Apremilast for Psoriasis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
The Kirklin Clinic, Birmingham, AL
Psoriasis+2 More
Apremilast - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug can help treat nail psoriasis.

See full description

Eligible Conditions

  • Psoriasis
  • Psoriasis Vulgaris (Plaque Psoriasis)
  • Psoriatic Nails

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Psoriasis

Study Objectives

This trial is evaluating whether Apremilast will improve 1 primary outcome and 7 secondary outcomes in patients with Psoriasis. Measurement will happen over the course of 36 weeks.

Week 52
Mean Percent Change in mNAPSI of Target Nail at Weeks 12, 24, 36, 48, and 52 Compared to Baseline.
Proportion of Patients Achieving a mNAPSI 75 Response, as Defined by 75% or Greater Reduction Over Baseline in mNAPSI Score at Weeks 12, 24, 36, 48, and 52 for the Target Fingernail.
36 and 52 weeks
Mean Change in the Total Number of Nails Involved Assessed at Weeks 36 and 52 Compared to Baseline.
Proportion of Patients Achieving mNAPSI of 0 in All Fingernails at Weeks 36 and 52.
36 weeks
Mean Percent Change of mNAPSI (Modified Nail Area Psoriasis Severity Index) at Week 36 Compared to Baseline for All Nails.
52 weeks
Change in Patient Reported Nail Pain, as Based on the Nail Pain VAS Score, at Week 52 Compared to Baseline Score.
Pain Change in Psoriatic Arthritis Symptoms at Week 52 Compared to Baseline, in Patients Who Self-identify as Having Psoriatic Arthritis at Baseline.
Safety Adverse Effects Will be Assessed at Each Visit

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Psoriasis

Side Effects for

Apremilast
diarrhea
30%
nausea
30%
headache
25%
upset stomach, unspecified
15%
abdominal cramping
15%
heartburn
10%
right flank pain
5%
irritability
5%
upper respiratory infection
5%
leg cramps
5%
abscess right hand
5%
otitis externa
5%
cyst left inner thigh
5%
viral gastroenteritis
5%
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT03000309) in the Apremilast ARM group. Side effects include: diarrhea with 30%, nausea with 30%, headache with 25%, upset stomach, unspecified with 15%, abdominal cramping with 15%.

Trial Design

1 Treatment Group

Study Group
1 of 1
Experimental Treatment

This trial requires 12 total participants across 1 different treatment group

This trial involves a single treatment. Apremilast is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Study Group
Drug
Open-label drug administration group. No comparator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apremilast
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12, 24, 36, 48, and 52 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12, 24, 36, 48, and 52 weeks for reporting.

Who is running the study

Principal Investigator
B. E.
Prof. Boni Elewski, Professor, Chairman
University of Alabama at Birmingham

Closest Location

The Kirklin Clinic - Birmingham, AL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
- 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)
Be willing and consent to having photos taken of their fingernails
Diagnosis of chronic plaque psoriasis that has been present for at least 6 months prior to baseline
Plaque psoriasis involving at least 5% of the patient's body surface area
Nail psoriasis in at least one finger nail with a mNAPSI of 5 or greater
A Nail Pain VAS score of 4 or higher. The Nail Pain VAS will assess the severity of pain linked to the nail disease.
Must have discontinued all systemic therapies for the treatment of psoriasis or psoriatic arthritis at least 4 weeks or 5 half-lives, and biologics 2 months or 5 half-lives (whichever is longer) prior to baseline visit
Must have discontinued all topical therapies for the treatment of psoriasis at least 2 weeks prior to baseline visit
Subjects must have discontinued UV therapy at least 2 weeks prior to baseline and PUVA (psoralen ultraviolet light therapy) at least 4 weeks prior to baseline.

Patient Q&A Section

What are the signs of psoriasis?

"The signs of skin lesions in Psoriasis usually vary depending upon the stage of plaque development and the severity of the disease. Psoriasis lesions may be more apparent on the body as a whole as compared to the arms and legs. Psoriasis lesions may also develop on the outer surface of the eyelid. Segmental skin lesions of psoriasis may be visible, for example, the face, neck, and scalp. When it is more severe, psoriasis lesions become visible and appear on the body as a whole, for example, the trunk, arms, and legs. When not enough is known about psoriasis, the condition is called unspecified psoriasis." - Anonymous Online Contributor

Unverified Answer

What is psoriasis?

