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Phosphodiesterase 4 (PDE4) inhibitor

Apremilast for Psoriasis

Phase 4
Waitlist Available
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
- Patients older than 18
Give written informed consent prior to any study procedures being conducted, and candidates will authorize the release and use of protected health information (PHI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24, 36, 48, and 52 weeks
Awards & highlights

Study Summary

This trial will investigate whether apremilast is an effective treatment for nail psoriasis, a common and often difficult to treat condition that causes scaly red itchy plaques.

Eligible Conditions
  • Psoriatic Nails
  • Plaque Psoriasis
  • Psoriasis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are willing and consent to having photos taken of your fingernails.
Select...
You have plaque psoriasis involving at least 5% of the patient's body surface area.
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You have chronic plaque psoriasis that has been present for at least 6 months prior to baseline.
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You have nail psoriasis in at least one finger nail with a mNAPSI of 5 or greater.
Select...
You have discontinued all topical therapies for the treatment of psoriasis at least 2 weeks prior to baseline visit.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Percent Change of mNAPSI (Modified Nail Area Psoriasis Severity Index) at Week 36 Compared to Baseline for All Nails.
Secondary outcome measures
Change in Patient Reported Nail Pain, as Based on the Nail Pain VAS Score, at Week 52 Compared to Baseline Score.
Mean Change in the Total Number of Nails Involved Assessed at Weeks 36 and 52 Compared to Baseline.
Mean Percent Change in mNAPSI of Target Nail at Weeks 12, 24, 36, 48, and 52 Compared to Baseline.
+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%
right flank pain
5%
abscess right hand
5%
cyst left inner thigh
5%
irritability
5%
leg cramps
5%
upper respiratory infection
5%
otitis externa
100%
80%
60%
40%
20%
0%
Study treatment Arm
Apremilast

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
~2500

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,569 Previous Clinical Trials
2,268,879 Total Patients Enrolled
7 Trials studying Psoriasis
40,670 Patients Enrolled for Psoriasis
CelgeneIndustry Sponsor
633 Previous Clinical Trials
127,940 Total Patients Enrolled
9 Trials studying Psoriasis
4,373 Patients Enrolled for Psoriasis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Tennessee
How old are they?
18 - 65
What site did they apply to?
The Kirklin Clinic
What portion of applicants met pre-screening criteria?
Met criteria
~1 spots leftby Mar 2025