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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524865-25-00 | EU Trial (CTIS) Number |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT-777991 | Experimental | Participants will receive ACT-777991 tablets orally for 24 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive placebo tablets orally for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT-777991 | Drug | ACT-777991 tablets |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Baseline; Week 24 | |
| Supplementary primary outcome measure: Percentage change from baseline in F-VASI at Week 4, 8 and 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 | 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 | 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 | Proportion of patients achieving at least a 90% improvement from baseline in F-VASI. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 4, 8, 16 and 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. |
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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:
Participants must agree not to use therapeutic agents and procedures to treat vitiligo from Screening until Participant Last Visit.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Information USA | Contact | +1 856 661 37 21 | idorsiaclinicaltrials@idorsia.com | |
| Clinical Trial Information Europe | Contact | +41 58 844 1977 | idorsiaclinicaltrials@idorsia.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Idorsia Pharmaceuticals Ltd. | Study Director |
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| Drug |
ACT-777991-matching placebo tablets |
|
| Baseline; Week 4; Week 8; Week 16; Week 24 |
| Baseline; Week 24 |
| Achievement of T-VASI50 at Week 4, 8, 16 and 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 | From start of trial intervention to last dose of trial intervention, assessed up to Week 24 |
| Treatment-emergent AEs and serious AEs (SAEs) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | From start of trial intervention up to 37 days after last dose of trial intervention (Follow-up visit) |