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GlaxoSmithKline
Traitements, essais et publications liés.
Traitements16programmes
Essais9liés
Publications25liées
SourceDBlocale
Traitements
16| Molécule | Indication / population | Phase | Objectif | Pays | Résultat |
|---|---|---|---|---|---|
| Belimumab (GSK1550188)This is a prospective, open-label, single arm 3-year clinical study to describe the short-term and long-term efficacy and safety of belimumab in participants with autoantibody positive early SLE with ongoing disease activity despite stable first-line SLE therapy. | Lupus | Phase 4 | À vérifier | United States, Argentina, Brazil, France, Germany, Greece, Italy, Japan, … | À vérifier |
| GSK1278863As per non-clinical studies, prolyl hydroxylase inhibitor GSK1278863 can protect muscle from unaccustomed exercise induced muscle damage and enhance functional muscle repair. This study is designed to investigate arm function, pain and other pharmacodynamic (PD) markers after unaccustomed maximal eccentric exercise with concurrent administration of GSK1278863 or placebo. Primary objective of the study is to evaluate the protective effects of GSK1278863 on eccentric exercise induced muscle injury. Subjects will be randomized in a 1:1 ratio (1 subject on GSK1278863 for every 1 subject on placebo). Each subject will be given five oral doses of GSK1278863/placebo in total. The first dose will be administered immediately after completion of eccentric exercise and then 4, 8, 24, and 48 hours later. Subjects will be housed till day 4 in unit and will return for a follow-up visit 7-10 days after discharge. After enrolment of approximately 30 subjects, enrolment will be paused and planned interim analysis will be performed to decide whether to terminate enrolment/study, continue dosing or to reduce the dose to 5 milligrams (mg). | Myopathies | Phase 1 | Traitement symptomatique | United States | À vérifier |
| GSK1550188 IVThis study is an open-label, randomized, 2 parallel group, single dose study in healthy Japanese males to assess the pharmacokinetics and safety/tolerability of single intravenous administration and single subcutaneous administration of GSK1550188. Serial blood samples for the determination of GSK1550188 concentration will be collected and safety assessments will be performed for each treatment group | Lupus | Phase 1 | À vérifier | Japan | À vérifier |
| GSK1550188 SCThis study is an open-label, randomized, 2 parallel group, single dose study in healthy Japanese males to assess the pharmacokinetics and safety/tolerability of single intravenous administration and single subcutaneous administration of GSK1550188. Serial blood samples for the determination of GSK1550188 concentration will be collected and safety assessments will be performed for each treatment group | Lupus | Phase 1 | À vérifier | Japan | À vérifier |
| GSK239512This is a randomized, parallel group, placebo-controlled study designed to assess whether GSK239512 can enhance lesion remyelination in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). Subjects with RRMS on stable background treatment with either Avonex (Interferon-beta1a) or Copaxone (Glatiramer Acetate) are eligible to participate. Subjects will be randomized in a 1:1 ratio between placebo and GSK239512, and will continue to be managed with their current standard of care therapy (Copaxone or Avonex). The total treatment period is 48 weeks, including a standard 4 week titration period and 44 week maintenance treatment period (which could be adapted to a 5-week titration and 43 week maintenance period, if needed). Titration doses start at 10 micrograms (mcg) and increase up to 80 mcg (10 mcg first week, 20 mcg second week, 40 mcg third week, 80 mcg fourth week). Subjects will be titrated to the maximum tolerated dose with the objective of titrating to the highest dose (80 mcg GSK239512), whenever possible, based on investigator judgement of tolerability. The post-treatment follow-up period will be a minimum of 2 weeks in duration following the end of treatment at Week 48 or early withdrawal, as appropriate. | SEP | Phase 2 | Remyélinisation | Bulgaria, Canada, Czechia, Germany, Spain, Sweden, Ukraine, United Kingdom | À vérifier |
