Clinical trials: in Georgia
Acute Myocardial Infarction
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.
- Trial name
- SOS-AMI (NCT04957719)
- Testing
- Selatogrel
- Where
- 872 sites in United States, Australia and 45 more
- Volunteers
- 25,000 people
- Sponsor
- Viatris Innovation GmbH
Chronic Hepatitis D Infection
A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection
This is a Phase 2b/3 study designed to evaluate the safety and efficacy of chronic treatment with brelovitug (a.k.a BJT-778; BTG) for chronic hepatitis delta virus (HDV) infection.
- Trial name
- NCT06907290
- Testing
- Brelovitug 300 mg, Brelovitug 900 mg, Delayed Treatment with Brelovitug 300mg
- Where
- 30 sites in United States, Australia and 9 more
- Volunteers
- 150 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Ulcerative Colitis, Inflammatory Bowel Diseases
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC).
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases, Colitis, Colitis, Ulcerative
- Trial name
- SKYLINE-UC (NCT07012395)
- Testing
- SPY001, SPY002, SPY003
- Where
- 276 sites in United States, Argentina and 33 more
- Volunteers
- 645 people
- Sponsor
- Spyre Therapeutics, Inc.
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
- 76 sites in United States, Bulgaria and 14 more
- Volunteers
- 705 people
- Sponsor
- Zenas BioPharma (USA), LLC
Chronic Inflammatory Demyelinating Polyneuropathy, CIDP
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo for 24 weeks (6…
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Trial name
- emnergize (NCT07091630)
- Testing
- Empasiprubart IV
- Where
- 89 sites in United States, Argentina and 23 more
- Volunteers
- 160 people
- Sponsor
- argenx
Pulmonary Hypertension, Interstitial Lung Disease
An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-311 (NCT07179380).
- Trial name
- NCT07234032
- Testing
- Treprostinil Palmitil Inhalation Powder
- Where
- 11 sites in United States, Czechia and 6 more
- Volunteers
- 344 people
- Sponsor
- Insmed Incorporated
Secondary Progressive Multiple Sclerosis
A Study of Orelabrutinib in Patients With Secondary 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…
- Trial name
- NCT07299019
- Testing
- Orelabrutinib
- Where
- 69 sites in United States, Australia and 14 more
- Volunteers
- 990 people
- Sponsor
- Zenas BioPharma (USA), LLC
Ocular Myasthenia Gravis
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
The purpose of the study is to demonstrate the efficacy, safety and tolerability of rozanolixizumab compared with placebo in the treatment of adult study participants with Ocular Myasthenia Gravis.
- Trial name
- MyVision (NCT07463521)
- Testing
- Rozanolixizumab
- Where
- 29 sites in United States, Canada and 6 more
- Volunteers
- 120 people
- Sponsor
- UCB Biopharma SRL
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
- 42 sites in Belgium, Bulgaria and 10 more
- Volunteers
- 230 people
- Sponsor
- argenx
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
- 91 sites in United States, Argentina and 21 more
- Volunteers
- 645 people
- Sponsor
- Spyre Therapeutics, Inc.
Non-small Cell Lung Cancer
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat…
- Trial name
- NCT06345729
- Testing
- Calderasib, Pembrolizumab
- Where
- 246 sites in United States, Argentina and 28 more
- Volunteers
- 348 people
- Sponsor
- Merck Sharp & Dohme LLC
Non-small Cell Lung Cancer Stage IV
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
The goal of this clinical trial is to confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer (NSCLC) patients.
- Trial name
- NCT06348199
- Testing
- SB27, Keytruda
- Where
- 93 sites in Bosnia and Herzegovina, Brazil and 12 more
- Volunteers
- 555 people
- Sponsor
- Samsung Bioepis Co., Ltd.
SLE, SLE (Systemic Lupus)
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT06613360
- Testing
- CLN-978
- Where
- 24 sites in United States, Australia and 7 more
- Volunteers
- 24 people
- Sponsor
- Cullinan Therapeutics Inc.
Pulmonary Hypertension, Interstitial Lung Disease
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP versus placebo on exercise capacity in adults with PH-ILD.
- Trial name
- PALM-ILD (NCT07179380)
- Testing
- Treprostinil Palmitil Inhalation Powder
- Where
- 186 sites in United States, Argentina and 28 more
- Volunteers
- 344 people
- Sponsor
- Insmed Incorporated
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.
Multiple Sclerosis
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC administered with a prefilled pen versus syringe.
- Trial name
- NCT07503873
- Testing
- Ublituximab, Prefilled pen
- Where
- 45 sites in Bosnia and Herzegovina, Georgia and 4 more
- Volunteers
- 350 people
- Sponsor
- TG Therapeutics, Inc.
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
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
- Trial name
- NCT06318169
- Testing
- Pegozafermin
- Where
- 370 sites in United States, Argentina and 25 more
- Volunteers
- 1,350 people
- Sponsor
- Hoffmann-La Roche
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
The study will assess the efficacy and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .
- Trial name
- NCT06419374
- Testing
- Pegozafermin
- Where
- 330 sites in United States, Argentina and 23 more
- Volunteers
- 1,800 people
- Sponsor
- Hoffmann-La Roche
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