number of Participants with treatment-emergent marked abnormalities in vital signs: systolic and diastolic blood pressure, pulse rate
Tidsramme: From start of trial intervention up to 37 days after last dose of trial intervention (Follow-up visit)
From start of trial intervention up to 37 days after last dose of trial intervention (Follow-up visit)
Number of Participants with treatment-emergent marked abnormalities in clinical laboratory variables: hematology and chemistry
Tidsramme: From start of trial intervention up to 37 days after last dose of trial intervention (Follow-up visit)
From start of trial intervention up to 37 days after last dose of trial intervention (Follow-up visit)
Number of Participants with treatment-emergent marked abnormalities in ECG parameters: PR interval, QRS duration, QTcF Value, Heart rate
Tidsramme: From start of trial intervention up to 37 days after last dose of trial intervention (Follow-up visit)
From start of trial intervention up to 37 days after last dose of trial intervention (Follow-up visit)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Idorsia Pharmaceuticals Ltd.

Efterforskere

  • Studieleder: Clinical Trials, Idorsia Pharmaceuticals Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

11. maj 2026

Først indsendt, der opfyldte QC-kriterier

24. juni 2026

Først opslået (Faktiske)

25. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • ID-089B201
  • 2025-524865-25-00 (Ctis)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Ikke-segmental vitiligo

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