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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• secukinumab 300 mg Q4W — DRUG
  secukinumab 300 mg administered every four weeks (Q4W) via a pre-filled syringe.
• secukinumab 300 mg Q2W — DRUG
  secukinumab 300 mg administered every two weeks (Q2W) via a pre-filled syringe.
• Placebo — OTHER
  Matching placebo administered via a pre-filled syringe

Study Details

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.

Key Dates

Start date

Jul 27, 2020

Status verified

Jul 2023

Primary completion

Nov 16, 2021

Completion

May 3, 2022

Study Design

Enrollment

111 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cutaneous lichen planus secukinumab 300mg Q4W
  Secukinumab 300 mg every 4 weeks provided in pre-filled syringe in cutaneous lichen planus patients
• Placebo Comparator: Cutaneous lichen planus placebo
  Placebo in 1ml PFS in cutaneous lichen patients
• Experimental: Mucosal lichen planus secukinumab 300 mg Q4W
  Secukinumab 300 mg every 4 weeks provided in pre-filled syringe in mucosal lichen planus patients.
• Placebo Comparator: Mucosal lichen planus placebo
  Placebo 1 ml PFS in mucosal lichen planus patients
• Experimental: Lichen planopilaris secukinumab 300 mg Q4W
  Secukinumab 300 mg every 4weeks provided in pre-filled syringe in lichen planopilaris patients.
• Placebo Comparator: Lichen planopilaris placebo
  Placebo in 1ml PFS in lichen planopilaris patients
• Experimental: 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
• Experimental: 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
• Experimental: Lichen planopilaris placebo to secukinumab 300 mg Q2W
  Non responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2

Primary Outcome Measure

Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP [ Time Frame: Baseline up to week 16 ]

Locations (15)

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