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Phosphodiesterase 4 (PDE4) Inhibitor

Apremilast (CC-10004) for Psoriasis

Phase 3
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks post last dose (max mean treatment duration in placebo-controlled phase was 15.3 weeks, and 41.9 weeks in the apremilast-exposure period)
Awards & highlights

Study Summary

This trial is testing a new drug, apremilast, to see if it is effective and safe in treating plaque psoriasis in children. The trial will last for 52 weeks and will enroll 230 children.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks post last dose (max mean treatment duration in placebo-controlled phase was 15.3 weeks, and 41.9 weeks in the apremilast-exposure period)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks post last dose (max mean treatment duration in placebo-controlled phase was 15.3 weeks, and 41.9 weeks in the apremilast-exposure period) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16
Secondary outcome measures
Change From Baseline in CDLQI Score at Week 16
Mean BMI of Participants During the Apremilast Exposure Period
Mean Body Mass Index (BMI) of Participants During the Placebo-controlled Phase
+26 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Administration of Apremilast (CC-10004) - 30mgExperimental Treatment1 Intervention
Apremilast 30mg Twice Daily (BID)
Group II: Administration of Apremilast (CC-10004) - 20mgExperimental Treatment1 Intervention
Apremilast 20mg Twice Daily (BID)
Group III: Administration of PlaceboPlacebo Group1 Intervention
Placebo tablet Twice Daily (BID)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apremilast (CC-10004)
2018
Completed Phase 4
~430

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,443 Total Patients Enrolled
76 Trials studying Psoriasis
116,265 Patients Enrolled for Psoriasis
MDStudy DirectorAmgen
913 Previous Clinical Trials
923,886 Total Patients Enrolled
64 Trials studying Psoriasis
23,075 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.

What is the official stance of the FDA on Apremilast (CC-10004)?

"There is some prior clinical data to support the efficacy of Apremilast, as well as multiple rounds of safety testing data. Therefore, it received a score of 3."

Answered by AI

At how many different sites is this trial being conducted?

"There are a total of 41 sites where this study is recruiting patients, with locations in Beverly, Overland Park and Santa Monica. If you are interested in participating, it might be best to choose a clinic near to reduce the amount travel required."

Answered by AI

Could you explain who would make a good candidate for this research?

"Eligible participants for this psoriasis medication clinical trial must be aged 6 to 17. There are plans to enroll around 230 patients in total."

Answered by AI

How many test subjects are involved in this experiment?

"This trial is no longer seeking new participants. It was originally posted on December 19, 2018 and last updated on November 10, 2022. However, there are presently 179 trials actively looking for participants with psoriasis and 14 trials for Apremilast (CC-10004) that are still recruiting patients."

Answered by AI

What is Apremilast (CC-10004) indicated to treat?

"Apremilast, marketed as CC-10004, can assist patients with ulcers, psoriasis, and behcet's syndrome."

Answered by AI

Are there any available openings for patients who want to participate in this trial?

"Although this study is not recruiting candidates at this time, there are 193 other trials currently searching for patients. According to clinicaltrials.gov, the last update was on 11/10/2022 and the trial was first posted on 12/19/2018."

Answered by AI

Does this research study include octogenarians as potential participants?

"This particular trial is only for children aged 6 to 17. Out of the 36 clinical trials conducted involving minors, this is one of them. Meanwhile, there are 162 other studies being run for patients 65 and older."

Answered by AI

What are the most recent studies that have been published on Apremilast?

"Apremilast (CC-10004), which was first studied in 2014, has completed 18336 trials. Currently, there are 14 clinical studies involving Apremilast underway with many of them taking place in Beverly, Massachusetts."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
2018. "Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03701763.
~39 spots leftby Apr 2025
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