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

Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02412644
• Other study ID #: AP-CL-PSOR-PI-004893
• Status: Completed
• Phase: Phase 4
• Start date: May 28, 2015
• Est. completion date: July 2016

Study information

• Verified date: December 2018
• Source: Psoriasis Treatment Center of Central New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• apremilast

Locations

Country	Name	City	State
United States	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Psoriasis Treatment Center of Central New Jersey	Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36	PASI 90 or greater at week 36	36 weeks
Secondary	Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36	PGA score 0 or 1	36 weeks