Non-segmental VitiligoPhase 2NCT04487860

Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo

A Phase 2 study testing AS012 in people with Non-segmental Vitiligo, run by Ache Laboratorios Farmaceuticos S.A. at 31 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a randomized, double blind, placebo-controlled, phase II study. The study will be performed as a multicenter, multinational study. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-segmental Vitiligo
What is being tested?: AS012
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 327 participants
Where: 31 sitesin 2 countries
Study dates: 13 Jan 2021to 27 Feb 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provide written informed consent.
Male or female ≥ 18 years of age at time of screening
Stable (without new patches ≥ 1 year) or unstable (with new patches for the last 1 year) vitiligo
VASI of ≥ 4 at screening and baseline

Who cannot join

Segmental vitiligo, focal, or mixed Vitiligo
Subjects who have high risk of suicidality at the Screening assessment based on Investigator's judgment
History of alcohol or drug abuse in the previous 2 years
Subjects who were submitted to melanocyte transfer
-

Trial locations and contacts

31 sites in 2 countries.

Country

City, postcode or hospital

31 sites in 2 countries

United States19 sites

Sun Pharma Site 12
Baton Rouge, Louisiana, 70809
Sun pharma site 31
Boston, Massachusetts, 02111
Sun Pharma Site 01
Brandon, Florida, 33511.
Sun Pharma Site 02
Bryant, Arkansas, 72022
Sun Pharma Site 03
Dallas, Texas, 75234
Sun Pharma Site 29
East Greenwich, Rhode Island, 02818
Sun Pharma Site 06
Fort Lauderdale, Florida, 33308
Sun Pharma Site 09
Fremont, California, 94538
Sun pharma site 30
Los Angeles, California, 90036
Sun Pharma Site 04
Miami, Florida, 33175
Sun Pharma Site 11
Mill Creek, Washington, 98012
Sun Pharma Site 05
Miramar, Florida, 33027
Sun Pharma Site 13
New Orleans, Louisiana, 70115
Sun Pharma Site 10
Ormond Beach, Florida, 32174
Sun Pharma Site 16
Pflugerville, Texas, 78660
Sun Pharma Site 15
Phoenix, Arizona, 85018
Sun Pharma Site 07
Troy, Michigan, 48084
Sun Pharma Site 08
Warwick, Rhode Island, 02886
Sun Pharma Site 14
West Lafayette, Indiana, 47906

Other trials in United States

India12 sites

Sun Pharma Site 19
Ahmedabad, Gujarat, 380016
Sun Pharma Site 23
Bangalore, Karnataka, 560074
Sun Pharma Site 22
Chandigarh, 160012
Sun Pharma Site 21
Chhatrapati Sambhajinagar, Maharashtra, 431001
Sun Pharma Site 20
Gandhinagar, Gujarat, 382428
Sun Pharma Site 27
Lucknow, Uttar Pradesh, 226003
Sun Pharma Site 18
Lucknow, Uttar Pradesh, 226005
Sun PharmaSite 24
Mysuru, Karnataka, 570001
Sun Pharma Site 25
Nashik, Maharashtra, 422101
Sun Pharma Site 26
Pune, Maharashtra, 411005
Sun Pharma Site 28
Rajkot, Gujarat, 360005
Sun Pharma Site 17
Rājsamand, Rajasthan, 313202

Other trials in India

About this study

Official title: A Phase II, Randomized, Double Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo

This is a randomized, double blind, placebo-controlled, phase II study. The study will be performed as a multicenter, multinational study.

Conditions: Non-segmental Vitiligo
Being tested: AS012, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AS012Drug
oral administration
PlaceboDrug
oral administration

Study groups in NCT04487860
Study group	Role	What they receive
AS012 dose regimen I	Experimental	Oral Receives: Drug: AS012
AS012 dose regimen II	Experimental	Oral Receives: Drug: AS012
AS012 dose regimen III	Experimental	Oral Receives: Drug: AS012
AS012 dose regimen IV	Experimental	Oral Receives: Drug: AS012
Placebo	Placebo comparator	Oral Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline in Vitiligo Area Scoring Index Score
Vitiligo Area Scoring Index score: numeric score that can range from 0 to 100, with higher VASI scores denoting poorer the disease state
Measured: Week 24

