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A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants

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ClinicalTrials.gov Identifier: NCT04316585
Recruitment Status : Recruiting
First Posted : March 20, 2020
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
Plaque psoriasis is a chronic relapsing inflammatory skin disease that is characterized by keratinocyte hyper-proliferation and epidermal hyperplasia. Standard treatment for psoriasis generally requires long-term use of topical therapies, psoralen and ultraviolet A (PUVA), ultraviolet B (UVB) and/or systemic immunosuppressant therapies to achieve and maintain adequate disease control. This is a multicenter, randomized, double-blind study conducted in participants with moderate to severe plaque psoriasis. The study will evaluate the efficacy, safety, pharmacokinetic and pharmacodynamics profile of 960 milligram (mg) GSK2982772 administered as a once daily modified release (MR) formulation. Participants will be randomized in a 2:1 ratio to receive either 960 mg GSK2982772 or placebo for 12 weeks. The duration of the study, including Screening and follow-up, will be approximately 21 weeks for each participant.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: GSK2982772 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will randomized in ratio of 2:1 to receive either 960 mg GSK2982772 or placebo
Masking: Double (Participant, Investigator)
Masking Description: This is a double-blind study where sponsor will be unblinded
Primary Purpose: Treatment
Official Title: A Multicentre, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of GSK2982772 in Participants With Moderate to Severe Plaque Psoriasis
Actual Study Start Date : September 28, 2020
Estimated Primary Completion Date : September 9, 2021
Estimated Study Completion Date : October 7, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Participants receiving GSK2982772 960 mg
Participants will receive GSK2982772 960 mg oral tablets once daily for 12 weeks.
Drug: GSK2982772
GSK2982772 will be available as MR tablet at a unit dose strength of 480 mg.

Placebo Comparator: Participants receiving placebo
Participants will receive GSK2982772 matching placebo oral tablets once daily for 12 weeks.
Drug: Placebo
GSK2982772 matching placebo tablets will be administered via the oral route.




Primary Outcome Measures :
  1. Percentage of participants who achieve >=75 percent improvement from Baseline in Psoriasis Area Severity Index (PASI) score at Week 12 [ Time Frame: Baseline and Week 12 ]
    Psoriatic lesions will be assessed using the PASI scoring system. Erythema, induration, and scale are each graded on a 5-point scale (0-4), and the percent body Surface Area (BSA) affected is scored on a 7-point scale (0-6) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The body region scores are each multiplied by a weighted factor; and the sum of the region scores give the overall PASI score. Higher scores indicate more severe disease.


Secondary Outcome Measures :
  1. Percentage of participants who achieve >=50 percent improvement from Baseline in PASI score at Week 12 [ Time Frame: Baseline and Week 12 ]
    Psoriatic lesions will be assessed using the PASI scoring system. Erythema, induration, and scale are each graded on a 5-point scale (0-4), and the percent BSA affected is scored on a 7-point scale (0-6) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The body region scores are each multiplied by a weighted factor; and the sum of the region scores give the overall PASI score. Higher scores indicate more severe disease.

  2. Percentage of participants who achieve >=90 percent improvement from Baseline in PASI score at Week 12 [ Time Frame: Baseline and Week 12 ]
    Psoriatic lesions will be assessed using the PASI scoring system. Erythema, induration, and scale are each graded on a 5-point scale (0-4), and the percent BSA affected is scored on a 7-point scale (0-6) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The body region scores are each multiplied by a weighted factor; and the sum of the region scores give the overall PASI score. Higher scores indicate more severe disease

  3. Percentage of participants who achieved >=100 percent improvement from Baseline in PASI score at Week 12 [ Time Frame: Baseline and Week 12 ]
    Psoriatic lesions will be assessed using the PASI scoring system. Erythema, induration, and scale are each graded on a 5-point scale (0-4), and the percent BSA affected is scored on a 7-point scale (0-6) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The body region scores are each multiplied by a weighted factor; and the sum of the region scores give the overall PASI score. Higher scores indicate more severe disease

  4. Change from Baseline PASI scores at Week 12 [ Time Frame: Baseline and Week 12 ]
    Psoriatic lesions will be assessed using the PASI scoring system. Erythema, induration, and scale are each graded on a 5-point scale (0-4), and the percent BSA affected is scored on a 7-point scale (0-6) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The body region scores are each multiplied by a weighted factor; and the sum of the region scores give the overall PASI score. Higher scores indicate more severe disease

  5. Percentage of participants who have a Static Investigator's Global Assessment (sIGA) score of 0 or 1 at Week 12 [ Time Frame: At Week 12 ]
    The Investigator or physician designee only will complete a global assessment of disease activity using the physician global assessment item. A 5-point scoring system will be used to measure the severity of psoriatic lesions over the entire body at the time of evaluation. Percentage of participants who have a sIGA score of 0=clear or 1=almost clear at Week 12 will be summarized.

