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NCT ID: NCT05644561 Recruiting - Clinical trials for Generalized Myasthenia Gravis

Evaluation of Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of Ravulizumab Administered Intravenously in Pediatric Participants With Generalized Myasthenia Gravis (gMG)

Start date: June 24, 2023
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to characterize the pharmacokinetics and pharmacodynamics of treatment with ravulizumab intravenous infusion in pediatric participants with gMG.

NCT ID: NCT05642325 Recruiting - Clinical trials for Uveitic Macular Edema

Vamikibart in Participants With Uveitic Macular Edema

Sandcat
Start date: March 23, 2023
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.

NCT ID: NCT05639114 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)

SIRIUS-SLE 1
Start date: March 2, 2023
Phase: Phase 3
Study type: Interventional

The trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab compared to placebo, given as monthly or quarterly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE).

NCT ID: NCT05636176 Recruiting - Heart Failure Clinical Trials

A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

HERMES
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.

NCT ID: NCT05633264 Recruiting - Psoriasis Clinical Trials

A Study to Assess Deucravacitinib Post-marketing Surveillance in Participants With Psoriasis in Japan

Start date: December 5, 2022
Phase:
Study type: Observational

The purpose of this study is to determine the safety and effectiveness of deucravacitinib for the treatment of plaque psoriasis (PsO) in Japan participants.

NCT ID: NCT05630833 Recruiting - Clinical trials for Urinary Tract Infections

A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)

EAGLE-J
Start date: January 11, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the consistency of therapeutic response of gepotidacin at the Test of cure (TOC) Visit (Days 10 to 13) in female participants with acute uncomplicated cystitis with qualifying bacterial uropathogen(s) at baseline that all are susceptible to nitrofurantoin in Japan, with that from global studies (Studies 204989 [NCT04020341] and 212390 [NCT04187144]).

NCT ID: NCT05629585 Recruiting - Breast Cancer Clinical Trials

A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)

Start date: November 28, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.

NCT ID: NCT05629052 Recruiting - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

TrEatment Approach in the Multimodal Era Registry

TEAM
Start date: April 12, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational patient registry is to learn how expert centers treat patients with chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH is a condition in which blood clots block the blood vessels in the lungs. There are currently three treatment options for patients with CTEPH: - surgery to remove blood clots from large vessels in the lungs (pulmonary endarterectomy (PEA)) - the use of a small balloon to unblock smaller blood vessels (balloon pulmonary angioplasty (BPA)) - drugs Patients can also receive a combination of these treatments. The main question this registry aims to answer are: - How many patients receive a given kind of treatment? - How do expert centers combine the different treatments? - Are patients doing better after they receive a given kind of treatment? - How many patients are alive 1, 3 and 5 years after they receive a given kind of treatment? Participants will receive the same treatments that they would receive if they did not participate in the study. During the study, patients will visit their doctors as they would do normally. The doctors will collect information on the patients' health and enter it into the study database. The follow-up time will be at least 3 years for all patients.

NCT ID: NCT05627648 Recruiting - Vocal Fold Scar Clinical Trials

Phase 3 Study of KP-100LI in Subjects With Vocal Fold Scar

Start date: November 24, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to confirm the efficacy and safety of KP-100LI, a intracordal formulation containing recombinant human dHGF as the active pharmaceutical ingredient, for voice function improvement therapy in patients with vocal fold scar (including vocal fold sulcus).

NCT ID: NCT05627557 Recruiting - Clinical trials for Childhood Idiopathic Nephrotic Syndrome

A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome

INShore
Start date: March 29, 2023
Phase: Phase 3
Study type: Interventional

This open-label, randomized multicenter study is to assess the efficacy, safety, and pharmacokinetics (PK)/pharmacodynamics (PD) of obinutuzumab compared with mycophenolate mofetil (MMF) in children and young adults (aged >= 2-25 years) with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS).