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NCT ID: NCT03345082 Completed - Clinical trials for Neovascular Age-related Macular Degeneration

A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD

Start date: November 6, 2017
Phase: Phase 2
Study type: Interventional

A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.

NCT ID: NCT03337724 Completed - Breast Cancer Clinical Trials

A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

IPATunity130
Start date: January 6, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) breast adenocarcinoma who are not suitable for endocrine therapy.

NCT ID: NCT03334435 Completed - Atopic Dermatitis Clinical Trials

A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis

BREEZE-AD3
Start date: March 28, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis. Participants were enrolled in this study from the originating studies (JAHL, JAHM, JAIY) or were directly enrolled in the open-label arm.

NCT ID: NCT03334422 Completed - Atopic Dermatitis Clinical Trials

Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis

BREEZE-AD2
Start date: November 27, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.

NCT ID: NCT03334214 Completed - Hepatic Steatosis Clinical Trials

Safety, Tolerability, and Pharmacodynamics of IONIS-DGAT2Rx in Adult Patients With Type 2 Diabetes

Start date: November 3, 2017
Phase: Phase 2
Study type: Interventional

The purpose is to assess the Safety, Tolerability, and Pharmacodynamics effect of IONIS DGAT2Rx in up to 45 Adult Patients with Type 2 Diabetes.

NCT ID: NCT03334058 Completed - Pemphigus Vulgaris Clinical Trials

A Study to Evaluate the Safety, PD, PK and Efficacy of ARGX-113 in Patients With Pemphigus

Start date: October 18, 2017
Phase: Phase 2
Study type: Interventional

The proposed study is an open-label, non-controlled, adaptive-design Phase II study to evaluate the safety, pharmacodynamics, pharmacokinetics, efficacy, and conditions of use (dosage, frequency of administration at maintenance) of ARGX-113 in patients with mild to moderate Pemphigus (Vulgaris or Foliaceus), either newly diagnosed or relapsing. The total study duration for each patient is less than 6 months. It consists of a Screening period, an Induction, a maintenance treatment period followed by a treatment-free Follow-up (FU) period.

NCT ID: NCT03332771 Completed - Clinical trials for Type 2 Diabetes Mellitus

Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy

SOTA-GLIM
Start date: December 1, 2017
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the non-inferiority of Sotagliflozin 400 milligrams (mg) compared to Glimepiride on hemoglobin A1c (HbA1c) reduction at Week 52 in participants with Type 2 Diabetes (T2D) who have inadequate glycemic control with metformin. Secondary Objectives: To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in body weight, systolic blood pressure (SBP) in participants with baseline SBP ≥130 millimeter of mercury (mmHg), SBP in all participants, and proportion of participants with at least 1 documented symptomatic hypoglycemic event (≤70 milligrams per deciliter [mg/dL]). - To demonstrate the superiority of Sotagliflozin 400 mg compared to placebo on change in HbA1c, body weight, SBP in participants with baseline SBP ≥130 mmHg, SBP in all participants. - To demonstrate the superiority of Sotagliflozin 200 mg compared to placebo on change in HbA1c. - To demonstrate the non-inferiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c. - To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c. - To evaluate the safety and tolerability of Sotagliflozin compared to Glimepiride and placebo.

NCT ID: NCT03322566 Completed - Lung Cancer Clinical Trials

A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)

Start date: January 9, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC).

NCT ID: NCT03317444 Completed - Metabolic Acidosis Clinical Trials

Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease

Start date: September 26, 2017
Phase: Phase 3
Study type: Interventional

This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12 weeks once daily. The maximum study duration is anticipated to be up to 16 weeks.

NCT ID: NCT03306264 Completed - Clinical trials for Acute Myeloid Leukemia

Study of ASTX727 vs IV Decitabine in MDS, CMML, and AML

Start date: February 15, 2018
Phase: Phase 3
Study type: Interventional

Multicenter, randomized, open-label, crossover PK study of ASTX727 versus IV decitabine. Adult subjects who are candidates to receive IV decitabine will be randomized 1:1 to receive the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20 mg/m^2 Daily×5 in Cycle 2, or the converse order. After completion of PK studies during the first 2 treatment cycles, subjects will continue to receive treatment with ASTX727 from Cycle 3 onward (in 28-day cycles) until disease progression, unacceptable toxicity, or the subject discontinues treatment or withdraws from the study.