New pill shows promise for severe baldness, but trial cut short
NCT ID NCT05496426
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a drug called KL130008 in 114 adults with severe alopecia areata, a condition causing major hair loss. The goal was to see if the drug could safely regrow hair, measured by how many people achieved 80% or more scalp coverage. However, the trial was terminated early, so we have less information than planned.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KL130008 capsule
- What this could lead to
- If successful, this could point toward a new treatment option for people with severe alopecia areata, potentially regrowing significant hair.
- What could go wrong
- This trial was terminated early, so results may be incomplete. It's a Phase 2 study, meaning it's still early and may not lead to a proven treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
114 people
The number who actually took part.
- Started
-
Nov 2022
- Finished
-
Apr 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female subjects with the age of ≥18 and ≤ 65 years old at the time of informed consent. 2. Able to understand the procedures and methods of this study, and will to provide a signed and dated informed consent form. 3. Diagnosed alopecia areata(AA) without other reasons caused alopecia. 4. Have severe AA, as determined by all of the following:Current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, including alopecia totalis (AT) and alopecia universalis (AU);No spontaneous improvement over the past 6 months;Current episode of severe AA of less than 8 years. 5. All women of childbearing potential and all men must be willing to use at least one highly effective method of contraception from the signing of informed consent, throughout the duration of the study, and for 3 months after the last dose of investigational drugs. Exclusion Criteria: 1. Known history of anaphylaxis to any of the ingredients and/or other similar products. 2. Participated in a clinical trial of any drug or medical device and has used an investigational product (including placebo and control group) or treatment within 1 month or 5 half-lives before randomization. 3. Previously treated with JAK inhibitors. 4. Corticosteroids, finasteride, minoxidil,topical immunotherapy treated within 8 weeks before randomization. 5. Diphenylcyclopropenone (DPCP), HMGCoA reductase inhibitor, Chinese herbal medicine treated within 4 weeks before randomization. 6. With other diseases: acute "diffuse" type of AA, lymphoproliferative disease, tumor, severe chronic gastrointestinal disease, thyroid disorders, serious cardiovascular disease. 7. Subjects with evidence of clinical laboratory abnormalities at screening that, in the opinion of the investigator, may affect the safety of subjects or the interpretation of study results: Hemoglobin level \< 10.0 g/dL. Absolute white blood cell (WBC) count /absolute neutrophil count (NEUT)/absolute lymphocyte count(LYMPH)\<LLN. Aspartate aminotransferase (AST), or alanine aminotransferase (ALT) \> 2 × ULN, total bilirubin(TBIL)\>1.5 × ULN. QTcF\> 450ms. Subjects with eGFR ≤ 60 mL/min based on Cockcroft-Gault calculation. 8. The subject had or currently has a severe infection, and had a severe infection judged by the investigator within 1 month before randomization: HBV, TP-Ab, HIV, HCV, TB positive. 9. Subjects who are unsuitable to the trial, as identified by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangzhou, 510080, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can allergy and glaucoma drugs regrow hair when delivered by microneedling?
- Can a daily pill bring back hair in severe alopecia?