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OpenTrials
Completed

NCT Number: NCT03587194

Evaluation of Add on Enstilar in Patients Using Otezla for Psoriasis

Add-on Enstilar to Otezla therapy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

About this study

50 adult patients with moderate to severe plaque psoriasis will be given OTEZLA® for 16 weeks with add-on Enstilar.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female adult ≥ 18 years of age;
  • Diagnosis of chronic plaque-type psoriasis
  • Moderate to severe plaque type psoriasis as defined at baseline by:
  • PGA score of 3 or greater
  • BSA affected by plaque-type psoriasis of 10% or greater
  • PASI ≥ 12
  • Able and willing to give written informed consent prior to performance of any study-related procedures
  • Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).

Exclusion criteria

  • Other than psoriasis, any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is uncontrolled.
  • Forms of psoriasis other than chronic plaque-type (e.g., Pustular erythrodermic and/or guttate psoriasis) or drug induced psoriasis
  • Subjects who previously used any biologic agent for psoriasis.
  • Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin and cyclosporine).
  • Patient used topical therapies to treat psoriasis on the hands and/or feet within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
  • Patient received UVB phototherapy within 2 weeks of Baseline.

Treatment and study plan

Otezla

Drug

Otezla 30mg BID

Primary outcomes

  1. Psoriasis Area Severity Index 75 at Week 12

    Time frame: 12 weeks

    Patients who achieve Psoriasis Area Severity Index 75 at week 12. PASI scores range 0-72 (maximal disease)

Sponsors and collaborators

Lead sponsor

Psoriasis Treatment Center of Central New Jersey

Other

Collaborators

  • Celgene Corporation

Registry information

Official study title

A Single Center Study to Evaluate the Effectiveness and Safety of Add on Enstilar® in Patients Using OTEZLA® for Moderate to Severe Plaque Psoriasis

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 16, 2018
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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