AuthorisedTherapeutic exploratory (Phase II)Interventional

J5D-MC-FPAC: A Phase 2a, Randomized, Multicenter, Double-Blind, Placebo-Controlled Proof of Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants With Severe Alopecia Areata

This research is looking into a new medicine called LY4005130 for adults who have severe alopecia areata, a condition where hair falls out in patches. It's a 'Phase 2a' study, meaning we're still in the early stages of testing. The main goal is to see how well the medicine helps hair grow back, measured by a special tool called SALT, and to check for any side effects. To make sure the results are clear, some participants will receive the active medicine, while others will get a placebo (a dummy treatment that looks the same but contains no medicine). Neither the participants nor the doctors will know who is getting which, to keep the study fair. This study is an important step to understand if LY4005130 could be a helpful treatment in the future.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Eli Lilly & Co.

Enrolment target

Start

08 Jun 2026

Alopecia Areata

What is this study about?

Alopecia areata is a condition where your immune system attacks your hair follicles, leading to hair loss on your scalp and sometimes other parts of your body. When it's severe, it can cause large patches of hair loss. This study, called J5D-MC-FPAC, is a research project designed to test a new experimental medicine, LY4005130, for adults who have severe alopecia areata. The main aim is to find out if this medicine can help hair grow back and if it is safe to use.

This is a 'Phase 2a' study, which means it’s an early but important step in developing new medicines. At this stage, we're particularly interested in seeing if the medicine has a positive effect on the condition and to understand its side effects better. A key part of this study is that it's 'randomised', meaning participants are put into groups by chance – some will get the new medicine, and others will get a 'placebo' (a treatment that looks exactly like the medicine but contains no active ingredients). It's also 'double-blind', which means neither you nor your study doctor will know whether you're receiving the active medicine or the placebo. This helps ensure the study results are as unbiased and accurate as possible.

The main thing researchers will be looking for is how many participants see their hair loss improve significantly, specifically if the amount of hair loss (measured by a tool called SALT) reduces to 20% or less across their scalp. This study is crucial for gathering information that could help decide if this new medicine should be tested in larger studies, moving it closer to potentially becoming a treatment option for people with severe alopecia areata.

Key takeaways

This study is testing a new medicine (LY4005130) for severe alopecia areata.
It aims to see if the medicine helps hair grow back and if it's safe.
Participation involves regular clinic visits for checks and assessments.
Some participants will receive the active medicine, others a dummy treatment (placebo).
Both men and women aged 18 and older with severe alopecia areata can potentially join.
You can stop participating at any time if you change your mind.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older, with severe alopecia areata. This means your hair loss must be significant on your scalp. Both men and women are welcome to take part.

Before you can join, the study doctors will review your medical history and conduct some tests to make sure you fit all the requirements for taking part in the study. These requirements are in place to ensure the safety of everyone involved and that the study can collect clear and reliable information about the new medicine.

There might be other specific health conditions or medications that would prevent you from taking part, even if you meet the age and condition criteria. The study team will discuss all these details with you thoroughly to see if this study is suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have severe alopecia areata?
Are you able to attend regular clinic visits?
Are you comfortable with the possibility of receiving a placebo?
Are you willing to share your medical history with the study team?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will visit the clinic regularly. At each visit, the study team will perform various tests and checks, which may include physical examinations, blood tests, and assessments of your hair loss using the SALT tool. You will receive either the investigational medicine (LY4005130) or a placebo, which you will take as instructed by the study team.

The visits will likely involve checking your general health and how well the treatment is working, as well as monitoring for any side effects. You will be asked to report any changes in your health or any new symptoms. The total duration of your participation in the study, including the treatment period and follow-up, will be clearly explained by the study team during the consent process.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit of receiving a new medicine that could help improve your alopecia areata, though there's no guarantee as it's still being tested. There are always potential risks, including side effects from the study medicine or discomfort from procedures like blood tests. You will be closely monitored for any adverse effects. You have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is alopecia areata?

Alopecia areata is a condition where your immune system mistakenly attacks your hair follicles, causing hair to fall out, usually in patches on the scalp.

What does 'Phase 2a' mean in a clinical trial?

Phase 2a means this is an early study to see if a new medicine works and is safe enough for further testing. It's a crucial step before larger studies.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It's used to compare results and see if the new medicine is actually effective.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are receiving the active medicine or the placebo until the study is over.

What is the SALT score?

SALT stands for 'Severity of Alopecia Tool' and it's a way for doctors to measure how much hair loss you have on your scalp. In this study, they want to see if it reduces to 20% or less.