Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 2
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
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.