A Phase 2 interventional study of 122-0551 and Vehicle in Psoriasis and Plaque Psoriasis, sponsored by Therapeutics, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-25.
Sponsored by Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 44 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Therapeutics, Inc. is the lead sponsor of 16 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: 122-0551
Drug: Vehicle
Applied twice daily for two weeks
Applied twice daily for two weeks
Change in Overall Disease Severity (ODS) Score
The percentage of subjects with ODS "treatment success" at EOS where EOS is the subject's last completed visit. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
Time frame: baseline and Day 15 (End of Study - EOS)
ODS "Treatment Success" at Day 8 and Day 15
The percentage of subjects with ODS "treatment success" at Day 8 and Day 15. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
Time frame: baseline, Day 8, and Day 15
ODS "Improved" at Day 8 and Day 15
The percentage of subjects rated "improved" with respect to ODS at Days 8 and 15. "Improved" is defined as at least a 2 grade decrease in ODS score relative to baseline. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
Time frame: baseline, Day 8, and Day 15
"Treatment Success" for Clinical Signs and Symptoms of Psoriasis
The percentage of subjects rated "treatment success" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation) at Days 8 and 15. "Treatment success" is defined as a score of 0 or 1 based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
Time frame: baseline, Day 8 and Day 15
"Improved" for Clinical Signs and Symptoms of Psoriasis
The percentage of subjects rated "improved" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation, pruritus) at Days 8 and 15. "Improved" is defined as at least a 2 grade decrease in score based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
Time frame: baseline, Day 8 and Day 15
Change in % Body Surface Area (BSA) With Psoriasis
Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15.
Time frame: baseline, Day 8 and Day 15
Recruitment period: May 2012 to September 2012 The location of clinical sites included dermatology clinical research centers.
| Milestone | 122-0551 | Vehicle |
|---|---|---|
| Started | 23 | 21 |
| Completed | 23 | 20 |
| Not completed | 0 | 1 |
| Withdrew: Incarcerated | 0 | 1 |
The percentage of subjects with ODS "treatment success" at EOS where EOS is the subject's last completed visit. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
| percentage of participants | 122-0551 | Vehicle |
|---|---|---|
| Change in Overall Disease Severity (ODS) Score | 52.2 | 0.0 |
The percentage of subjects with ODS "treatment success" at Day 8 and Day 15. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
| percentage of participants | 122-0551 | Vehicle |
|---|---|---|
| Day 8 | 0.0 | 0.0 |
| Day 15 | 52.2 | 0.0 |
The percentage of subjects rated "improved" with respect to ODS at Days 8 and 15. "Improved" is defined as at least a 2 grade decrease in ODS score relative to baseline. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
| percentage of participants | 122-0551 | Vehicle |
|---|---|---|
| Day 8 | 0.0 | 0.0 |
| Day 15 | 52.2 | 0.0 |
The percentage of subjects rated "treatment success" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation) at Days 8 and 15. "Treatment success" is defined as a score of 0 or 1 based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
| percentage of participants | 122-0551 | Vehicle |
|---|---|---|
| Scaling (Day 8) | 21.7 | 0.0 |
| Scaling (Day 15) | 60.9 | 0.0 |
| Erythema (Day 8) | 0.0 | 0.0 |
| Erythema (Day 15) | 21.7 | 0.0 |
| Plaque Elevation (Day 8) | 8.7 | 0.0 |
| Plaque Elevation (Day 15) | 56.5 | 0.0 |
The percentage of subjects rated "improved" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation, pruritus) at Days 8 and 15. "Improved" is defined as at least a 2 grade decrease in score based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
| percentage of participants | 122-0551 | Vehicle |
|---|---|---|
| Scaling (Day 8) | 26.1 | 0.0 |
| Scaling (Day 15) | 73.9 | 0.0 |
| Erythema (Day 8) | 0.0 | 0.0 |
| Erythema (Day 15) | 34.8 | 0.0 |
| Plaque Elevation (Day 8) | 4.3 | 0.0 |
| Plaque Elevation (Day 15) | 56.5 | 0.0 |
Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15.
| Change in percent BSA | 122-0551 | Vehicle |
|---|---|---|
| Day 8 | -0.3 ± 0.69 | 0.0 ± 0.0 |
| Day 15 | -1.3 ± 2.07 | 0.0 ± 0.32 |
Collected over Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 122-0551 | 0/23 (0%) | 0/23 (0%) | 1/23 (4.3%) |
| Vehicle | 0/21 (0%) | 0/21 (0%) | 3/21 (14.3%) |
| Event | 122-0551 | Vehicle |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 0/23 | 2/21 |
| PharyngitisInfections and infestations | 0/23 | 1/21 |
| Influenza like illnessGeneral disorders | 1/23 | 0/21 |
Baseline analyses are based on the Safety population. All participants enrolled in the study who were dispensed and applied test article at least once.
| Age, Continuous(years) | 122-0551 | Vehicle | Total |
|---|---|---|---|
| Mean | 51.3 ± 14.3 | 48.6 ± 14.9 | 50.0 ± 14.5 |
| Sex: Female, Male(Participants) | 122-0551 | Vehicle | Total |
|---|---|---|---|
| Female | 4 | 7 | 11 |
| Male | 19 | 14 | 33 |
| Ethnicity (NIH/OMB)(Participants) | 122-0551 | Vehicle | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 6 | 9 |
| Not Hispanic or Latino | 20 | 15 | 35 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 122-0551 | Vehicle | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 21 | 19 | 40 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | 122-0551 | Vehicle | Total |
|---|---|---|---|
| United States | 23 | 21 | 44 |
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Therapeutics, Inc.