45 Participants Needed

EI-001 for Vitiligo

Recruiting at 2 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?

The trial aims to determine if a new drug, EI-001, can improve symptoms of vitiligo, a condition causing patches of skin to lose color. EI-001 is an antibody drug that targets the immune system to reduce inflammation. Participants will receive either the actual drug or a placebo (a pill with no active medicine) to compare results. The trial seeks individuals with non-segmental vitiligo for at least three months who have not found success with other treatments like creams or light therapy. Participants must agree to stop other vitiligo treatments during the trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

Yes, you will need to stop all vitiligo treatments from the screening until the final follow-up.

Is there any evidence suggesting that EI-001 is likely to be safe for humans?

Research has shown that EI-001, a new antibody drug, could be a promising treatment for vitiligo. In earlier studies, researchers tested EI-001 on human cells, animals, and healthy volunteers. The results suggested that EI-001 is generally safe, with most participants experiencing no serious side effects.

While detailed information about side effects remains unavailable, the ongoing human trials indicate that EI-001 is safe enough for further study. Treatments reaching this stage have typically demonstrated safety in early tests and can be tried in more people.

Overall, EI-001 appears to be a potential new option for reducing inflammation, which may help alleviate vitiligo symptoms.12345

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

Unlike other treatments for vitiligo, which often involve topical corticosteroids or light therapy, EI-001 is unique because it targets specific pathways that may help restore skin pigmentation. Researchers are excited about EI-001 because it represents a novel approach by potentially modulating the immune response directly related to vitiligo, which could lead to more effective and lasting results. This innovative mechanism sets EI-001 apart from conventional therapies, offering hope for improved outcomes for individuals with vitiligo.

What evidence suggests that EI-001 might be an effective treatment for vitiligo?

Research shows that EI-001, which participants in this trial may receive, is a promising new treatment for vitiligo, a condition where the skin loses its color. Studies have found that EI-001 can help reduce inflammation in the immune system, believed to contribute to vitiligo. Although limited data from human studies on vitiligo exist, EI-001 has been tested in lab settings and animal studies, demonstrating safety and potential effectiveness for immune-related diseases. Early results suggest it might improve symptoms by targeting the immune response. This drug remains under study, but initial signs are hopeful for people with vitiligo.13567

Are You a Good Fit for This Trial?

Adults aged 18-65 with non-segmental vitiligo who've tried topical, phototherapy, or oral treatments for several months can join. They must understand the study and agree to stop other vitiligo treatments during the trial. Women of childbearing age should use contraception.

Inclusion Criteria

Contraception
Able to understand and voluntarily sign the informed consent form (ICF)
Agree to discontinue all vitiligo treatments from screening until final follow-up
See 8 more

Exclusion Criteria

Psychiatric risk
Pregnancy or lactation
Abnormal chest X-ray
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study medication EI-001 or placebo to evaluate its efficacy and safety in improving vitiligo symptoms

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the evaluation of adverse events and clinical laboratory studies

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • EI-001

Trial Overview

The trial is testing EI-001, a new antibody drug designed to reduce inflammation in immune diseases like vitiligo. Participants will either receive EI-001 or a placebo to see if there's an improvement in their skin condition.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Drug: EI-001Experimental Treatment1 Intervention
Group II: Drug: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Elixiron Immunotherapeutics (Hong Kong) Ltd.

Lead Sponsor

Citations

NCT07223229 | Phase 2 Study to Evaluate EI-001 in Non- ...

The primary purpose of this study is to evaluate whether the drug EI-001 can help improve vitiligo symptoms. EI-001 is a novel antibody drug ...

EI-001, Elixiron's drug candidate for treating vitiligo, has ...

EI-001, Elixiron's drug candidate for treating vitiligo, has received approval for a clinical trial in China from the National Medical Products Administration.

Emerging Therapeutic Innovations for Vitiligo Treatment - PMC

A recent open-label phase 2 study (NCT03468855) evaluated the safety and efficacy of a 0.46% efinetinib solution for the treatment of non-segmental facial ...

Mount Sinai Dermatologists Show Promising Results Using ...

Notably, the combination led to a mean 69.6 percent improvement in facial repigmentation, compared to 55.1 percent with ritlecitinib alone. Total body ...

Indemakitug - Drug Targets, Indications, Patents

EI-1 was equally active against cell-culture adapted HCV (HCVcc), blocking both cell-free entry and cell-to-cell transmission of virus. HCVcc with high-level ...

A Randomized, Double-blind, Placebo-controlled Proof-of ...

The primary purpose of this study is to evaluate whether the drug EI-001 can help improve vitiligo symptoms. EI-001 is a novel antibody drug ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40966008/

Immune checkpoint inhibitor-induced vitiligo: A large-scale ...

This study confirms vitiligo as a multi-dimensional irAE with cross-tumor prognostic value and reveals the modulating role of metabolic factors ...