A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04175613|
Recruitment Status : Not yet recruiting
First Posted : November 25, 2019
Last Update Posted : November 25, 2019
This study was created to provide subjects who complete Week 52 (end of Apremilast Extension Phase) of study CC-10004-PPSO-003 the option to continue to receive open-label apremilast therapy.
The study will consist of up to 208 weeks of long-term treatment followed by an 8-week observational follow-up phase.
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Apremilast||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3b, Multi Center, Open-label, Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis|
|Estimated Study Start Date :||December 19, 2019|
|Estimated Primary Completion Date :||June 19, 2025|
|Estimated Study Completion Date :||December 19, 2025|
Experimental: Patients treated with Apremilast
Subjects with a weight between 20 kg to < 50 kg will receive apremilast 20 mg BID and subjects with weight ≥ 50 kg at Visit 1 will receive apremilast 30 mg BID. Subjects that begin the study receiving apremilast 20 mg BID and later record a body weight ≥ 50 kg, will be switched to apremilast 30 mg BID.
Apremilast dose will be increased from 20 mg BID to 30 mg BID for those subjects that reach a weight of 50 kg or more during the study
Other Name: CC-10004, Otezla
- Adverse Events (AEs) [ Time Frame: Up to approximately 4 years ]An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
- Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Collected at each study visit throughout the life of the study - up to 4 years ]Questionnaire to monitor depression, suicidal thoughts and behavior
- Weight of patients treated with Apremilast [ Time Frame: Collected at each study visit throughout the life of the study - up to 4 years ]Body weight in kg
- Mean body mass index of the patient treated with Apremilast [ Time Frame: Collected at each study visit throughout the life of the study - up to 4 years ]BMI (combined outcome of weight and height in the form of kg/m^2)
- Height patients treated with Apremilast [ Time Frame: Collected at each study visit throughout the life of the study - up to 4 years ]Height (inches or centimeters) will be collected for all pediatric subjects and descriptively summarized
- Assessment of sexual maturity [ Time Frame: Collected every 52 weeks throughout the life of the study - up to 4 years ]Sexual maturation, assessed by Tanner staging system, will be conducted for all pediatric subjects and descriptively summarized
- Static Physician Global Assessment (sPGA) [ Time Frame: Collected at each study visit throughout the life of the study - up to 4 years ]is the assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04175613
|Contact: Associate Director Clinical Trial Disclosurefirstname.lastname@example.org|
|Study Director:||Weimin Zhang, MD||Celgene|