Phase 2
Completed N=44
A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis
Source: ClinicalTrials.gov NCT01700985 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Change in Overall Disease Severity (ODS) Score — 52.2; 0.0 percentage of participants — p=<0.0001
Summary
Corticosteroids are one of the mainstays of treatment for subjects with corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to determine and compare the efficacy and safety of a formulation of 122-0551 versus the corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for 14 consecutive days.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Overall Disease Severity (ODS) Score |
52.2; 0.0 | <0.0001 sig |
| SECONDARY ODS "Treatment Success" at Day 8 and Day 15 |
0.0; 0.0; 52.2; 0.0 | <0.0001 sig |
| SECONDARY ODS "Improved" at Day 8 and Day 15 |
0.0; 0.0; 52.2; 0.0 | <0.0001 sig |
| SECONDARY "Treatment Success" for Clinical Signs and Symptoms of Psoriasis |
21.7; 0.0; 60.9; 0.0; 0.0; 0.0 | — |
| SECONDARY "Improved" for Clinical Signs and Symptoms of Psoriasis |
26.1; 0.0; 73.9; 0.0; 0.0; 0.0 | — |
| SECONDARY Change in % Body Surface Area (BSA) With Psoriasis |
-0.3; 0.0; -1.3; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has a clinical diagnosis of stable plaque psoriasis
- Subject has an ODS score for the Treatment Area of 3 or 4 at study start
Exclusion Criteria
- Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
- Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
- Subject has used any phototherapy, photo-chemotherapy or systemic corticosteroid therapy within 30 days prior to study start
- Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous products within 90 days prior to study start
- Subject has used any systemic biologic therapy for the treatment of psoriasis within 5 half-lives of the biologic prior to study start
- Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to study start
- Subject has used topical body (excluding the scalp) psoriasis therapy including coal tar, anthralin, steroids, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to study start
- Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at study start
- Subject is currently using lithium or Plaquenil (hydroxychloroquine)
- Subject is currently using a beta-blocking medication (e.g., propranolol) or ACE (e.g., lisinopril) inhibitor at a dose that has not been stabilized
- Subject is pregnant, lactating, or is planning to become pregnant during the study
- Subject is currently enrolled in an investigational drug or device study
- Subject has used an investigational drug or investigational device treatment within 30 days prior to study start
- Subject has been previously enrolled in this study and treated with a test article
Data sourced from ClinicalTrials.gov (NCT01700985). 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.