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Monoclonal Antibodies

Ixekizumab for Lichen Planus

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of ixekizumab on people with lichen planus or lichen planopilaris.

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.Check my eligibility
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.See study design
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
Select...
I have been diagnosed with a skin condition related to lichen planus for at least 6 months.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Investigator Global Assessment (IGA)
Secondary outcome measures
Frontal Fibrosing Alopecia Severity Score (FFASS)
Lichen Planopilaris Activity Index (LPPAI)

Side effects data

From 2015 Phase 3 trial • 204 Patients • NCT01777191
9%
Upper respiratory tract infection
4%
Injection site reaction
1%
Supraventricular tachycardia
1%
Colitis
1%
Gastric ulcer haemorrhage
1%
Cardio-respiratory arrest
1%
Cholecystitis
1%
Cellulitis
1%
Diverticulitis
1%
Chronic obstructive pulmonary disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
80 mg Ixe Prefilled Syringe Optional Safety Extension
Follow Up Period
80 mg Ixekizumab Prefilled Syringe Treatment Period
80 mg Ixekizumab Auto-Injector Treatment Period

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

Find a Location

Who is running the clinical trial?

University of New MexicoLead Sponsor
372 Previous Clinical Trials
3,528,780 Total Patients Enrolled

Media Library

Lichen Planus Research Study Groups: Ixekizumab

Frequently Asked Questions

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

How many subjects are included in the current research?

"Affirmative. According to clinicaltrials.gov, recruitment for this medical trial is underway and began on August 12th 2021. This information was last updated on October 31st 2022; 10 patients are required from a single site for the study's completion."

Answered by AI

Is recruitment for this research project still underway?

"This clinical trial is actively looking for participants, as per the information available on clinicaltrials.gov. It was launched on August 12th 2021 and modified lastly on October 31st 2022."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
65+
What site did they apply to?
University of New Mexico
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

What questions have other patients asked about this trial?

Duration of trial and number of visits to Universit?
PatientReceived 2+ prior treatments
Recent research and studies
Applied Immunohistochemistry & Molecular MorphologyJournal
Immunoexpression of Th17-related Cytokines in Oral Lichen Planus
Monteiro, Bárbara Vanessa de Brito, Joabe dos Santos Pereira, Cassiano F.W. Nonaka, Gustavo P. Godoy, Éricka J.D. da Silveira, and Márcia Cristina da Costa Miguel. 2015. “Immunoexpression of Th17-related Cytokines in Oral Lichen Planus”. Applied Immunohistochemistry & Molecular Morphology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/pai.0000000000000096.
clinicaltrials.govStudy
Ixekizumab in Adult Patients With Lichen Planus and Lichen Planopilaris
John R. Durkin 2021. "Ixekizumab in Adult Patients With Lichen Planus and Lichen Planopilaris". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05030415.
~2 spots leftby Apr 2025
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