Clinical trials: in Georgia
Graves Disease
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.
The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves' Disease (GD). The study will also check whether efgartigimod is safe and well tolerated.
- Trial name
- VitaliThy (NCT07596849)
- Testing
- efgartigimod PH20 SC
- Where
- 51 sites in Belgium, Bulgaria and 12 more
- Volunteers
- 230 people
- Sponsor
- argenx
Multiple Sclerosis (MS) Primary Progressive
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with PPMS.
- Trial name
- NCT07067463
- Testing
- Orelabrutinib
- Where
- 83 sites in United States, Australia and 15 more
- Volunteers
- 705 people
- Sponsor
- Zenas BioPharma (USA), LLC
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
Graves' Disease, Graves Disease
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease
The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves' Disease (GD). The study will also check whether efgartigimod is safe and well tolerated.
- Trial name
- VitaliThy (NCT07570316)
- Testing
- Efgartigimod PH20 SC
- Where
- 35 sites in United States, Georgia and 1 more
- Volunteers
- 230 people
- Sponsor
- argenx
Viral Hepatitis
A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection
This is a multicenter, open label, randomized Phase 3 clinical study to evaluate the efficacy and safety of the combination of tobevibart + elebsiran for the treatment of chronic hepatitis delta in comparison to delayed treatment.
- Trial name
- NCT06903338
- Testing
- Tobevibart, Elebsiran
- Where
- 39 sites in United States, Canada and 8 more
- Volunteers
- 124 people
- Sponsor
- Vir Biotechnology, Inc.
Carcinoma, Squamous Cell
JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) / radiation therapy (RT)±cetuximab versus RT±cetuximab in…
- Trial name
- NCT04892173
- Testing
- JNJ-90301900 (NBTXR3), Cetuximab, Radiation Therapy
- Where
- 196 sites in United States, Austria and 25 more
- Volunteers
- 500 people
- Sponsor
- Johnson & Johnson Enterprise Innovation Inc.
Ulcerative Colitis, Inflammatory Bowel Diseases
Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases, Colitis, Colitis, Ulcerative
- Trial name
- SKYLINE-LTE (NCT07652294)
- Testing
- SPY001, SPY002, SPY003
- Where
- 98 sites in United States, Argentina and 21 more
- Volunteers
- 645 people
- Sponsor
- Spyre Therapeutics, Inc.
Gastroesophageal Adenocarcinoma
A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations as perioperative treatment in participants with locally advanced…
- Trial name
- NCT07069712
- Testing
- Sonesitatug Vedotin, Rilvegostomig, Trastuzumab Deruxtecan (T-DXd)
- Where
- 70 sites in United States, Canada and 9 more
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Thrombocytopenia Associated With Chronic Liver Disease
Phase 3 Study of rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
This is a global, multicenter, randomized, double-blind, placebo-controlled study using recombinant human thrombopoietin stimulating factor ( rhTPO) to treat adults with Chronic liver disease-related thrombocytopenia (CLDT).
- Trial name
- NCT07911800
- Testing
- rhTPO
- Where
- 2 sites in Georgia
- Volunteers
- 150 people
- Sponsor
- MIBIO PTE. LTD.
Lupus Erythematosus, Systemic
A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks…
- Trial name
- GARDENIA-SLE (NCT07438496)
- Testing
- Nipocalimab, Standard of care treatment
- Where
- 272 sites in United States, Argentina and 31 more
- Volunteers
- 600 people
- Sponsor
- Janssen Research & Development, 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
Prostatic Neoplasms
A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
The purpose of this study is to determine the relative bioavailability (rBA; Period 1) and bioequivalence (BE; Period 2 and 3) of various strengths and formulations of niraparib and abiraterone acetate (AA) at steady state under…
- Trial name
- NCT04577833
- Testing
- Niraparib, Abiraterone Acetate (AA), Prednisone
- Where
- 16 sites in United States, Belgium and 9 more
- Volunteers
- 136 people
- Sponsor
- Janssen Research & Development, LLC
Chronic Spontaneous Urticaria
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3…
- Trial name
- NCT07256392
- Testing
- barzolvolimab, Standard of Care
- Where
- 201 sites in United States, Argentina and 28 more
- Volunteers
- 1,370 people
- Sponsor
- Celldex Therapeutics
Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
The goal of this clinical trial is to learn if VENT-03 works to treat patients with cutaneous lupus erythematosus (CLE) who may or may not have systemic lupus erythematosus (SLE).
- Conditions
- Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus, SLE, SLE (Systemic Lupus)
- Trial name
- AERIS (NCT07260877)
- Testing
- VENT-03
- Where
- 34 sites in United States, Bulgaria and 6 more
- Volunteers
- 24 people
- Sponsor
- Ventus Therapeutics U.S., 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.
Systemic Lupus Erythematosus, Rheumatoid Arthritis
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
This study looks at a study medicine called MK-1045 in people with lupus and rheumatoid arthritis (RA). The main goal of the study is to learn about the safety of MK-1045 and if people tolerate it when they receive it at…
- Trial name
- NCT07363590
- Testing
- MK-1045
- Where
- 21 sites in Australia, Belgium and 9 more
- Volunteers
- 21 people
- Sponsor
- Merck Sharp & Dohme LLC
Non-small Cell Lung Cancer
Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)
This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC).
- Trial name
- NCT06712316
- Testing
- Pumitamig, Pembrolizumab, Carboplatin
- Where
- 366 sites in United States, Argentina and 20 more
- Volunteers
- 1,580 people
- Sponsor
- BioNTech SE
Pancreatic Cancer, Pancreatic Cancer Metastatic
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.
- Conditions
- Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma
- Trial name
- MAPKeeper 301 (NCT07562152)
- Testing
- Atebimetinib, GnP, mGnP
- Where
- 72 sites in United States, Australia and 7 more
- Volunteers
- 570 people
- Sponsor
- Immuneering Corporation
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.