Lichen Planus ScalpEarly Phase 1NCT05030415
Ixekizumab in Adult Patients With Lichen Planus and Lichen Planopilaris
A Early Phase 1 study testing Ixekizumab Auto-Injector in people with Lichen Planus Scalp and Lichen Planus, run by University of New Mexico at 1 site in United States.
Trial summary
To evaluate the safety and efficacy of ixekizumab in lichen planus and lichen planopilaris clinical response by Total Body Surface (TBS) determination, Investigator Global Assessment (IGA) Score, Lichen Planopilaris Activity Index (LPPAI), and Frontal Fibrosing Alopecia Severity Score (FFASS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lichen Planus Scalp, Lichen Planus, Lichen Planopilaris
- What is being tested?
- Ixekizumab Auto-Injector
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2021to 25 Mar 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- Forms of diagnosed lichen planus other than cutaneous or lichen planopilaris
- Previous exposure to ixekizumab or any other biologic drug directly targeting IL-17A or IL-17RA receptors (e.g., secukinumab, brodalumab, etc)
- Presence of skin comorbidities that may interfere with study assessments
- Plans for administration of live vaccines during the study period or within 6 weeks before randomization
- Use of any investigational treatment within 4 weeks prior to Randomization, or within a period of 5 half-lives of the investigational treatment prior to Randomization, whichever is longer
- Currently enrolled in any other clinical trial involving any investigational agent or device
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- Known history of positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody. If a patient has a documented negative result for any of these tests within 1 year of baseline, that particular test is not required at screening. Patients with isolated positive HBcAb or with positive hepatitis C antibody may undergo additional tests and consultations, and may enter the study only if active hepatitis B infection or carrier status has been definitively ruled out
- Known history of human immunodeficiency virus (HIV) infection or HIV seropositivity (HIV testing is not required at screening for patients with a negative HIV result within the past 1 year prior to baseline)
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for skin Bowen's disease, non-invasive squamous cell carcinoma, basal cell carcinoma, actinic keratosis that have been treated, carcinoma in situ of the cervix, or non-invasive malignant colon polyps that have been removed)
- History or evidence of ongoing alcohol or drug abuse, within the last 6 months prior to randomization
- History of elevated liver functioning tests 2-3 times of its normal
- Current requirement for systemic immunosuppressive/ immunomodulatory agent (including but not exclusively metronidazole) other than study Ixekizumab; if currently on immunosuppressive/ immunomodulatory therapy, excluded if not possible to have washout period of 2 weeks for topicals and 4 weeks for systemic required
- Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study. Examples include, but are not limited to patients with short life expectancy, patients with uncontrolled diabetes (HbA1c ≥9%), patients with cardiovascular conditions (eg, stage III or IV cardiac failure according to the New York Heart Association classification), severe renal conditions (eg, patients on dialysis), neurological conditions (eg, demyelinating diseases), active major autoimmune diseases (eg, lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), other severe endocrinological, gastrointestinal, hepato-biliary, metabolic, pulmonary or lymphatic diseases. The specific justification for patients excluded under this criterion will be noted in study documents
- Any other medical or psychological condition (including relevant laboratory abnormalities at screening) that, in the opinion of the investigator, may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient as a result of his/her participation in this clinical trial, may make patient's participation unreliable, or may interfere with study assessments. The specific justification for patients excluded under this criterion will be noted in study documents
- Active systemic infections during 2 weeks prior to randomization (exception: the common cold) or any infection that reoccurs on a regular basis
- History of an ongoing, chronic or recurrent infectious disease, or positive or indeterminate QuantiFERON TB-Gold test at screening
- Planned major surgical procedure during the patient's participation in this study
- Patient is a member of the investigational team or his/her immediate family
- Pregnant or nursing women; women planning a pregnancy within the study period
- 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.
- For females, menopause is defined as at least 12 consecutive months without menses; if in question, a follicle stimulating hormone (FSH) of ≥25 mU/mL must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable; if documented, women with these conditions are not required to use additional contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87102
About this study
Official title: A Proof of Concept, Non-randomized, One Center Study to Explore the Safety and Efficacy of 16 Weeks of Treatment With Ixekizumab in Adult Patients With Lichen Planus and Lichen Planopilaris
To evaluate the safety and efficacy of ixekizumab in lichen planus and lichen planopilaris clinical response by Total Body Surface (TBS) determination, Investigator Global Assessment (IGA) Score, Lichen Planopilaris Activity Index (LPPAI), and Frontal Fibrosing Alopecia Severity Score (FFASS).
