Clinical trials: in Georgia
Ulcerative Colitis
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment…
- Trial name
- ELEVATE UC OLE (NCT03950232)
- Testing
- Etrasimod
- Where
- 472 sites in United States, Argentina and 37 more
- Volunteers
- 896 people
- Sponsor
- Pfizer
Focal Segmental Glomerulosclerosis
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
PODOMOUNT-pFSGS This study is open to adults and adolescents with a kidney condition called focal segmental glomerulosclerosis (FSGS).
- Trial name
- NCT07220083
- Testing
- BI 764198
- Where
- 315 sites in United States, Argentina and 38 more
- Volunteers
- 286 people
- Sponsor
- Boehringer Ingelheim
Duchenne Muscular Dystrophy
Safety and Efficacy of KER-065 in Participants With Duchenne Muscular Dystrophy
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of KER-065 administered to adult and pediatric ambulatory and nonambulatory male participants with…
- Trial name
- NCT07704099
- Testing
- KER-065
- Where
- 4 sites in Georgia, New Zealand
- Volunteers
- 36 people
- Sponsor
- Keros Therapeutics, Inc.
Crohn Disease, Colitis, Ulcerative
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC).
- Trial name
- NCT06651281
- Testing
- Tulisokibart
- Where
- 37 sites in United States, Czechia and 5 more
- Volunteers
- 1,380 people
- Sponsor
- Merck Sharp & Dohme LLC
Severe Asthma
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)
The objective of this study is to assess the potential for GB-0895 to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers.
- Trial name
- NCT07359846
- Testing
- GB-0895
- Where
- 158 sites in United States, Argentina and 17 more
- Volunteers
- 786 people
- Sponsor
- Generate Biomedicines
Rett Syndrome
A Phase 3 Study of Fenfluramine Hydrochloride in Rett Syndrome
The purpose of this study is to investigate the efficacy of fenfluramine hydrochloride (HCl) versus placebo in study participants with Rett syndrome (RTT).
- Trial name
- NCT07503444
- Testing
- fenfluramine hydrochloride
- Where
- 40 sites in United States, Belgium and 10 more
- Volunteers
- 200 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Focal Epilepsy, Tonic-Clonic Seizures
An Open-label Study of XEN1101 in Epilepsy
This study will evaluate the long term safety, tolerability, pharmacokinetics (PK), and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of…
- Trial name
- X-TOLE4 (NCT05718817)
- Testing
- XEN1101
- Where
- 153 sites in United States, Argentina and 23 more
- Volunteers
- 880 people
- Sponsor
- Xenon Pharmaceuticals Inc.
Clostridium Difficile, Clostridium Difficile Infections
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo.
- Conditions
- Clostridium Difficile, Clostridium Difficile Infections, Clostridium Difficile Infection Recurrence, Clostridioides Difficile Infection
- Trial name
- RESTORATiVE303 (NCT06237452)
- Testing
- VE303
- Where
- 215 sites in United States, Australia and 22 more
- Volunteers
- 852 people
- Sponsor
- Vedanta Biosciences, Inc.
Crohn's Disease
A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease.
- Trial name
- NCT06430801
- Testing
- IV Tulisokibart, SC Tulisokibart
- Where
- 499 sites in United States, Australia and 45 more
- Volunteers
- 1,200 people
- Sponsor
- Merck Sharp & Dohme LLC
Childhood Absence Epilepsy, Juvenile Absence Epilepsy
A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
The purpose of the study is to test the efficacy, safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).
- Trial name
- EXPAND (NCT04666610)
- Testing
- Brivaracetam
- Where
- 35 sites in United States, Georgia and 5 more
- Volunteers
- 154 people
- Sponsor
- UCB Biopharma SRL
Generalized Myasthenia Gravis
Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis
The purpose of this trial is to investigate the PK, PD, safety, and activity of efgartigimod IV in children and adolescents aged from 2 to less than 18 years of age with gMG.
- Trial name
- ADAPT Jr (NCT04833894)
- Testing
- Efgartigimod IV
- Where
- 25 sites in United States, Austria and 10 more
- Volunteers
- 15 people
- Sponsor
- argenx
Dravet Syndrome
A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hydrochloride (EPX-100) as adjunctive therapy in children and adult participants with…
- Trial name
- ARGUS (NCT04462770)
- Testing
- Clemizole HCl
- Where
- 86 sites in United States, Argentina and 9 more
- Volunteers
- 150 people
- Sponsor
- Epygenix
Acute Kidney Injury, Fluid Overload
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
There is a growing focus on short- and long-term kidney health in neonates, including those with acute kidney injury (AKI). AKI occurs commonly in the Neonatal Intensive Care Unit (NICU) and is associated with adverse outcomes.
- Conditions
- Acute Kidney Injury, Fluid Overload, Prematurity Complications, Risk Factors
- Trial name
- AWAKEN 2 (NCT06823115)
- Where
- 125 sites in United States, Argentina and 31 more
- Volunteers
- 8,000 people
- Sponsor
- Indiana University
Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
This is a Phase 3, randomized, open-label, active-controlled, multicenter trial evaluating the efficacy, safety, and tolerability of quabodepistat-containing regimens for the treatment of rifampicin-resistant or…
- Trial name
- QUANTUM-TB (NCT07209761)
- Testing
- Bedaquiline, Quabodepistat, Pretomanid
- Where
- 42 sites in China, Georgia and 8 more
- Volunteers
- 532 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Ulcerative Colitis
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis…
- Trial name
- SUNSCAPE-1 (NCT07184996)
- Testing
- Duvakitug
- Where
- 240 sites in United States, Argentina and 23 more
- Volunteers
- 980 people
- Sponsor
- Sanofi
Acute Myeloid Leukemias
Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone.
- Trial name
- REVEAL-ND NPM1 (NCT07211958)
- Testing
- Revumenib, Intensive Chemotherapy Regimen
- Where
- 173 sites in United States, Argentina and 21 more
- Volunteers
- 468 people
- Sponsor
- Syndax Pharmaceuticals
Colitis, Ulcerative
Confirmatory Clinical Study in Active Ulcerative Colitis
The main goal of the study is to check if MH002 works and is safe to use. In a previous study in 45 patients with Ulcerative Colitis, MH002 was found to have favorable effects.
- Trial name
- StarFish-UC (NCT07296315)
- Testing
- Low-dose MH002, High-dose MH002
- Where
- 49 sites in United States, Czechia and 5 more
- Volunteers
- 204 people
- Sponsor
- MRM Health NV
Crohn's Disease
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely…
- Trial name
- STARSCAPE-1 (NCT07184931)
- Testing
- Duvakitug
- Where
- 461 sites in United States, Argentina and 34 more
- Volunteers
- 980 people
- Sponsor
- Sanofi
Crohn's Disease
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD).
- Trial name
- STARSCAPE-2 (NCT07184944)
- Testing
- Duvakitug
- Where
- 109 sites in United States, Australia and 25 more
- Volunteers
- 751 people
- Sponsor
- Sanofi
Moderate-to-Severe Atopic Dermatitis
Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis
Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description
- Trial name
- NCT03989206
- Testing
- Nemolizumab
- Where
- 343 sites in United States, Australia and 20 more
- Volunteers
- 1,935 people
- Sponsor
- Galderma R&D