80 Participants NeededMy employer runs this trial

EB06 for Vitiligo

Recruiting at 4 trial locations
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called EB06 for individuals with moderate to severe non-segmental vitiligo, a condition where skin loses color in patches. The researchers aim to determine if EB06, designed to block a chemical that harms skin cells, is safe and effective compared to a placebo (a substance with no active medicine). Participants should have noticeable skin color loss from vitiligo on their face and body and must be willing to stop other vitiligo treatments for the trial's duration. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking all medications used to treat vitiligo from the start of the trial until Week 28. Over-the-counter products approved by the investigator and camouflage makeups are allowed.

Is there any evidence suggesting that EB06 is likely to be safe for humans?

Research has shown that EB06, a fully human monoclonal antibody, is being tested for safety. EB06 targets the protein CXCL10, which contributes to the harmful activity of certain immune cells in vitiligo.

Although detailed safety information from earlier studies isn't available, the U.S. FDA has allowed the trial to continue. This usually indicates that initial safety tests did not find major issues, deeming the treatment safe enough for further testing.

Now in Phase 2, EB06 demonstrated some safety in earlier, smaller studies. Researchers are currently assessing its tolerability in a larger group. This phase is crucial for understanding any side effects or risks associated with EB06.12345

Why do researchers think this study treatment might be promising for vitiligo?

Unlike the standard vitiligo treatments, which often involve topical corticosteroids or phototherapy, EB06 is unique because it introduces a new mechanism of action targeting specific pathways involved in skin pigmentation. Researchers are excited about EB06 because it could offer a more precise approach, potentially leading to better repigmentation results with fewer side effects. This innovative treatment could offer hope to patients who have not seen success with existing therapies.

What evidence suggests that EB06 might be an effective treatment for vitiligo?

Research suggests that EB06, which participants in this trial may receive, might help treat vitiligo. EB06 blocks a protein called CXCL10, which normally aids harmful immune cells in attacking and destroying the skin's pigment cells. Studies have shown that stopping CXCL10 can prevent the skin damage leading to vitiligo. In earlier tests, this method halted the loss of skin color by reducing the activity of these immune cells. Although more research is needed, these findings suggest that EB06 may help restore skin color in people with vitiligo.678910

Are You a Good Fit for This Trial?

This trial is for adults with moderate to severe non-segmental vitiligo, a skin condition causing loss of pigment. Participants should not have other major health issues that could interfere with the study.

Inclusion Criteria

I am not pregnant and will use birth control during and after the study.
I agree to use effective birth control during and for 12 weeks after treatment.
I have non-segmental vitiligo with noticeable patches on my face and body.
See 2 more

Exclusion Criteria

I have facial vitiligo with over 30% white hair in the affected areas.
Pregnant and/or breastfeeding subjects
Subjects of childbearing potential unwilling or unable to use one method of contraception for the study duration and 12 weeks after last dose
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EB06 intravenous infusion with a loading dose of 20mg/kg followed by a maintenance dose of 10mg/kg, compared with placebo

28 weeks
Regular visits for infusion and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • EB06

Trial Overview

The study compares EB06, an intravenous antibody treatment targeting immune cells involved in vitiligo, against a placebo. It is randomized and double-blind, meaning neither patients nor doctors know who gets which treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: EB06Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Edesa Biotech Inc.

Lead Sponsor

Trials
6
Recruited
2,100+

JSS Medical Research Inc.

Industry Sponsor

Trials
19
Recruited
5,600+

Citations

Edesa Biotech Receives FDA IND Clearance for Phase 2 ...

EB06 is a monoclonal antibody that targets CXCL10, interrupting immune-cell recruitment and preventing melanocyte loss in vitiligo. Disclaimer: ...

EDSA: Advancing EB06 for the Treatment of Vitiligo

Once cleared by the FDA, topline results could be available in approximately 12-18 months. Once cleared by the FDA, topline results could be ...

Edesa Biotech Confirms Mid-2026 Start for Phase 2 Vitiligo ...

The Phase 2 study will test the safety and efficacy of intravenous EB06 versus placebo, building on earlier clinical and preclinical data ...

Are vitiligo treatments cost-effective? A systematic review

Are vitiligo treatments cost-effective? A systematic review. Health Expenditures Humans Treatment Outcome Vitiligo / economics*

EDSA: Advancing EB06 for the Treatment of Vitiligo

Manufacturing of EB06 is likely to be finished in the second half of 2025 such that the company can submit the manufacturing data to the FDA ...

Edesa Biotech Receives the US FDA's IND Clearance for P ...

The US FDA cleared Edesa Biotech's IND for a P-II study of EB06 in vitiligo, expanding recruitment to the US; topline data are anticipated ...

A clinical trial to evaluate safety and efficacy of AB1001 ...

A Phase II, multicenter, randomized study to evaluate safety and efficacy of topical AB1001 in adult patients with non-segmental vitiligo.

Edesa Biotech Announces FDA IND Clearance for ... - ADVFN

The safety and efficacy of EB06 remain subject to clinical evaluation. About EB06. EB06 is a fully human monoclonal antibody candidate that binds ...

EB 06 - AdisInsight

EB 06 (also know as NI 0801) is a fully human monoclonal antibody being developed by Edesa Biotech and Light Chain Biosciences (formerly NovImmune SA), ...