What side effects are associated with this type of intervention?

Treatments for Lichen Planus similar to Ixekizumab, such as monoclonal antibodies targeting IL-17A, include drugs like secukinumab and brodalumab. Common side effects of these treatments can include upper respiratory tract infections, nasopharyngitis, headache, and injection site reactions. Additionally, there is a potential risk for inflammatory bowel disease and other infections. Long-term safety data are still being evaluated, but current studies do not show a significant increase in the risk of malignancies.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Lichen Planus that target IL-17A, like Ixekizumab. Treatments for Lichen Planus generally include corticosteroids, retinoids, and immunosuppressive agents. Ixekizumab, which is being studied for its efficacy in treating Lichen Planus, is a monoclonal antibody that targets IL-17A and has shown promise in treating other inflammatory conditions such as psoriasis.

What other types of research exist?

Promising novel alternatives to Ixekizumab for Lichen Planus patients in 2024 include anti-IL-23 agents such as Ustekinumab and Mirikizumab. These agents have demonstrated efficacy and a favorable safety profile in related inflammatory conditions like ulcerative colitis and psoriasis.

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Monoclonal Antibodies

Ixekizumab for Lichen Planus

Q: What is the mechanism of action of this treatment?

The most common treatments for Lichen Planus include topical corticosteroids, systemic immunosuppressants like mycophenolate mofetil (MMF), and biologics such as Ixekizumab. Topical corticosteroids work by reducing inflammation and suppressing the immune response locally. Systemic immunosuppressants like MMF inhibit the proliferation of T and B lymphocytes, thereby reducing the overall immune response. Ixekizumab, a monoclonal antibody targeting IL-17A, works by inhibiting the activity of interleukin-17A, a cytokine involved in inflammatory and immune responses. This is particularly important for Lichen Planus patients as it helps to control the chronic inflammation and immune dysregulation that characterize the disease, potentially leading to better management of symptoms and disease progression.

Phase < 1

Waitlist Available

Research Sponsored by University of New Mexico

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis of cutaneous lichen planus, lichen planopilaris, frontal fibrosing alopecia at least 6 months prior to enrollment as determined by patient interview of his/her medical history, biopsy proven lichen planus and by confirmation of diagnosis through physical examination by the investigator

Be older than 18 years old

Must not have

Women unwilling to use adequate birth control, if of reproductive potential* and sexually active. Adequate birth control is defined as agreement to consistently practice an effective and accepted method of contraception whenever engaging in heterosexual intercourse throughout the duration of the study and for 16 weeks after last dose of study drug. These include: hormonal contraceptives, intrauterine device (IUD), a double barrier method (eg, condom + diaphragm), or male partner with documented vasectomy.

Planned major surgical procedure during the patient's participation in this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing ixekizumab, a medication that reduces inflammation, in adults with lichen planus and lichen planopilaris. These conditions cause skin problems, and the study aims to see if the medication can help. Ixekizumab works by blocking a protein that leads to swelling and redness.

Who is the study for?

Adults over 18 with a history of lichen planus or lichen planopilaris, who have tried at least one topical or systemic treatment without success, can join this trial. Participants must be able to follow the study protocol and provide informed consent. Exclusions include recent use of investigational drugs, certain vaccinations, other forms of lichen planus, prior biologic treatments targeting IL-17A/RA receptors, skin conditions that could affect assessments, substance abuse history within six months, severe illnesses that might impact participation or pose risks.

What is being tested?

The trial is testing the safety and effectiveness of ixekizumab delivered via auto-injector in treating lichen planus and lichen planopilaris. Success will be measured by changes in Total Body Surface area affected, Investigator Global Assessment Score (IGA), LPPAI for activity index assessment and FFASS for severity scoring.

What are the potential side effects?

Ixekizumab may cause side effects such as injection site reactions (like redness or pain), increased risk of infections due to immune system suppression, possible allergic reactions including hives or swelling under the skin. Other potential side effects are not specified but would be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a skin condition related to lichen planus for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I agree to use effective birth control during and 16 weeks after the study.

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I am scheduled for a major surgery during this study.

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I am not planning to get any live vaccines during or 6 weeks before the study.

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I have a chronic infection or a positive TB test result.

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I have a type of lichen planus that is not on the skin or scalp.

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I have been treated with drugs targeting IL-17A or IL-17RA before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Investigator Global Assessment (IGA)

Secondary study objectives

Frontal Fibrosing Alopecia Severity Score (FFASS)

Lichen Planopilaris Activity Index (LPPAI)

Side effects data

From 2015 Phase 3 trial • 204 Patients • NCT01777191

Cellulitis

100%

80%

60%

40%

20%

Study treatment Arm

Follow Up Period

80 mg Ixe Prefilled Syringe Optional Safety Extension

80 mg Ixekizumab Prefilled Syringe Treatment Period

80 mg Ixekizumab Auto-Injector Treatment Period

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: IxekizumabExperimental Treatment1 Intervention

ixekizumab 80 mg injection, 160 mgs injected subcutaneously on week 0, 80 mgs injected subcutaneously every two weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ixekizumab Auto-Injector

2013

Completed Phase 3

~220

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Lichen Planus include topical corticosteroids, systemic immunosuppressants like mycophenolate mofetil (MMF), and biologics such as Ixekizumab. Topical corticosteroids work by reducing inflammation and suppressing the immune response locally. Systemic immunosuppressants like MMF inhibit the proliferation of T and B lymphocytes, thereby reducing the overall immune response. Ixekizumab, a monoclonal antibody targeting IL-17A, works by inhibiting the activity of interleukin-17A, a cytokine involved in inflammatory and immune responses. This is particularly important for Lichen Planus patients as it helps to control the chronic inflammation and immune dysregulation that characterize the disease, potentially leading to better management of symptoms and disease progression.

Comparison of systemic mycophenolate mofetil with topical clobetasol in lichen planopilaris: a parallel-group, assessor- and analyst-blinded, randomized controlled trial.