Clinical trials: in Georgia
Bladder Cancer, Urothelial Carcinoma
A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
This Phase 3, single-arm, multicenter study was designed to evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with recurrent low-grade intermediate-risk…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- UTOPIA (NCT06331299)
- Testing
- UGN-103
- Where
- 48 sites in United States, Bulgaria and 5 more
- Volunteers
- 99 people
- Sponsor
- UroGen Pharma Ltd.
Inflammatory Bowel Diseases, Colitis, Ulcerative
A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC
This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adult patients with moderately to severely active Ulcerative Colitis (UC).
- Trial name
- EMERALD-2 (NCT05611671)
- Testing
- MORF-057
- Where
- 102 sites in United States, Australia and 19 more
- Volunteers
- 280 people
- Sponsor
- Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
Chronic Obstructive Pulmonary Disease
Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
Primary Objective: Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: Evaluate the…
- Trial name
- AERIFY-1 (NCT04701983)
- Testing
- Itepekimab SAR440340
- Where
- 232 sites in United States, Argentina and 19 more
- Volunteers
- 1,127 people
- Sponsor
- Sanofi
Chronic Obstructive Pulmonary Disease
Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
Primary Objective: Primary population (former smokers cohort): Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with…
- Trial name
- AERIFY-2 (NCT04751487)
- Testing
- Itepekimab SAR440340
- Where
- 238 sites in United States, Argentina and 27 more
- Volunteers
- 1,234 people
- Sponsor
- Sanofi
Staphylococcus Aureus Bacteremia
Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia
The purpose of this study was to compare the efficacy and safety of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated Staphylococcus aureus bacteremia (SAB).
- Trial name
- NCT03138733
- Testing
- Ceftobiprole medocaril, Daptomycin
- Where
- 60 sites in United States, Argentina and 15 more
- Volunteers
- 390 people
- Sponsor
- Basilea Pharmaceutica
Osteoporosis, Postmenopausal
A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis
The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)
- Trial name
- NCT04729621
- Testing
- TVB-009, Prolia®
- Where
- 78 sites in United States, Bulgaria and 8 more
- Volunteers
- 332 people
- Sponsor
- Teva Pharmaceuticals USA
Crohn's Disease
A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.
- Trial name
- GALAXI (NCT03466411)
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3
- Where
- 579 sites in United States, Australia and 41 more
- Volunteers
- 1,409 people
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Psoriatic
A Study of Guselkumab in Participants With Active Psoriatic Arthritis
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
- Trial name
- APEX (NCT04882098)
- Testing
- Guselkumab
- Where
- 280 sites in United States, Australia and 27 more
- Volunteers
- 1,054 people
- Sponsor
- Janssen Research & Development, LLC
Head and Neck Cancer
Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in…
- Trial name
- NCT05287113
- Testing
- Retifanlimab, INCAGN02385, INCAGN02390
- Where
- 91 sites in United States, Belgium and 12 more
- Volunteers
- 176 people
- Sponsor
- Incyte Biosciences International Sàrl
COVID-19
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir)
Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication.
- Trial name
- NCT05605093
- Testing
- Shionogi Protease Inhibitor (S-217622)
- Where
- 187 sites in United States, Argentina and 22 more
- Volunteers
- 602 people
- Sponsor
- University of Minnesota
Seasonal Influenza
A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age
The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1010, and to evaluate relative vaccine efficacy (rVE) of mRNA-1010 versus an active comparator against reverse transcription polymerase…
- Trial name
- NCT06602024
- Testing
- mRNA-1010, Fluarix®, Influsplit® Tetra
- Where
- 301 sites in United States, Belgium and 9 more
- Volunteers
- 40,805 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone…
- Trial name
- INAVO120 (NCT04191499)
- Testing
- Inavolisib, Palbociclib, Fulvestrant
- Where
- 135 sites in United States, Argentina and 26 more
- Volunteers
- 325 people
- Sponsor
- Hoffmann-La Roche
Solid Tumors
GEN1046 Safety Trial in Patients With Malignant Solid Tumors
The goal of this trial is to learn about the antibody acasunlimab (an antibody also known as GEN1046) when it is used alone and when it is used together with standard of care treatment (docetaxel) or another antibody cancer drug…
- Trial name
- NCT03917381
- Testing
- Acasunlimab, Acasunlimab in combination with docetaxel (in a single expansion cohort), Acasunlimab in combination with pembrolizumab (in a separate expansion cohort)
- Where
- 57 sites in United States, Czechia and 8 more
- Volunteers
- 429 people
- Sponsor
- Genmab
Bone or Joint Infection
Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus
This is a randomized, active-controlled, open-label study to assess the safety, tolerability and efficacy of Afabicin in the treatment of participants with bone or joint infection due to Staphylococcus aureus [both…
- Trial name
- NCT03723551
- Testing
- Afabicin, Cefazolin, Vancomycin
- Where
- 19 sites in Georgia, South Africa and 1 more
- Volunteers
- 67 people
- Sponsor
- Debiopharm International SA
Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer
A Study of Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma
This study is designed to evaluate the efficacy and safety of tislelizumab and tislelizumab in combination with investigational agent(s) in first-line recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
- Trial name
- NCT05909904
- Testing
- Tislelizumab, BGB-A425, LBL-007
- Where
- 73 sites in United States, Australia and 12 more
- Volunteers
- 160 people
- Sponsor
- BeiGene
Ulcerative Colitis
A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with moderately to severely active Ulcerative Colitis (UC).
- Trial name
- ARTEMIS-UC (NCT04996797)
- Testing
- Tulisokibart, Companion Diagnostic (CDx) Testing
- Where
- 88 sites in United States, Australia and 10 more
- Volunteers
- 178 people
- Sponsor
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
COVID-19
Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation Strategy Trial
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients.
- Trial name
- NCT05822583
- Testing
- abatacept infusion
- Where
- 127 sites in United States, Australia and 17 more
- Volunteers
- 285 people
- Sponsor
- University of Minnesota
Recent Onset type1 Diabetes
A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function
Objectives The objective of this clinical trial is to assess whether ladarixin treatment has an effect to preserve β-cell function and delay the progression of T1D in adolescent and adult patients.
- Trial name
- NCT04628481
- Testing
- Ladarixin
- Where
- 57 sites in United States, Belgium and 6 more
- Volunteers
- 289 people
- Sponsor
- Dompé Farmaceutici S.p.A
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
To evaluate the efficacy, safety and tolerability at 8 weeks (2-months), 52 weeks (12-months), and 104 Weeks (24-months) post the start of the following treatment regimens in participants with: Drug Sensitive TB (DS-TB) patients…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis
- Trial name
- NCT03338621
- Testing
- Pretomanid, Bedaquiline, Moxifloxacin
- Where
- 26 sites in Brazil, Georgia and 6 more
- Volunteers
- 455 people
- Sponsor
- Global Alliance for TB Drug Development
Advanced ER-Positive HER2-Negative Breast Cancer
A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer
This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.
- Trial name
- SERENA-2 (NCT04214288)
- Testing
- AZD9833, Fulvestrant
- Where
- 85 sites in United States, Belgium and 14 more
- Volunteers
- 240 people
- Sponsor
- AstraZeneca