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

NCT04300296 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2023-08-22

Study results available
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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.

Conditions

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

Interventions

DRUG

secukinumab 300 mg Q4W

secukinumab 300 mg administered every four weeks (Q4W) via a pre-filled syringe.

DRUG

secukinumab 300 mg Q2W

secukinumab 300 mg administered every two weeks (Q2W) via a pre-filled syringe.

OTHER

Placebo

Matching placebo administered via a pre-filled syringe

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2021-11-16
Completion
2022-05-03
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04300296 on ClinicalTrials.gov