Non-Segmental Vitiligo (NSV)Phase 2NCT07889492
A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
A Phase 2 study testing EB06 in people with Non-Segmental Vitiligo (NSV), run by Edesa Biotech Inc. at 4 sites in Canada.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of EB06 intravenous infusion (loading dose of 20mg/kg followed by a maintenance dose of 10mg/kg) compared with placebo in adults with moderate to severe non-segmental vitiligo.. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Segmental Vitiligo (NSV)
- What is being tested?
- EB06
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 4 sitesCanada
- Study dates
- Sep 2026to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 5% total BSA, and ≥ 4 T-VASI.
- Men and women ≥ 18 years of age at the time of consent.
- Subjects who agree to discontinue all agents used to treat vitiligo from screening through to Week 28. Over the counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
- Female subjects of childbearing potential and at risk for pregnancy: negative pregnancy test and agreement to use at least one method of effective contraception throughout the study and for at least 12 weeks after the last dose of assigned treatment.
- Male subjects with female partners of childbearing potential agree to use at least one method of effective contraception by yourself or your partner, as applicable, during study duration and for at least 12 weeks after the last dose of assigned treatment.
Who cannot join
- Subjects with more than 30% of poliosis within facial vitiligo areas.
- Other forms of vitiligo (e.g., segmental) or other hypopigmentation disorders (including but not limited to tinea versicolor, piebaldism, pityriasis alba, post-inflammatory hypopigmentation, nevus anemicus, nevus depigmentosus, senile leukoderma, chemical/drug-induced leukoderma, tuberous sclerosis, etc.).
- Subjects who have used permanent depigmentation treatments, such as monobenzone, for past treatment of vitiligo. Note: prior use of hydroquinone is not prohibited (as it is a bleaching agent, not a depigmentation treatment).
- Subjects who have used topical treatments applied on vitiligo affected areas such as corticosteroids, calcineurin inhibitors, phosphodiesterase-4 inhibitor, retinoids or JAK inhibitors within 1 week prior to Day 1.
- Subjects who have used systemic immunomodulators (other than biologics, e.g., methotrexate, cyclosporin, corticosteroids, JAK inhibitors), and/or melanocyte stimulating pharmaceuticals (e.g. afamelanotide) that could affect vitiligo, or treatments that would increase skin sensitivity to ultraviolet (UV) light (e.g. 8 methoxypsoralen) within 4 weeks prior to Day 1.
- Subjects who have used laser or light-based vitiligo treatments within 4 weeks prior to Day 1.
Show all 16Show fewer
- Subjects who have used any biological agent or experimental procedure for vitiligo within 12 weeks or 5 half-lives (whichever is longest) prior to Day 1.
- Pregnant and/or breastfeeding subjects.
- Subjects of childbearing potential who are unwilling or unable to use one method of contraception as outlined in this protocol for the duration of the study and for at least 12 weeks after the last dose of investigational product.
- Subjects who have a known history of being inadequately treated for chronic infectious disease (e.g. hepatitis B or C, human immunodeficiency virus).
- Current or recent history (< 30 days) of a clinically meaningful bacterial, fungal, or parasitic infection.
- Subjects with a history of malignancy in the past 5 years, except for the following adequately treated, nonmetastatic malignancies: basal cell skin cancer not involving areas with vitiligo, squamous cell carcinomas of the skin not involving areas with vitiligo, or in situ cervical cancer.
- Subjects with other active coexisting skin (e.g. rosacea, melasma, psoriasis) and non-skin autoimmune diseases (e.g. multiple sclerosis, etc.) which in the investigator's opinion interferes with vitiligo assessments or poses a safety risk.
- Subjects with a history of eczema herpeticum.
- Clinically significant findings or conditions which might, in the opinion of the Principal Investigator, interfere with study evaluations, pose a risk to subject safety during the study, or require treatment with an interfering therapy.
- Subjects with known allergy or reaction to any component of the study formulation.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Not yet recruiting
Vida Clinical Research
Edmonton, Alberta, T6H 4J8
- Not yet recruiting
Guelph Dermatology Research
Guelph, Ontario, N1L 0B7
- Not yet recruiting
Clear Skin Dermatology
Newmarket, Ontario, L3Y 5G8
- Recruiting
FACET Dermatology
Toronto, Ontario, M4E 1R7
Dr. Yadav, 416-698-5521, research@facetdermatology.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
The purpose of this study is to evaluate the safety and efficacy of EB06 intravenous infusion (loading dose of 20mg/kg followed by a maintenance dose of 10mg/kg) compared with placebo in adults with moderate to severe non-segmental vitiligo..
