Trial Outcomes & Findings for Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies (NCT NCT00688519)
NCT ID: NCT00688519
Last Updated: 2017-01-02
Results Overview
Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.
COMPLETED
PHASE3
336 participants
8 weeks
2017-01-02
Participant Flow
Participant milestones
| Measure |
Calcipotriene Foam
Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
Vehicle Foam
Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
|---|---|---|
|
Overall Study
STARTED
|
223
|
113
|
|
Overall Study
COMPLETED
|
204
|
98
|
|
Overall Study
NOT COMPLETED
|
19
|
15
|
Reasons for withdrawal
| Measure |
Calcipotriene Foam
Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
Vehicle Foam
Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Lack of Efficacy
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
6
|
|
Overall Study
Prohibited medication
|
1
|
0
|
|
Overall Study
Non-compliance
|
0
|
1
|
|
Overall Study
Subject moved out of state
|
1
|
0
|
|
Overall Study
Investigator decision
|
1
|
0
|
|
Overall Study
Subject moved out of area
|
1
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
Baseline Characteristics
Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies
Baseline characteristics by cohort
| Measure |
Calcipotriene Foam
n=223 Participants
Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
Vehicle Foam
n=113 Participants
Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
Total
n=336 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 14.7 • n=99 Participants
|
49.2 years
STANDARD_DEVIATION 13.9 • n=107 Participants
|
48.7 years
STANDARD_DEVIATION 14.4 • n=206 Participants
|
|
Age, Customized
12 to <18 years
|
4 participants
n=99 Participants
|
1 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Age, Customized
18 to <65 years
|
191 participants
n=99 Participants
|
95 participants
n=107 Participants
|
286 participants
n=206 Participants
|
|
Age, Customized
> 65 years
|
28 participants
n=99 Participants
|
17 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Gender
Female
|
91 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Gender
Male
|
132 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
203 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 participants
n=99 Participants
|
1 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
13 participants
n=99 Participants
|
5 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
188 participants
n=99 Participants
|
101 participants
n=107 Participants
|
289 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Missing
|
6 participants
n=99 Participants
|
0 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Disease Characteristic - Erythema
Light red coloration
|
74 participants
n=99 Participants
|
37 participants
n=107 Participants
|
111 participants
n=206 Participants
|
|
Disease Characteristic - Erythema
Moderate red coloration
|
149 participants
n=99 Participants
|
75 participants
n=107 Participants
|
224 participants
n=206 Participants
|
|
Disease Characteristic - Erythema
Bright red coloration
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Disease Characteristic - Scaling
Mild
|
91 participants
n=99 Participants
|
51 participants
n=107 Participants
|
142 participants
n=206 Participants
|
|
Disease Characteristic - Scaling
Moderate
|
131 participants
n=99 Participants
|
61 participants
n=107 Participants
|
192 participants
n=206 Participants
|
|
Disease Characteristic - Scaling
Marked
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Disease Characteristic - Plaque Thickness
Slight but definite elevation
|
101 participants
n=99 Participants
|
49 participants
n=107 Participants
|
150 participants
n=206 Participants
|
|
Disease Characteristic - Plaque Thickness
Moderate elevation
|
122 participants
n=99 Participants
|
64 participants
n=107 Participants
|
186 participants
n=206 Participants
|
|
Disease Characteristic- Target Lesion Location
Arm
|
60 participants
n=99 Participants
|
32 participants
n=107 Participants
|
92 participants
n=206 Participants
|
|
Disease Characteristic- Target Lesion Location
Leg
|
123 participants
n=99 Participants
|
59 participants
n=107 Participants
|
182 participants
n=206 Participants
|
|
Disease Characteristic- Target Lesion Location
Trunk
|
40 participants
n=99 Participants
|
22 participants
n=107 Participants
|
62 participants
n=206 Participants
|
|
Disease Characteristic - Investigator's Static Global Assessment
Mild
|
73 participants
n=99 Participants
|
34 participants
n=107 Participants
|
107 participants
n=206 Participants
|
|
Disease Characteristic - Investigator's Static Global Assessment
Moderate
|
150 participants
n=99 Participants
|
79 participants
n=107 Participants
|
229 participants
n=206 Participants
|
|
Disease Characteristic - Subject's Global Assessment
Clear
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Disease Characteristic - Subject's Global Assessment
Almost Clear
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Disease Characteristic - Subject's Global Assessment
Mild
|
14 participants
n=99 Participants
|
12 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Disease Characteristic - Subject's Global Assessment
Moderate
|
66 participants
n=99 Participants
|
24 participants
n=107 Participants
|
90 participants
n=206 Participants
|
|
Disease Characteristic - Subject's Global Assessment
Very Noticeable
|
109 participants
n=99 Participants
|
63 participants
n=107 Participants
|
172 participants
n=206 Participants
|
|
Disease Characteristic - Subject's Global Assessment
Severe
|
33 participants
n=99 Participants
|
13 participants
n=107 Participants
|
46 participants
n=206 Participants
|
|
Disease Characteristic - Percent BSA (extent of psoriasis)
|
6.4 percent of body surface
STANDARD_DEVIATION 4.8 • n=99 Participants
|
5.8 percent of body surface
STANDARD_DEVIATION 4.7 • n=107 Participants
|
6.2 percent of body surface
STANDARD_DEVIATION 4.8 • n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Intent-to-Treat (ITT) Population
Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.
