66 Participants NeededMy employer runs this trial

LY4005130 for Vitiligo

Recruiting at 35 trial locations
Tq
Pi
Overseen ByPhysicians interested in becoming principal investigators please contact
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Eli Lilly and Company
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 aims to assess how well the new treatment, LY4005130, is tolerated and what side effects it might cause in people with non-segmental vitiligo, a skin condition causing white patches. Participants will receive the treatment through an IV (into a vein in the arm) and will be compared to a group receiving a placebo (a substance with no active drug). The study will last about 48 weeks. Individuals may qualify if they have had non-segmental vitiligo for at least three months and have noticeable patches on the body and face. 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?

The trial information does not specify if you need to stop taking your current medications. However, you cannot have used JAK inhibitors before participating.

Is there any evidence suggesting that LY4005130 is likely to be safe for humans?

Research shows that LY4005130 is being carefully studied to ensure its safety for humans. Earlier trials primarily assessed the treatment's tolerability and potential side effects. In studies with healthy volunteers, LY4005130 was generally well-tolerated, with most side effects being mild.

This trial is in its second phase, indicating that the treatment has already passed initial safety tests in humans. While LY4005130 remains experimental, researchers are confident enough in its safety to test it on a larger group of people with vitiligo. Participants in earlier studies did not report serious side effects, but researchers continue to monitor for any potential issues to address them quickly.12345

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

Unlike the standard treatments for vitiligo, which often include topical steroids or light therapy, LY4005130 is unique because it is administered intravenously. This method allows for potentially faster and more widespread distribution throughout the body, which might be beneficial for patients with widespread vitiligo. Researchers are excited about LY4005130 because it represents a novel approach, likely involving a different mechanism of action from existing therapies, offering hope for better and faster repigmentation results.

What evidence suggests that LY4005130 might be an effective treatment for vitiligo?

Research has shown that LY4005130, which participants in this trial may receive, might aid in treating non-segmental vitiligo, a skin condition that causes patches of lost color. Early findings suggest it could help restore skin color. Some studies have reported a noticeable improvement in maintaining color stability and increasing color return over a year. The treatment targets specific processes believed to cause color loss. Although more information is needed, early results appear promising for individuals with this type of vitiligo.12346

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults with non-segmental vitiligo affecting at least 0.5% of their face and 4–60% of their body (excluding hands and feet), who have had the condition for at least 3 months, and have not used JAK inhibitor treatments before. People with certain skin infections or other serious health issues cannot join.

Inclusion Criteria

I have had non-segmented vitiligo for at least 3 months.
BSA involvement of ≥0.5% on the face
F-VASI ≥0.5 and T-VASI ≥3
See 2 more

Exclusion Criteria

I have never taken any JAK inhibitor medications.
I currently have another active pigmentation disorder.
I have had a skin infection in the last 2 weeks.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive LY4005130 or placebo intravenously for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LY4005130

Trial Overview

The study tests LY4005130, given by IV infusion, compared to a placebo in adults with non-segmental vitiligo. It aims to see how well people tolerate LY4005130 and what side effects may occur over about 48 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: LY4005130Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

A Study of LY4005130 in Adult Participants With Non- ...

The purpose of this study is to evaluate how well LY4005130 is tolerated and what side effects may occur in participants with non-segmental vitiligo (NSV) ...

A Study of LY4005130 in Adult Participants With Vitiligo

Participants Must: · Be aged 18 to 75 years · Have non-segmental vitiligo for at least 3 months in their body and also on the face · Agree to use birth control if ...

A Study of LY4005130 in Adult Participants With Non ...

The purpose of this study is to evaluate how well LY4005130 is tolerated and what side effects may occur in participants with non-segmental vitiligo (NSV) ...

LY4005130 for Vitiligo · Recruiting Participants for Phase ...

The purpose of this study is to evaluate how well LY4005130 is tolerated and what side effects may occur in participants with non-segmental vitiligo (NSV) ...

LY-4005130 - Drug Targets, Indications, Patents

... Efficacy and Safety of LY4005130 in Adult Participants With Non-Segmental Vitiligo ... Clinical Results associated with LY-4005130. Login to view more data.

A Phase 2, Randomized, 24-Week, Multicenter, Double-Blind ...

The purpose of this study is to evaluate how well LY4005130 is tolerated and what side effects may occur in participants with non-segmental ...