Health Trials

A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo

ConditionsVitiligoNon-Segmental Vitiligo (NSV)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEli Lilly and Company

About this trial

The purpose of this study is to evaluate how well LY4005130 is tolerated and what side effects may occur in participants with non-segmental vitiligo (NSV) when compared with placebo. The study drug will be administered intravenously (IV) (into a vein in the arm).

Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

The study will last approximately 48 weeks, including screening.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

A clinical diagnosis of non-segmented vitiligo (NSV) for at least 3 months

Body surface area (BSA) involvement of 4% to 60%, inclusive, excluding involvement at palms of the hands, soles of the feet, or dorsal aspect of the feet

BSA involvement of ≥0.5% on the face

F-VASI ≥0.5 and T-VASI ≥3, and

Disqualifiers

Participants who have other types of vitiligo that are not considered active or stable vitiligo

Currently have active forms of other disorders of pigmentation

Currently have active forms of inflammatory skin disease(s) or evidence of skin conditions that would interfere with evaluation of vitiligo or response to treatment

Have a superficial skin infection within 2 weeks before baseline. Participants may be rescreened after the infection is resolved

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY4005130

    Drug

    Administered IV

  • Placebo

    Drug

    Administered IV

Treatment groups

66 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 Facial Vitiligo Area Scoring Index (F-VASI) 75

Time frame
Week 24

Secondary outcomes

1

Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 75

Time frame
Week 24
2

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

Time frame
Baseline, Week 24
3

Pharmacokinetics (PK): Observed Trough of LY4005130 Serum Concentration

Time frame
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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