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NCT ID: NCT05987423 Recruiting - Thyroid Eye Disease Clinical Trials

A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease

Start date: October 26, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED).

NCT ID: NCT05985915 Recruiting - Sjogrens Syndrome Clinical Trials

A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.

NEPTUNUS-Ext
Start date: October 27, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjogrens syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 or CVAY736A2302). - The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe for injection. All participants will receive ianalumab either monthly or every 3 months. - The treatment duration will be 3 years with an additional up to 2-year safety follow-up. The total duration of this extension study will be up to 5 years. - The visit frequency will be monthly during both the treatment period and mandatory follow-up, and then less frequently during the subsequent conditional follow-up Treatment of interest: The randomized treatment (ianalumab) will be received monthly or every 3 months. Participants assigned to treatment every 3 months will receive placebo every month between the ianalumab doses to maintain blinding. Number of Participants: Approximately 600 participants from the NEPTUNUS core studies will be rolled over into the extension study. Treatment Groups:There will be no screening period in this trial. From Week 48 of the NEPTUNUS core study, participants will be given the opportunity to consent to this extension study. From Week 52 of the NEPTUNUS core studies (i.e., Day 1 in the extension study), eligible participants will be assigned to either one of the treatment regimens: - ianalumab 300 mg monthly or - ianalumab 300 mg once every 3 months Participants receiving placebo in either of the NEPTUNUS core studies will be randomized 1:1 to receive ianalumab 300 mg monthly or every 3 months starting from Week 60 and participants receiving ianalumab in either of the NEPTUNUS core studies will continue the same treatment in the extension study. Ianalumab will be given as a subcutaneous injection from a 2 mL pre-filled syringe. Participants will be given the opportunity to self-inject at home on some visits after receiving training.

NCT ID: NCT05984277 Recruiting - Clinical trials for Metastatic Non-small Cell Lung Cancer

A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.

eVOLVE-Lung02
Start date: October 24, 2023
Phase: Phase 3
Study type: Interventional

The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety of volrustomig in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 < 50%.

NCT ID: NCT05983575 Recruiting - Clinical trials for Alzheimer Disease, Early Onset

A Pivotal Study of LIPUS-Brain in Patients With Early Alzheimer's Disease

Start date: October 31, 2023
Phase: Phase 3
Study type: Interventional

This study is a multicenter, randomized, double-blinded, placebo-controlled Phase 3 study comparing LIPUS-Brain transcranial low-intensity pulsed-wave ultrasound device to placebo in patients with Early Alzheimer's Disease. The primary objective of the study is to assess changes in ADAS-J-cog-14 scores from baseline to 72 weeks.

NCT ID: NCT05980416 Recruiting - Neoplasms Clinical Trials

Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2

Start date: August 10, 2023
Phase: Phase 1
Study type: Interventional

This study is an open-label, international, multi-center, Phase 1 study in adult patients with solid tumors likely to express CLDN18.2.

NCT ID: NCT05976243 Recruiting - Clinical trials for Chronic Inducible Urticaria

A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines

Start date: December 7, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE). The purpose of the core period (52 weeks of treatment) of this study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering from CINDU inadequately controlled by H1-antihistamines (H1-AHs). The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data on remibrutinib in participants after having completed the Core period

NCT ID: NCT05976230 Recruiting - Hypertension Clinical Trials

Special Drug Use Surveillance of Entresto Tablets (Hypertension)

ENLIGHT
Start date: September 4, 2023
Phase:
Study type: Observational

This is a single arm, multicenter, observational study to evaluate the safety and efficacy of Entresto Tablets during the first 52 weeks of treatment in Japanese patients with hypertension.

NCT ID: NCT05973773 Recruiting - Clinical trials for Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation

REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)

REZILIENT3
Start date: June 30, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of zipalertinib in combination with standard first-line platinum-based chemotherapy compared to chemotherapy alone, in patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations.

NCT ID: NCT05972551 Recruiting - Clinical trials for Osteogenesis Imperfecta

Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

Start date: April 22, 2024
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.

NCT ID: NCT05967689 Recruiting - Clinical trials for Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations

A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.

REZILIENT2
Start date: July 27, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of zipalertinib in patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations and other mutations.