  6. Change from Baseline in psoriatic BSA at Week 12 [ Time Frame: Baseline and Week 12 ]
    The BSA affected with psoriasis will be evaluated at all study visits by the Investigator or suitably trained delegate. As a reference, the area of the whole palm is counted as 1 percent BSA.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants between 18 and 75 years of age inclusive, at the time of signing the informed consent.
  • Diagnosis of plaque psoriasis for at least 6 months before Screening visit.
  • Evidence of moderate to severe psoriasis, at Screening and Baseline before the first dose of study treatment, with: PASI score >=12; Psoriasis plaques involving BSA >=10 percent and sIGA>=3.
  • Candidate for systemic therapy or phototherapy (includes naïve or previously treated), in the opinion of the Investigator.
  • Agrees to avoid any prolonged exposure to natural or artificial sources of ultraviolet (UV) radiation from 28 days before Day 1 until the follow-up visit, which may potentially impact the participant's psoriasis in the opinion of the Investigator.
  • Body mass index (BMI) within the range of 18.5 to 40.0 kilogram (kg)/meter square (m^2).
  • Preclinical data has not identified risk of clinically relevant genotoxicity, however there is demonstrated/suspected risk of teratogenicity/fetotoxicity. Accordingly, the following contraceptive advice must be adhered to for male and female participants.
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Male participants are eligible to participate if they agree to the following during the intervention period and for at least 2 days (i.e. 5 terminal half-lives of GSK2982772) after the last dose of study intervention: Refrain from donating sperm plus either: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed: Agree to use a male condom and will also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a WOCBP OR Is a WOCBP and using a contraceptive method that is highly effective preferably with low user dependency, during the intervention period and for at least 28 days (i.e. until resolution of potential drug interaction with combined hormonal contraceptives) after the last dose of study intervention. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative (example an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
  • The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.

Exclusion Criteria:

