Ixekizumab in Adult Patients With Lichen Planus and Lichen Planopilaris (NCT05030415) | Clinical Trial Compass
CompletedEarly Phase 1
Ixekizumab in Adult Patients With Lichen Planus and Lichen Planopilaris
United States9 participantsStarted 2021-08-12
Plain-language 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).
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 week…