10 Participants Needed

Nemolizumab for Lichen Planopilaris

PF
Overseen ByPeter Friedman, MD PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests nemolizumab, a medication typically used for conditions like eczema, to determine its effectiveness for lichen planopilaris (LPP), which causes permanent hair loss and scalp itching. Researchers seek new treatments because current options often prove ineffective or cause side effects. Individuals diagnosed with LPP and experiencing frequent scalp itching might be suitable for this trial. Participants will receive nemolizumab injections every four weeks. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how it can benefit more patients with LPP.

Will I have to stop taking my current medications?

You may need to stop certain medications before joining the trial. If you're using JAK inhibitors, biologics, DMARDs, or corticosteroids, you must stop them for at least 12 weeks (for JAK inhibitors, biologics, and DMARDs) or 4 weeks (for corticosteroids) before starting the trial. Other hair loss treatments must be stable for 6 months or stopped for 3 months.

What is the safety track record for Nemolizumab?

Studies have shown that nemolizumab is generally safe. Research on its use for conditions like prurigo nodularis and atopic dermatitis indicates that patients tolerate nemolizumab well. Most side effects are mild, with some experiencing skin reactions such as redness or itchiness at the injection site. In one study, 39.5% of patients reported side effects, mostly related to the skin and not severe.

The FDA has approved nemolizumab for certain skin conditions, suggesting its safety. Other studies have used it without major safety concerns, making it a promising option for treating lichen planopilaris. However, as with any treatment, monitoring for side effects remains important.12345

Why are researchers enthusiastic about this study treatment?

Most treatments for lichen planopilaris involve corticosteroids or immunosuppressants to reduce inflammation and slow disease progression. However, nemolizumab is unique because it targets the IL-31 receptor, which is involved in the itch and inflammation process of this condition. By blocking this receptor, nemolizumab may provide relief from symptoms with potentially fewer side effects compared to traditional immunosuppressants. Researchers are excited about nemolizumab as it offers a new mechanism of action that could improve patient outcomes and quality of life.

What evidence suggests that nemolizumab might be an effective treatment for lichen planopilaris?

Research has shown that nemolizumab works well for conditions causing itching and thickened skin. It is approved for treating prurigo nodularis and atopic dermatitis, where it reduces itching and improves skin health. In studies, patients using nemolizumab were more than three times as likely to experience significant itch relief. This trial will evaluate nemolizumab as a promising option for lichen planopilaris, a condition that leads to hair loss and an itchy scalp. Its success in similar conditions suggests it might effectively manage symptoms of lichen planopilaris.12567

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Lichen Planopilaris, experiencing scalp itching. Participants must be willing to follow study procedures and agree to optional scalp biopsies. They should have a clinical diagnosis of LPP and an itchiness score of at least 4 out of 10.

Inclusion Criteria

I am willing and able to follow the study rules and sign the consent form.
I have itchy scalp.
I am 18 years old or older.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nemolizumab injections every 4 weeks, with weight-based dosing

12 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Nemolizumab

Trial Overview

The trial is testing Nemolizumab, an FDA-approved drug for skin conditions involving itchiness and inflammation. It's designed as a new treatment option for Lichen Planopilaris, which causes hair loss and scalp discomfort.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Patients receive nemolizumab injections every 4 weeks, weight based dosingExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Skin Center Dermatology Group

Lead Sponsor

Trials
5
Recruited
170+

Citations

Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled ...

3,4 Nemolizumab, an IL-31 receptor antagonist, FDA-approved for prurigo nodularis and atopic dermatitis, has demonstrated efficacy in pruritic ...

Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled ...

3,4 Nemolizumab, an IL-31 receptor antagonist, FDA-approved for prurigo nodularis and atopic dermatitis, has demonstrated efficacy in pruritic ...

Nemolizumab for Lichen Planopilaris

It's designed as a new treatment option for Lichen Planopilaris, which causes hair loss and scalp discomfort.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41631581/

24-week real world outcomes of nemolizumab in patients ...

Conclusion: Nemolizumab provided rapid and sustained itch relief with gradual lesion improvement in real-world PN. Early pruritus response may ...

Nemolizumab Demonstrates Strong Efficacy in PN

Meta-analysis of RCTs reveals nemolizumab's efficacy, with patients 3.52 times more likely to achieve meaningful itch reduction compared to ...

761390Orig1s000 INTEGRATED REVIEW - accessdata.fda.gov

The available safety data show that nemolizumab is safe for its intended use as labeled. ... nemolizumab exposure and safety outcomes ...

NEMLUVIO (nemolizumab) – Risk Management Plan (RMP)

T-cell lymphoma, lichen planus, keratoacanthomas, and bullous pemphigoid (Iking, ... Updated safety data from both LTE studies for long-term safety analyses are.