Trial Outcomes & Findings for Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis Two of Two Phase 3 Studies (NCT NCT00689481)

Last Updated: 2016-10-07

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

323 participants

Primary outcome timeframe

8 weeks

Results posted on

2016-10-07

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	214	109
Overall Study COMPLETED	190	95
Overall Study NOT COMPLETED	24	14

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	7	1
Overall Study Lost to Follow-up	4	3
Overall Study Lack of Efficacy	4	3
Overall Study Non-compliance with study treatment	1	1
Overall Study Withdrawal by Subject	8	4
Overall Study Excluded medication started during study	0	1
Overall Study Subject early term, left on vacation	0	1

Baseline Characteristics

Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis Two of Two Phase 3 Studies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Calcipotriene Foam n=214 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=109 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=323 Participants Total of all reporting groups
Age, Continuous	47.9 years STANDARD_DEVIATION 14.2 • n=5 Participants	47.5 years STANDARD_DEVIATION 16.9 • n=7 Participants	47.8 years STANDARD_DEVIATION 15.2 • n=5 Participants
Age, Customized 12 to < 18 years	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Age, Customized 18 to < 65 years	185 participants n=5 Participants	88 participants n=7 Participants	273 participants n=5 Participants
Age, Customized > 65 years	27 participants n=5 Participants	18 participants n=7 Participants	45 participants n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants	59 Participants n=7 Participants	167 Participants n=5 Participants
Sex: Female, Male Male	106 Participants n=5 Participants	50 Participants n=7 Participants	156 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race/Ethnicity, Customized Asian	10 participants n=5 Participants	3 participants n=7 Participants	13 participants n=5 Participants
Race/Ethnicity, Customized Black	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
Race/Ethnicity, Customized Mulitracial	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized White	194 participants n=5 Participants	99 participants n=7 Participants	293 participants n=5 Participants
Disease Characteristic - Erythema Light red coloration	52 participants n=5 Participants	30 participants n=7 Participants	82 participants n=5 Participants
Disease Characteristic - Erythema Moderate red coloration	158 participants n=5 Participants	76 participants n=7 Participants	234 participants n=5 Participants
Disease Characteristic - Erythema Bright red coloration	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Disease Characteristic - Scaling Minimal	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Disease Characteristic - Scaling Mild	65 participants n=5 Participants	33 participants n=7 Participants	98 participants n=5 Participants
Disease Characteristic - Scaling Moderate	145 participants n=5 Participants	76 participants n=7 Participants	221 participants n=5 Participants
Disease Characteristic - Scaling Marked	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Disease Characteristic - Scaling Severe	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Disease Characteristic - Plaque Thickness Possible but difficult to ascertain	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Disease Characteristic - Plaque Thickness Slight but definite elevation	66 participants n=5 Participants	41 participants n=7 Participants	107 participants n=5 Participants
Disease Characteristic - Plaque Thickness Moderate elevation	144 participants n=5 Participants	66 participants n=7 Participants	210 participants n=5 Participants
Disease Characteristic - Plaque Thickness Marked elevation	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Disease Characteristic - Plaque Thickness Very marked elevation	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Disease Characteristic - Target Lesion Location Arm	53 participants n=5 Participants	27 participants n=7 Participants	80 participants n=5 Participants
Disease Characteristic - Target Lesion Location Leg	129 participants n=5 Participants	55 participants n=7 Participants	184 participants n=5 Participants
Disease Characteristic - Target Lesion Location Trunk	32 participants n=5 Participants	27 participants n=7 Participants	59 participants n=5 Participants
Disease Characteristic - Investigator Static Global Assesssment (ISGA) Mild	56 participants n=5 Participants	31 participants n=7 Participants	87 participants n=5 Participants
Disease Characteristic - Investigator Static Global Assesssment (ISGA) Moderate	158 participants n=5 Participants	78 participants n=7 Participants	236 participants n=5 Participants
Disease Characteristic - Subject's Global Assessment Almost clear	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Disease Characteristic - Subject's Global Assessment Mild	18 participants n=5 Participants	9 participants n=7 Participants	27 participants n=5 Participants
Disease Characteristic - Subject's Global Assessment Moderate	62 participants n=5 Participants	26 participants n=7 Participants	88 participants n=5 Participants
Disease Characteristic - Subject's Global Assessment Very noticeable	96 participants n=5 Participants	55 participants n=7 Participants	151 participants n=5 Participants
Disease Characteristic - Subject's Global Assessment Severe	36 participants n=5 Participants	17 participants n=7 Participants	53 participants n=5 Participants
Disease Characteristic - Percent BSA (extent of psoriasis)	6.3 percentage STANDARD_DEVIATION 4.7 • n=5 Participants	6.4 percentage STANDARD_DEVIATION 5.2 • n=7 Participants	6.4 percentage STANDARD_DEVIATION 4.9 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Intent-to-Treat (ITT) Population

Outcome measures

Outcome measures
Measure	Calcipotriene Foam n=214 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=109 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	58 participants	17 participants

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=214 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=109 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	67 participants	22 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=214 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=109 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	72 participants	20 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=214 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=109 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	42 participants	12 participants

SECONDARY outcome

Timeframe: 8 Weeks

Population: ITT

Outcome measures

Outcome measures
Measure	Calcipotriene Foam n=214 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=109 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	78 participants	27 participants

SECONDARY outcome

Timeframe: 8 Weeks

Population: ITT

Outcome measures

Outcome measures
Measure	Calcipotriene Foam n=214 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=109 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	8 participants	4 participants
Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate) Moderate	50 participants	13 participants

Adverse Events

Calcipotriene Foam

Serious events: 0 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=214 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=109 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.
Ear and labyrinth disorders Unilateral deafness	0.00% 0/214	0.92% 1/109 • Number of events 1

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