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RecruitingNCT07889492Updated Nov 9, 2026

A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo

A Phase 2 interventional study of Placebo IV and EB06 in Non-Segmental Vitiligo (NSV), sponsored by Edesa Biotech Inc.. Recruiting at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Edesa Biotech Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Updated Nov 6, 2026First site in PanamaStart date moved+4 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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..

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.

02

Conditions studied

  • Non-Segmental Vitiligo (NSV)

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03

In context

Vitiligo

343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.

This study's planned enrollment of 80 is above the median of 36 across 265 interventional studies indexed under Vitiligo.

Browse Vitiligo studies →

Lead sponsor

Edesa Biotech Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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.
  2. Men and women ≥ 18 years of age at the time of consent.
  3. 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.
  4. Female subjects of and at risk for pregnancy: negative pregnancy test and agreement to use at least one method of effective throughout the study and for at least 12 weeks after the last dose of assigned treatment.
  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with more than 30% of poliosis within facial vitiligo areas.
  2. 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.).
  3. 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).
  4. Subjects who have used topical treatments applied on vitiligo affected areas such as , calcineurin inhibitors, phosphodiesterase-4 inhibitor, retinoids or JAK inhibitors within 1 week prior to Day 1.
  5. 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.
  6. Subjects who have used laser or light-based vitiligo treatments within 4 weeks prior to Day 1.
  7. 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.
  8. Pregnant and/or breastfeeding subjects.
  9. Subjects of who are unwilling or unable to use one method of as outlined in this protocol for the duration of the study and for at least 12 weeks after the last dose of product.
  10. Subjects who have a known history of being inadequately treated for chronic infectious disease (e.g. or C, ).
  11. Current or recent history (\< 30 days) of a bacterial, fungal, or parasitic infection.
  12. Subjects with a history of 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.
  13. Subjects with other active coexisting skin (e.g. rosacea, melasma, psoriasis) and non-skin diseases (e.g. multiple sclerosis, etc.) which in the investigator's opinion interferes with vitiligo assessments or poses a safety risk.
  14. Subjects with a history of eczema herpeticum.
  15. 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.
  16. Subjects with known allergy or reaction to any component of the study formulation.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Other: Placebo IV

  • Experimental
    EB06

    Biological: EB06

Interventions

  • OtherPlacebo IV

    Placebo IV

  • BiologicalEB06

    EB06 IV loading 20 mg/kg followed by 10 mg/kg

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 28 Weeks

Secondary outcomes

  1. 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.

    Time frame: Weeks 24 and 32

  2. 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.

    Time frame: Weeks 24, 28, and 32

  3. 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.

    Time frame: Baseline through Week 32

  4. 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.

    Time frame: Weeks 24, 28, and 32

  5. 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.

    Time frame: Weeks 24, 28, and 32

  6. 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.

    Time frame: Weeks 24, 28, and 32

  7. 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.

    Time frame: Weeks 24, 28, and 32.

  8. 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.

    Time frame: Baseline through Week 32

  9. 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).

    Time frame: Weeks 24, 28, and 32

  10. 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).

    Time frame: Weeks 24, 28, and 32

  11. 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).

    Time frame: Weeks 24, 28, and 32

  12. 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).

    Time frame: Weeks 24, 28, and 32

  13. 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.

    Time frame: Weeks 24, 28, and 32

07

Study locations

1 of 5 sites recruiting
  • Vida Clinical Research
    Edmonton, Alberta T6H 4J8, Canada
    Not yet recruiting
  • Guelph Dermatology Research
    Guelph, Ontario N1L 0B7, Canada
    Not yet recruiting
  • Clear Skin Dermatology
    Newmarket, Ontario L3Y 5G8, Canada
    Not yet recruiting
  • FACET Dermatology
    Toronto, Ontario M4E 1R7, Canada
    Recruiting
  • CURAEX
    Panama City, Panama
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

3 registry updates since Sep 25, 2026
Sites
1 site added — first site in Panama
Show site
  • CURAEX · Panama City, Panama
Nov 6, 2026
Start date
Sep 2026→Aug 5, 2026 (actual)
Nov 6, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionMean percent change from baseline in F-VASI at Week 28: how it is measured was reworded
Oct 26, 2026
Secondary outcomes
2 description edited
What changed in the outcomes
  • DescriptionMean percent change from baseline in the T-VASI at Weeks 24, 28 and 32.: how it is measured was reworded
  • DescriptionProportion of subjects achieving T VASI50 at Weeks 24, 28 and 32.: how it is measured was reworded
Oct 26, 2026
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
Oct 26, 2026
Registered
First appeared on the registry
Oct 22, 2026
Show all 3 updates
  1. Nov 6, 2026
    1 site added — first site in Panama
    Show site
    • CURAEX · Panama City, Panama
    Start date Sep 2026→Aug 5, 2026 (now actual)
    + 1 other change: verification date
  2. Oct 26, 2026
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionMean percent change from baseline in F-VASI at Week 28: how it is measured was reworded
    Secondary outcomes 2 description edited
    What changed in the outcomes
    • DescriptionMean percent change from baseline in the T-VASI at Weeks 24, 28 and 32.: how it is measured was reworded
    • DescriptionProportion of subjects achieving T VASI50 at Weeks 24, 28 and 32.: how it is measured was reworded
    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
  3. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07889492
Lead sponsor
Edesa Biotech Inc.
Collaborators
JSS Medical Research Inc.
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Aug 5, 2026
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Nov 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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