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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: Completed Phase 2 study of Dermatomyositis, Adult Type, sponsored by Tulane University.
NCT03529955 is a Phase 2 study of Dermatomyositis, Adult Type that has completed, run by Tulane University. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cutaneous dermatomyositis disease area and severity index (CDASI) activity score is a validated tool to measure skin disease activity in dermatomyositis. The overall response rate (ORR) includes partial and complete responses. Complete response is defined by a CDASI activity score of zero. Partial response is defined by a decrease of CDASI activity score of at least 4 points. Calculation is performed as the CDASI activity score at 3 month(s) minus the score at baseline. Missing data will be hand
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 |
What the finished NCT03529955 record still lists
NCT03529955 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03529955's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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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