Vitiligo is a chronic autoimmune skin disorder characterized by the loss of skin pigmentation due to the destruction of melanocytes. EB06 is a fully human monoclonal antibody that binds and neutralizes CXCL10, a chemokine implicated in the trafficking of anti-melanocytic T-cells to the epidermis and in inducing cell death. Elevated levels of CXCL10 have been associated with both the initiation of the disease and the maintenance of vitiligo lesions. The study will evaluate the safety, tolerability, and efficacy of EB06 in adults with moderate to severe non-segmental vitiligo.
- Conditions
- Non-Segmental Vitiligo (NSV)
- Being tested
- Placebo IV, EB06
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo IVOther
Placebo IV
EB06Biological
EB06 IV loading 20 mg/kg followed by 10 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo IV |
| EB06 | Experimental | Not described Receives: Biological: EB06 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent change from baseline in F-VASI at Week 28
The Facial Vitiligo Area Scoring Index (F-VASI) is a validated assessment of the extent and degree of depigmentation affecting the face with scores ranging from 0 to 3.5, where higher scores indicate greater facial vitiligo involvement. The primary endpoint is the mean percent change from baseline in F-VASI at Week 28. A greater reduction from baseline reflects greater improvement in facial vitiligo.
Measured: 28 Weeks
Secondary outcomes (13)
Mean percent change from baseline in F-VASI at Weeks 24 and 32
Difference in mean change from baseline in F-VASI.
F VASI is an assessment of the extent and degree of depigmentation affecting the face with scores ranging from 0 to 3.5, where higher scores indicate greater facial vitiligo involvement.
Measured: Weeks 24 and 32
Proportion of subjects achieving F VASI50 at Weeks 24, 28 and 32.
Proportion of subjects achieving at least 50% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI).
F VASI is an assessment of the extent and degree of depigmentation affecting the face with scores ranging from 0 to 3.5, where higher scores indicate greater facial vitiligo involvement.
Measured: Weeks 24, 28, and 32
Time to achieving F-VASI50
Time from baseline to first achievement of at least 50% improvement from baseline in F-VASI.
F VASI is an assessment of the extent and degree of depigmentation affecting the face with scores ranging from 0 to 3.5, where higher scores indicate greater facial vitiligo involvement.
Measured: Baseline through Week 32
Mean percent change from baseline in the T-VASI at Weeks 24, 28 and 32.
Mean percent change from baseline in Total Body VASI (T-VASI).
T-VASI is a measure of total body vitiligo extent and depigmentation severity, with scores ranging from 0 to 100, where higher scores indicate greater vitiligo involvement.
Measured: Weeks 24, 28, and 32
Proportion of subjects achieving T VASI50 at Weeks 24, 28 and 32.
Proportion of subjects achieving at least 50% improvement from baseline in Total Vitiligo Area Scoring Index (T-VASI).
T-VASI is a measure of total body vitiligo extent and depigmentation severity, with scores ranging from 0 to 100, where higher scores indicate greater vitiligo involvement.
Measured: Weeks 24, 28, and 32
Proportion of subjects achieving F-VASI75 at Weeks 24, 28 and 32.
Proportion of subjects achieving at least 75% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI).
F VASI is an assessment of the extent and degree of depigmentation affecting the face with scores ranging from 0 to 3.5, where higher scores indicate greater facial vitiligo involvement.
Measured: Weeks 24, 28, and 32
Proportion of subjects achieving a score of 4 (a lot less noticeable) or 5 (no longer noticeable) on the Vitiligo Noticeability Scale (VNS) at Weeks 24, 28 and 32.
Proportion of subjects achieving a VNS score of 4 (a lot less noticeable) or 5 (no longer noticeable)
VNS is a patient-reported 5-point assessment of how noticeable facial vitiligo appears compared with before treatment, where a score of 1 indicates "more noticeable" and a score of 5 indicates "no longer noticeable.
Measured: Weeks 24, 28, and 32.
Time to achieving a score of 4 (a lot less noticeable) or 5 (no longer noticeable) on the Vitiligo Noticeability Scale (VNS).
Time from baseline to first achievement of a VNS score of 4 or 5.
VNS is a patient-reported 5-point assessment of how noticeable facial vitiligo appears compared with before treatment, where a score of 1 indicates "more noticeable" and a score of 5 indicates "no longer noticeable.
