18 and older, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Psoriasis Area Severity Index (PASI)75 Success at Visit 6Primary· Week 12 (Visit 6)
PASI75 success at Visit 6 was defined as number of participants who achieved at least 75% reduction in PASI scores at Visit 6 compared to Visit 2 (Baseline). The PASI score was determined through evaluation of body surface area (BSA) covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (ev
Group
Value
95% CI
Placebo
4
R115866 0.5 mg
7
R115866 1.0 mg
4
R115866 2.0 mg
5
PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline VisitSecondary· Week 1 to Week 20 (Visit 3 to Visit 8)
PASI50 success was defined as number of participants who achieved at least 50% reduction in PASI scores at each post baseline visit (Visit 3 to 8) compared to Visit 2 (Baseline). The PASI score was determined through evaluation of BSA covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (e
Visit 3
Group
Value
95% CI
Placebo
0
R115866 0.5 mg
0
R115866 1.0 mg
0
R115866 2.0 mg
0
Visit 4
Group
Value
95% CI
Placebo
2
R115866 0.5 mg
0
R115866 1.0 mg
1
R115866 2.0 mg
1
Visit 5
Group
Value
95% CI
Placebo
7
R115866 0.5 mg
9
R115866 1.0 mg
8
R115866 2.0 mg
11
Visit 6
Group
Value
95% CI
Placebo
8
R115866 0.5 mg
18
R115866 1.0 mg
18
R115866 2.0 mg
19
Visit 7
Group
Value
95% CI
Placebo
11
R115866 0.5 mg
18
R115866 1.0 mg
17
R115866 2.0 mg
21
Visit 8
Group
Value
95% CI
Placebo
15
R115866 0.5 mg
16
R115866 1.0 mg
18
R115866 2.0 mg
24
Investigator's Global Assessment (IGA) at Each Post Baseline VisitSecondary· Week 1 to Week 20 (Visit 3 to Visit 8)
The IGA was used to assess the overall severity of a participant's plaque psoriasis at a particular time point and the evaluation took into consideration the three individual characteristics of plaque psoriasis (scaling, plaque elevation, and erythema). The IGA was recorded using a scale that ranged from 0 (clear), 1 = almost clear, 2 = mild, 3 = moderate to 4 (severe) in whole-unit increments; higher scores indicating worse psoriasis. Investigators did not refer to previous evaluations when conducting the IGA assessment. At every study visit, the investigator evaluated each participant's plaq
Clear; Visit 3
Group
Value
95% CI
Placebo
0
R115866 0.5 mg
0
R115866 1.0 mg
0
R115866 2.0 mg
0
Almost clear; Visit 3
Group
Value
95% CI
Placebo
0
R115866 0.5 mg
0
R115866 1.0 mg
0
R115866 2.0 mg
0
Mild; Visit 3
Group
Value
95% CI
Placebo
8
R115866 0.5 mg
7
R115866 1.0 mg
12
R115866 2.0 mg
15
Moderate; Visit 3
Group
Value
95% CI
Placebo
27
R115866 0.5 mg
31
R115866 1.0 mg
30
R115866 2.0 mg
25
Severe; Visit 3
Group
Value
95% CI
Placebo
6
R115866 0.5 mg
7
R115866 1.0 mg
3
R115866 2.0 mg
5
Clear; Visit 4
Group
Value
95% CI
Placebo
0
R115866 0.5 mg
0
R115866 1.0 mg
0
R115866 2.0 mg
0
Almost clear; Visit 4
Group
Value
95% CI
Placebo
0
R115866 0.5 mg
0
R115866 1.0 mg
0
R115866 2.0 mg
0
Mild; Visit 4
Group
Value
95% CI
Placebo
15
R115866 0.5 mg
14
R115866 1.0 mg
19
R115866 2.0 mg
18
PASI75 at Each Post Baseline Visit Except Visit 6Secondary· Week 1 to Week 20 (Visit 3 to Visit 8) except Week 12 (Visit 6)
PASI75 success was defined as number of participants who achieved at least 75% reduction in PASI scores at each post baseline visit (Visit 3 to Visit 8) except Visit 6. The PASI score was determined through evaluation of BSA covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated i
Visit 3
Group
Value
95% CI
Placebo
0
R115866 0.5 mg
0
R115866 1.0 mg
0
R115866 2.0 mg
0
Visit 4
Group
Value
95% CI
Placebo
0
R115866 0.5 mg
0
R115866 1.0 mg
1
R115866 2.0 mg
0
Visit 5
Group
Value
95% CI
Placebo
4
R115866 0.5 mg
0
R115866 1.0 mg
2
R115866 2.0 mg
5
Visit 7
Group
Value
95% CI
Placebo
5
R115866 0.5 mg
8
R115866 1.0 mg
6
R115866 2.0 mg
7
Visit 8
Group
Value
95% CI
Placebo
6
R115866 0.5 mg
7
R115866 1.0 mg
10
R115866 2.0 mg
13
Adverse events — posted to ClinicalTrials.gov
Time frame: Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 1/41 (2%)
Deaths: 0/41
R115866 0.5 mg
Serious: 1/45 (2%)
Deaths: 0/45
R115866 1.0 mg
Serious: 0/45 (0%)
Deaths: 0/45
R115866 2.0 mg
Serious: 0/45 (0%)
Deaths: 0/45
Serious adverse events (2 terms)
Reaction
System
Placebo
R115866 0.5 mg
R115866 1.0 mg
R115866 2.0 mg
Jaw fracture
Injury, poisoning and procedural complications
—
—
—
—
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eligible subjects will be randomly assigned to one of three dose regimens of oral R115866 or placebo for the treatment of severe plaque psoriasis for 12 twelve weeks. The safety and efficacy of R115866 will be evaluated during the treatment period and the 8-week post treatment follow-up period.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stiefel, a GSK Company
Last refreshed: 29 January 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00716144.