| 1 |
NCT02466152 |
Completed |
Pharmacokinetic Study of Topical GSK2894512 Cream |
|
- Drug: GSK2894512 Topical Cream
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Composite of pharmacokinetic (PK) parameters
- Number of subjects with adverse events (AEs)
- Safety as assessed by Vital signs
- (and 9 more...)
|
11 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02466152 |
201851 |
|
May 28, 2015 |
October 27, 2015 |
October 27, 2015 |
June 9, 2015 |
May 9, 2017 |
|
- GSK Investigational Site
Montreal, Quebec, Canada
|
|
| 2 |
NCT02411162 |
Completed |
A Single Dose Phase I Exploratory Study in Healthy Volunteers With GSK2894512 Cream |
|
- Drug: Combination therapy GSK2894512 Cream A + GSK2894512 Cream B
- Drug: Combination therapy Vehicle Cream A + Vehicle Cream B
|
Interventional
|
Phase 1 |
- Stiefel, a GSK Company
- GlaxoSmithKline
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Residence time in skin following topical application of two formulations of GSK2894512 Cream
- Adverse events (AEs) monitoring after two formulations of GSK2894512 cream
- Composite of vital signs assessment including temperature, systolic and diastolic blood pressure and pulse rate of two formulations after two GSK2894512 cream
- (and 4 more...)
|
15 |
Male |
18 Years to 45 Years (Adult) |
NCT02411162 |
201661 |
|
July 7, 2015 |
September 24, 2015 |
September 24, 2015 |
April 8, 2015 |
May 9, 2017 |
|
- GSK Investigational Site
Urbana, Illinois, United States
|
|
| 3 |
NCT03202004 |
Withdrawn |
GSK2894512 Vehicle-Controlled Study for Adult Plaque Psoriasis |
|
- Drug: GSK2894512 1% cream
- Drug: Vehicle cream
|
Interventional
|
Phase 3 |
- GlaxoSmithKline
- PPD
- ERT: Clinical Trial Technology Solutions
- Q2 Solutions
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Proportion OF SUBJECTS WITH PGA SCORE OF CLEAR OR ALMOST CLEAR (0 OR 1) AND A MINIMUM 2-GRADE IMPROVEMENT IN PGA SCORE FROM BASELINE AND WEEK 12
- Proportion of subjects with >=75% improvement in Psoriasis Area and Severity Index (PASI) from Baseline to Week 12
- Proportion OF SUBJECTS WITH>=3-POINT REDUCTION IN WEEKLY AVERAGE ITCH/PRURITUS NUMERIC RATING SCALE (NRS) FROM BASELINE TO WEEK 12 FOR SUBJECTS WITH A BASELINE SCORE >=4
|
0 |
All |
18 Years and older (Adult, Older Adult) |
NCT03202004 |
200852 |
|
January 22, 2018 |
September 28, 2018 |
September 28, 2018 |
June 28, 2017 |
December 7, 2017 |
|
|
|
| 4 |
NCT03201978 |
Withdrawn |
A Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of GSK2894512 in Healthy Adult Subjects |
|
- Drug: GSK2894512 1% CREAM
- Drug: GSK2894512 MATCHING VEHICLE CREAM
|
Interventional
|
Phase 1 |
- GlaxoSmithKline
- iCardiac
- Innovaderm Research Inc.
- (and 2 more...)