| GSK3439171AThe FTIH study with GSK3439171A will evaluate the safety of GSK3439171A in healthy subjects in order to avoid confounding factors due to the disease or concomitant drugs in patients. The study design is based on pre-clinical findings for GSK3439171A, contributing to the frequency, type and duration of safety assessment and monitoring during treatment periods in each cohort. The single dose assessments in Part A will be conducted to determine safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the study intervention in individuals before progressing to doses explored further in other parts of the study and will allow for any adjustments needed based on emerging safety, tolerability, and PK information. Part A will also serve to identify a dose for use in examining the effect of food on GSK3439171A exposure in Part C. In Part B, a single dose safety, tolerability and PK will be collected followed by progression of these subjects to the repeat dose portion of the study. The up to 14-day dosing was chosen as it is thought to provide sufficient safety and tolerability data to bridge to longer duration studies. The dosing period can be adjusted depending on PK and PD data collected in Part A of the study. Part B will involve more detailed PK/PD/metabolite assessments to better understand the impact of GSK3439171A on target engagement and metabolism in humans. Approximately 150 subjects will be screened to achieve 75 randomly assigned to study intervention. Duration for Part A, B and C will be approximately 10 weeks, 9 weeks and 8 weeks respectively. | Myopathies | Phase 1 | Ralentissement de la progression | United States | À vérifier |
| Non-steroidal anti-inflammatory drug (NSAID)Chronic Migraine (CM), or 15 or more migraine headaches per month, is common in tertiary headache care and is associated with a number of deleterious outcomes, especially higher disability and poorer quality of life, relative to those with Episodic Migraine (EM) defined as 14 or fewer migraine headaches per month. Limited work has begun to examine factors that increase or decrease the risk of developing CM. One factor that appears especially relevant is symptomatic medication use. The current study builds upon and expands previous work considering the influence non-steroidal anti-inflammatory drug (NSAID) and/or triptan use has on the likelihood of developing CM. This study is a retrospective observational cohort study of data collected via mail survey and collated in the American Migraine Prevalence and Prevention (AMPP) database. Survey results from the AMPP study will be analyzed retrospectively. The AMPP is a longitudinal, population-based, mailed-questionnaire survey. In 2004, 120,000 United States (US) households were screened and 24,000 individuals who reported severe headaches were identified and additional questionnaires have been administered annually. This analysis uses data from respondents who meet second edition of the International Headache Classification-2 (IHCD-2) criteria for EM in 2005 with follow up results in 2006, 2007, 2008, and 2009. EM is defined as 1 to 14 headaches per month and CM is defined as 15 or more headaches per month. | Migraine | À vérifier | Immunomodulation + Traitement symptomatique | À vérifier | |
| SC belimumab 200 mgGlaxoSmithKline (GSK) have submitted a Biologic License Application (BLA) for the subcutaneous formulation of belimumab which is currently under review by the Food and Drug Administration (FDA). The goal of this individual patient compassionate use supply is to provide a patient with subcutaneous belimumab for the period of 1 year or until the subcutaneous formulation of belimumab becomes approved for use by the FDA and is commercially available to this patient, whichever is sooner. You can access GSK's Policy on Compassionate via http://www.gsk.com/media/3368/compassionate-use.pdf. | Lupus | À vérifier | À vérifier | United States | À vérifier |
| TriptanChronic Migraine (CM), or 15 or more migraine headaches per month, is common in tertiary headache care and is associated with a number of deleterious outcomes, especially higher disability and poorer quality of life, relative to those with Episodic Migraine (EM) defined as 14 or fewer migraine headaches per month. Limited work has begun to examine factors that increase or decrease the risk of developing CM. One factor that appears especially relevant is symptomatic medication use. The current study builds upon and expands previous work considering the influence non-steroidal anti-inflammatory drug (NSAID) and/or triptan use has on the likelihood of developing CM. This study is a retrospective observational cohort study of data collected via mail survey and collated in the American Migraine Prevalence and Prevention (AMPP) database. Survey results from the AMPP study will be analyzed retrospectively. The AMPP is a longitudinal, population-based, mailed-questionnaire survey. In 2004, 120,000 United States (US) households were screened and 24,000 individuals who reported severe headaches were identified and additional questionnaires have been administered annually. This analysis uses data from respondents who meet second edition of the International Headache Classification-2 (IHCD-2) criteria for EM in 2005 with follow up results in 2006, 2007, 2008, and 2009. EM is defined as 1 to 14 headaches per month and CM is defined as 15 or more headaches per month. | Migraine | À vérifier | Immunomodulation + Traitement symptomatique | À vérifier | |
