Ixekizumab Auto-Injector for Lichen Planus

1
Effectiveness
1
Safety
University of New Mexico, Albuquerque, NM
Lichen Planus+2 More
Ixekizumab Auto-Injector - Drug
Eligibility
18+
Female
Eligible conditions
Lichen Planus

Study Summary

This study is evaluating whether ixekizumab is safe and effective in treating lichen planus and lichen planopilaris.

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Eligible Conditions

  • Lichen Planus
  • Lichen Planus Scalp
  • Lichen Planopilaris

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Ixekizumab Auto-Injector will improve 1 primary outcome and 2 secondary outcomes in patients with Lichen Planus. Measurement will happen over the course of 16 weeks.

16 weeks
Frontal Fibrosing Alopecia Severity Score (FFASS)
Investigator Global Assessment (IGA)
Lichen Planopilaris Activity Index (LPPAI)

Trial Safety

Safety Estimate

1 of 3

Side Effects for

80 mg Ixe Prefilled Syringe Optional Safety Extension
Upper respiratory tract infection
9%
Injection site reaction
4%
Cholecystitis
1%
Gastric ulcer haemorrhage
1%
Chronic obstructive pulmonary disease
1%
Supraventricular tachycardia
1%
Colitis
1%
Cardio-respiratory arrest
1%
Cellulitis
1%
Diverticulitis
1%
Anaphylactic reaction
0%
Tooth abscess
0%
Hip fracture
0%
Squamous cell carcinoma of skin
0%
Urinary tract infection
0%
Acute myocardial infarction
0%
This histogram enumerates side effects from a completed 2015 Phase 3 trial (NCT01777191) in the 80 mg Ixe Prefilled Syringe Optional Safety Extension ARM group. Side effects include: Upper respiratory tract infection with 9%, Injection site reaction with 4%, Cholecystitis with 1%, Gastric ulcer haemorrhage with 1%, Chronic obstructive pulmonary disease with 1%.

Trial Design

2 Treatment Groups

Control
Ixekizumab

This trial requires 10 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ixekizumab Auto-Injector is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Ixekizumab
Drug
ixekizumab 80 mg injection, 160 mgs injected subcutaneously on week 0, 80 mgs injected subcutaneously every two weeks
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixekizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 16 weeks for reporting.

Who is running the study

Principal Investigator
J. R. D.
Prof. John R. Durkin, Assistnat Professor of Dermatology
University of New Mexico

Closest Location

University of New Mexico - Albuquerque, NM

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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 Failure to at least one topical treatment (including but not exclusively topical corticosteroids, topical calcineurin inhibitors, topical vitamin D analogues) and/or systemic treatments (including but not exclusively systemic retinoids, griseofulvin, sulfasalazine, hydroxychloroquine, light therapy, methotrexate, etc.) for 4 weeks
Written informed consent for study participation must be obtained before any study assessment is performed
Male and female patients 18 years or older at the time of screening
Patients who are willing and capable of cooperating to the extent and degree required by the protocol
Patients who read and sign an approved informed consent for this study

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of lichen planus?

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Lichen planus lesions are characterized by a circumscribed red, circumscribed, raised papilla surrounded by a lichenoid ring. The pattern of LP lesions can be seen as a ring-like or annular rim-like, blue to reddish-purple papules or plaques.

Unverified Answer

Can lichen planus be cured?

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Lp is rarely a serious illness, unless patients have debilitating symptoms. Treatment includes a combination of short course oral or intranasal steroids and short courses of topical steroids, followed by long term use of topical steroids.

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What is lichen planus?

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Listed here are just some of the common features which might contribute to different diagnoses of LP. In order to facilitate differential diagnoses of this disease, this paper is expected to be a good guide.

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What are common treatments for lichen planus?

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Although the number of patients suffering from this autoimmune skin disease appears to be low, a considerable number of individuals seek medical professional consultation owing to pain, itching and loss of nail and hair.

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What causes lichen planus?

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The exact cause of LP is unknown. A number of contributing factors may exist, including a genetic predisposition and certain medications (i.e., tetracyclines, psoralens, penicillins, other medications). Other drugs may trigger LP in susceptible individuals. Factors such as gender, race, and family history of autoimmune disorders may also be involved. Aspects of LP associated with HLA-B27 include ustekinumab, which is a monoclonal antibody against ustekinumab and ustekinumab have been proven effective in preventing the relapse of LP. Patients with LP may have a predisposition to autoimmune diseases.

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How many people get lichen planus a year in the United States?

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Nearly 20.8% of adult US citizens have LP. Each year approximately 17,000 Americans will be diagnosed with LP. LP is more common in women (30%) and whites (28%), compared to other ethnicities.

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What are the common side effects of ixekizumab auto-injector?

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Injection site hypersensitivity, injection site pain (mainly in injection sites), bruising, pruritus and dry lips that occur most often early after treatment initiation. Rarely, patients experienced swelling of the face and lips with injection sites reaction and skin color changes. The injection sites tended to be more painful over time. There was no difference in terms of injection sites sensitivity between the 1mL/2mL or 3mL/3mL dose. Mild skin reactions can be managed with only mild pain relief methods. Rarely, patients reported allergic or skin irritation reactions in more than a few injection sites, such as facial and lips swelling, skin color change, itching, scaling, and tenderness.

Unverified Answer

What is the latest research for lichen planus?

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Lichen planus has been classified by many different names over the years. In this research, we have not only reviewed and analyzed lichen planus but also investigated its pathogenesis. Findings from a recent study have led us to speculate that lichen planus can be regarded as a disease that can be related to chronic subclinical infections. Further research and studies are required to validate the hypothesis.

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Have there been any new discoveries for treating lichen planus?

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There are some new treatments developed and investigated to treat lichen planus and one of these treatments is based on pulsed blue light. In this treatment, the whole body of the patient is exposed to the light pulses for many seconds at the same time. This treatment shows an improvement over the conventional treatment of corticosteroids and an improvement over radiation phototherapy. The pulsed blue light is a new treatment of interest in treating lichen planus. The treatment is based on using pulses of ultra-violet light that is created by the lasers. The pulses are used to treat a patient's whole body and not just the hands or the face. Some studies are underway to validate the findings.

Unverified Answer

How does ixekizumab auto-injector work?

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These auto-injector devices do not act on the underlying mechanism which has now been proven. These devices act by enhancing the absorption of IgG which is already in circulation. It would be expected that they provide temporary relief of the skin lesions and would be no different in this regard to the auto-sensitising injections. However, the device is effective in eliminating the scars and also in the management of LP.

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What are the latest developments in ixekizumab auto-injector for therapeutic use?

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Recent findings obtained in our study showed an excellent long and complete remission rate and the most prominent benefit of use of this auto-injector as compared to the group of patients who received the subcutaneous injections, including those that previously had been treated with the same auto-injector. This new auto-injector is effective and safe for daily use. It may have a wider application scope for the treatment of ixekizumab auto-injector associated indications.

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Who should consider clinical trials for lichen planus?

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Clinical trials for lichen planus may provide an opportunity to elucidate additional mechanisms of disease pathogenesis, including the mechanisms which are responsible for the long-term nature of the lesion. The large size of clinical trials will also require effective data analysis and new approaches for study planning.

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