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NCT03497897 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
NCT03497897: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT03497897 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 66 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03497897, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
Study Summary
The main purpose of this study is to assess preliminary efficacy and safety of LYS006 in patients with moderate to severe inflammatory acne and to determine if LYS006 has an adequate clinical profile for further clinical development.
Primary Outcome
Inflammatory facial lesion count included papules, pustules, and nodules. The natural log transformed inflammatory facial lesion count up to Week 12 was analyzed using a Bayesian mixed effect model for repeated measurements (MMRM). Values estimated from the model at Week 12 are presented in the table. Posterior geometric mean and 90% credible intervals in each group are presented.
Interventions
- DRUG Placebo
- DRUG LYS006 20 mg
- DRUG LYS006 2 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2018-09-10 |
| Est. Completion | 2022-03-09 |
| Phase | Phase 2 |
What the finished NCT03497897 record still lists
NCT03497897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03497897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03497897 about?
NCT03497897 is a clinical study titled "Study to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne". The main purpose of this study is to assess preliminary efficacy and safety of LYS006 in patients with moderate to severe inflammatory acne and to determine if LYS006 has an adequate clinical profile for further clinical development.
What is the current status of trial NCT03497897?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2018-09-10. Estimated completion is 2022-03-09.
What interventions are being tested in trial NCT03497897?
The interventions under investigation include: Placebo (DRUG), LYS006 20 mg (DRUG), LYS006 2 mg (DRUG).
Who is sponsoring clinical trial NCT03497897?
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 NCT03497897's enrollment target sits among peer trials
66 975th of 2000 higher than 1,014 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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