Trial Outcomes & Findings for Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies (NCT 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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

336 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-01-02

Participant Flow

Participant milestones

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

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

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=5 Participants	49.2 years STANDARD_DEVIATION 13.9 • n=7 Participants	48.7 years STANDARD_DEVIATION 14.4 • n=5 Participants
Age, Customized 12 to <18 years	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants
Age, Customized 18 to <65 years	191 participants n=5 Participants	95 participants n=7 Participants	286 participants n=5 Participants
Age, Customized > 65 years	28 participants n=5 Participants	17 participants n=7 Participants	45 participants n=5 Participants
Gender Female	91 Participants n=5 Participants	42 Participants n=7 Participants	133 Participants n=5 Participants
Gender Male	132 Participants n=5 Participants	71 Participants n=7 Participants	203 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Asian	8 participants n=5 Participants	1 participants n=7 Participants	9 participants n=5 Participants
Race/Ethnicity, Customized Black	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Race/Ethnicity, Customized Multiracial	13 participants n=5 Participants	5 participants n=7 Participants	18 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White	188 participants n=5 Participants	101 participants n=7 Participants	289 participants n=5 Participants
Race/Ethnicity, Customized Missing	6 participants n=5 Participants	0 participants n=7 Participants	6 participants n=5 Participants
Disease Characteristic - Erythema Light red coloration	74 participants n=5 Participants	37 participants n=7 Participants	111 participants n=5 Participants
Disease Characteristic - Erythema Moderate red coloration	149 participants n=5 Participants	75 participants n=7 Participants	224 participants n=5 Participants
Disease Characteristic - Erythema Bright red coloration	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Disease Characteristic - Scaling Mild	91 participants n=5 Participants	51 participants n=7 Participants	142 participants n=5 Participants
Disease Characteristic - Scaling Moderate	131 participants n=5 Participants	61 participants n=7 Participants	192 participants n=5 Participants
Disease Characteristic - Scaling Marked	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Disease Characteristic - Plaque Thickness Slight but definite elevation	101 participants n=5 Participants	49 participants n=7 Participants	150 participants n=5 Participants
Disease Characteristic - Plaque Thickness Moderate elevation	122 participants n=5 Participants	64 participants n=7 Participants	186 participants n=5 Participants
Disease Characteristic- Target Lesion Location Arm	60 participants n=5 Participants	32 participants n=7 Participants	92 participants n=5 Participants
Disease Characteristic- Target Lesion Location Leg	123 participants n=5 Participants	59 participants n=7 Participants	182 participants n=5 Participants
Disease Characteristic- Target Lesion Location Trunk	40 participants n=5 Participants	22 participants n=7 Participants	62 participants n=5 Participants
Disease Characteristic - Investigator's Static Global Assessment Mild	73 participants n=5 Participants	34 participants n=7 Participants	107 participants n=5 Participants
Disease Characteristic - Investigator's Static Global Assessment Moderate	150 participants n=5 Participants	79 participants n=7 Participants	229 participants n=5 Participants
Disease Characteristic - Subject's Global Assessment Clear	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Disease Characteristic - Subject's Global Assessment Almost Clear	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Disease Characteristic - Subject's Global Assessment Mild	14 participants n=5 Participants	12 participants n=7 Participants	26 participants n=5 Participants
Disease Characteristic - Subject's Global Assessment Moderate	66 participants n=5 Participants	24 participants n=7 Participants	90 participants n=5 Participants
Disease Characteristic - Subject's Global Assessment Very Noticeable	109 participants n=5 Participants	63 participants n=7 Participants	172 participants n=5 Participants
Disease Characteristic - Subject's Global Assessment Severe	33 participants n=5 Participants	13 participants n=7 Participants	46 participants n=5 Participants
Disease Characteristic - Percent BSA (extent of psoriasis)	6.4 percent of body surface STANDARD_DEVIATION 4.8 • n=5 Participants	5.8 percent of body surface STANDARD_DEVIATION 4.7 • n=7 Participants	6.2 percent of body surface STANDARD_DEVIATION 4.8 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Intent-to-Treat (ITT) Population

Outcome measures

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: ITT

Outcome measures

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 weeks

Population: ITT

Outcome measures

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

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle Foam

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

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

Phone: 866-435-7343

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