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

Novartis

Status and phase: Completed; Phase 2

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

Treatments: Other: Placebo; Drug: secukinumab 300 mg Q4W; Drug: secukinumab 300 mg Q2W

Study type: Interventional

Funder types: Industry

Identifiers

NCT04300296

2019-003588-24 (EudraCT Number)

CAIN457S12201

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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111 participants in 9 patient groups, including a placebo group

Cutaneous lichen planus secukinumab 300mg Q4W

Experimental group

Description:

Secukinumab 300 mg every 4 weeks provided in pre-filled syringe in cutaneous lichen planus patients

Treatment:

Drug: secukinumab 300 mg Q4W

Cutaneous lichen planus placebo

Placebo Comparator group

Description:

Placebo in 1ml PFS in cutaneous lichen patients

Treatment:

Other: Placebo

Mucosal lichen planus secukinumab 300 mg Q4W

Experimental group

Description:

Secukinumab 300 mg every 4 weeks provided in pre-filled syringe in mucosal lichen planus patients.

Treatment:

Drug: secukinumab 300 mg Q4W

Mucosal lichen planus placebo

Placebo Comparator group

Description:

Placebo 1 ml PFS in mucosal lichen planus patients

Treatment:

Other: Placebo

Lichen planopilaris secukinumab 300 mg Q4W

Experimental group

Description:

Secukinumab 300 mg every 4weeks provided in pre-filled syringe in lichen planopilaris patients.

Treatment:

Drug: secukinumab 300 mg Q4W

Lichen planopilaris placebo

Placebo Comparator group

Description:

Placebo in 1ml PFS in lichen planopilaris patients

Treatment:

Other: Placebo

Cutaneous lichen planus placebo to secukinumab 300 mg Q2W

Experimental group

Description:

Non responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2

Treatment:

Drug: secukinumab 300 mg Q2W

Mucosal lichen planus placebo to secukinumab 300 mg Q2W

Experimental group

Description:

Non responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2

Treatment:

Drug: secukinumab 300 mg Q2W

Lichen planopilaris placebo to secukinumab 300 mg Q2W

Experimental group

Description:

Non responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2

Treatment:

Drug: secukinumab 300 mg Q2W