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

Browse trials for

• Dermatitis, Atopic 1,419
• Dermatitis 1,435
• Eczema 1,084

Keywords

• Atopic Dermatitis
• Atopic Eczema

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 191 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Study arms

• Experimental
  Apremilast 40 mg

  Apremilast 40 mg administered orally twice daily (BID) for 12 weeks (following dose titration) during the placebo controlled phase followed by 40 mg Apremilast tablets orally administered BID for an additional 12 weeks in the active treatment phase

  Drug: Apremilast

• Experimental
  Apremilast 30 mg

  Apremilast 30 mg administered orally BID for 12 weeks (following dose titration) during the placebo controlled phase followed by 30 mg Apremilast tablets orally administered BID for an additional 12 weeks in the active treatment phase

  Drug: Apremilast

• Experimental
  Placebo + Apremilast 40 mg

  Placebo administered orally BID for 12 weeks, during the placebo controlled phase followed by 40 mg Apremilast tablets orally BID for an additional 12 weeks in the active treatment phase

  Drug: Apremilast · Drug: Placebo

• Experimental
  Placebo + Apremilast 30 mg

  Placebo administered orally BID for 12 weeks, during the placebo controlled phase followed by 30 mg Apremilast tablets orally BID for an additional 12 weeks in the active treatment phase

  Drug: Apremilast · Drug: Placebo

• Placebo comparator
  Placebo

  Oral Placebo tablets administered twice daily (BID) for 12 weeks during the placebo-controlled phase.

  Drug: Placebo

Interventions

• DrugApremilast

  Orally twice a day (BID)

  Also known as: CC-10004, Otezla

• DrugApremilast

  Orally twice a day (BID)

  Also known as: CC-10004, Otezla

• DrugPlacebo

  Orally twice a day (BID)

• DrugPlacebo

  Orally twice a day (BID)

Primary outcomes

1. Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12.

   EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). A representative lesion is selected for each of the four body regions for assessing the intensity of each of the four signs (erythema, induration /papulation, excoriation, and lichenification). Symptoms (eg, pruritus) and secondary signs (eg, xerosis, scaling) are excluded from the assessment. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.

   Time frame: Baseline to Week 12

Secondary outcomes

1. 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.

   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).

   Time frame: Baseline to Week 12

2. Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI 50) at 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.

   Time frame: Baseline to Week 12

3. The Percentage Change From Baseline in the Average Weekly Pruritus Numerical Rating Scale (NRS) Score at 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.

   Time frame: Baseline to Week 4

4. Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period

   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.

   Time frame: Baseline to Week 12

5. Number of Participants With TEAEs During the Apremilast Exposure Period

   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.

   Time frame: Baseline to Week 24; median duration of apremilast 30 mg was 23.3 weeks and 22.4 weeks for apremilast 40 mg

Baseline characteristics

Publications

• Simpson EL, Imafuku S, Poulin Y, Ungar B, Zhou L, Malik K, Wen HC, Xu H, Estrada YD, Peng X, Chen M, Shah N, Suarez-Farinas M, Pavel AB, Nograles K, Guttman-Yassky E. A Phase 2 Randomized Trial of Apremilast in Patients with Atopic Dermatitis. J Invest Dermatol. 2019 May;139(5):1063-1072. doi: 10.1016/j.jid.2018.10.043. Epub 2018 Dec 5. PubMed 30528828 ↗

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting information: Study protocol, Sap, Icf, Csr