Measured: Baseline through Week 32
Proportion of subjects achieving a Face Patient Global Impression of Change-Vitiligo (F-PaGIC-V) score of 1, 2, or 3 at Weeks 24, 28, and 32.
Proportion of subjects achieving a Face Patient Global Impression of Change-Vitiligo (F-PaGIC-V) score of 1, 2, or 3.
F-PaGIC V (Facial Patient Global Impression of Change-Vitiligo) is a patient-reported assessment of change in facial vitiligo since baseline using a 7-point scale ranging from 1 (very much improved) and 7 (very much worse).
Measured: Weeks 24, 28, and 32
Proportion of subjects achieving a Total Patient Global Impression of Change-Vitiligo (T-PaGIC-V) score of 1, 2, or 3 at Weeks 24, 28, and 32.
Proportion of subjects achieving a Total Patient Global Impression of Change-Vitiligo (T-PaGIC-V) score of 1, 2, or 3.
T-PaGIC V (Total Patient Global Impression of Change-Vitiligo) is a patient-reported assessment of change in overall body vitiligo since baseline using a 7-point scale ranging from 1 (very much improved) and 7 (very much worse).
Measured: Weeks 24, 28, and 32
Proportion of subjects achieving a facial static investigator global assessment (F-sIGA) of 0 or 1, with at least a 2-point reduction from baseline at Week 24, 28 and Week 32.
Proportion of subjects achieving a facial static investigator global assessment (F-sIGA) of 0 or 1, with at least a 2-point reduction from baseline.
F-sIGA (Facial Static Investigator Global Assessment) is an investigator-assessed measure of facial vitiligo severity using a 5-point scale of ranging from 0 (clear) to 4 (severe vitiligo).
Measured: Weeks 24, 28, and 32
Proportion of subjects achieving a total body static investigator global assessment (T-sIGA) of 0 or 1, with at least a 2-point reduction from baseline at Week 24, 28 and Week 32.
Proportion of subjects achieving a total body static investigator global assessment (T-sIGA) of 0 or 1, with at least a 2-point reduction from baseline.
T-sIGA (Total Static Investigator Global Assessment) is an investigator-assessed measure of overall body vitiligo severity using a 5-point scale ranging from 0 (clear) to 4 (severe vitiligo).
Measured: Weeks 24, 28, and 32
Mean percent change from baseline in Body Surface Area (BSA) affected with depigmentation at Week 24, 28 and Week 32.
Mean percent change from baseline in Body Surface Area (BSA) affected with depigmentation.
BSA is an investigator-assessed measure of the percentage of total body surface area affected by vitiligo and reflects the extent of disease involvement.
Measured: Weeks 24, 28, and 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 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 Vitiligo (NSV)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edesa Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889492
- Sponsor's protocol ID
- EB06-12-2022
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
- ClinicalTrials.gov ID
- NCT07889492
- Acronym / sponsor ID
- EB06-12-2022
- Conditions
- Non-Segmental Vitiligo (NSV)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Edesa Biotech Inc.Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Oct 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 study is to evaluate the safety and efficacy of EB06 intravenous infusion (loading dose of 20mg/kg followed by a maintenance dose of 10mg/kg) compared with placebo in adults with moderate to severe non-segmental vitiligo..
Vitiligo is a chronic autoimmune skin disorder characterized by the loss of skin pigmentation due to the destruction of melanocytes. EB06 is a fully human monoclonal antibody that binds and neutralizes CXCL10, a chemokine implicated in the trafficking of anti-melanocytic T-cells to the epidermis and in inducing cell death. Elevated levels of CXCL10 have been associated with both the initiation of the disease and the maintenance of vitiligo lesions. The study will evaluate the safety, tolerability, and efficacy of EB06 in adults with moderate to severe non-segmental vitiligo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo IV |
| EB06 | Experimental | Biological: EB06 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 5% total BSA, and ≥ 4 T-VASI.
- Men and women ≥ 18 years of age at the time of consent.
- Subjects who agree to discontinue all agents used to treat vitiligo from screening through to Week 28. Over the counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
- Female subjects of childbearing potential and at risk for pregnancy: negative pregnancy test and agreement to use at least one method of effective contraception throughout the study and for at least 12 weeks after the last dose of assigned treatment.
- Male subjects with female partners of childbearing potential agree to use at least one method of effective contraception by yourself or your partner, as applicable, during study duration and for at least 12 weeks after the last dose of assigned treatment.
