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NCT ID: NCT05844202 Completed - Clinical trials for Sars-CoV-2 Infection

Safety, Tolerability and Immunogenicity of Alveavax-v1.2, a BA.2/Omicron-optimized, DNA Vaccine for COVID-19 Prevention

Start date: June 27, 2022
Phase: Phase 1
Study type: Interventional

The investigated product is a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Booster Vaccine candidate optimized for the Omicron/BA.2 variant. There are currently no licensed, variant-optimized vaccines to prevent infection with SARS-CoV-2 Omicron/BA.2. Approved or authorized SARS-CoV-2 vaccines are expensive, require a stringent cold chain, and have large-scale manufacturing issues, resulting in very limited availability in low- and middle-income countries (LMICs). Given the rapid global spread of the Omicron/BA.2 variant and potential for future novel SARS-CoV-2 variants, the rapid development of an easy-to-manufacture and easy-to-distribute vaccine is of great importance. The objective of the study is to assess the tolerability, safety, and immunogenicity of different doses and routes of administration of the Alveavax-v1.2 vaccine in healthy individuals. The study aims to evaluate: - the safety and tolerability of Alveavax-v1.2 in healthy participants compared to a control booster vaccine in a dose-finding design; - the immunogenicity against SARS-CoV-2 BA.2/Omicron after a booster dose of Alveavax-v1.2; - the clinical efficacy against SARS-CoV-2 after a booster dose of Alveavax-v1.2; - and the success rate of intradermal (ID) injections.

NCT ID: NCT05843643 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus

SELECT-SLE
Start date: July 19, 2023
Phase: Phase 3
Study type: Interventional

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 3 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib based on their disease activity and their original treatment assignment in Study 1 or 2. Approximately 500 participants diagnosed with SLE will be enrolled in each of the Study 1 and Study 2 in approximately 320 sites across the world. Participants will receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2. Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

NCT ID: NCT05842161 Recruiting - HIV Infections Clinical Trials

South Africa Smoking Cessation and Engagement in HIV/TB Care Care

Start date: March 12, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to integrate elements from existing interventions developed by our team into a single intervention (QUIT-AD), designed to improve smoking cessation and favorable HIV/TB treatment outcomes among individuals with HIV and/or TB in Cape Town, South Africa. If feasibility, acceptability, and preliminary efficacy are demonstrated, the intervention will be ready for large-scale effectiveness/implementation testing. This program will has the potential to dramatically improve public health by increasing the smoking quit rate and facilitating favorable HIV/TB treatment outcomes among patients with HIV and/or TB in resource limited South African settings.

NCT ID: NCT05840211 Recruiting - Clinical trials for Stage IV Breast Cancer

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

ASCENT-07
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).

NCT ID: NCT05838755 Recruiting - Pain Clinical Trials

A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain

NEPTUNE-17
Start date: September 20, 2023
Phase: Phase 2
Study type: Interventional

This is a multicenter randomized, double-blind, placebo-controlled phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics, and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP). The primary objective of the study is to assess the efficacy of GSK3858279 in participants with DPNP who have been unable to sufficiently manage their pain.

NCT ID: NCT05838742 Recruiting - Pain Clinical Trials

A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis Pain

MARS-17
Start date: September 13, 2023
Phase: Phase 2
Study type: Interventional

This is dose-finding study of GSK3858279 in participants with moderate to severe knee osteoarthritis (OA) pain. The purpose of this study is to investigate and provide the data necessary to select the optimal effective and safe dose(s) of GSK3858279.

NCT ID: NCT05835986 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus

Start date: December 18, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7507062 in participants with systemic lupus erythematosus (SLE). The study will have 2 parts: Part 1 is a single ascending dose-finding (SAD) part and Part 2 is a dose escalation with fractionated dosing part.

NCT ID: NCT05835479 Recruiting - Clinical trials for Pneumocystis Pneumonia

Rezafungin for Treatment of Pneumocystis Pneumonia in HIV Adults

Start date: November 14, 2023
Phase: Phase 2
Study type: Interventional

This study aims to generate clinical data on the efficacy, safety, and tolerability of rezafungin combined with 7 days of co-trimoxazole for treatment of Pneumocystis pneumonia (PCP) in adults living with human immunodeficiency virus (HIV), which would expand the knowledge of clinical use of rezafungin.

NCT ID: NCT05835310 Recruiting - Clinical trials for Systemic Lupus Erythematosus

An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants

SLE
Start date: March 14, 2024
Phase: Phase 3
Study type: Interventional

A Study to evaluate the PK, PD, efficacy, and safety of Anifrolumab in children with moderate to severe active SLE

NCT ID: NCT05823974 Active, not recruiting - Influenza, Human Clinical Trials

A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults

Start date: February 27, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to find and confirm the dose and asses the reactogenicity, safety and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine (GSK4382276A) candidates administered in healthy younger and older adults (OA).