Outcome measures
| Measure |
Calcipotriene Foam
n=223 Participants
Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
Vehicle Foam
n=113 Participants
Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
|---|---|---|
|
Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA)
|
31 particpants
|
8 particpants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: ITT
Erythema was assessed on a 6-point scale. 0=no evidence of erythema; hyperpigmentation may be present. 1=faint erythema. 2=light red coloration. 3=moderate red coloration. 4=bright red coloration. 5=dusky to deep red coloration.
Outcome measures
| Measure |
Calcipotriene Foam
n=223 Participants
Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
Vehicle Foam
n=113 Participants
Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
|---|---|---|
|
Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8
|
41 participants
|
11 participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: ITT
Scaling was assessed on a 6-point scale. 0=no evidence of scaling. 1=minimal; occasional fine scale over less than 5% of the lesion. 2=mild, fine scales predominate. 3=moderate; course scales predominate. 4=marked; thick non-tenacious scale predominates. 5=severe; very thick tenacious scale predominates.
Outcome measures
| Measure |
Calcipotriene Foam
n=223 Participants
Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
Vehicle Foam
n=113 Participants
Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
|---|---|---|
|
Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8
|
48 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: ITT
Plaque thickness was assessed on a 6-point scale. 0=no evidence of plaque thickness. 1=barely perceptible plaque thickness, approximately 0.5 millimeters (mm). 2=mild plaque thickness, approximately 1 mm. 3=moderate plaque thickness, approximately 1.5 mm. 4=marked plaque thickness, approximately 2 mm. 5=severe plaque thickness, approximately 2.5 mm or more.
Outcome measures
| Measure |
Calcipotriene Foam
n=223 Participants
Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
Vehicle Foam
n=113 Participants
Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
|---|---|---|
|
Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8
|
30 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: ITT
Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT.
Outcome measures
| Measure |
Calcipotriene Foam
n=223 Participants
Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
Vehicle Foam
n=113 Participants
Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
|---|---|---|
|
Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8
|
51 participants
|
14 participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: ITT
Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.
Outcome measures
| Measure |
Calcipotriene Foam
n=223 Participants
Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
Vehicle Foam
n=113 Participants
Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
|---|---|---|
|
Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate)
Mild
|
2 participants
|
3 participants
|
|
Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate)
Moderate
|
29 participants
|
5 participants
|
Adverse Events
Calcipotriene Foam
Vehicle Foam
Serious adverse events
| Measure |
Calcipotriene Foam
n=223 participants at risk
Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
Vehicle Foam
n=113 participants at risk
Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.45%
1/223 • Number of events 1 • Baseline through week 8
|
0.00%
0/113 • Baseline through week 8
|
|
Cardiac disorders
Cadiac failure congestive
|
0.45%
1/223 • Number of events 1 • Baseline through week 8
|
0.00%
0/113 • Baseline through week 8
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/223 • Baseline through week 8
|
0.88%
1/113 • Number of events 1 • Baseline through week 8
|
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER