PoC Study to Evaluate the Efficacy and Safety of Secukinumab 300 mg in Patients With Lichen Planus

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

ClinicalTrials.gov Identifier: NCT04300296

Novartis Reference Number: CAIN457S12201

Last Update: Dec 09, 2020

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Condition

Lichen Planus: Cutaneous Lichen Planus, Mucosal Lichen Planus and Lichen Planopilaris

Phase

Phase 2

Overall status

Recruiting

Enrollment count

108 participants

Start date

Jul 27, 2020

Completion date

May 09, 2022

Gender

All

Age(s)

18 Years and older (Adult, Older Adult)

Interventions

Drug

Cutaneous lichen planus secukinumab 300 mg Q4W

All cutaneous lichen planus patients assigned to active secukinumab will receive 2x 1ml PFS at randomization, Week 1, Week 2, Week 3, Week 4, Week 8 and Week 12. At Week 16, they will stay on the weekly placebo dosis and monthly secukinumab until Week 32.

Drug

Cutaneous lichen planus placebo

All cutaneous LP patients assigned to placebo will receive 2x 1ml placebo PFS at randomization , Week 1, Week 2, Week 3, Week 4, Week 8 and Week 12. At Week 16, they will be switched to secukinumab (if no spontanoues remision) for weekly dosis until Week 20, then bi-weekly injection of secukinumab until Week 30

Drug

Mucosal lichen planus placebo

All mucosal lichen planus patients assigned to placebo will receive 2x 1ml placebo PFS at randomization , Week 1, Week 2, Week 3, Week 4, Week 8 and Week 12. At Week 16, they will be switched to secukinumab (if no spontaneous remission) for weekly dosis until Week 20, then bi-weekly injection of secukinumab until Week 30

Drug

Lichen planopilaris placebo

All lichen planopilaris patients assigned to placebo will receive 2x 1ml placebo PFS at randomization , Week 1, Week 2, Week 3, Week 4, Week 8 and Week 12. At Week 16, they will be switched to secukinumab (if no spontanoues remision) for weekly dosis until week 20, then bi-weekly injection of secukinumab until Week 30

Drug

Mucosal lichen planus secukinumab 300 mg Q4W

All mucosal lichen planus patients assigned to active secukinumab will receive 2x 1ml PFS at randomization , Week 1, Week 2, Week 3, Week 4, Week 8 and Week 12. At week 16, they will stay on the weekly placebo dosis and monthly secukinumab until Week 30.

Drug

Lichen planopilaris secukinumab 300 mg Q4W

All lichen planopilaris LP patients assigned to active secukinumab will receive 2x 1ml PFS at randomization , Week 1, Week 2, Week 3, Week 4, Week 8 and Week 12. At Week 16, they will stay on the weekly placebo dosis and monthly secukinumab until Week 30.

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.