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NCT ID: NCT04895358 Active, not recruiting - Breast Neoplasms Clinical Trials

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)

Start date: June 18, 2021
Phase: Phase 3
Study type: Interventional

The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10.

NCT ID: NCT04895241 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

TOPAZ-1
Start date: May 25, 2021
Phase: Phase 3
Study type: Interventional

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: - How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS). Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: - After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. - All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. - Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - There will be a follow-up safety period that lasts up to 24 weeks. - In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.

NCT ID: NCT04884360 Recruiting - Ovarian Cancer Clinical Trials

D9319C00001- 1L OC Mono Global RCT

MONO-OLA1
Start date: May 31, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of maintenance olaparib compared with placebo in BRCAwt participants with Stage III to IV high grade serous or endometroid ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who are in complete or partial response following treatment with standard first-line platinum-based chemotherapy.

NCT ID: NCT04882098 Recruiting - Clinical trials for Arthritis, Psoriatic

A Study of Guselkumab in Participants With Active Psoriatic Arthritis

APEX
Start date: June 17, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

NCT ID: NCT04880642 Completed - COVID-19 Clinical Trials

A Trial to Investigate Recovery From COVID-19 With C21 in Adult Subjects

ATTRACT-3
Start date: September 16, 2021
Phase: Phase 3
Study type: Interventional

This trial is a randomized, double-blind, placebo-controlled, parallel-group, 2-arm, multicenter trial to evaluate the efficacy and safety of C21 versus placebo as add-on to standard of care (SoC) in adult subjects with COVID-19. The trial planned to enroll a total of maximum 300 randomized subjects, 150 per arm (oral C21 100 mg twice a day (BID) or placebo for 14 days) according to the 1:1 randomization.

NCT ID: NCT04877691 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

Tulip SC
Start date: June 8, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy

NCT ID: NCT04849637 Active, not recruiting - Covid19 Clinical Trials

Virgin Coconut Oil as Adjunctive Therapy for Hospitalized COVID-19 Patients

Start date: October 22, 2020
Phase: Phase 2
Study type: Interventional

This is a research that will investigate the safety and efficacy of virgin coconut oil (VCO) as an adjunctive therapy for Coronavirus Disease 2019 (COVID-19)

NCT ID: NCT04846868 Active, not recruiting - Schizophrenia Clinical Trials

Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-1)

Start date: June 16, 2021
Phase: Phase 3
Study type: Interventional

This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called Iclepertin improves learning and memory in people with schizophrenia. Participants are put into two groups randomly, which means by chance. One group takes Iclepertin tablets and the other group takes placebo tablets. Placebo tablets look like Iclepertin tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia. During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups. Participants are in the study for about 8 months and visit the study site about 14 times. During this time, doctors regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT04830371 Completed - Typhoid Fever Clinical Trials

Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants

Start date: September 7, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This is an observer-blinded, comparative, single dose, clinical phase II/III study to assess the immunogenicity and safety of EuTCV compared to Typhoid conjugate vaccine in healthy Filipino participants aged 6 months to 45 years.

NCT ID: NCT04825860 Terminated - Schizophrenia Clinical Trials

A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Followed by an Open-label Extension Phase

Start date: March 29, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

A clinical study to investigate the effect of 2 doses of an investigational drug in acutely psychotic adult patients with schizophrenia. The study will consist of a double-blind phase followed by an open-label extension phase.