Clinical trials: Biologic
Systemic Lupus Erythematosus
Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.
- Trial name
- NCT02472795
- Testing
- Cenerimod
- Where
- 18 sites in United States, Belarus and 4 more
- Volunteers
- 105 people
- Sponsor
- Viatris Innovation GmbH
Osteoarthritis, Knee
A Study Evaluating the Safety, Tolerability, and Range of Biologically Active Doses of ICM-203 in Mild to Moderate Knee Osteoarthritis
The purpose of this study is to determine the safety, tolerability, and activity of ICM-203, a recombinant adeno-associated viral (AAV) vector that expresses a therapeutic gene that promotes cartilage formation, reduces joint…
- Trial name
- NCT04875754
- Testing
- ICM-203
- Where
- 2 sites in Australia
- Volunteers
- 12 people
- Sponsor
- ICM Biotech Australia Pty Ltd.
Influenza
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
The purpose of the study is to evaluate the safety and immunogenicity of GSK Biologicals' influenza vaccine GSK2340272A.
- Trial name
- NCT00951041
- Testing
- GSK investigational vaccine GSK2340272A, GSK investigational vaccine GSK2340269A
- Where
- 3 sites in Germany
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
IgA Nephropathy, Lupus Nephritis
Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies
This is a Phase II trial assessing the safety and preliminary efficacy of daily APL-2 subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients with glomerulopathies
- Conditions
- IgA Nephropathy, Lupus Nephritis, Membranous Nephropathy, C3 Glomerulonephritis
- Trial name
- NCT03453619
- Testing
- APL-2
- Where
- 17 sites in United States
- Volunteers
- 21 people
- Sponsor
- Apellis Pharmaceuticals, Inc.
Herpes Zoster
Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A
The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older.
- Trial name
- NCT01610414
- Testing
- Herpes Zoster vaccine GSK1437173A
- Where
- 178 sites in United States, Australia and 26 more
- Volunteers
- 1,877 people
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections+Metapneumovirus
A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and Older Adults
The aim of this study is to evaluate the safety, reactogenicity, and immune response of the different formulations of the investigational RSV/hMPV combination vaccine and investigational hMPV vaccine in younger and older adults.
- Trial name
- NCT07628049
- Testing
- RSV/hMPV_V low dose vaccine, RSV/hMPV_V medium dose vaccine, RSV/hMPV_V high dose vaccine
- Where
- 5 sites in United States, Australia
- Volunteers
- 1,456 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Nigeria
The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination…
- Trial name
- NCT01153893
- Testing
- Pneumococcal vaccine GSK1024850A, InfanrixTM
- Where
- Nigeria
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Allergy Dermatophagoides Pteronyssinus, Allergic Rhinitis
Biological Standardization of Dermatophagoides Pteronyssinus Allergen Extract
The objective of this study is to determine the biologic activity of a Dermatophagoides pteronyssinus allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
- Conditions
- Allergy Dermatophagoides Pteronyssinus, Allergic Rhinitis, Allergic Asthma
- Trial name
- NCT01821716
- Testing
- Prick test Dermatophagoides pteronyssinus allergen extract
- Where
- 2 sites in Spain
- Volunteers
- 42 people
- Sponsor
- Laboratorios Leti, S.L.
Asthma
Comparative Study of the Efficacy of Biologics vs Usual Treatment on OCS Reduction for Severe Asthma Patients Using Health Insurance Claim Database
This study is a retrospective cohort study of patients diagnosed with asthma based on the data extracted from the MDV database. The study period is from 1st Jun 2016 to 29th February 2020 .
- Trial name
- HAYATE (NCT05136547)
- Where
- Japan
- Volunteers
- 2,927 people
- Sponsor
- AstraZeneca
Systemic Sclerosis
Proof of Biological Activity of SAR100842 in Systemic Sclerosis
Primary Objective: To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse cutaneous systemic sclerosis.
- Trial name
- NCT01651143
- Testing
- SAR100842
- Where
- 13 sites in United States, France and 3 more
- Volunteers
- 32 people
- Sponsor
- Sanofi
Atopic Dermatitis
To Assess the Safety and Activity of GBR 830, Compared to Placebo, in Adults With Moderate-to-severe Atopic Dermatitis
The purpose of this study is to determine the effect of GBR 830 on biomarkers in atopic dermatitis to enable further studies in this indication.
