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NCT04300296 · ClinicalTrials.gov registry record · Phase 2
PoC Study to Evaluate the Efficacy and Safety of Secukinumab 300 mg in Patients With Lichen Planus
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 111
- Enrollment target
NCT04300296: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT04300296 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 111 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04300296, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 111 participants
- Enrollment target
Study 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.
Primary Outcome
Number of treatment responders at week 16, where response is defined as an Investigator's Global Assessment (IGA) score of 2 or lower at Week 16. IGA is measured on a scale from 0 - 4 with 0 = Clear, 1 = Minimal; 2 = Mild; 3 = Moderate; and 4 = Severe with 0 being best score and 4 being worst score. CLP=Cutaneous lichen planus, MLP=Mucosal lichen planus, LPP=Lichen planopilaris. Posterior median and 95% credible interval (instead of 95% confidence interval) were derived using Bayesian method bas
Interventions
- OTHER Placebo
- DRUG secukinumab 300 mg Q4W
- DRUG secukinumab 300 mg Q2W
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2020-07-27 |
| Est. Completion | 2022-05-03 |
| Phase | Phase 2 |
What the finished NCT04300296 record still lists
NCT04300296 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04300296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04300296 about?
NCT04300296 is a clinical study titled "PoC Study to Evaluate the Efficacy and Safety of Secukinumab 300 mg in Patients With Lichen Planus". 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.
What is the current status of trial NCT04300296?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 111 participants. The study started on 2020-07-27. Estimated completion is 2022-05-03.
What interventions are being tested in trial NCT04300296?
The interventions under investigation include: Placebo (OTHER), secukinumab 300 mg Q4W (DRUG), secukinumab 300 mg Q2W (DRUG).
Who is sponsoring clinical trial NCT04300296?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04300296's enrollment target sits among peer trials
111 632nd of 2000 higher than 1,369 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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