  • Non-plaque forms of psoriasis (example erythrodermic, guttate, or pustular), in the opinion of the Investigator.
  • Drug-induced psoriasis (example a new onset of psoriasis or an exacerbation from beta blockers, calcium channel blockers, lithium or anti-Tumor-Necrosis Factor [TNF] therapies).
  • Diagnosis of psoriatic arthritis, uveitis, inflammatory bowel disease, or other immune-mediated conditions that are commonly associated with psoriasis for which a participant requires current systemic (oral, subcutaneous [SC], or intravenous [IV]) (including corticosteroids and biologics) immunosuppressant medical treatment.
  • Current Suicidal Ideation Behavior (SIB) as measured using the Columbia Suicide Severity Rating Scale (C-SSRS) or a history of attempted suicide at Screening and before first dose of study treatment.
  • Active infection, or a history of infections as follows: Hospitalization for treatment of infection within 60 days before Day 1; Current use of any suppressive therapy for a chronic infection (such as pneumocystis jirovecii, cytomegalovirus, herpes simplex virus, herpes zoster virus and atypical mycobacteria); Use of parenteral (IV or intramuscular) antibiotics (anti-bacterials, antivirals, antifungals, or anti-parasitic agents) within 60 days before Day 1; History of opportunistic infections within 1 year of Screening (example pneumocystis jirovecii, Cytomegalovirus [CMV] pneumonitis, aspergillosis). This does not include infections that may occur in immunocompetent individuals, such as fungal nail infections or vaginal candidiasis, unless it is of an unusual severity or recurrent nature; History of recurrent, chronic or other active infection that in the opinion of the Investigator may put the participant at unacceptable risk or interfere/confound the integrity of study data; Positive test for Severe Acute Respiratory Syndrome-Related Coronavirus 2 (SARS-CoV-2) at screening or interaction with known Coronovirus Disease 2019 (COVID19) positive contacts within 14 days prior to Day 1; History of latent or active Tuberculosis (TB), irrespective of treatment status; A positive diagnostic TB test at Screening defined as a positive QuantiFERON-TB Gold plus test.
  • Current or history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Current or history of renal disease.
  • Significant unstable or uncontrolled cardiovascular disease including uncontrolled hypertension.
  • Hereditary or acquired immunodeficiency disorder, including immunoglobulin deficiency.
  • History of major organ transplant (example heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
  • Planned surgical procedure that makes the participant unsuitable for the study, in the opinion of the Investigator.
  • History of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell carcinoma) or carcinoma in situ of the uterine cervix that has been fully treated and shows no evidence of recurrence after at least 12 months following treatment.
  • History of significant progressive neurologic disorders including, but not limited to, progressive Multiple Sclerosis (MS), Amyotrophic Lateral Sclerosis (ALS), Alzheimer's and dementia.
  • History of a medical condition other than plaque psoriasis, or other considerations, which may confound interpretation of efficacy or safety study data, or put the participant at unacceptable risk, in the opinion of the Investigator.
  • History of lack of primary response to anti-TNF biologic therapies (either approved or experimental) at approved doses (or at the doses received if experimental therapies) after at least 3 months of therapy.
  • Participant has previous exposure to 3 or more biologic therapies of any mechanism of action.
  • Treatment with the prohibited therapies or changes to those treatments, within the specified timeframe. Other medications (including vitamins, herbal and dietary supplements) will be considered on a case-by-case basis and will be allowed if the medication will not interfere with the study procedures or compromise participant safety, in the opinion of the Investigator.
  • Participation in a clinical trial and has received an investigational product within 30 days or 5 half-lives whichever is longer (or 12 weeks for biologic therapies), before the first dose of study medication, or plans to take part in another clinical trial at the same time as participating in this clinical trial.
  • Exposure to more than four investigational products within 12 months prior to the first dosing day.
  • Average QT Duration Corrected for Heart Rate (QTc) >450 milliseconds (msec) or QTc>480 msec in participants with bundle branch block at Screening and before first dose of study treatment. The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF). It is either machine-read or manually over-read.
  • Alanine transferase (ALT) >2 × upper limit of normal (ULN)
  • Bilirubin >1.5 × ULN at Screening (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent).
  • Estimated glomerular filtration rate (GFR) by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) <60 milliliter (mL)/minute (min)/1.73 m^2.
  • Hemoglobin < 10 gram per deciliter (g/dL); hematocrit < 30 percent, white blood cell count <= 3000 /cubic millimeter (mm^3) (<= 3.0 x 10^9/Liter); platelet count <= 100,000 /microliter (μL) (<= 100 x 10^9/Liter); absolute neutrophil count (<= 1.5 x 10^9/Liter).
  • Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb).
  • Presence of hepatitis C antibody at Screening. Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative hepatitis C Ribonucleic acid (RNA) test is obtained.
  • Positive serology for Human Immunodeficiency Virus (HIV) 1 or 2.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 3 months.
  • History of alcohol or drug abuse, that would interfere with the ability to comply with the study or interfere with interpretation of the study, in the opinion of the Investigator.
  • History of sensitivity to any of the study treatments, or components thereof, or a history of drug or other allergy that contraindicates their participation (including lidocaine or other local anesthetic), in the opinion of the Investigator or Medical Monitor.
  • History of receiving a live or attenuated vaccine within 30 days of randomization OR plan to receive a live or attenuated vaccination during the study until completion of the follow-up visit.
  • History of hypertrophic or keloid scarring.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04316585


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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Canada, Alberta
GSK Investigational Site Completed
Edmonton, Alberta, Canada, T5K 1X3
GSK Investigational Site Recruiting
Edmonton, Alberta, Canada, T6G 1C3
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jaggi Rao         
Canada, British Columbia
GSK Investigational Site Recruiting
Surrey, British Columbia, Canada, V3R 6A7
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Chih-Ho Hong         
Canada, Nova Scotia
GSK Investigational Site Recruiting
Truro, Nova Scotia, Canada, B2N 1L2
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Murdo Ferguson         
Canada, Ontario
GSK Investigational Site Recruiting
London, Ontario, Canada, N6H 5L5
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Wei Jing Loo         
GSK Investigational Site Recruiting
Oakville, Ontario, Canada, L6J 7W5
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sheetal Sapra         
GSK Investigational Site Recruiting
Peterborough, Ontario, Canada, K9J 5K2
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Melinda Gooderham         
GSK Investigational Site Recruiting
Waterloo, Ontario, Canada, N2J 1C4
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ajith Cy         
Canada, Quebec
GSK Investigational Site Recruiting
Montreal, Quebec, Canada, H3H 1V4
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: David Gratton         
Canada
GSK Investigational Site Recruiting
Quebec, Canada, G1N 4V3
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Helene Veillette         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04316585    
Other Study ID Numbers: 208022
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Plaque Psoriasis
Modified Release
GSK2982772
Skin Biopsy
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases