A5004980206- Liver Diseases and Immunity
- Systemic Lupus Erythematosus Research
- Inflammatory Bowel Disease
- Drug Transport and Resistance Mechanisms
- T-cell and B-cell Immunology
- Monoclonal and Polyclonal Antibodies Research
- Autoimmune Bullous Skin Diseases
- Dermatology and Skin Diseases
- Coagulation, Bradykinin, Polyphosphates, and Angioedema
- Protease and Inhibitor Mechanisms
- Anesthesia and Pain Management
- Urticaria and Related Conditions
- Pediatric Hepatobiliary Diseases and Treatments
- Veterinary Pharmacology and Anesthesia
- Cholangiocarcinoma and Gallbladder Cancer Studies
- Inflammation biomarkers and pathways
- Immunodeficiency and Autoimmune Disorders
- Gallbladder and Bile Duct Disorders
- Pharmacology and Obesity Treatment
- Helicobacter pylori-related gastroenterology studies
- Peripheral Artery Disease Management
- Respiratory and Cough-Related Research
- Inflammatory mediators and NSAID effects
- Pain Mechanisms and Treatments
- Public Health and Nutrition
CTI BioPharma (United Kingdom)
2024-2025
Mundipharma (United Kingdom)
2022-2024
GlaxoSmithKline (United Kingdom)
2013-2023
Akari Therapeutics (United Kingdom)
2021-2022
Age UK
2022
GlaxoSmithKline (India)
2022
Frimley Park Hospital
2018
To investigate the long-term safety and efficacy of intravenous (IV) belimumab plus standard care (SOC) therapy for systemic lupus erythematosus (SLE) in patients with active, autoantibody-positive SLE.The study was designed as a multicenter, open-label, continuation IV given every 4 weeks conjunction SOC SLE who completed phase II, double-blind study. Adverse events (AEs) laboratory data were monitored from first dose (in either study) until 24 after final dose. Efficacy assessments...
Objective To examine long-term organ damage and safety following treatment with belimumab plus standard of care (SoC) in patients systemic lupus erythematosus (SLE). Methods Pooled data were examined from two ongoing open-label studies that enrolled who completed BLISS-52 or BLISS-76. Patients received every four weeks SoC. SLICC Damage Index (SDI) values assessed 48 (study years) initiation (baseline). The primary endpoint was change SDI baseline at study years 5–6. Incidences adverse...
Background: Pruritus affects up to 80% of patients with primary biliary cholangitis (PBC) and reduces health-related quality life (HRQoL). GLIMMER (NCT02966834) was a randomized, placebo-controlled phase IIb study linerixibat in PBC pruritus. Using patient-reported outcome data from GLIMMER, we characterize the impact pruritus PBC. Methods: To objectively assess HRQoL impact, EQ-5D-5L (0–1 scale; 0 = death, 1 perfect health) were analyzed post-hoc across severities. Inter-relationships...
We undertook this US multicenter continuation study (GlaxoSmithKline BEL112233; ClinicalTrials.gov identifier: NCT00724867) to assess long-term safety and efficacy of belimumab in patients with systemic lupus erythematosus (SLE) who completed the Study Belimumab Subjects SLE 76-week trial (ClinicalTrials.gov NCT00410384).
This extension study of the Phase III, randomized, placebo-controlled Belimumab International SLE Study (BLISS)-52 and BLISS-76 studies allowed non-US patients with to continue belimumab treatment, in order evaluate its long-term safety tolerability including organ damage accrual.
Co-crystal of tramadol-celecoxib (CTC) is the first analgesic co-crystal for acute pain. This completed phase 3 multicenter, double-blind trial assessed efficacy and safety/tolerability CTC in comparison with that tramadol setting moderate-to-severe pain up to 72 h after elective third molar extraction requiring bone removal. Adults (n = 726) were assigned randomly five groups (2:2:2:2:1): orally administered twice-daily 100 mg (44 rac-tramadol hydrochloride/56 celecoxib; n 164), 150 (66/84...
