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NCT ID: NCT04080752 Completed - Clinical trials for Major Depressive Disorder With Anxious Distress

A Study of JNJ-61393215 in the Treatment of Depression

Start date: September 17, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of JNJ-61393215 as adjunctive treatment compared to adjunctive placebo, as assessed by the change from baseline to week 6 on a 17-item Hamilton Depression Rating Scale (HDRS-17) in participants with major depressive disorder (MDD) with anxious distress with a score greater than or equal to (>=) 2 on item 26 or 27 of the Inventory of Depressive Symptomatology, Clinician Rating -30 (IDS-C30), who have a suboptimal response to current treatment with a standard antidepressant.

NCT ID: NCT04080206 Completed - Plaque Psoriasis Clinical Trials

A Safety Study of 188-0551 Spray Versus Reference Listed Drug (RLD) in Adult Subjects With Plaque Psoriasis

Start date: April 7, 2020
Phase: Phase 2
Study type: Interventional

Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is to determine and compare the adrenal suppression potential and the pharmacokinetic (PK) properties of 188-0551 Spray versus an FDA-approved drug (also known as a "Reference Listed Drug" [RLD]) under maximal use conditions when applied twice daily (approximately every 12 hours) in adult subjects with stable, moderate to severe, plaque psoriasis.

NCT ID: NCT04079374 Recruiting - Clinical trials for Rheumatoid Arthritis

Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel

Start date: September 3, 2018
Phase: Phase 3
Study type: Interventional

The Study objectives are: 1. To compare the efficacy and safety of Etanercept, lyophilisate for solution for injection and Enbrel, lyophilisate for solution for subcutaneous injection, which are used as subcutaneous injections at a dose of 25 mg 2 times a week for 24 weeks in combination with methotrexate in patients with rheumatoid arthritis. 2. To prove the therapeutic equivalence of Etanercept, lyophilisate for solution for injection and Enbrel, lyophilisate for solution for subcutaneous injection in patients with rheumatoid arthritis. 3. To evaluate the immunogenicity of Etanercept, lyophilisate for solution for injection.

NCT ID: NCT04078152 Active, not recruiting - Solid Tumor Clinical Trials

Durvalumab Long-Term Safety and Efficacy Study

WAVE
Start date: September 5, 2019
Phase: Phase 4
Study type: Interventional

The aims of the study are to monitor the long-term safety of durvalumab, to provide continued treatment or retreatment with durvalumab to eligible patients, and to collect overall survival (OS) information.

NCT ID: NCT04072575 Completed - Schizophrenia Clinical Trials

A Study of Paliperidone Palmitate 6-Month Formulation

Start date: September 19, 2019
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to assess the long-term safety and tolerability of paliperidone 6-month PP6M (Dose 1 or Dose 2 [milligram] mg eq.) and to provide access to PP6M in participants with schizophrenia completing the R092670PSY3015 study without relapse.

NCT ID: NCT04072354 Completed - Schizophrenia Clinical Trials

A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

Start date: September 11, 2019
Phase: Phase 3
Study type: Interventional

A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 13 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 70 locations worldwide. The study will last up to 9 weeks total time.

NCT ID: NCT04063163 Active, not recruiting - Clinical trials for Extensive Stage Small Cell Lung Cancer

A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Start date: September 12, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10+ Chemotherapy vs placebo+Chemotherapy in Previously Untreated Patients with Extensive Stage Small Cell Lung Cancer. Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows: Arm A (HLX10 arm): HLX10 + chemotherapy (Carboplatin-Etoposide) ; Arm B (placebo arm): Placebo + chemotherapy (Carboplatin-Etoposide); The three stratification factors for randomization include: PD-L1 expression level (negative, positive, not available), Brain metastasis (yes versus no), Age (≥ 65 years versus < 65 years)

NCT ID: NCT04060199 Completed - Clinical trials for Duchenne Muscular Dystrophy

Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With DMD (RACER53)

Start date: April 14, 2020
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the efficacy of Viltolarsen compared to placebo in Duchenne muscular dystrophy (DMD) patients amenable to exon 53 skipping.

NCT ID: NCT04059484 Active, not recruiting - Clinical trials for Breast Cancer Metastatic

Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

AMEERA-3
Start date: October 22, 2019
Phase: Phase 2
Study type: Interventional

Primary Objective: To determine whether amcenestrant per overall survival (os) improves progression free survival (PFS) when compared with an endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer Secondary Objectives: - To compare the overall survival in the 2 treatment arms - To assess the objective response rate in the 2 treatment arms - To evaluate the disease control rate in the 2 treatment arms - To evaluate the clinical benefit rate in the 2 treatment arms - To evaluate the duration of response in the 2 treatment arms - To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms - To evaluate the pharmacokinetics of amcenestrant as single agent - To evaluate health-related quality of life in the 2 treatment arms - To compare the overall safety profile in the 2 treatment arms

NCT ID: NCT04058158 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria

Start date: August 7, 2019
Phase: Phase 3
Study type: Interventional

This is a randomised Phase III, double-blind, multicentre, cross-over study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB12 and Soliris® in subjects with PNH.