Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study.

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Skin Center Dermatology Group

About this trial

Lichen planopilaris (LPP) is a primary lymphocytic cicatricial alopecia characterized by progressive, permanent hair loss and scalp symptoms such as pruritus and burning. Current treatments-including topical and intralesional corticosteroids, hydroxychloroquine, and immunosuppressants-are often inadequate, with limited evidence for efficacy and frequent treatment switching or discontinuation due to side effects or lack of response.1,2 Recent systematic reviews and meta-analyses highlight the need for new, targeted therapies. 3,4 Nemolizumab, an IL-31 receptor antagonist, FDA-approved for prurigo nodularis and atopic dermatitis, has demonstrated efficacy in pruritic and fibrosing dermatoses, making it a rational candidate for LPP.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

Clinical and/or histopathologic diagnosis of LPP.

Presence of scalp pruritus.

Average Peak Pruritus Numerical Rating Scale (PP-NRS) score ≥4 in the 7 days prior to Day 1.

Disqualifiers

Other forms of alopecia that may interfere with study assessments.

Any systemic disease associated with hair loss.

Inflammatory or infectious scalp disease that may interfere with the study.

Any other conditions associated with pruritus.

Trial design

Design model

Single group

Treatments tested in this trial

  • Nemolizumab

    Drug

    subcutaneous injection

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Patients receive nemolizumab injections every 4 weeks, weight based dosingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline at 24 weeks in Lichen Planopilaris Activity Index (LPPAI)

Time frame
24 weeks
2

Change from baseline at 24 weeks in Investigator Global Assessment (IGA) score (scarring alopecia version)

Time frame
24 weeks

Secondary outcomes

1

Change from baseline at 24 weeks in Peak Pruritus NRS.

Time frame
24 weeks

Other outcomes

1

Change from baseline at 24 weeks in hair count and average hair shaft thickness (digital trichoscopy).

Time frame
24 weeks
2

Incidence and severity of treatment-emergent adverse events.

Time frame
28 weeks

Sponsors and contacts

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