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Phase 4 N=50 Treatment

Evaluation of Add on Enstilar in Patients Using Otezla for Psoriasis

Psoriasis

Enrolled (actual)
50
Serious AEs
3.2%
Results posted
Apr 2024
Primary outcome: Primary: Psoriasis Area Severity Index 75 at Week 12 — 29 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Otezla (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Psoriasis Treatment Center of Central New Jersey
Primary completion
Jul 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Psoriasis Area Severity Index 75 at Week 12
29

Summary

Add-on Enstilar to Otezla therapy.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03587194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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