- Trial name
- NCT02683928
- Testing
- GBR 830
- Where
- 17 sites in United States, Canada
- Volunteers
- 64 people
- Sponsor
- Ichnos Sciences SA
Respiratory Synctial Virus Infections
A Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' RSV Investigational Vaccine (ChAd155-RSV) (GSK3389245A) in Healthy Adults
The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of 2 doses of the RSV investigational vaccine, when administered intramuscularly according to a 0, 1 month schedule…
- Trial name
- NCT02491463
- Testing
- GSK3389245A_LD GROUP, GSK3389245A_HD GROUP, Bexsero
- Where
- United Kingdom
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal, Meningococcal Vaccines
Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines
The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2 months of age.
- Trial name
- NCT01144663
- Testing
- Nimenrix™, Menjugate®, NeisVac-CTM
- Where
- 44 sites in Estonia, Germany and 1 more
- Volunteers
- 2,095 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Immune Response to Oral Polio Vaccine
A Clinical Study Comparing Safety and Immunogenicity of bOPV of Bilthoven Biologicals
Bilthoven Biologicals has developed a new bivalent oral polio vaccine (bOPV) containing World Health Organization (WHO) approved Sabin strains of poliovirus type 1 and type 3.
- Trial name
- NCT02766816
- Testing
- Part 1 study - BBio bOPV, Part 2 study - BBio bOPV Lot 1, Part 2 study - BBio bOPV Lot 2
- Where
- Bangladesh
- Volunteers
- 1,120 people, healthy volunteers welcome
- Sponsor
- Bilthoven Biologicals
Herpes Zoster
Month 30 & 42 Extension Studies of CRD-004 Primary Study
The safety and immunogenicity of the GSK324332A vaccine has been evaluated up to Month 12 post-vaccination in the primary study.
- Trial name
- NCT00492648
- Testing
- Blood sampling for assay of persistence of immunogenicity
- Where
- Belgium
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Postoperative Prevention of Tumor
The Exploratory Study on the Biological Function of Dendritic Cells In Vivo Supported by Nicotinamide Mononucleotide (Vital NAD)
The main purpose of this study is to explore the PK/PD changes of NMN and DC cells after oral NMN combined with DC cells injection in patients after tumor surgery, and evaluate the biological age of adults, TCR diversity, SiRT1…
- Trial name
- NCT06036355
- Testing
- Oral NMN combined with DC cell vaccine
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai Cell Therapy Group Co.,Ltd
Biological Availability
Bioavailability of Omega-3 Food Supplement in Healthy Subjects
The study will evaluate the relative bioavailability of Pronovum PRF-037 and Pronovum PRF-041 with PronovaPure 150:150 EE EU and Eskimo-3 (500 mg omega-3 acid triglyceride containing 80 mg EPA and 50 mg DHA per gram oil) in…
- Trial name
- NCT02376608
- Testing
- Pronova Pure 150:500 EE EU, Pronovum PRF-037, Pronovum PRF-041
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pronova BioPharma
Infections, Respiratory Syncytial Virus
Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccines
The purpose of this first time in human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of Respiratory Syncytial Virus (RSV) investigational vaccines in healthy men.
- Trial name
- NCT01905215
- Testing
- RSV vaccine GSK3003892A (formulation 1), RSV vaccine GSK3003893A (formulation 2), RSV vaccine GSK3003895A (formulation 3)
- Where
- 3 sites in Canada
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rheumatoid Arthritis
Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry
This study will assess the rates of serious adverse events and death in adult rheumatoid arthritis patients treated with etanercept over the long-term in real-life clinical practice.
- Trial name
- NCT01646385
- Testing
- etanercept, non-biologic anti-rheumatic drugs
- Volunteers
- 6,393 people
- Sponsor
- Pfizer
Influenza
Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly
The purpose of the present study is to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with vaccine GSK2340272A when co-administered with GSK Biologicals' Fluarix™ vaccine either at the time of first…
- Trial name
- NCT00968890
- Testing
- Pandemrix (Influenza vaccine GSK2340272A), Fluarix™
- Where
- 2 sites in Sweden
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline