PoC Study to Evaluate the Efficacy and Safety of Secukinumab 300 mg in Patients With Lichen Planus
Condition: Lichen Planus: Cutaneous Lichen Planus, Mucosal Lichen Planus and Lichen Planopilaris
MeSH terms: Lichen Planus
Intervention: secukinumab 300 mg Q4W; secukinumab 300 mg Q2W; Placebo
Intervention description: secukinumab 300 mg administered every four weeks (Q4W) via a pre-filled syringe.; secukinumab 300 mg administered every two weeks (Q2W) via a pre-filled syringe.; Matching placebo administered via a pre-filled syringe
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: PoC study, 32-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial assessing the efficacy and safety of secukinumab 300 mg in two different dosing regimens in 108 patients with biopsy-proven forms of lichen planus.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lichen planus; CLP; MLP; LPP

Summary:

      The primary purpose of the proof of concept study is to elucidate the efficacy of secukinumab
      in the treatment of adult patients with biopsy-proven lichen planus not adequately controlled
      by topical therapies, and to assess the safety and tolerability over 32 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent must be obtained before any assessment is performed.

          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 (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 prior to randomization and
             until Week 16.

        Exclusion Criteria:

          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).

         10. Currently enrolled in any other clinical trial involving any investigational agent or
             device.

         11. Previous exposure to any other biologic drug directly targeting IL-17A or IL-17RA
             (e.g. secukinumab, ixekizumab or brodalumab) or IL-23/p19 (e.g. tildrakizumab,
             guselkumab, risankizumab).

         12. Diagnosis of active infectious diseases of the skin, scalp or mucosa (for example
             bacterial, viral or fungal infections of the mouth) that may interfere with the
             assessment of the study disease or require treatment with prohibited medications.

         13. Diagnosis of active inflammatory diseases of the skin, scalp or mucosa other than
             lichen planus that may interfere with the assessment of the study disease or require
             treatment with prohibited medications.

         14. Presence of any other skin condition that may affect the evaluations of the study
             disease.

         15. Underlying conditions (including, but not limited to metabolic, hematologic, renal,
             hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal)
             and/or presence of laboratory abnormalities which in the opinion of the investigator
             significantly immunocompromises the subject and/or places the subject at unacceptable
             risk for receiving an immunomodulatory therapy.

         16. Current, severe, progressive or uncontrolled diseases that render the patient
             unsuitable for the trial, including any medical or psychiatric condition that, in the
             Investigator's opinion, would preclude the participant from adhering to the protocol
             or completing the study per protocol.