Bullous pemphigoid is a difficult-to-treat autoimmune blistering skin disease that predominantly affects older adults and associated with an increased mortality rate.To examine the safety therapeutic potential of nomacopan, inhibitor leukotriene B4 complement C5, in patients bullous pemphigoid.This multicenter, single-group, phase 2a nonrandomized controlled trial was conducted dermatology departments universities Netherlands Germany. Participants were enrolled between September 2018 April...
Objective Intravenous belimumab 10 mg/kg is approved as an add-on therapy in patients with active, autoantibody-positive systemic lupus erythematosus. This study aimed to assess the impact of on immune response pneumococcal vaccination Methods was a Phase 4, open-label (GSK BEL115470; NCT01597492) conducted United States. Patients were randomized (7:9) receive 23-valent four weeks prior (pre-belimumab cohort) or 24 after (belimumab-concurrent commencing four-weekly intravenous treatment plus...
STARDOM2 is a randomized, double-blind, phase 3 trial evaluating the efficacy and safety of co-crystal tramadol-celecoxib (CTC)-a first-in-class analgesic comprising racemic tramadol hydrochloride celecoxib in supramolecular network that modifies their pharmacokinetic properties-for management acute postoperative pain (NCT03062644; EudraCT:2016-000593-38).Patients with moderate-to-severe following abdominal hysterectomy were randomized 2:2:2:2:2:1 to oral CTC 100 mg (rac-tramadol 44...
Abstract Background & Aims Total serum bile acid (TSBA) levels are elevated in patients with primary biliary cholangitis (PBC) and may mediate cholestatic pruritus. Linerixibat, an ileal transporter inhibitor, improved pruritus PBC. We explored the relationship between linerixibat dose, TSBA concentration, Methods Data from Phase 1/2 trials were used to develop a population kinetic‐pharmacodynamic model characterize dose–TSBA relationship. Individual Bayesian parameter estimates for...
<h3>Background</h3> Preliminary safety and efficacy data from the Phase II BEL open-label extension study (LBSL02; NCT00071487) have been reported. <h3>Objectives</h3> Here we present final 10-year data. <h3>Methods</h3> This was a multicentre, open-label, continuation trial (BEL112626; NCT00583362) of + SoC in patients with satisfactory response parent study. Patients received intravenous 10 mg/kg every 4 weeks. Baseline prior to first ever dose BEL. <h3>Results</h3> Of 298 trial, 131 (44%)...
<h3>Background</h3> Belimumab, a fully human IgG1λ monoclonal antibody for B Lymphocyte Stimulator protein, was licensed in 2011 by the FDA and EMA add-on therapy adult patients with active systemic lupus erythematosus (SLE). As part of paediatric investigational plan, study belimumab SLE designed commenced 2012 (BEL114055, ClinicalTrials.gov: NCT01649765). <h3>Objectives</h3> To outline design, participation rationale subject selection. <h3>Methods</h3> The PLUTO is 52-week multi-centre,...
<h3>Background</h3> Systemic lupus erythematosus (SLE) is a chronic relapsing and remitting condition in which long-term damage can accrue over time. <h3>Objectives</h3> To examine organ safety following 5 years of treatment with belimumab plus standard care (SoC) patients SLE. <h3>Methods</h3> We examined pooled interim data (GSK201223) from two open-label studies that enrolled who completed the BLISS-52 BLISS-76 studies. Patients received SoC every 4 weeks. Baseline was defined as prior to...
<h3>Background</h3> Non-United States completers of the Phase 3 BLISS-52 (BEL110752) and BLISS-76 (BEL110751) studies could continue treatment with BEL. <h3>Objectives</h3> To evaluate long-term safety, tolerability organ damage progression in patients SLE treated <h3>Methods</h3> In this multicentre, open-label study (BEL112234/NCT00712933), received intravenous BEL every 4 weeks, plus standard therapy. Safety was assessed at each visit. Organ (Systemic Lupus International Collaborative...