CompletedPhase 2

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

United States111 participantsStarted 2020-07-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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:
✓. 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

What they're measuring

Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP

Timeframe: Baseline up to week 16

Trial details

NCT IDNCT04300296

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-11-16

Results submitted2023-04-05

View on ClinicalTrials.gov More Lichen Planus: Cutaneous Lichen Planus, Mucosal Lichen Planus and Lichen Planopilaris trials