Non-Segmental VitiligoPhase 2NCT07667569
A Study to Learn How Safe ACT-777991 is and How Well it Works in Adults With Non-segmental Vitiligo
A Phase 2 study testing ACT-777991 in people with Non-Segmental Vitiligo, run by Idorsia Pharmaceuticals Ltd..
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Segmental Vitiligo
- What is being tested?
- ACT-777991
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Non-Segmental Vitiligo
- Being tested
- ACT-777991, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-777991Drug
ACT-777991 tablets
PlaceboDrug
ACT-777991-matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| ACT-777991 | Experimental | Participants will receive ACT-777991 tablets orally for 24 weeks. Receives: Drug: ACT-777991 |
| Placebo | Placebo comparator | Participants will receive placebo tablets orally for 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; Week 24
Supplementary primary outcome measure: Percentage change from baseline in F-VASI based on investigator assessment at Week 24
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline; Week 4; Week 8; Week 16; Week 24
Secondary outcomes (14)
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.
Measured: 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.
Measured: Baseline; Week 4; Week 8; Week 16; Week 24
Adverse events (AEs) leading to premature discontinuation of trial intervention
Measured: 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).
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From start of trial intervention up to 37 days after last dose of trial intervention (Follow-up visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Segmental VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667569
- Sponsor's protocol ID
- ID-089B201
- Other IDs
- 2025-524865-25-00, 2025
- Status last verified
- Jun 2026
- First submitted
- 11 May 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07667569
- Acronym / sponsor ID
- ID-089B201
- Conditions
- Non-Segmental Vitiligo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT-777991 | Experimental | Drug: ACT-777991Participants will receive ACT-777991 tablets orally for 24 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo tablets orally for 24 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-777991ACT-777991 tablets | Drug | ACT-777991 |
| PlaceboACT-777991-matching placebo tablets | Drug | Placebo |
Primary outcome
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
Time frame: 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.
Supplementary primary outcome measure: Percentage change from baseline in F-VASI based on investigator assessment at Week 24
Time frame: Baseline; Week 24
Supplementary primary outcome measure: Percentage change from baseline in F-VASI at Week 4, 8 and 16
Time frame: Baseline; Week 4, Week 8; Week 16
F-VASI will be assessed by the investigator and by BICR.
Supplementary primary outcome measure: Achievement of F-VASI50 at Week 4, 8, 16 and 24
Time frame: Baseline; Week 4; Week 8; Week 16; Week 24
Proportion of patients achieving at least a 50% improvement from baseline in F-VASI.
Supplementary primary outcome measure: Achievement of F-VASI75 at Week 4, 8, 16 and 24
Time frame: Baseline; Week 4; Week 8; Week 16; Week 24
Proportion of patients achieving at least a 75% improvement from baseline in F-VASI.
Supplementary primary outcome measure: Achievement of F-VASI90 at Week 4, 8, 16 and 24
Time frame: Baseline; Week 4; Week 8; Week 16; Week 24
Proportion of patients achieving at least a 90% improvement from baseline in F-VASI.
14 secondary outcomes
Percentage change from baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 4, 8, 16 and 24
Time frame: Baseline; Week 24
Achievement of T-VASI50 at Week 4, 8, 16 and 24
Time frame: Baseline; Week 4; Week 8; Week 16; Week 24
Adverse events (AEs) leading to premature discontinuation of trial intervention
Time frame: From start of trial intervention to last dose of trial intervention, assessed up to Week 24
Treatment-emergent AEs and serious AEs (SAEs)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From start of trial intervention up to 37 days after last dose of trial intervention (Follow-up visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trials study director
Idorsia Pharmaceuticals Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACT-777991 in people with Non-Segmental Vitiligo, run by Idorsia Pharmaceuticals Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Information USA (+1 856 661 37 21, idorsiaclinicaltrials@idorsia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline; Week 24). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.