Psoriasis Clinical Trial
PoC Study to Evaluate the Efficacy and Safety of Secukinumab 300 mg in Patients With Lichen Planus
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.
This was a 32-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial which assessed the efficacy and safety of secukinumab 300 mg in two different dosing regimens: every 4 weeks (Q4W) and every 2 weeks (Q2W) in approximately 111 patients with biopsy-proven forms of lichen planus.
There was a screening period (up to 4 weeks prior to baseline), a treatment period 1 (baseline to Week 16), a treatment period 2 (Week 16 to Week 32) and a follow-up period (8 weeks after Week 32).
Written informed consent must be obtained before any assessment is performed.
Female and male patients ≥ 18 years of age.
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.
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.
Clinical history suspicious for lichenoid drug eruption.
Lichen planus pigmentosus.
Clinical picture or history suspicious of paraneoplastic mucosal lichen planus.
Subjects whose lichen planus is a predominantly bullous variant.
Mucosal LP of the oral cavity or gastrointestinal involvement requiring the patient to use parenteral nutrition or feeding tube.
Clinical picture of scarring alopecia without active inflammation.
Clinical picture of burnt-out cicatricial alopecia (alopecia of Brocque).
Patients diagnosed with frontal fibrosing alopecia (FFA) without active patches of LPP
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).
Currently enrolled in any other clinical trial involving any investigational agent or device.
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).
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.
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.
Presence of any other skin condition that may affect the evaluations of the study disease.
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.
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.
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There are 35 Locations for this study
Birmingham Alabama, 35233, United States
Thousand Oaks California, 91320, United States
Cromwell Connecticut, 06416, United States
Jacksonville Florida, 32224, United States
Miami Florida, 33125, United States
Snellville Georgia, 30078, United States
Omaha Nebraska, 68144, United States
Las Vegas Nevada, 89128, United States
East Windsor New Jersey, 08520, United States
Forest Hills New York, 11375, United States
New York New York, 10025, United States
Portland Oregon, 97223, United States
Charleston South Carolina, 29407, United States
Houston Texas, 77030, United States
Pflugerville Texas, 78660, United States
Bordeaux Cedex , 33075, France
Chambray les Tours , 37170, France
Lyon , 69437, France
Marseille Cedex 05 , 13885, France
Nantes Cedex 1 , 44093, France
Nice Cedex , 06202, France
Paris Cedex 10 , 75475, France
Rouen Cedex , 76031, France
Toulouse , 31400, France
Aachen , 52074, Germany
Berlin , 13353, Germany
Bramsche , 49565, Germany
Erlangen , 91054, Germany
Frankfurt , 60590, Germany
Halle , 06120, Germany
Hamburg , 20354, Germany
Luebeck , 23538, Germany
Marburg , 35039, Germany
Muenchen , 81377, Germany
Wuerzburg , 97080, Germany
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