Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

24 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: ACT-777991
Participants will receive ACT-777991 tablets orally for 24 weeks.
Droga: ACT-777991
ACT-777991 tablets
Comparatore placebo: Placebo
Participants will receive placebo tablets orally for 24 weeks.
Droga: Placebo
ACT-777991-matching placebo tablets

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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
Lasso di tempo: Baseline; Week 24
Baseline; Week 24
Supplementary primary outcome measure: Percentage change from baseline in F-VASI at Week 4, 8 and 16
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage change from baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 4, 8, 16 and 24
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Idorsia Pharmaceuticals Ltd.

Investigatori

  • Direttore dello studio: Clinical Trials, Idorsia Pharmaceuticals Ltd.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

1 luglio 2027

Date di iscrizione allo studio

Primo inviato

11 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 giugno 2026

Primo Inserito (Effettivo)

25 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su ACT-777991

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Uruguay

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi