An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184

NCT01777256 | Terminated Phase 2 DMC

• 1 other identifier: 115919
• Study Type: interventional
• Target: 51
• Locations: 15 countries
• Sites: 51

Brief Summary

This is an adaptive, dose ranging, Phase II study to investigate the relationship between repeat doses of GSK2586184 and the pharmacodynamic effect and clinical efficacy in patients with active systemic lupus erythematosus (SLE). This study will also investigate the safety and tolerability of repeat doses of GSK2586184. During the study, up to 3 Interim Analyses will be conducted. These are to monitor the pharmacodynamic effect and safety following 2 weeks of therapy (Interim Analysis 1); and the clinical efficacy and safety of GSK2586184 following 12 weeks of therapy (Interim Analyses 2 and 3). Subjects who meet the entry criteria (approximately 150 to 250) will be randomized in a 1:1:1:1:1 ratio to receive GSK2586184 at doses of 50 milligram (mg) twice daily (b.i.d), 100 mg b.i.d, 200 mg b.i.d, 400 mg b.i.d or Placebo b.i.d. GSK2586184 tablets available in 50 and 200 mg dose strength will be administered orally up to 12 weeks. Subjects who complete the study will participate in the study for approximately 21 weeks.

Conditions

Systemic Lupus Erythematosus

Keywords

systemic lupus erythematosus; adaptive design; clinical safety and efficacy; pharmacodynamics

Outcome Measures

Primary Outcomes (23)

• Percentage Inhibition from Baseline of interferon (IFN) Transcriptional Biomarkers at Week 2

  Mean reduction (40%) from Baseline of the IFN transcriptional signature biomarker was monitored at Week 2. Percentage (Per) inhibition (=\[(Day x-Baseline)/Baseline\]\*-100), was the Per reduction from Baseline (Day1) and evaluated in any pre-designated panels of genes i.e. Addenbrookes 1, Addenbrookes 2, JAK439, PD, Panel Stripping, Flare and Transcription. Analysis was performed using a repeated measures model with covariates of treatment, baseline, Day, Day by baseline and Day by treatment interactions. Only those Par available at the specified time points were analysed (n=X,X,X,X,X). Different Par may have been analysed at different time points, so the overall number of Par analysed reflects everyone in the Intent To Treat (ITT) Population i.e. Par randomised to treatment, received \>=1 dose of study medication and had \>=1 valid post dose assessment

  Baseline(Day1) and Week 2

• Change from Baseline of SELENA SLEDAI score at indicated time points up to Week 16

  The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a validated index for assessing SLE disease activity. It is a weighted index in which signs and symptoms, laboratory tests, and physician's assessment for each of 9 organ systems are given a weighted score and summed, if present at the time of the visit or in the preceding 10 days. Modified version of SLEDAI is Safety of Estrogen in Lupus National Assessment (SELENA) SLEDAI where the maximum theoretical score for the SELENA SLEDAI was 105 with 0 indicating inactive disease. Baseline value is defined as Day 1 (pre-dose) SELENA SLEDAI score.

  Baseline(Day1), Weeks 2, 4, 6, 8, 10, 12 and 16

• Change from Baseline in systolic blood pressure and diastolic blood pressure at the indicated time points up to Week 16

  Change from Baseline in systolic blood pressure (BP) and diastolic BP is summarized for each post-Baseline assessment up to Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

  Baseline(Day1), Weeks 2, 4, 6, 8, 10, 12 and 16

• Change from Baseline in heart rate at the indicated time points up to Week 16

  Change from Baseline in sitting and supine heart rate is summarized for each post-Baseline assessment up to Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last pre-treatment value observed.

  Baseline (Day 1), Weeks 2, 4, 6, 8, 10, 12 and 16

• Change from Baseline in temperature at the indicated time points up to Week 16

  Change from Baseline in temperature is summarized for each post-Baseline assessment up to Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

  Baseline (Day 1), Weeks 2, 4, 6, 8, 10, 12 and 16

• Change from Baseline in albumin, globulin and protein at the indicated time points up to Week 16

  Change from Baseline in the albumin, globulin and protein values are summarized for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

  Baseline (Day 1), Weeks 2, 3, 4, 5, 6, 8, 10, 12 and 16

• Change from baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase at the indicated time points up to Week 16

  Change from Baseline in the alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), creatine kinase (CK), gamma glutamyl transferase (GGT) and lactate dehydrogenase (LDH) values are summarized for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

  Baseline(Day 1), Weeks 2, 3, 4, 5, 6, 8, 10, 12 and 16

• Change from Baseline in anion gap, calcium, cholesterol, chloride, carbon dioxide, glucose, HDL cholesterol, potassium, LDL cholesterol, magnesium, phosphate, soidium, triglycerides, urea, VLDL cholesterol at the indicated time points up to Week 16

  Change from Baseline in the anion gap, calcium, ionised calcium, cholesterol, chloride, carbon dioxide, glucose, high density lipoprotein (HDL) cholesterol (fasted and not fasted), potassium, low density lipoprotein (LDL) cholesterol (fasted and not fasted), magnesium, phosphate, sodium, triglycerides (fasted and not fasted), urea and very low density lipoprotein (VLDL) cholesterol values are summarized for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

  Baseline (Day 1), Weeks 2, 3, 4, 5, 6, 8, 10, 12 and 16

• Change from Baseline in bilirubin, creatinine, iron binding capacity, iron and urate at the indicated time points up to Week 16

  Change from Baseline in the bilirubin, direct and indirect bilirubin, creatinine, total iron binding capacity (TIBC), unsaturated iron binding capacity (UIBC), iron and uric acid values are summarized for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

  Baseline(Day 1), Weeks 2, 3, 4, 5, 6, 8, 10, 12 and 16

• Change from Baseline in albumin/globulin, BUN/creatinine and transferrin saturation at the indicated time points up to Week 16

  Change from baseline in the albumin/globulin, blood urea nitrogen (BUN)/creatinine and transferrin saturation values are summarized for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

  Baseline(Day 1), Weeks 2, 3, 4, 5, 6, 8, 10, 12 and 16

• Change from Baseline in creatinine clearance at the indicated time points up to Week 16

  Change from Baseline in the Creatinine Clearance values are summarized for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

  Baseline (Day 1), Weeks 2, 3, 4, 5, 6, 8, 10, 12 and 16

• Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils segmented (SG), platelets and leukocytes at the indicated time points up to Week 16

  Change from Baseline in the basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils segmented (SG), platelets and leukocytes values are summarized for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

  Baseline(Day 1), Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 16

• Change from Baseline in basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, neutrophils/leukocytes, neutrophils SG/leukocytes and erythrocyte distribution width (EDW) at the indicated time points up to Week 16

  Change from Baseline in the basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, neutrophils/leukocytes, neutrophils segmented (SG)/leukocytes and erythrocyte distribution width (EDW) values are summarized for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

  Baseline(Day 1), Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 16

• Change from Baseline in erythrocytes and reticulocytes at the indicated time points up to Week 16

  Change from Baseline in the erythrocyte and reticulocyte values are summarized for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

  Baseline (Day 1), Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 16

• Change from Baseline in hemoglobin and erythrocyte mean corpuscular hemoglobin concentration (EMCHC) at the indicated time points up to Week 16

  Change from Baseline in the hemoglobin and erythrocyte mean corpuscular hemoglobin concentration (EMCHC) values are summarized for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

  Baseline(Day 1), Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 16

• Change from Baseline in erythrocyte mean corpuscular hemoglobin (EMCH) at the indicated time points up to Week 16

  Change from Baseline in the hemoglobin and erythrocyte mean corpuscular hemoglobin (EMCH) values are summarized for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

  Baseline(Day 1), Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 16

• Change from Baseline in erythrocyte mean corpuscular volume (EMCV) and mean platelet volume (MPV) at the indicated time points up to Week 16

  Change from Baseline in the erythrocyte mean corpuscular volume (EMCV) and mean platelet volume (MPV) values are summarized for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

  Baseline(Day 1), Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 16

• Change from Baseline in hematocrit and reticulocytes/erythrocytes at the indicated time points up to Week 16

  Change from Baseline in the hematocrit and reticulocytes/erythrocytes values are summarized for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

  Baseline(Day 1), Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 16

• Number of participants with urinalysis data at the indicated time points up to Week 16

  Number of participants with negative and positives (trace, +, ++ and +++) data for urine glucose (UGLU), urine ketones (UKET) and urine occult blood (UOB) are summarized for each post-Baseline assessment until Week 16. Urinalysis was performed by dipstick method. Baseline value is defined as the last Pre-treatment value observed.

  Baseline(Day 1), Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12 and 16

• Change from Baseline in urine protein at the indicated time points up to Week 16

  Change from Baseline in the urine protein values are summarized for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

  Baseline(Day 1), Weeks 2, 3, 4, 5, 6, 8, 10, 12 and 16

• Change from Baseline in urine protein/creatinine at the indicated time points up to Week 16

  Change from Baseline in the urine protein/creatinine values are summarized for each post-Baseline assessment until Week 16. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

  Baseline(Day 1), Weeks 2, 3, 4, 5, 6, 8, 10, 12 and 16

• Number of participants with any adverse events (AEs) and any serious adverse events (SAEs) up to Week 16

  An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.

  Up to Week 16

• Number of participants with severity Grade 1, 2, 3, 4 and 5 adverse events (AEs)

  The Common Terminology Criteria for Adverse Events (CTCAE, Version 4) has categorised AEs in five grades. Grade refers to the severity of the AE. Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.

  Up to 16 Weeks

Secondary Outcomes (9)

• SRI Response Rate at Week 4, 8, 12 and 16

  Week 4, 8, 12 and 16

• Change from baseline in SLEDAI-2K score and the S2K RI-50 score over time (up to Week 12)

  Baseline(Day 1) to Week 12

• Mean GSK2586184 plasma concentrations on Weeks 2, 4, 6, 8, 10 and 12

  Weeks 2, 4, 6, 8, 10 and 12

• Area under the concentration-time curve over the dosing interval (AUC[0-tau]) up to Week 12

  Weeks 2, 4, 6, 8, 10 and 12

• Apparent clearance (CL/F) up to Week 12

  Weeks 2, 4, 6, 8, 10 and 12

Study Arms (5)

GSK2586184 50 mg Arm

EXPERIMENTAL

Subjects in the GSK2586184 50 mg Arm will receive twice daily dose of GSK2586184 50 mg 1 x 50 mg tablet + 1x placebo tablet) orally up to 12 weeks. Study medication should be taken with food, immediately following a meal

Drug: GSK2586184 50 mg; Drug: Placebo

GSK2586184 100 mg Arm

EXPERIMENTAL

Subjects in the GSK2586184 100 mg Arm will receive twice daily dose of GSK2586184 100 mg (2 x 50 mg tablets) orally up to 12 weeks. Study medication should be taken with food, immediately following a meal.

Drug: GSK2586184 100 mg

GSK2586184 200 mg Arm

EXPERIMENTAL

Subjects in the GSK2586184 200 mg Arm will receive twice daily dose of GSK2586184 200 mg (1 x 200 mg tablet + 1x placebo tablet) orally up to 12 weeks. Study medication should be taken with food, immediately following a meal.

Drug: GSK2586184 200 mg; Drug: Placebo

GSK2586184 400 mg Arm

EXPERIMENTAL

Subjects in the GSK2586184 400 mg Arm will receive twice daily dose of GSK2586184 400 mg (2 x 200 mg tablets) orally up to 12 weeks. Study medication should be taken with food, immediately following a meal.

Drug: GSK2586184 400 mg

Placebo

PLACEBO COMPARATOR

Subjects in the placebo arm will receive twice daily dose of 2 matching placebo tablets orally up to 12 weeks; taken with food, immediately following a meal.

Drug: Placebo

Interventions

GSK2586184 50 mg DRUG

GSK2586184 tablet will be administered orally as twice daily dose of 50 mg (1 x 50 mg tablet) up to 12 weeks.

