Apremilast 30mg Bid With Narrowband UVB in the Treatment of Plaque Psoriasis

Efficacy and Safety of Combining Apremilast 30mg Bid With Narrowband UVB in the Treatment of Moderate-to-severe Plaque Psoriasis

12 weeks open label with Otezla® and NUVB, followed by 6 month double blind Otezla® (apremilast) or placebo to subjects who obtain PASI 75 at week 12 of phototherapy

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: apremilast

Detailed Description

Primary Objective: To evaluate the effectiveness of Otezla (apremilast®) in promoting maintenance of response in those subjects who obtained PASI-75 at week 12 of phototherapy.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: Subjects must meet the following criteria to be enrolled in this study:

1. Male or female adult ≥ 18 years of age;
2. Diagnosis of chronic plaque-type

3. Moderate to severe plaque type psoriasis as defined at baseline by:

   • PASI score of 12 or greater,
   • PGA score of 3 or greater
   • BSA affected by plaque-type psoriasis of 10% or greater,
4. Able and willing to give written informed consent prior to performance of any study-related procedures

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from participation in this study:

1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis
2. Subjects with previous exposure to apremilast

3. Malignancy or history of malignancy, except for:

   • treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
   • treated [ie, cured] malignancy with no evidence of recurrence within the previous 5 years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Apremilast + apremilast; apremilast 30mg bid for 12 weeks.followed by apremilast 30 mg bid for 24 weeks	Drug: apremilast
Placebo Comparator: apremilast + placebo; apremilast 30mg bid for 12 weeks followed by placebo bid for 24 weeks	Drug: apremilast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36	Analysis of Psoriasis Area Severity Index Score at week 36 to determine number of subjects who maintained PASI 75 at week 36	36weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12	Psoriasis Area Severity Score of 75 or greater at week 12	12WEEKS
Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36	PASI 90 or greater at week 36	36 weeks
Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36	PGA score 0 or 1	36 weeks

Collaborators and Investigators

• Sponsor: Psoriasis Treatment Center of Central New Jersey
• Collaborators: Celgene
• Investigators: Principal Investigator: Jerry Bagel, MD, Psoriasis Treatment Center of Central New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: February 23, 2015
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (Estimate): April 9, 2015

Study Record Updates

• Last Update Posted (Actual): January 28, 2019
• Last Update Submitted That Met QC Criteria: December 28, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Apremilast
• Other Study ID Numbers: AP-CL-PSOR-PI-004893