| SC belimumab 200 mgGlaxoSmithKline (GSK) have submitted a Biologic License Application (BLA) for the subcutaneous formulation of belimumab which is currently under review by the Food and Drug Administration (FDA). The goal of this individual patient compassionate use supply is to provide a patient with subcutaneous belimumab for the period of 1 year or until the subcutaneous formulation of belimumab becomes approved for use by the FDA and is commercially available to this patient, whichever is sooner. You can access GSK's Policy on Compassionate via http://www.gsk.com/media/3368/compassionate-use.pdf. | Lupus | À vérifier | À vérifier | United States | À vérifier |
| GSK3439171AThe FTIH study with GSK3439171A will evaluate the safety of GSK3439171A in healthy subjects in order to avoid confounding factors due to the disease or concomitant drugs in patients. The study design is based on pre-clinical findings for GSK3439171A, contributing to the frequency, type and duration of safety assessment and monitoring during treatment periods in each cohort. The single dose assessments in Part A will be conducted to determine safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the study intervention in individuals before progressing to doses explored further in other parts of the study and will allow for any adjustments needed based on emerging safety, tolerability, and PK information. Part A will also serve to identify a dose for use in examining the effect of food on GSK3439171A exposure in Part C. In Part B, a single dose safety, tolerability and PK will be collected followed by progression of these subjects to the repeat dose portion of the study. The up to 14-day dosing was chosen as it is thought to provide sufficient safety and tolerability data to bridge to longer duration studies. The dosing period can be adjusted depending on PK and PD data collected in Part A of the study. Part B will involve more detailed PK/PD/metabolite assessments to better understand the impact of GSK3439171A on target engagement and metabolism in humans. Approximately 150 subjects will be screened to achieve 75 randomly assigned to study intervention. Duration for Part A, B and C will be approximately 10 weeks, 9 weeks and 8 weeks respectively. | Myopathies | Phase 1 | Ralentissement de la progression | United States | À vérifier |
| GSK1278863As per non-clinical studies, prolyl hydroxylase inhibitor GSK1278863 can protect muscle from unaccustomed exercise induced muscle damage and enhance functional muscle repair. This study is designed to investigate arm function, pain and other pharmacodynamic (PD) markers after unaccustomed maximal eccentric exercise with concurrent administration of GSK1278863 or placebo. Primary objective of the study is to evaluate the protective effects of GSK1278863 on eccentric exercise induced muscle injury. Subjects will be randomized in a 1:1 ratio (1 subject on GSK1278863 for every 1 subject on placebo). Each subject will be given five oral doses of GSK1278863/placebo in total. The first dose will be administered immediately after completion of eccentric exercise and then 4, 8, 24, and 48 hours later. Subjects will be housed till day 4 in unit and will return for a follow-up visit 7-10 days after discharge. After enrolment of approximately 30 subjects, enrolment will be paused and planned interim analysis will be performed to decide whether to terminate enrolment/study, continue dosing or to reduce the dose to 5 milligrams (mg). | Myopathies | Phase 1 | Traitement symptomatique | United States | À vérifier |
| Non-steroidal anti-inflammatory drug (NSAID)Chronic Migraine (CM), or 15 or more migraine headaches per month, is common in tertiary headache care and is associated with a number of deleterious outcomes, especially higher disability and poorer quality of life, relative to those with Episodic Migraine (EM) defined as 14 or fewer migraine headaches per month. Limited work has begun to examine factors that increase or decrease the risk of developing CM. One factor that appears especially relevant is symptomatic medication use. The current study builds upon and expands previous work considering the influence non-steroidal anti-inflammatory drug (NSAID) and/or triptan use has on the likelihood of developing CM. This study is a retrospective observational cohort study of data collected via mail survey and collated in the American Migraine Prevalence and Prevention (AMPP) database. Survey results from the AMPP study will be analyzed retrospectively. The AMPP is a longitudinal, population-based, mailed-questionnaire survey. In 2004, 120,000 United States (US) households were screened and 24,000 individuals who reported severe headaches were identified and additional questionnaires have been administered annually. This analysis uses data from respondents who meet second edition of the International Headache Classification-2 (IHCD-2) criteria for EM in 2005 with follow up results in 2006, 2007, 2008, and 2009. EM is defined as 1 to 14 headaches per month and CM is defined as 15 or more headaches per month. | Migraine | À vérifier | Immunomodulation + Traitement symptomatique | À vérifier | |
| GSK1550188 IVThis study is an open-label, randomized, 2 parallel group, single dose study in healthy Japanese males to assess the pharmacokinetics and safety/tolerability of single intravenous administration and single subcutaneous administration of GSK1550188. Serial blood samples for the determination of GSK1550188 concentration will be collected and safety assessments will be performed for each treatment group | Lupus | Phase 1 | À vérifier | Japan | À vérifier |
| GSK239512This is a randomized, parallel group, placebo-controlled study designed to assess whether GSK239512 can enhance lesion remyelination in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). Subjects with RRMS on stable background treatment with either Avonex (Interferon-beta1a) or Copaxone (Glatiramer Acetate) are eligible to participate. Subjects will be randomized in a 1:1 ratio between placebo and GSK239512, and will continue to be managed with their current standard of care therapy (Copaxone or Avonex). The total treatment period is 48 weeks, including a standard 4 week titration period and 44 week maintenance treatment period (which could be adapted to a 5-week titration and 43 week maintenance period, if needed). Titration doses start at 10 micrograms (mcg) and increase up to 80 mcg (10 mcg first week, 20 mcg second week, 40 mcg third week, 80 mcg fourth week). Subjects will be titrated to the maximum tolerated dose with the objective of titrating to the highest dose (80 mcg GSK239512), whenever possible, based on investigator judgement of tolerability. The post-treatment follow-up period will be a minimum of 2 weeks in duration following the end of treatment at Week 48 or early withdrawal, as appropriate. | SEP | Phase 2 | Remyélinisation | Bulgaria, Canada, Czechia, Germany, Spain, Sweden, Ukraine, United Kingdom | À vérifier |
| Belimumab (GSK1550188)This is a prospective, open-label, single arm 3-year clinical study to describe the short-term and long-term efficacy and safety of belimumab in participants with autoantibody positive early SLE with ongoing disease activity despite stable first-line SLE therapy. | Lupus | Phase 4 | À vérifier | United States, Argentina, Brazil, France, Germany, Greece, Italy, Japan, Mexico, Portugal, Spain | À vérifier |
Essais cliniques
9| Molécule | Indication / population | Phase | NCT | Titre | Statut |
|---|---|---|---|---|---|
| Belimumab (GSK1550188) | Lupus | Phase 4 | NCT06411249 | A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE) | ACTIVE_NOT_RECRUITING |
| GSK239512 | SEP | Phase 2 | NCT01772199 | Study to Assess Whether GSK239512 Can Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis | COMPLETED |
| Belimumab | Myasthénie | Phase 2 | NCT01480596 | The Evaluation of Belimumab in Myasthenia Gravis (MG) | COMPLETED |
| GSK1550188 IV | Lupus | Phase 1 | NCT01516450 | Japanese phase1 Study of Belimumab (IV vs SC) | COMPLETED |
| Belimumab | Lupus | Phase 1 | NCT05917288 | A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus | COMPLETED |
| Non-steroidal anti-inflammatory drug (NSAID) | Migraine | À vérifier | NCT01435941 | Non-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine | COMPLETED |
| GSK1278863 | Myopathies | Phase 1 | NCT02231190 | GSK1278863 Effects on Eccentric Exercise-Induced Muscle Damage | COMPLETED |
| GSK3439171A | Myopathies | Phase 1 | NCT03627494 | First Time in Human (FTIH) Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of GSK3439171A in Healthy Subjects and to Assess Food Effect | COMPLETED |
| SC belimumab 200 mg | Lupus | À vérifier | NCT03125486 | Compassionate Use for Subcutaneous (SC) Belimumab | NO_LONGER_AVAILABLE |
Publications
25| Molécule | Indication / population | Titre | Journal | Date |
|---|---|---|---|---|
| Belimumab (GSK1550188) | Continuation of belimumab in patients with systemic lupus erythematosus in a real-world setting: A single-center retrospective cohort study. | Lupus | ||
| Belimumab (GSK1550188) | Recent advances in the management of pediatric neuropsychiatric lupus from conventional therapies to novel immunomodulators. | Lupus | ||
| GSK1278863 | HIF-Prolyl Hydroxylase Inhibitor Desidustat Increases Pyruvate Kinase Activity and Reduces Oxidative Stress in Red Blood Cells, Causes Erythrocytosis in Thalassaemic Mice, and Reduces Sickling in Sickle Cell Patient's Blood. | Drug development research | ||
| GSK1550188 SC | Belimumab outperforms placebo for attainment of modified DORIS remission and LLDAS without the glucocorticoid component: a post hoc analysis of five phase III SLE trials. | RMD open | ||
| GSK1550188 SC | Real-world experience with personalised belimumab spacing in sustained SLE remission: a multicentre study. | Lupus science & medicine | ||
| GSK1550188 IV | Spanish multicenter registry of belimumab in systemic lupus erythematosus: Data from daily clinical practice. | Seminars in arthritis and rheumatism | ||
| SC belimumab 200 mg | Efficacy and Safety of Subcutaneous Belimumab in Anti-Double-Stranded DNA-Positive, Hypocomplementemic Patients With Systemic Lupus Erythematosus. | Arthritis & rheumatology (Hoboken, N.J.) | ||
| Triptan | Diagnosis and management of migraine in adults: a population-based study in England. | BJGP open | ||
| Triptan | Stroke in combined hormonal contraceptive users treated with triptans. | Contraception | ||
| Triptan | Prescription practices and reasons for referral to tertiary care among patients with headache in India. | Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia | ||
| Non-steroidal anti-inflammatory drug (NSAID) | Management of pain with oral analgesia after extraction of lower third molars: a network meta-analysis of randomized controlled trials. | International journal of oral and maxillofacial surgery | ||
| Non-steroidal anti-inflammatory drug (NSAID) | Elucidation of a novel fungal biotransformation pathway of ibuprofen by Phanerochaete sordida YK-624 under non-ligninolytic conditions. | Journal of bioscience and bioengineering | ||
| GSK1550188 SC | Efficacy and safety of emerging immunomodulatory agents versus standard therapies in refractory cutaneous lupus: A systematic review. | Dermatology online journal | ||
| GSK1550188 IV | Clinicopathological Correlations, Treatment Response, and Predictors of Outcomes in Childhood Lupus Nephritis in China. | International journal of rheumatic diseases | ||
| GSK1550188 IV | Subcutaneous Belimumab Demonstrates Consistent Steady-State Pharmacokinetics and is Well Tolerated in Paediatric Patients with SLE in China: An Open-Label Study. | Rheumatology and therapy | ||
| Triptan | Targeting G-coupled GPCRs to inhibit nociceptors: Insights from the serotonin receptor Htr1b and triptans. | Cell reports. Medicine | ||
| Triptan | Impact of semaglutide introduction on the use of triptans: an interrupted-time series. | The journal of headache and pain | ||
| Non-steroidal anti-inflammatory drug (NSAID) | Gastrointestinal Ascariasis: Unusual Presentation in 2 Cases. | Nigerian medical journal : journal of the Nigeria Medical Association | ||
| Non-steroidal anti-inflammatory drug (NSAID) | In Vitro Evaluation of Lornoxicam Liquitablets: Permeability, Anti-Inflammatory Action, Cytotoxicity, and Stability. | European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences | ||
| Non-steroidal anti-inflammatory drug (NSAID) | Design of active pharmaceutical ingredient-ionic liquids for enhanced delivery to skin. | Journal of controlled release : official journal of the Controlled Release Society | ||
| Non-steroidal anti-inflammatory drug (NSAID) | Incidence of Heterotopic Ossification Following Double-Incision Technique for Distal Biceps Tendon Repair. | Cureus | ||
| GSK1278863 | Model-Informed Drug Development for Daprodustat Supports the Design of Individualized Dosing Regimens in Chronic Kidney Disease Patients With Anemia. | Clinical pharmacology and therapeutics | ||
| GSK1278863 | LC-PDA & LC-MS/MS approach of Daprodustat: forced degradation study. | Xenobiotica; the fate of foreign compounds in biological systems | ||
| SC belimumab 200 mg | Within-trial economic analysis of flare data from the BLISS-SC trial of subcutaneous belimumab in systemic lupus erythematosus. | Lupus science & medicine | ||
| SC belimumab 200 mg | Effect of Belimumab on Preventing Renal Lupus Flares. | Kidney international reports |