Last updated: 11/03/2018 16:48:19
Trial of an Injectable Biologic and U0279 as Combination Therapy for Severe Plaque-Type Psoriasis
GSK study ID
114549
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
Trial overview
Official title: Randomized, Controlled Trial of an Injectable Biologic and U0279 as Combination Therapy for Severe Plaque-Type Psoriasis
Trial description: The purpose of the study is to assess the safety and efficacy of an injectable biologic and U0279 as combination therapy compared to that of an injectable biologic alone for severe plaque-type psoriasis.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Primary endpoints - Mean change in % BSA psoriasis involvement from baseline to week 12 and the mean change in PASI score from baseline to Week 12.
Timeframe: Baseline & Week 12
Secondary outcomes:
Mean change from baseline in PGA at week 12, % of subjects with improvement in PASI 50 to 75 from baseline to week 12 and % of subjects with improvement in PASI 75 to 90 from baseline to week 12.
Timeframe: Baseline & Week 12
Interventions:
Drug: Acitretin (also called U0279)
Drug: Placebo
Biological/vaccine: Etanercept
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Plaque Psoriasis
Product
acitretin
Collaborators
GSK
Study date(s)
June 2009 to November 2009
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 years - 0 Not applicable
Accepts healthy volunteers
No
- Male or female subjects 18 years of age or older.
- Surgically sterile females. Females who have had a hysterectomy or completed menopause are allowed.
- Understand that the sponsor can not pay for the an injectable biologic therapy during the course of the study; be willing to pay out of pocket or secure payment through their private health insurance for an injectable biologic.
- History of systemic infection, or other conditions that may interfere with study evaluations or may increase risk for participation. such as, tuberculosis, human immunodeficiency virus (HIV), hepatitis; congestive heart failure or demyelinating disorder.
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female subjects 18 years of age or older.
- Surgically sterile females. Females who have had a hysterectomy or completed menopause are allowed.
- Affected Body Surface Area with psoriasis of ≥10%.
- Psoriasis Global Assessment rating of "moderate to severe" or "severe".
- Achieved mild to moderate improvement after receiving an injectable biologic therapy for at least 12 weeks.
- A PASI score of ≥ 50 and ≤75
- Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed
Exclusion criteria:
- Understand that the sponsor can not pay for the an injectable biologic therapy during the course of the study; be willing to pay out of pocket or secure payment through their private health insurance for an injectable biologic.
- History of systemic infection, or other conditions that may interfere with study evaluations or may increase risk for participation. such as, tuberculosis, human immunodeficiency virus (HIV), hepatitis; congestive heart failure or demyelinating disorder.
- Used of prohibited medications or therapies
Trial location(s)
Location
UCSF - Dermatology Psoriasis & Skin Treatment Center
San Francisco, CA, United States, 94118
Status
Recruiting
Location
Mt. Sinai School of Medicine Department of Dermatology
New York, NY, United States, 10029
Status
Recruiting
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Withdrawn
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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