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Efficacy and Safety of LY4005130 Compared with Placebo in Adults with Severe Alopecia Areata

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What is this study about?

Alopecia Areata is an autoimmune condition that causes sudden patches of hair loss and can become severe, leaving large areas of the scalp without hair. The study is testing an experimental medication called LY4005130, which is given through an IV (a drip placed into a vein) to see if it can help regrow hair in adults with this severe form of the disease.

The purpose of the study is to compare how well LY4005130 works against a placebo in reducing hair loss. Participants will receive a series of infusions over several weeks and will be monitored with regular visits to check safety and any changes in hair growth. Hair loss is measured using a scoring system called SALT, which rates the amount of scalp covered by hair; a lower score means more hair has returned.

1 enrollment and baseline assessment

after joining, baseline information is recorded, including measurement of hair loss severity using the absolute severity of alopecia tool (salt).

enrollment takes place during the recruitment period that began on 2026-05-31.

2 randomization

you are randomly assigned to receive either ly4005130 or a placebo without knowing which one.

3 study medication administration

the assigned product is given by intravenous infusion.

the product information lists a dose of 0 mg; other dosage, frequency, and duration are not provided in the available description.

4 follow‑up visits and assessments

you will attend scheduled visits where the same hair loss measurement is repeated.

the primary goal is to determine the percentage of participants achieving a salt score of 20 or lower.

5 study completion

the study ends on 2026-07-27, after which data are analyzed.

Who Can Join the Study?

  • Have severe alopecia areata, a strong form of an autoimmune condition that causes patchy hair loss.
  • Have hair loss covering at least 50% and no more than 90% of the scalp, measured with the Severity of Alopecia Tool (SALT) score (a scale doctors use to rate how much hair is missing).
  • Have had this current episode of severe hair loss for at least 6 months but not longer than 4 years.
  • Have not experienced noticeable natural hair regrowth for at least 6 months, as judged by the study doctor (the investigator).
  • Agree not to use any other alopecia areata (AA) treatments while participating in the study.
  • Be either male or female.
  • Be within the age range defined by the study.

Who Cannot Join the Study?

  • Having the “diffuse” type of alopecia areata, which means hair loss is spread out over the scalp rather than in distinct patches.
  • Having any other form of alopecia (hair loss) besides alopecia areata.
  • Having a serious or unstable additional illness that often requires hospital stays or frequent use of strong medicines that suppress the immune system (systemic immunosuppressants), as judged by the doctor.
  • Having taken oral JAK inhibitor medications in the past (these are pills that block specific pathways in the immune system).
  • Having undergone any major surgery within 8 weeks before screening or needing major surgery during the study.
  • Having a history or current serious problems with the heart, lungs, liver, stomach or intestines, hormone glands, blood, nerves, or mental health (cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders) or any other serious and/or unstable illness.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Diamond Clinic Sp. z o.o. Cracow Poland

Other Sites

Site Name City Country Status
Gsgybidcwm Rfmwxuwc Ssf z obmc Wroclaw Poland
Eengyng Udejyjghojym Mxnrwrc Cramajw Rpvtkrric (zextbzp Mof Rotterdam The Netherlands
Cinfmsm Bqtfx Kxksagbhzbn Pfkjwved Six z ojuc Gdansk Poland
Zrseuuc Mzh Ssw z ohfk Lublin Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not yet recruiting
31.05.2026
The Netherlands The Netherlands
Not yet recruiting
31.05.2026

Trial locations

LY4005130 is an experimental medicine being studied to see if it can help adults with severe alopecia areata, a condition that causes large patches of hair loss. In this trial the drug is given through a vein (intravenously) as a liquid that can be injected. Researchers are testing whether the medicine can promote new hair growth and whether it is safe to use. Participants receive the medicine in a double‑blind study, meaning neither the participants nor the doctors know who is getting the test drug, so the results can be compared fairly against a placebo group.

Alopecia Areata – Alopecia Areata is an immune‑system condition that leads to sudden hair loss, often in small round patches on the scalp. The patches can grow larger and new patches may appear over weeks or months. In some people the hair loss spreads to the whole scalp or other parts of the body. Hair can grow back on its own, but the loss and regrowth may happen repeatedly. The amount of hair loss can range from a few spots to extensive thinning.

Trial ID:
2025-524727-41-00
Protocol code:
J5D-MC-FPAC
Trial Phase:
Therapeutic exploratory (Phase II)

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