GSK2586184 50 mg Arm

GSK2586184 100 mg DRUG

GSK2586184 tablet will be administered orally as twice daily dose of (2 X 50 mg tablet) up to 12 weeks.

GSK2586184 100 mg Arm

GSK2586184 200 mg DRUG

GSK2586184 tablet will be administered orally as twice daily dose of 200 mg (1 x 200 mg) up to 12 weeks.

GSK2586184 200 mg Arm

GSK2586184 400 mg DRUG

GSK2586184 tablet will be administered orally as twice daily dose of (2 X 200 mg) up to 12 weeks.

GSK2586184 400 mg Arm

Placebo DRUG

Matching placebo tablet will be administered orally twice daily up to 12 weeks.

GSK2586184 200 mg Arm; GSK2586184 50 mg Arm; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \& Gender: Male or female between 18 and 75 years of age inclusive
• SLE classification: a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria
• Severity of disease: clinically active SLE disease defined as a SELENA SLEDAI score ≥8 at screening
• Auto antibodies: serologically active having unequivocally positive anti-nuclear antibody (ANA) or anti-double stranded DNA (anti-dsDNA) antibody test results from 2 independent time points
• Treatment for SLE: patient stable on either no treatment or a stable dose of: corticosteroids (\<=15 mg/day prednisolone or equivalent) and /or hydroxychloroquine (\<=400 mg daily dose) Subjects receiving azathioprine (\<=2 mg/kg/day or \<=150 mg/day, whichever is greater) or mycophenolate mofetil (\<=1.5 g/day), or methotrexate (MTX) (\<=20 mg/week), either alone or in addition to steroids and / or hydroxychloroquine
• Prevention of Pregnancy:
• A female Subject is eligible to participate if she is not pregnant or nursing; is of non-childbearing potential. Females of child-bearing potential must agree to use one highly effective contraception method in addition to barrier protection OR two forms of highly effective contraception.
• Informed consent: Capable of giving written informed consent

You may not qualify if:

• Kidney Disease: meeting any of the following criteria:
• Proteinuria \> 0.5g/24 hour OR equivalent spot urine protein to creatinine ratio of 0.5mg/mg; Serum creatinine \> 1.5 X upper limit of normal (ULN); active nephritis requiring acute therapy not permitted by protocol; required peritoneal dialysis or hemodialysis or high dose corticosteroid (\> 100 mg/day prednisone or equivalent) within 90 days prior to first dose; active renal disease shown on renal biopsy in the three months prior to screening.
• CNS Disease: active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident \[CVA\], cerebritis or CNS vasculitis) requiring therapeutic intervention within 60 days prior to first dose.
• Alcohol Abuse: Evidence or, in the opinion of the investigator, suspicion of alcohol consumption exceeding national guidelines and / or symptoms of alcohol dependency.
• Substance abuse: evidence of current recreational drug abuse or dependence.
• Hepatitis B: A positive pre-study Hepatitis B surface antigen or anti-Hepatitis B core antibody test at screening
• Hepatitis C: A positive Hepatitis C antibody at screening.
• HIV: A positive test for HIV antibody
• Previous Investigational Product Exposure:
• The subject has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) prior to the first dosing day in the current study; OR exposure to more than four new chemical entities within 12 months prior to the first dosing day.
• Previous and current medication: Use of prescription or non-prescription drugs, including: agents known to interact with GSK2586184, erythopoetic stimulation factors; vitamins, herbal and dietary supplements
• Prior biological therapies: treatment with a biological therapy within the last 12 months
• Transplantation: Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
• Uncontrolled Other Diseases: Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk.
• Surgery and Other Conditions: Have a planned surgical procedure or a history of any other medical disease laboratory abnormality, or condition that, in the opinion of the investigator, makes the subject unsuitable for the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (53)

