EUCTR2019-003588-24-DE
Active, not recruiting
Phase 1
A proof of concept study to evaluate the efficacy, safety and tolerability of secukinumab 300 mg over 32 weeks in adult patients with biopsy-proven forms of lichen planus not adequately controlled with topical therapies - PRELUDE - PRELUDE
Conditionsichen planusMedDRA version: 20.0Level: PTClassification code 10024429Term: Lichen planusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
DrugsCosentyx
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ichen planus
- Sponsor
- ovartis Pharma AG
- Enrollment
- 108
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects eligible for inclusion in this study must meet all of the following
- •1\. Written informed consent must be obtained before any assessment is
- •2\. Female and male patients \= 18 years of age.
- •3\. Subjects must have biopsy\-confirmed forms of cutaneous lichen
- •planus (CLP), mucosal lichen planus (MLP), or active lichen planopilaris (LPP) eligible for systemic therapy based on the following criteria:
- •Rated IGA of \= 3 at screening and baseline (moderate or severe) AND
- •Inadequate response to topical corticosteroids of high \- ultrahigh
- •potency in the opinion of the investigator
- •4\. If using any of the allowed topical treatments on the affected areas,
- •the dose and application frequency should remain stable for 2 weeks
Exclusion Criteria
- •Subjects meeting any of the following criteria are not eligible for inclusion in this study.
- •1\. Clinical history suspicious for lichenoid drug eruption.
- •2\. Lichen planus pigmentosus.
- •3\. Clinical picture or history suspicious of paraneoplastic mucosal lichen planus.
- •4\. Subjects whose lichen planus is a predominantly bullous variant.
- •5\. Mucosal LP of the oral cavity or gastrointestinal involvement requiring the patient to use parenteral nutrition or feeding tube.
- •6\. Clinical picture of scarring alopecia without active inflammation.
- •7\. Clinical picture of burnt\-out cicatricial alopecia (alopecia of Brocque).
- •8\. Patients diagnosed with frontal fibrosing alopecia (FFA) without active patches of LPP
- •9\. Clinical picture of LPP in patients who have already failed 3 or more systemic immunosuppressive or immunomodulatory agents (e.g. systemic steroids, hydroxychloroquine, cyclosporine, methotrexate and mycophenolate mofetil).
Outcomes
Primary Outcomes
Not specified
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