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Sequential Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Plasma concentrations of GSK2894512 (trans-isomer)
- Area under the plasma concentration-time curve from time zero to the end of the dosing interval (AUC [0-tau]) of GSK2894512
- Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC [0-t) of GSK2894512
- (and 12 more...)
|
0 |
All |
18 Years to 60 Years (Adult) |
NCT03201978 |
207539 |
|
December 14, 2017 |
May 15, 2018 |
May 15, 2018 |
June 28, 2017 |
November 29, 2017 |
|
|
|
| 5 |
NCT02637206 |
Completed |
Skin Irritation Study of GSK2894512 Cream |
|
- Drug: GSK2894512 Cream
- Drug: Vehicle Cream
- Drug: Empty Patch
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Part 1-Positive rate of skin irritability as assessed by simple-patch test following single application of GSK2894512 cream
- Part 1-Positive rate of photo-urticaria reaction as assessed by photo patch test following single application of GSK2894512 cream
- Part 1-Positive rate of photo-toxicity as assessed by photo patch test following single application of GSK2894512 cream
- (and 13 more...)
|
26 |
All |
20 Years to 64 Years (Adult) |
NCT02637206 |
200920 |
|
October 27, 2015 |
December 2, 2015 |
December 2, 2015 |
December 22, 2015 |
July 18, 2017 |
|
- GSK Investigational Site
Fukuoka, Japan
|
|
| 6 |
NCT02564042 |
Completed
Has Results |
A Dose-Finding Study of GSK2894512 Cream in Subjects With Plaque Psoriasis |
|
- Drug: GSK2894512 1% Cream
- Drug: GSK2894512 0.5% Cream
- Drug: Vehicle cream
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of Participants Who Have a Physician Global Assessment (PGA) Score of 0 or 1 at Week 12 and a Minimum 2-grade Improvement in PGA Score From Baseline to Week 12
- Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit
- Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit
- (and 31 more...)
|
227 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02564042 |
203120 |
|
November 23, 2015 |
October 1, 2016 |
October 5, 2016 |
September 30, 2015 |
November 13, 2017 |
November 13, 2017 |
- GSK Investigational Site
San Diego, California, United States - GSK Investigational Site
North Logan, Connecticut, United States - GSK Investigational Site
Miami, Florida, United States - (and 43 more...)
|
|
| 7 |
NCT02564055 |
Completed
Has Results |
A Dose-Finding Study of GSK2894512 Cream in Subjects With Atopic Dermatitis (AD) |
|
- Drug: GSK2894512 1% Cream
- Drug: GSK2894512 0.5% Cream
- Drug: Vehicle cream
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of Participants Who Have an Investigator Global Assessment (IGA) Score of Clear or Almost Clear (0 or 1) at Week 12 and a Minimum 2 Grade Improvement in IGA Score From Baseline to Week 12 for Intent to Treat (ITT) Population
- Mean Change From Baseline in Weekly Average of Daily Itch/Pruritus (Numeric Rating Scale [NRS]) Score
- Mean Percent Change From Baseline in Weekly Average of Daily Itch/Pruritus NRS Score
- (and 37 more...)
|
247 |
All |
12 Years to 65 Years (Child, Adult, Older Adult) |
NCT02564055 |
203121 |
|
December 1, 2015 |
January 1, 2017 |
January 12, 2017 |
September 30, 2015 |
November 20, 2017 |
November 20, 2017 |
- GSK Investigational Site
Fort Smith, Arkansas, United States - GSK Investigational Site
Fresno, California, United States - GSK Investigational Site
Irvine, California, United States - (and 57 more...)
|
|
| 8 |
NCT01984775 |
Completed |
A Study to Evaluate the Irritation Potential of GSK2894512 Cream on Skin in Healthy Subjects |
|
- Drug: GSK2894512 cream
- Drug: Vehicle cream
- Drug: Positive control
- Drug: Negative control
|
Interventional
|
Phase 1 |
- Stiefel, a GSK Company
- GlaxoSmithKline
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Mean cumulative irritation score
- Total cumulative irritation score
- Incidence of adverse events (AEs) and treatment-related AEs
- (and 4 more...)
|
52 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01984775 |
117191 |
|
October 30, 2013 |
July 2, 2014 |
July 2, 2014 |
November 15, 2013 |
June 16, 2017 |
|
- GSK Investigational Site
Baltimore, Maryland, United States - GSK Investigational Site
Hamburg, Germany
|
|
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