Key exclusion criteria (16 listed)
- Subjects with more than 30% of poliosis within facial vitiligo areas.
- Other forms of vitiligo (e.g., segmental) or other hypopigmentation disorders (including but not limited to tinea versicolor, piebaldism, pityriasis alba, post-inflammatory hypopigmentation, nevus anemicus, nevus depigmentosus, senile leukoderma, chemical/drug-induced leukoderma, tuberous sclerosis, etc.).
- Subjects who have used permanent depigmentation treatments, such as monobenzone, for past treatment of vitiligo. Note: prior use of hydroquinone is not prohibited (as it is a bleaching agent, not a depigmentation treatment).
- Subjects who have used topical treatments applied on vitiligo affected areas such as corticosteroids, calcineurin inhibitors, phosphodiesterase-4 inhibitor, retinoids or JAK inhibitors within 1 week prior to Day 1.
- Subjects who have used systemic immunomodulators (other than biologics, e.g., methotrexate, cyclosporin, corticosteroids, JAK inhibitors), and/or melanocyte stimulating pharmaceuticals (e.g. afamelanotide) that could affect vitiligo, or treatments that would increase skin sensitivity to ultraviolet (UV) light (e.g. 8 methoxypsoralen) within 4 weeks prior to Day 1.
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 |
|---|---|---|
| Placebo IVPlacebo IV | Other | Placebo |
| EB06EB06 IV loading 20 mg/kg followed by 10 mg/kg | Biological | EB06 |
Primary outcome
Mean percent change from baseline in F-VASI at Week 28
Time frame: 28 Weeks
The Facial Vitiligo Area Scoring Index (F-VASI) is a validated assessment of the extent and degree of depigmentation affecting the face with scores ranging from 0 to 3.5, where higher scores indicate greater facial vitiligo involvement. The primary endpoint is the mean percent change from baseline in F-VASI at Week 28. A greater reduction from baseline reflects greater improvement in facial vitiligo.
13 secondary outcomes
Mean percent change from baseline in F-VASI at Weeks 24 and 32
Time frame: Weeks 24 and 32
Proportion of subjects achieving F VASI50 at Weeks 24, 28 and 32.
Time frame: Weeks 24, 28, and 32
Time to achieving F-VASI50
Time frame: Baseline through Week 32
Mean percent change from baseline in the T-VASI at Weeks 24, 28 and 32.
Time frame: Weeks 24, 28, and 32
Proportion of subjects achieving T VASI50 at Weeks 24, 28 and 32.
Time frame: Weeks 24, 28, and 32
Proportion of subjects achieving F-VASI75 at Weeks 24, 28 and 32.
Time frame: Weeks 24, 28, and 32
Proportion of subjects achieving a score of 4 (a lot less noticeable) or 5 (no longer noticeable) on the Vitiligo Noticeability Scale (VNS) at Weeks 24, 28 and 32.
Time frame: Weeks 24, 28, and 32.
Time to achieving a score of 4 (a lot less noticeable) or 5 (no longer noticeable) on the Vitiligo Noticeability Scale (VNS).
Time frame: Baseline through Week 32
Proportion of subjects achieving a Face Patient Global Impression of Change-Vitiligo (F-PaGIC-V) score of 1, 2, or 3 at Weeks 24, 28, and 32.
Time frame: Weeks 24, 28, and 32
Proportion of subjects achieving a Total Patient Global Impression of Change-Vitiligo (T-PaGIC-V) score of 1, 2, or 3 at Weeks 24, 28, and 32.
Time frame: Weeks 24, 28, and 32
Proportion of subjects achieving a facial static investigator global assessment (F-sIGA) of 0 or 1, with at least a 2-point reduction from baseline at Week 24, 28 and Week 32.
Time frame: Weeks 24, 28, and 32
Proportion of subjects achieving a total body static investigator global assessment (T-sIGA) of 0 or 1, with at least a 2-point reduction from baseline at Week 24, 28 and Week 32.
Time frame: Weeks 24, 28, and 32
Mean percent change from baseline in Body Surface Area (BSA) affected with depigmentation at Week 24, 28 and Week 32.
Time frame: Weeks 24, 28, and 32
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 26 Oct 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EB06 in people with Non-Segmental Vitiligo (NSV), run by Edesa Biotech Inc. at 4 sites in Canada.
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 16 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean percent change from baseline in F-VASI at Week 28 (time frame: 28 Weeks). 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 26 Oct 2026.