Health Trials

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

ConditionAlopecia Areata
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-50
SponsorEli Lilly and Company

About this trial

The purpose of this study is to evaluate how well LY4005130 works in participants with severe alopecia areata (hair loss) when compared with placebo, and how well it's tolerated and what side effects may occur. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

The study drug will be administered intravenously (IV) (into a vein in the arm).

The study will last approximately 48 weeks, including screening.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hair loss encompassing ≥50% and ≤90% of the scalp, as measured by Severity of Alopecia Tool (SALT) score

The duration of the current episode of severe AA is at least 6 months and does not exceed 4 years

No significant spontaneous hair regrowth in the investigator's opinion for at least 6 months

Agree not to use any AA treatments during the study

Disqualifiers

Primarily "diffuse" type of AA (characterized by diffuse hair shedding)

Are currently experiencing other forms of alopecia

Participants who, in the opinion of the investigator, are currently experiencing or have a history of unstable concomitant disease that requires frequent hospitalizations, and/or frequent use of systemic immunosuppressants that may interfere with participation in the study

Have received oral JAK Inhibitors in the past

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY4005130

    Drug

    Administered IV

  • Placebo

    Drug

    Administered IV

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: LY4005130Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Less than or Equal to (≤) 20

Time frame
Week 24

Secondary outcomes

1

Percentage of Participants Achieving At Least 50 Percent (%) Improvement from Baseline (SALT50)

Time frame
Week 24
2

Pharmacokinetics (PK): Trough Concentrations of LY4005130

Time frame
Baseline Through Week 20
3

Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Scalp Biopsy

Scalp Biopsy

Time frame
Baseline, Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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