GSK Investigational Site

Ciudad de Buenos Aires, Buenos Aires, C1431FWO, Argentina

Location

GSK Investigational Site

Rosario, Santa Fe Province, 2000, Argentina

Location

GSK Investigational Site

San Juan, J5402DIL, Argentina

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Location

GSK Investigational Site

Olomouc, 775 20, Czechia

Location

GSK Investigational Site

Prague, 12850, Czechia

Location

GSK Investigational Site

Tallinn, 11312, Estonia

Location

GSK Investigational Site

Tallinn, 13419, Estonia

Location

GSK Investigational Site

Brest, 29609, France

Location

GSK Investigational Site

Lille, 59037, France

Location

GSK Investigational Site

Limoges, 87042, France

Location

GSK Investigational Site

Paris, 75651, France

Location

GSK Investigational Site

Pessac, 33604, France

Location

GSK Investigational Site

Cologne, North Rhine-Westphalia, 50937, Germany

Location

GSK Investigational Site

Herne, North Rhine-Westphalia, 44652, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

Location

GSK Investigational Site

Kiel, Schleswig-Holstein, 24105, Germany

Location

GSK Investigational Site

Jena, Thuringia, 07747, Germany

Location

GSK Investigational Site

Athens, 115 21, Greece

Location

GSK Investigational Site

Heraklion-Crete, 71110, Greece

Location

GSK Investigational Site

Larissa, 41110, Greece

Location

GSK Investigational Site

Thessaloniki, 546 42, Greece

Location

GSK Investigational Site

Hong Kong, Hong Kong

Location

GSK Investigational Site

Shatin, Hong Kong

Location

GSK Investigational Site

Tuenmen, Hong Kong

Location

GSK Investigational Site

Budapest, 1023, Hungary

Location

GSK Investigational Site

Budapest, 1097, Hungary

Location

GSK Investigational Site

Debrecen, 4032, Hungary

Location

GSK Investigational Site

Zalaegerszeg, 8900, Hungary

Location

GSK Investigational Site

La Victoria, Lima region, Lima 13, Peru

Location

GSK Investigational Site

San Borja, Lima region, Peru

Location

GSK Investigational Site

Surco, Lima region, Peru

Location

GSK Investigational Site

Lima, Lima 27, Peru

Location

GSK Investigational Site

Bialystok, 15-297, Poland

Location

GSK Investigational Site

Gdynia, 81-384, Poland

Location

GSK Investigational Site

Lublin, 20-954, Poland

Location

GSK Investigational Site

Poznan, 60-856, Poland

Location

GSK Investigational Site

Poznan, 61-397, Poland

Location

GSK Investigational Site

Bucharest, 020125, Romania

Location

GSK Investigational Site

Bucharest, 11172, Romania

Location

GSK Investigational Site

Cluj-Napoca, 400006, Romania

Location

GSK Investigational Site

Cape Town, 7925, South Africa

Location

GSK Investigational Site

Parow, 7505, South Africa

Location

GSK Investigational Site

Pinelands, Cape Town, 7405, South Africa

Location

GSK Investigational Site

Stellenbosch, 7600, South Africa

Location

GSK Investigational Site

Seoul, 120-752, South Korea

Location

GSK Investigational Site

Seoul, 137-701, South Korea

Location

GSK Investigational Site

Seoul, 143-729, South Korea

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Santiago de Compostela, 15706, Spain

Location

GSK Investigational Site

Seville, 41013, Spain

Location

GSK Investigational Site

Gothenburg, SE-413 45, Sweden

Location

GSK Investigational Site

Linköping, SE-581 85, Sweden

Location

Related Publications (1)

• Kahl L, Patel J, Layton M, Binks M, Hicks K, Leon G, Hachulla E, Machado D, Staumont-Salle D, Dickson M, Condreay L, Schifano L, Zamuner S, van Vollenhoven RF; JAK115919 Study Team. Safety, tolerability, efficacy and pharmacodynamics of the selective JAK1 inhibitor GSK2586184 in patients with systemic lupus erythematosus. Lupus. 2016 Nov;25(13):1420-1430. doi: 10.1177/0961203316640910. Epub 2016 Jul 11.

  PMID: 27055521 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

GSK2586184

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 28, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 31, 2014
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

PL (5); CZ (2); HK (3); GR (4); CL (1); SE (2); HU (4); DE (5); RO (3); ZA (4); ES (3); AR (3); PE (4); KR (3); FR (5)