Clinical Trial: Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Atopi

Brief Summary: A study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe atopic dermatitis

Detailed Summary:
Sponsor: Celgene

Current Primary Outcome: Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12. [ Time Frame: Baseline to Week 12 ]

Original Primary Outcome: Eczema Area and Severity Index (EASI) Score [ Time Frame: Week 12 ]

Current Secondary Outcome:

• Percentage of Participants Who Achieved a Score of 0 (Cleared) or 1 (Almost Cleared) and at Least a 2-point Reduction From Baseline in a Static Physician's Global Assessment of Acute Signs (sPGA-A) at Week 12. [ Time Frame: Baseline to Week 12 ]
  The sPGA-A is intended to assess the global severities (ie, a "visual average" integrating all areas of AD) of key acute clinical signs of AD, including erythema, induration/papulation, oozing/crusting (lichenification excluded) based on a 5-point scale of cleared (0), almost cleared (1), mild (2), moderate (3) and severe (4).
• Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI 50) at Week 12 [ Time Frame: Baseline to Week 12 ]
  The EASI 50 reduction (defined as ≥ 50% reduction from baseline in EASI score) was selected to serve as the key responder endpoint. A ≥ 50% improvement is clinically meaningful for this population.
• The Percentage Change From Baseline in the Average Weekly Pruritus Numerical Rating Scale (NRS) Score at Week 4 [ Time Frame: Baseline to Week 4 ]
  The participant completed a daily diary recording the average intensity of pruritus they experienced during the preceding 24 hrs. The intensity of pruritus was assessed using a validated 11-point NRS, ranging from 0 ("no pruritus") to 10 ("the worst pruritus imaginable"). It should be noted that this NRS is distinct from the pruritus, Visual Analogue Scale (VAS) in the Modified SCORAD Index with respect to recall period (three days for the VAS). The weekly NRS score was calculated as the average of the NRS scores over 7 days within the specified week. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
• Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period [ Time Frame: Baseline to Week 12 ]
  A TEAE is an adverse event with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen 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 participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.
• Number of Participants With TEAEs During the Apremilast Exposure Period [ Time Frame: Baseline to Week 24; median duration of apremilast 30 mg was 23.3 weeks and 22.4 weeks for apremilast 40 mg ]
  A TEAE is an adverse event with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen 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 participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.

Original Secondary Outcome:

• Adverse Events [ Time Frame: Up to 30 weeks ]
  Type, frequency and severity of adverse events, and relationship of adverse events to the investigational product
• EASI Score [ Time Frame: Week 12 ]
  The proportion of subjects who achieve at least a 50% reduction from Baseline in the EASI score at Week 12
• Pruritus Numeric Rating Scale (NRS) [ Time Frame: Week 4 ]
  The percentage change from Baseline in the average weekly pruritus NRS score at Week 4

Dates:
Date Received: March 13, 2014
Date Started: June 2014
Date Completion:
Last Updated: April 24, 2017
Last Verified: April 2017