Read the detailed description
A proof of concept, non-randomized, one center study to explore the safety and efficacy of 16 weeks of treatment with ixekizumab in adult patients with lichen planus. The total study period will consist of 24 weeks including a 2 week screening/washout, 16 weeks of active therapy and 8 weeks of follow up.
- Conditions
- Lichen Planus Scalp, Lichen Planus, Lichen Planopilaris
- Being tested
- Ixekizumab Auto-Injector
- Keywords
- IL17 lichen planus
- Medical subject headings
- Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ixekizumab Auto-InjectorDrug
160 mg week 0 followed by 80 mg every two weeks
| Study group | Role | What they receive |
|---|---|---|
| Ixekizumab | Experimental | ixekizumab 80 mg injection, 160 mgs injected subcutaneously on week 0, 80 mgs injected subcutaneously every two weeks Receives: Drug: Ixekizumab Auto-Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Global Assessment (IGA)
Change in IGA
Measured: 16 weeks
Secondary outcomes (2)
Lichen Planopilaris Activity Index (LPPAI)
Change in LPPAI
Measured: 16 weeks
Frontal Fibrosing Alopecia Severity Score (FFASS)
Change in FFASS
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start12 Aug 2021
- Primary completion25 Mar 2024
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lichen Planus ScalpStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John R. Durkin, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030415
- Sponsor's protocol ID
- 21-087
- Status last verified
- Mar 2024
- First submitted
- 25 Aug 2021
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monteiro BV, Pereira Jdos S, Nonaka CF, Godoy GP, da Silveira EJ, Miguel MC. Immunoexpression of Th17-related cytokines in oral lichen planus. Appl Immunohistochem Mol Morphol. 2015 Jul;23(6):409-15. doi: 10.1097/PAI.0000000000000096.
PubMed 25356945
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept, Non-randomized, One Center Study to Explore the Safety and Efficacy of 16 Weeks of Treatment With Ixekizumab in Adult Patients With Lichen Planus and Lichen Planopilaris
- ClinicalTrials.gov ID
- NCT05030415
- Acronym / sponsor ID
- 21-087
- Conditions
- Lichen Planus Scalp, Lichen Planus, Lichen Planopilaris
- Keywords
- IL17 lichen planus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of ixekizumab in lichen planus and lichen planopilaris clinical response by Total Body Surface (TBS) determination, Investigator Global Assessment (IGA) Score, Lichen Planopilaris Activity Index (LPPAI), and Frontal Fibrosing Alopecia Severity Score (FFASS).
Detailed description
A proof of concept, non-randomized, one center study to explore the safety and efficacy of 16 weeks of treatment with ixekizumab in adult patients with lichen planus. The total study period will consist of 24 weeks including a 2 week screening/washout, 16 weeks of active therapy and 8 weeks of follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ixekizumab | Experimental | Drug: Ixekizumab Auto-Injectorixekizumab 80 mg injection, 160 mgs injected subcutaneously on week 0, 80 mgs injected subcutaneously every two weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- 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
Key exclusion criteria (21 listed)
- Forms of diagnosed lichen planus other than cutaneous or lichen planopilaris
- Previous exposure to ixekizumab or any other biologic drug directly targeting IL-17A or IL-17RA receptors (e.g., secukinumab, brodalumab, etc)
- Presence of skin comorbidities that may interfere with study assessments
- Plans for administration of live vaccines during the study period or within 6 weeks before randomization
- Use of any investigational treatment within 4 weeks prior to Randomization, or within a period of 5 half-lives of the investigational treatment prior to Randomization, whichever is longer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ixekizumab Auto-Injector160 mg week 0 followed by 80 mg every two weeks | Drug | Ixekizumab |
Primary outcome
Investigator Global Assessment (IGA)
Time frame: 16 weeks
Change in IGA
2 secondary outcomes
Lichen Planopilaris Activity Index (LPPAI)
Time frame: 16 weeks
Frontal Fibrosing Alopecia Severity Score (FFASS)
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Background: PubMed 25356945Monteiro BV, Pereira Jdos S, Nonaka CF, Godoy GP, da Silveira EJ, Miguel MC. Immunoexpression of Th17-related cytokines in oral lichen planus. Appl Immunohistochem Mol Morphol. 2015 Jul;23(6):409-15. doi: 10.1097/PAI.0000000000000096.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ixekizumab Auto-Injector in people with Lichen Planus Scalp and Lichen Planus, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator Global Assessment (IGA) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05030415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.