Phase 4
Completed N=29
Apremilast 30mg Bid With Narrowband UVB in the Treatment of Plaque Psoriasis
Source: ClinicalTrials.gov NCT02412644 ↗Enrolled (actual)
29
Serious AEs
4.4%
Results posted
Jan 2019
Primary outcomePrimary: Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36 — 4; 2 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36 |
4; 2 | — |
| SECONDARY Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12 |
16 | — |
| SECONDARY Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36 |
1; 0 | — |
| SECONDARY Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36 |
1; 0 | — |
Eligibility Criteria
Inclusion Criteria: Subjects must meet the following criteria to be enrolled in this study:
- 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
Exclusion Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02412644). 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. Informational only — not medical advice.