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NCT03529955 · ClinicalTrials.gov registry record · Phase 2
Evaluating Safety & Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Recalcitrant Dermatomyositis
A Phase 2 study of Dermatomyositis, Adult Type, sponsored by Tulane University.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT03529955 is a Phase 2 study of Dermatomyositis, Adult Type that has completed, run by Tulane University. The registered enrollment target is 8 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03529955, a Phase 2 study of Dermatomyositis, Adult Type, has completed, sponsored by Tulane University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
With limited treatment options available for dermatomyositis, the investigators hypothesize that apremilast, a phosphodiesterase-4 (PDE-4) inhibitor, is a safe and efficacious add-on treatment in patients with refractory cutaneous dermatomyositis. The study will investigate the efficacy, safety and toxicity of apremilast given at 30 mg twice daily to patients with refractory cutaneous dermatomyositis. Clinical response will be assessed at 1 and 3 months. Patients will also be evaluated for durability of their response for up to 6 months. Treatment will be monitored with frequent clinical visits (0, 1, 3 and 6 months) and blood tests (CBC, CMP, creatine kinase, aldolase). Treatment will be discontinued at disease progression or unacceptable adverse events. Disease progression is defined as 4 points increase in the cutaneous dermatomyositis disease area and severity index (CDASI) score, worsening of muscle disease by manual muscle testing (MMT-8) score and 5 points increase in dermatomyositis life quality index (DLQI). 5 mm skin biopsies from lesional skin will be performed before treatment with apremilast and after 3 months of treatment for gene expression profiling and confirmatory immunohistochemical stains.
Conditions Studied
Interventions
- DRUG Apremilast 30mg
Study Locations (1)
Louisiana
- Tulane University - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-06-12 |
| Est. Completion | 2021-04-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03529955
The ClinicalTrials.gov registry entry for NCT03529955 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tulane University, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Dermatomyositis, Adult Type appearing as the primary indexed condition, and to 1 intervention - of which Apremilast 30mg is the first listed.
NCT03529955 reports 1 study location spanning 1 distinct geographic area - top geographies include Louisiana.
Frequently Asked Questions
What is clinical trial NCT03529955 about?
NCT03529955 is a clinical study titled "Evaluating Safety & Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Recalcitrant Dermatomyositis". With limited treatment options available for dermatomyositis, the investigators hypothesize that apremilast, a phosphodiesterase-4 (PDE-4) inhibitor, is a safe and efficacious add-on treatment in patients with refractory cutaneous dermatomyositis. The study will investigate the efficacy, safety and...
What is the current status of trial NCT03529955?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2018-06-12. Estimated completion is 2021-04-07.
What conditions does trial NCT03529955 study?
This clinical trial studies the following conditions: Dermatomyositis, Adult Type.
What interventions are being tested in trial NCT03529955?
The interventions under investigation include: Apremilast 30mg (DRUG).
Who is sponsoring clinical trial NCT03529955?
This trial is sponsored by Tulane University, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03529955 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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