"This disorder is an inflammatory skin disease characterized by enlargement of red, scaly lesions that usually involves joints and may involve a variety of other affected organ systems including the nails, scalp, tongue, nails, intestines, heart, and central nervous system. Clinically the differential diagnoses involve many conditions. The most important initial step to obtaining the diagnosis of these conditions is history and physical examination." - Anonymous Online Contributor

Unverified Answer

What are common treatments for psoriasis?

"This review showed that multiple types of medications are available for psoriasis treatment. Phototherapy and photochemotherapy are the two principal modalities of therapy, and both are shown effective. Combination therapies (phototherapy + photochemotherapy, systemic therapy, topical therapy) are also shown to be highly effective." - Anonymous Online Contributor

Unverified Answer

Can psoriasis be cured?

"Psoriasis can be cured because a variety of factors influence disease progression and response to treatment. These factors include the host's immune status, the use of concomitant medications, the response to treatment per se, and how severe the disease is in the patient's lifetime. These factors are all highly dependent on the severity of psoriasis in a patient's lifetime." - Anonymous Online Contributor

Unverified Answer

What causes psoriasis?

"Various hypotheses have been proposed in the literature, but none are supported yet. Although it is not yet established what the sole cause of psoriasis is, immune activation might be one factor of interest. Further studies are necessary to further explore this hypothesis." - Anonymous Online Contributor

Unverified Answer

How many people get psoriasis a year in the United States?

"The National Survey of Health Attitudes and Lifestyles (NSHAL), conducted by the National Center for Health Statistics (NCS), conducted a nationally representative survey (N=4,724) of 15 million people (14% of Americans) between ages 18 and 74. The study found that 21.3 million new and/or previous cases of psoriasis have occurred in the United States since 2001 (1,600 cases per 100,000 population). Based on the estimates obtained, 2.8 million new cases of psoriasis are likely to occur between 2001 and 2043. In the United States, the prevalence of psoriasis is relatively high, with an estimated 7%-15% of Americans reporting it." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in apremilast for therapeutic use?

"Apremilast showed a significantly reduced incidence of psoriasis lesions across multiple disease manifestations in patients with moderate to severe plaque psoriasis for the first month of therapy; no serious adverse events were reported or observed. These data support the development of apremilast in patients with moderate to severe plaque psoriasis." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of apremilast?

"The most frequent side effects were gastrointestinal abnormalities (nausea or diarrhea in 13.5%) and headache (in 8%). Only one case (3.3%) was associated with hypersensitivity (allergic hypersensitivity)." - Anonymous Online Contributor

Unverified Answer

Is apremilast typically used in combination with any other treatments?

"Several clinical trials have demonstrated improvements in various psoriatic lesions, with responses comparable with traditional therapy, such as TNF inhibitors. Combinations of methotrexate with either apremilast or ixekizumab have been shown to be effective in clinical trials of moderate-to-severe psoriasis, but are not recommended for use in routine practice. Although the addition of apremilast does not appear to significantly increase the efficacy of methotrexate in the treatment of moderate-to-severe facial plaques in patients with moderate-to-severe psoriasis, further data will be required to determine whether such an added benefit is clinically relevant and the duration of efficacy." - Anonymous Online Contributor

Unverified Answer

Does psoriasis run in families?

"The findings suggest that psoriasis (specifically, maternal transmission) is much more common in families, than is in the general population. A number of studies have documented a similar familial disposition to psoriasis. However, the present study demonstrates that psoriasis is not a simple trait." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for psoriasis?

"Many experts in the field of the clinical trials for psoriasis have expressed their fear of the high cost of studies and the high number of patients required to show any effect in a study. On the other hand, clinical trials offer a quick way to evaluate new therapies. The question is whose patients should be included in any study." - Anonymous Online Contributor

Unverified Answer

Does apremilast improve quality of life for those with psoriasis?

"APremilast significantly reduces the severity of PASI and significantly increases QOL in patients with moderate to severe psoriasis. Patients with severe psoriasis should be offered this drug in clinical practice." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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