Clinical Trial: A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis.

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase 4, Multicenter, Randomized, Placebo-controlled, Double-blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate Plaque Psoriasis

Brief Summary: This study will evaluate the clinical efficacy, patients quality of life, satisfaction, and safety of oral apremilast 30 mg twice daily (BID) compared to placebo, in subjects with moderate plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year in the Extension Phase of the trial.

Detailed Summary:

This is a Phase 4, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast in subjects with moderate plaque psoriasis.

Approximately 219 subjects will be randomized 2 (apremilast):1 (placebo) at approximately 25 sites in the United States. Subjects randomized to the apremilast treatment group will receive apremilast 30 mg tablets orally twice daily for 52 weeks. Subjects randomized to the placebo treatment group will receive placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally twice daily for 16 weeks. Beginning Week 16, subjects initially randomized to placebo will be switched to receive apremilast 30 mg BID for an additional 36 weeks (52 weeks total).

Study will enroll adult patients with stable moderate plaque psoriasis, who are naïve to systemic psoriasis treatments.

The primary efficacy endpoint will be assessed at Week 16 and will be the mean percentage change from baseline in the product of body surface area (BSA) (%) and static Physician's Global Assessment (sPGA).

Current Primary Outcome: The primary outcome measure is the mean percentage change from baseline in the product of body surface area (BSA) (%) multiplied by the static Physician's Global Assessment (sPGA) at Week 16 [ Time Frame: Up to week 16 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Dermatology Life Quality Index (DLQI) total score at Week 16 [ Time Frame: Up to 16 weeks ]
  DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.
• Percent of subjects achieving 0 (clear) or 1 (almost clear) on static Physician's Global Assessment (sPGA) scale at Week 16 [ Time Frame: Up to week 16 ]
  The sPGA is a 6-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), 5 (very severe) incorporating a separate assessment of the severity of the three primary signs of the plaques of all involved areas: erythema, scaling and plaque elevation. Scores for each assessment are averaged and rounded to the nearest whole number to result in the final sPGA score.
• Percent of subjects achieving 0 (clear) or 1 (very mild) on Patient Global Assessment (PtGA) scale at Week 16 [ Time Frame: Up to week 16 ]
  The PtGA is the assessment by the subject of the overall disease severity and its effect on life activities at the time of evaluation. The PtGA is a 5-point scale ranging from 0 (clear) to 4 (severe).
• Mean change from baseline in Pruritus Visual Analog Scale (VAS) at Weeks 1 and 16 [ Time Frame: Up to week 16 ]
  The Pruritus Visual Analog Scores (VAS) is used to measure the amount of itching and discomfort a participant experiences. Participant's Assessment of Pruritus (Itch) asks: On average, how much itch have you had because of your condition in the past week All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease. Change from baseline was calculated for the VAS scale, where change = visit value − baseline value.
• In subjects with scalp psoriasis at baseline, proportion of subjects with scalp Physician's Global Assessment (ScPGA) 0 (clear) or 1 (minimal) at Week 16 [ Time Frame: Up to week 16 ]
  The ScPGA will assess scalp involvement, if present at Baseline. The 6-point ScPGA scale ranges from 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), to 5 (very severe).
• Treatment Satisfaction Questionnaire for Medication (TSQM) at Weeks 16 [ Time Frame: Up to weeks 16 ]
  The TSQM version II is a 11-question self-administrated instrument to understand a subject's satisfaction on the current therapy.
• Treatment Satisfaction Questionnaire for Medication (TSQM) at Weeks 52 [ Time Frame: Up to weeks 52 ]
  The TSQM version II is a 11-question self-administrated instrument to understand a subject's satisfaction on the current therapy.
• Mean percentage change from baseline in psoriasis area severity index (PASI) at Week 16 [ Time Frame: Up to week 16 ]
  The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.
• Subjects who achieve a PASI 50 at Week 16 [ Time Frame: Up to week 16 ]
  PASI-50 response is the percentage of participants who achieve at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score is used as a measure of efficacy. The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Celgene Corporation
  

  Dates:
  Date Received: April 3, 2015
  Date Started: April 2015
  Date Completion: November 2016
  Last Updated: August 9, 2016
  Last Verified: August 2016
  

  

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