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NCT ID: NCT05531565 Recruiting - Clinical trials for Subacute Cutaneous Lupus Erythematosus

A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

AMETHYST
Start date: September 13, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B].

NCT ID: NCT05531149 Recruiting - COVID-19 Clinical Trials

Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia

TRICOVID
Start date: December 22, 2022
Phase: Phase 3
Study type: Interventional

The main objectives of the trial are to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with non-severe community-acquired pneumonia (CAP) or moderate / severe Coronavirus Disease 2019 (COVID-19) pneumonia. Other objectives are to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties of trimodulin.

NCT ID: NCT05524571 Recruiting - Thyroid Eye Disease Clinical Trials

Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

Start date: January 5, 2023
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of batoclimab 680 milligrams (mg) subcutaneous (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24.

NCT ID: NCT05518149 Recruiting - Clinical trials for Depressive Disorder, Major

A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)

VENTURA-LT
Start date: September 22, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI]) in all participants with major depressive disorder (MDD).

NCT ID: NCT05517447 Recruiting - Thyroid Eye Disease Clinical Trials

Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

Start date: November 6, 2023
Phase: Phase 3
Study type: Interventional

This is a 2-cohort (observational and treatment cohort) extension study for participants completing feeder studies (IMVT-1401-3201 or IMVT-1401-3202). The observational cohort will assess the durability of proptosis response of feeder studies off treatment. The treatment cohort will evaluate the efficacy of batoclimab as assessed by proptosis responder rate.

NCT ID: NCT05514535 Recruiting - Obesity Clinical Trials

A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)

Start date: August 29, 2022
Phase: Phase 3
Study type: Interventional

This study compares semaglutide, together with a lower dose of insulin glargine, to a higher dose of insulin glargine in participants with type 2 diabetes. The study looks at how well the study medicines control blood glucose levels. Participants will either get semaglutide together with a lower dose of insulin glargine or a higher dose of insulin glargine. The study will last for about 47 weeks (approximately 11 months). Participants will have 9 clinic visits, 15 phone/video calls and 1 home visit. Participants will be asked to wear a sensor that measures their blood sugar all the time in 2 periods of 10 days during the study.

NCT ID: NCT05514054 Recruiting - Breast Neoplasms Clinical Trials

A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

EMBER-4
Start date: October 4, 2022
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.

NCT ID: NCT05513001 Recruiting - Clinical trials for Chronic Spontaneous Urticaria

An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib

Start date: December 9, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 studies. This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.

NCT ID: NCT05511922 Recruiting - Clinical trials for Hereditary Angioedema

PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial

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

This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II.

NCT ID: NCT05511363 Recruiting - Clinical trials for Psychosis Associated With Alzheimer's Disease

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)

ADEPT-1
Start date: August 23, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.