CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 111 enrolled
Drug / intervention
secukinumab 300 mg Q4W +2 moredrug
Likely dose
secukinumab 300 mg Q4Wfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04300296
NCT04300296Phase 2Completed

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

Novartis Pharmaceuticals·interventional·Posted Mar 9, 2020·Updated Aug 22, 2023

In Brief

A Phase 2 clinical trial evaluating secukinumab 300 mg Q4W, secukinumab 300 mg Q2W, and 1 other intervention for Lichen Planus: Cutaneous Lichen Planus, Mucosal Lichen Planus and Lichen Planopilaris. Completed, enrolled 111 participants across 35 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Germany, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMar 9, 2020
Enrollment StartJul 27, 2020
Primary CompletionNov 16, 2021
Study CompletionMay 3, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.3 years ago

Interventions

secukinumab 300 mg Q4Wdrug

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

secukinumab 300 mg Q2Wdrug

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

Placeboother

Matching placebo administered via a pre-filled syringe