Secondary outcomes (4)

Mean Change From Baseline in Vitiligo Extent Score (VES) on Clinical Pictures
The Vitiligo Extent Score (VES) measures the overall vitiligo involvement in the body based on clinical pictures reflecting the natural distribution of the disease across 19 body areas (e.g., face, trunk, arms, legs, hands, axillae, back, gluteal). For each area, one representative image is selected, assigning one of six degrees of involvement (1%, 5%, 10%, 25%, 50%, 75%). The total and final score is the sum of the measurements from all areas, calculated using a conversion table available in the online calculator (www.vitiligo-calculator.com), and expressed as the extension of body surface area affected (0-100). Higher scores indicate worse clinical involvement. The VES change from baseline to Week 24 was assessed for the ITT population.
Measured: Week 24
Mean Change in Vitiligo Impact Patient Scale
Subjects will be asked to complete a questionnaire to assess the burden experienced by individuals affected. For each of the statements in the Vitiligo Impact Patient Scale, 7 responses are suggested: always, very often, often, sometimes, rarely, never and not applicable. The individual answered as spontaneously as possible while thinking about their situation over the last 7 days. Summary scores range from 0 to 100. Higher values indicate a worse clinical condition.
Measured: Week 24
Physician's Global Assessment Scores
Description: The investigator will perform an average assessment of all vitiligo lesions. The following scale will be used for the PGA: Score 0= No involvement, Score 1= Limited, Score 2= moderate, Score 3= Extensive or Score 4= Very extensive. Higher values indicate a worse clinical condition. The static Physician's Global Assessment determines vitiligo extend at a single point in time, without taking the baseline disease condition into consideration, in other words, represents the Proportion of subjects achieving a PGA score of "no involvement" (score 0) or "limited extent" (score 1) with at least 2-point reduction from Baseline Week 52.
Measured: Week 52
Mean Change From Baseline in Dermatology Life Quality Index
The DLQI scores are based on the response from the patient. Each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired OR lower scores indicate better quality of life.
Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jan 202127 Feb 2023

First posted27 Jul 2020
Study start13 Jan 2021
Primary completion20 May 2022
Study completion27 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 327 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04487860
Sponsor's protocol ID: AS012-20-01
Status last verified: Jun 2022
First submitted: 22 Jul 2020
Last updated: 10 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
Non-Segmental Vitiligo (NSV)
Not yet recruitingPhase 2/3
Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
Vitiligo
RecruitingPhase 2
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
Vitiligo, Non-Segmental Vitiligo (NSV)
Active, not recruiting
Plasma Exeresis Plus NB-UVB Versus NB-UVB Alone for Stable Vitiligo
Vitiligo
RecruitingPhase 2
Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients
Non-segmental Vitiligo

All Non-segmental Vitiligo trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Double Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo
ClinicalTrials.gov ID: NCT04487860
Acronym / sponsor ID: AS012-20-01
Conditions: Non-segmental Vitiligo
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 327 participants (actual)
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
Study start: 13 Jan 2021 (actual)
Primary completion: 20 May 2022 (actual)
Study completion: 27 Feb 2023 (actual)
First posted: 27 Jul 2020 (actual)
Results: Posted 10 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a randomized, double blind, placebo-controlled, phase II study. The study will be performed as a multicenter, multinational study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
AS012 dose regimen I	Experimental	Drug: AS012Oral
AS012 dose regimen II	Experimental	Drug: AS012Oral
AS012 dose regimen III	Experimental	Drug: AS012Oral
AS012 dose regimen IV	Experimental	Drug: AS012Oral
Placebo	Placebo comparator	Drug: PlaceboOral

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Provide written informed consent.
Male or female ≥ 18 years of age at time of screening
Stable (without new patches ≥ 1 year) or unstable (with new patches for the last 1 year) vitiligo
VASI of ≥ 4 at screening and baseline

Key exclusion criteria (5 listed)

Segmental vitiligo, focal, or mixed Vitiligo
Subjects who have high risk of suicidality at the Screening assessment based on Investigator's judgment
History of alcohol or drug abuse in the previous 2 years
Subjects who were submitted to melanocyte transfer
-

