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

NCT02412644 | Completed Phase 4 Results

• 1 other identifier: AP-CL-PSOR-PI-004893
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12

  12WEEKS

• Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36

  36 weeks

• Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36

  36 weeks

Study Arms (2)

Apremilast + apremilast

ACTIVE COMPARATOR

apremilast 30mg bid for 12 weeks.followed by apremilast 30 mg bid for 24 weeks

Drug: apremilast

apremilast + placebo

PLACEBO COMPARATOR

apremilast 30mg bid for 12 weeks followed by placebo bid for 24 weeks

Drug: apremilast

Interventions

apremilast DRUG

Apremilast + apremilast; apremilast + placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adult ≥ 18 years of age;
• Diagnosis of chronic plaque-type
• 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,
• Able and willing to give written informed consent prior to performance of any study-related procedures

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from participation in this study:
• Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis
• Subjects with previous exposure to apremilast
• 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.

Sponsors & Collaborators

• Psoriasis Treatment Center of Central New Jersey: lead
• Celgene: collaborator

Study Sites (1)

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

MeSH Terms

Interventions

apremilast

Results Point of Contact

• Title: Jerry Bagel Director of Clinical Trials
• Organization: Psoriasis Treatment Center of Central New Jersey

dreamacres1@aol.com

6094434500

Study Officials

• Jerry Bagel, MD

  Psoriasis Treatment Center of Central New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: April 9, 2015
• Study Start: May 28, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 28, 2019
• Results First Posted: January 28, 2019

Record last verified: 2018-12

Locations

US (1)