Phase 4
N=50
Evaluation of Add on Enstilar in Patients Using Otezla for Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT03587194 ↗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
| Outcome | Result | p-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.
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.