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
AS012oral administration	Drug	AS012 dose regimen I, AS012 dose regimen II, AS012 dose regimen III, AS012 dose regimen IV
Placebooral administration	Drug	Placebo

Primary outcome

Mean Change From Baseline in Vitiligo Area Scoring Index Score
Time frame: Week 24
Vitiligo Area Scoring Index score: numeric score that can range from 0 to 100, with higher VASI scores denoting poorer the disease state

4 secondary outcomes

Mean Change From Baseline in Vitiligo Extent Score (VES) on Clinical Pictures
Time frame: Week 24
Mean Change in Vitiligo Impact Patient Scale
Time frame: Week 24
Physician's Global Assessment Scores
Time frame: Week 52
Mean Change From Baseline in Dermatology Life Quality Index
Time frame: Week 52

Results and safety

Results posted to the registry on 10 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	59	40
Placebo to AS012 Dose Regimen II at Week 24	0	0
Placebo to AS012 Dose Regimen IV at Week 24	0	0
AS012 Dose Regimen I	62	44
AS012 Dose Regimen II	71	59
AS012 Dose Regimen III	63	46
AS012 Dose Regimen IV	72	54

Primary outcome: Mean Change From Baseline in Vitiligo Area Scoring Index Score

Time frame: Week 24. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo n = 59	AS012 Dose Regimen I n = 62	AS012 Dose Regimen II n = 71	AS012 Dose Regimen III n = 63	AS012 Dose Regimen IV n = 72
Value	-0.472 (1.0422)	-0.271 (2.5139)	-0.706 (1.7301)	-1.145 (2.7721)	-0.110 (2.6168)

Placebo vs AS012 Dose Regimen I: p = 0.7905, ANCOVA
Placebo vs AS012 Dose Regimen II: p = 0.7372, ANCOVA
Placebo vs AS012 Dose Regimen III: p = 0.2989, ANCOVA

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 64 Week. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo - Part I	0 of 59 (0%)	0 of 59 (0%)	0 of 59
AS012 Dose Regimen I- Part I	0 of 62 (0%)	0 of 62 (0%)	0 of 62
AS012 Dose Regimen II - Part I	0 of 70 (0%)	0 of 70 (0%)	0 of 70
AS012 Dose Regimen III - Part I	0 of 63 (0%)	0 of 63 (0%)	0 of 63
AS012 Dose Regimen IV - Part I	0 of 72 (0%)	0 of 72 (0%)	0 of 72
Placebo to AS012 Dose Regimen II at Week 24 - Part II	0 of 20 (0%)	1 of 20 (5%)	0 of 20
Placebo to AS012 Dose Regimen IV at Week 24 - Part II	0 of 20 (0%)	0 of 20 (0%)	0 of 20
AS012 Dose - Regimen I - Part II	0 of 44 (0%)	0 of 44 (0%)	0 of 44
AS012 Dose Regimen II - Part II	0 of 59 (0%)	0 of 59 (0%)	0 of 59
AS012 Dose Regimen III - Part II	0 of 46 (0%)	0 of 46 (0%)	0 of 46
AS012 Dose Regimen IV - Part II	0 of 54 (0%)	0 of 54 (0%)	0 of 54
AS012 - Part III	0 of 162 (0%)	0 of 162 (0%)	0 of 162

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Non-segmental Vitiligo

RecruitingPhase 2
A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
Non-Segmental Vitiligo (NSV)
Not yet recruitingPhase 2/3
Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
Vitiligo
RecruitingPhase 2
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
Vitiligo, Non-Segmental Vitiligo (NSV)
Active, not recruiting
Plasma Exeresis Plus NB-UVB Versus NB-UVB Alone for Stable Vitiligo
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RecruitingPhase 2
Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

31 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AS012 in people with Non-segmental Vitiligo, run by Ache Laboratorios Farmaceuticos S.A. at 31 sites in 2 countries.

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 4 inclusion and 5 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: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 10 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Vitiligo Area Scoring Index Score (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04487860.

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 10 Mar 2025.