PoC Study to Evaluate the Efficacy and Safety of Secukinumab 300 mg in Patients With Lichen Planus
NCT ID: NCT04300296
Last Updated: 2023-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
111 participants
INTERVENTIONAL
2020-07-27
2022-05-03
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cutaneous lichen planus secukinumab 300mg Q4W
Secukinumab 300 mg every 4 weeks provided in pre-filled syringe in cutaneous lichen planus patients
secukinumab 300 mg Q4W
secukinumab 300 mg administered every four weeks (Q4W) via a pre-filled syringe.
Cutaneous lichen planus placebo
Placebo in 1ml PFS in cutaneous lichen patients
Placebo
Matching placebo administered via a pre-filled syringe
Mucosal lichen planus secukinumab 300 mg Q4W
Secukinumab 300 mg every 4 weeks provided in pre-filled syringe in mucosal lichen planus patients.
secukinumab 300 mg Q4W
secukinumab 300 mg administered every four weeks (Q4W) via a pre-filled syringe.
Mucosal lichen planus placebo
Placebo 1 ml PFS in mucosal lichen planus patients
Placebo
Matching placebo administered via a pre-filled syringe
Lichen planopilaris secukinumab 300 mg Q4W
Secukinumab 300 mg every 4weeks provided in pre-filled syringe in lichen planopilaris patients.
secukinumab 300 mg Q4W
secukinumab 300 mg administered every four weeks (Q4W) via a pre-filled syringe.
Lichen planopilaris placebo
Placebo in 1ml PFS in lichen planopilaris patients
Placebo
Matching placebo administered via a pre-filled syringe
Cutaneous lichen planus placebo to secukinumab 300 mg Q2W
Non responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2
secukinumab 300 mg Q2W
secukinumab 300 mg administered every two weeks (Q2W) via a pre-filled syringe.
Mucosal lichen planus placebo to secukinumab 300 mg Q2W
Non responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2
secukinumab 300 mg Q2W
secukinumab 300 mg administered every two weeks (Q2W) via a pre-filled syringe.
Lichen planopilaris placebo to secukinumab 300 mg Q2W
Non responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2
secukinumab 300 mg Q2W
secukinumab 300 mg administered every two weeks (Q2W) via a pre-filled syringe.
Interventions
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secukinumab 300 mg Q4W
secukinumab 300 mg administered every four weeks (Q4W) via a pre-filled syringe.
secukinumab 300 mg Q2W
secukinumab 300 mg administered every two weeks (Q2W) via a pre-filled syringe.
Placebo
Matching placebo administered via a pre-filled syringe
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Thousand Oaks, California, United States
Novartis Investigative Site
Cromwell, Connecticut, United States
Novartis Investigative Site
Jacksonville, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Snellville, Georgia, United States
Novartis Investigative Site
Omaha, Nebraska, United States
Novartis Investigative Site
Las Vegas, Nevada, United States
Novartis Investigative Site
East Windsor, New Jersey, United States
Novartis Investigative Site
Forest Hills, New York, United States
Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Charleston, South Carolina, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Pflugerville, Texas, United States
Novartis Investigative Site
Bordeaux, , France
Novartis Investigative Site
Chambray-lès-Tours, , France
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Marseille, , France
Novartis Investigative Site
Nantes, , France
Novartis Investigative Site
Nice, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Rouen, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Aachen, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Bramsche, , Germany
Novartis Investigative Site
Erlangen, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Halle, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Lübeck, , Germany
Novartis Investigative Site
Marburg, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Würzburg, , Germany
Countries
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References
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Mahon-Smith A, Skingley G, Ayala-Nunes L, Batish A, Sharp R, Naujoks C, Schruf E, Compagno N, Moreno SG. Evaluating the Appropriateness of Existing Health-Related Quality of Life Measures in Lichen Planus. Dermatol Ther (Heidelb). 2023 Nov;13(11):2817-2837. doi: 10.1007/s13555-023-00990-4. Epub 2023 Oct 5.
Mahon-Smith A, Clifford M, Batish A, Sharp R, Panter C, Naujoks C, Schruf E, Compagno N, Moreno SG. Patient Experience of Lichen Planus: A Qualitative Exploration of Signs, Symptoms, and Health-Related Quality of Life Impacts. Dermatol Ther (Heidelb). 2023 Sep;13(9):2001-2017. doi: 10.1007/s13555-023-00968-2. Epub 2023 Jul 28.
Miteva M, Nadji M, Billero V, LaSenna C, Nattkemper L, Romanelli P. IL-17 Expression in the Perifollicular Fibrosis in Biopsies From Lichen Planopilaris. Am J Dermatopathol. 2022 Dec 1;44(12):874-878. doi: 10.1097/DAD.0000000000002316. Epub 2022 Sep 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-003588-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457S12201
Identifier Type: -
Identifier Source: org_study_id
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