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Phosphodiesterase 4 (PDE4) inhibitor

Apremilast for Psoriasis

Phase 4
Waitlist Available
Led By Boni Elewski, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24, 36, 48, and 52 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial aims to test the effectiveness of Apremilast, a pill that reduces inflammation, in treating nail psoriasis. The study will focus on patients with nail psoriasis who have not had success with other treatments. Apremilast works by blocking an enzyme that causes inflammation, potentially improving symptoms. Apremilast was approved by the FDA in 2014 for the treatment of psoriasis and psoriatic arthritis.

Eligible Conditions
  • Plaque Psoriasis
  • Psoriasis
  • Psoriatic Nails

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12, 24, 36, 48, and 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12, 24, 36, 48, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Percent Change of mNAPSI (Modified Nail Area Psoriasis Severity Index) at Week 36 Compared to Baseline for All Nails.
Secondary study objectives
Mean Percent Change in mNAPSI of Target Nail at Weeks 12, 24, 36, 48, and 52 Compared to Baseline.
Pain Change in Psoriatic Arthritis (PsA) Symptoms at Week 52 Compared to Baseline, in Patients Who Self-identify as Having Psoriatic Arthritis at Baseline.
Percent Change in Patient Reported Nail Pain, as Based on the Nail Pain VAS Score, at Week 52 Compared to Baseline Score.
+4 more

Side effects data

From 2018 Phase 4 trial • 20 Patients • NCT03000309
30%
diarrhea
30%
nausea
25%
headache
15%
abdominal cramping
15%
upset stomach, unspecified
10%
heartburn
5%
viral gastroenteritis
5%
cyst left inner thigh
5%
abscess right hand
5%
right flank pain
5%
irritability
5%
leg cramps
5%
upper respiratory infection
5%
otitis externa
100%
80%
60%
40%
20%
0%
Study treatment Arm
Apremilast

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study GroupExperimental Treatment1 Intervention
Open-label drug administration group. No comparator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apremilast
2017
Completed Phase 4
~2300

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,761 Total Patients Enrolled
7 Trials studying Psoriasis
40,670 Patients Enrolled for Psoriasis
CelgeneIndustry Sponsor
645 Previous Clinical Trials
130,420 Total Patients Enrolled
9 Trials studying Psoriasis
4,373 Patients Enrolled for Psoriasis
Boni Elewski, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
5 Previous Clinical Trials
523 Total Patients Enrolled
1 Trials studying Psoriasis
11 Patients Enrolled for Psoriasis
~1 spots leftby Nov 2025
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