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A Phase 2a Study of ly4005130 in Adults with Severe Alopecia Areata

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults with severe Alopecia Areata, an autoimmune condition that causes sudden, patchy hair loss. Participants will receive an intravenous (through a vein) infusion of the experimental drug LY4005130 or a placebo. The purpose of the study is to compare the effectiveness of LY4005130 with placebo in reducing hair loss in this population.

During the trial, participants are randomly assigned to receive either the study drug or placebo, and neither the participants nor the study staff know which treatment is given (double‑blind). The study lasts several weeks, with regular clinic visits for the infusion and monitoring of safety. Hair growth is measured using the SALT score, which rates the amount of scalp covered by hair, and a lower score indicates improvement. Simple explanations are provided at each visit to help participants understand the procedures and any medical terms used.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and baseline assessment

    After joining the study, you are assigned by a computer system to receive either ly4005130 or the placebo sub12581mig without knowing which one you receive.

    A baseline visit is scheduled where your hair loss severity and overall health are recorded.

  2. Step 2

    First infusion

    On the day of the first visit, an intravenous (through a vein) infusion is given.

    The infusion contains either ly4005130 at a dose of 0 mg (solution for injection) or the matching placebo, administered according to the study protocol.

  3. Step 3

    Treatment period

    Additional infusions are given at the intervals defined by the protocol; the exact schedule is followed by the study staff.

    Each infusion is performed in the same manner as the first, using the same dose and route.

  4. Step 4

    Safety and efficacy monitoring

    Regular visits are scheduled to check for side effects and to measure changes in hair loss using the severity of alopecia tool (salt).

    These visits continue throughout the study period, which runs from may 31 2026 to july 27 2026.

  5. Step 5

    Final evaluation

    At the end of the study, a final assessment is performed to determine whether the percentage of participants with a salt score of 20 or less has changed.

    The results are recorded and the trial is concluded.

Who can join the trial?

7 criteria

  • You have severe Alopecia Areata (AA), a strong form of the condition that causes hair loss.
  • Your hair loss covers at least 50% but no more than 90% of your scalp, measured with the Severity of Alopecia Tool (SALT) score, a scale doctors use to count the area without hair.
  • The current episode of severe AA has lasted at least 6 months and no longer than 4 years.
  • In the doctor’s opinion, you have not had any noticeable spontaneous hair regrowth (hair growing back on its own) for at least 6 months.
  • You agree not to use any other AA treatments (medicines or therapies for Alopecia Areata) while in the study.
  • Both men and women are eligible to join the study.
  • You must be within the age range set by the study.

Who cannot join the trial?

13 criteria

  • Having the diffuse type of alopecia areata, which means hair loss is spread out over the scalp rather than in patches.
  • Currently having any other type of alopecia (different forms of hair loss).
  • Having a serious or unstable additional illness that often needs hospital stays or the regular use of strong medicines that lower the immune system (systemic immunosuppressants).
  • Having taken oral JAK inhibitors (pills that affect the immune system) before joining the study.
  • Having had a major operation within the last 8 weeks before screening, or needing a major operation during the study.
  • Having a history or current problem with any serious condition such as:
    • Cardiovascular disorders (heart or blood‑vessel problems),
    • Respiratory disorders (lung or breathing problems),
    • Hepatic disorders (liver problems),
    • Gastrointestinal disorders (stomach or intestine problems),
    • Endocrine disorders (hormone problems),
    • Hematological disorders (blood problems),
    • Neurological disorders (nerve or brain problems),
    • Neuropsychiatric disorders (mental health or behavior problems), or any other serious and/or unstable illness.
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Investigated drugs

LY4005130 is an experimental medicine being tested to see if it can help people with severe alopecia areata, a condition that causes large patches of hair loss. In this study the drug is given as a sterile liquid that is injected into a vein (intravenous use). Researchers are looking at whether the medicine can promote hair regrowth and be safe for patients.

What is already known about the treatment

  • LY4005130

    This medication is given as a sterile solution that is injected into a vein (intravenous infusion). It is still an investigational drug and is being studied in a Phase 2a clinical trial, so it is not yet approved for general medical use. The drug is being tested for people with severe alopecia areata, a condition that causes patchy hair loss. It works by blocking a specific protein inside immune cells that triggers inflammation and hair‑follicle damage, and it belongs to the class of small‑molecule immune‑system modulators.

  • SUB12581MIG

    This product is a placebo, meaning it contains no active medicine and is used only as a control in the study. It has no therapeutic use and is not approved for any medical condition outside of clinical trials. The placebo is administered in the same way as the active drug (intravenous) to keep the study blind. Because it contains no active ingredient, it has no mechanism of action or pharmacological class.

Investigated diseases

Alopecia Areata - Alopecia Areata is an autoimmune condition that causes sudden hair loss in patches on the scalp or other body areas. The immune system mistakenly attacks hair follicles, leading to hair shedding. The patches can appear quickly and may expand over weeks or months. In some people the condition remains limited to small areas, while in others it can spread to larger portions of the scalp. The pattern of hair loss can change over time, with new spots developing and some areas regrowing hair intermittently.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524727-41-00Protocol codeJ5D-MC-FPACEstimated enrolment65 patientsSponsorEli Lilly & Co.

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