RecruitingPHASE2INTERVENTIONAL

A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)

This research study is looking into a new medicine called LY4005130 for adults with severe alopecia areata, a condition where people experience significant hair loss. The main goals are to find out how effective this medicine is at helping hair regrow compared to a 'dummy' treatment (placebo), and to understand any side effects it might cause. Researchers will also take blood tests to see how the body handles the medicine and how the medicine affects the body. The medicine will be given directly into a vein in the arm. The study will last for about 48 weeks, which is roughly 11-12 months, including an initial checking period.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Eli Lilly and Company

Enrolment target

Start

14 Apr 2026

Estimated completion

01 Oct 2027

Alopecia Areata

What is this study about?

Alopecia areata is a condition where your immune system mistakenly attacks your hair follicles, leading to hair loss. This study is exploring a potential new treatment, called LY4005130, for people with a severe form of this condition. The aim is to see if this new medicine can help people grow their hair back, and how it compares to not receiving the active medicine.

Researchers will carefully compare the new medicine to a 'placebo', which looks exactly like the medicine but contains no active ingredients. This is a standard way to test new treatments, as it helps determine if any changes or improvements are truly due to the medicine itself rather than other factors. They will also be closely monitoring participants for any side effects to understand how well the medicine is tolerated by the body. Blood tests will be part of the study to help us understand how your body uses and responds to the medicine.

Understanding how new treatments work and what their side effects might be is really important for developing better ways to help people with alopecia areata. This study is a stepping stone in that process, providing valuable information that could one day lead to approved medicines to help manage this condition.

Key takeaways

Tests a new medicine (LY4005130) for severe alopecia areata.
Compares the medicine to a dummy treatment (placebo).
Aims to understand effectiveness and potential side effects.
Medicine given into a vein; involves regular clinic visits.
Total study duration is about 48 weeks.
Suitable for adults aged 18-50 with specific hair loss criteria.

Who may be eligible?

This study is looking for adults aged between 18 and 50 years old. To join, you must have severe alopecia areata, meaning you've lost hair on at least half, but not more than 90%, of your scalp. Your current hair loss episode must have lasted for at least 6 months but no longer than 4 years, and your hair shouldn't have grown back much on its own in the last six months.

You cannot join this study if you have a different type of hair loss, or if you are currently using other alopecia areata treatments or planning to use them during the study. It's also not suitable for you if you've had certain other treatments in the past, like specific 'JAK inhibitors' medicines, or if you've had major surgery recently or need one soon.

Also, if you have other serious health conditions that need frequent hospital visits or strong medicines, or specific heart, lung, stomach, or other disorders, this study might not be safe for you. The study team will review your full medical history to make sure it's safe for you to take part.

Quick self-check

Are you between 18 and 50 years old?
Have you lost more than half, but not all, of your scalp hair from alopecia areata?
Has your current hair loss lasted for at least 6 months but no more than 4 years?
Have you avoided specific hair loss treatments like JAK inhibitors in the past?
Are you generally in good health without other serious medical conditions?
Are you able to commit to regular clinic visits for about 48 weeks?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, the study medicine, LY4005130, will be given to you directly into a vein in your arm (this is called an intravenous or IV infusion). You will receive either the active medicine or a placebo (a dummy medicine) – you won't know which one you are getting. During the study, you will have several appointments at the study clinic. These visits will involve various checks, such as measuring your hair loss, physical examinations, and taking blood samples. These blood tests help us understand how the medicine is working and how your body is reacting to it. The entire study, including the initial checks to see if you can join, will last for about 48 weeks, which is nearly a year.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that isn't widely available yet, which might help your hair regrow. However, like all medicines, LY4005130 could have side effects, and we don't yet know all of them. Being in the study also means regular hospital visits, blood tests, and scans. You will be closely monitored for your safety and well-being throughout, and you are free to change your mind and withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (30)

Center For Dermatology Clinical Research, Inc.
Fremont, United States· Recruiting
Northridge Clinical Trials
Northridge, United States· Recruiting
Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway
Santa Clarita, United States· Not yet recruiting
Health Clinical Research, LLC
Cutler Bay, United States· Recruiting
Brigham and Women's Hospital
Boston, United States· Not yet recruiting
Revival Research Institute, LLC
Troy, United States· Recruiting
Stracskin
Portsmouth, United States· Recruiting
Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
San Antonio, United States· Recruiting
Jordan Valley Dermatology & Research Center
South Jordan, United States· Recruiting
Kelowna Health and Memory Centre
Kelowna, Canada· Not yet recruiting
Ryan Clinical Research Inc.
Newmarket, Canada· Not yet recruiting
Dar Clinical Research - Ottawa - Hunt Club Road
Ottawa, Canada· Not yet recruiting

+18 more sites — see the official record for the full list.

Common questions

What is alopecia areata?

Alopecia areata is an autoimmune condition where your immune system mistakenly attacks your hair follicles, causing hair to fall out in patches or, in severe cases, all over the body.

What is LY4005130?

LY4005130 is the name of the new experimental medicine being tested in this study for severe alopecia areata.

What does 'placebo' mean in a study?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare if the new medicine is actually effective.

How will I receive the study medicine?

The study medicine will be given to you directly into a vein in your arm, similar to getting a drip.

How long will the study last if I join?

If you join this study, it will last for about 48 weeks in total, which is nearly a year.

How to find out more

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

LillyTrials@Lilly.com 1-317-615-4559 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.