EB06 for Vitiligo
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 EB06.12345Why 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive EB06 intravenous infusion with a loading dose of 20mg/kg followed by a maintenance dose of 10mg/kg, compared with placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Edesa Biotech Inc.
Lead Sponsor
JSS Medical Research Inc.
Industry Sponsor
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 ...
Edesa Biotech gets FDA clearance for EB06 vitiligo study
FDA has cleared the company's Investigational New Drug (IND) application for its Phase 2 clinical study of EB06 in vitiligo,
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), ...
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