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NCT ID: NCT03311477 Not yet recruiting - Clinical trials for Cancer - Solid Tumors

A Study to Evaluate the Safety and Pharmacokinetics ABBV-399 in Japanese Participants With Solid Tumors

Start date: November 14, 2017
Phase: Phase 1
Study type: Interventional

An open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-399 in participants with advanced solid tumors.

NCT ID: NCT03311464 Recruiting - Clinical trials for Pyoderma Gangrenosum

A Study Assessing the Efficacy and Safety of Adalimumab in Active Ulcer(s) of Pyoderma Gangrenosum in Participants in Japan

Start date: October 27, 2017
Phase: Phase 3
Study type: Interventional

This study is designed to investigate the efficacy, safety and pharmacokinetics of adalimumab in subjects in Japan with active ulcer(s) due to Pyoderma Gangrenosum (PG).

NCT ID: NCT03306667 Not yet recruiting - Healthy Clinical Trials

Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)

Start date: October 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with hepatic insufficiency and with normal hepatic function.

NCT ID: NCT03305224 Recruiting - Bone Metastases Clinical Trials

The Combination Therapy With Ra-223 and Enzalutamide

CORE-OCU
Start date: October 2017
Phase: Phase 2
Study type: Interventional

This study is to evaluate preliminary efficacy of Ra-223 in combination with Enzalutamide in progressive CRPC patients with bone metastasis

NCT ID: NCT03303105 Recruiting - Migraine Clinical Trials

Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine

Start date: November 2018
Phase: Phase 3
Study type: Interventional

To evaluate the long-term safety and tolerability of subcutaneous (SC) administration of TEV-48125 (at 225 mg once monthly [except for a loading dose of 675 mg for CM patients] or at 675 mg every 3 months) for the preventive treatment of Chronic Migraine and Episodic Migraine patients

NCT ID: NCT03303092 Recruiting - Migraine Clinical Trials

Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Episodic Migraine

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

To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 (monthly TEV-48125 225 mg and TEV-48125 675 mg once over a period of 3 months) compared with placebo for preventive treatment in Episodic Migraine patients

NCT ID: NCT03303079 Recruiting - Migraine Clinical Trials

Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Chronic Migraine

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

To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 [monthly TEV-48125 225 mg (loading dose only: 675 mg) and TEV-48125 675 mg once over a period of 3 months] compared with placebo for preventive treatment in Chronic Migraine patients

NCT ID: NCT03301896 Not yet recruiting - Solid Tumors Clinical Trials

Study of the Safety and Efficacy of LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies

Start date: November 21, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this trial is to explore the clinical utility of two investigational agents in patients with advanced cancer. This is a multi-center, open-label Phase I/Ib study. The study consists of four dose escalation parts and two dose expansion parts testing LHC165 as a single agent or LHC165 in combination with PDR001. The dose escalation parts will estimate the Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion (RDE) and test two different dosing schedules for LHC165. The dose expansion parts of the study will use the MTD/RDE for each the LHC165 single agent and in combination with PDR001, determined in the respective dose escalation parts to assess the activity, safety and tolerability of LHC165 as a single agent or LHC165 in combination with PDR001 in patients with specific types of solid tumors. Approximately 206 adult patients with advanced solid tumors will be enrolled.

NCT ID: NCT03298451 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma

HIMALAYA
Start date: October 30, 2017
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy.

NCT ID: NCT03298061 Active, not recruiting - Clinical trials for Churg-Strauss Syndrome

Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921

Start date: April 14, 2015
Phase: Phase 3
Study type: Interventional

Eosinophilic Granulomatosis with Polyangiitis (EGPA), also referred to as Churg-Strauss syndrome, is a rare hyper-eosinophilic syndrome. Eosinophilia is central to the pathophysiology of EGPA and interleukin-5 (IL-5) is a key cytokine regulating the life-cycle of the eosinophil. Neutralization of IL-5 with mepolizumab, an anti-IL5 monoclonal antibody, therefore offers a potential therapeutic option for EGPA. The objective of study MEA115921 was to investigate the efficacy and safety of mepolizumab compared with placebo wherein the subjects were randomized to receive either: 300 milligram (mg) mepolizumab or Placebo subcutaneous (SC) injection every 4 weeks in addition to their background standard-of-care therapy. Subjects were treated for a period of 52 weeks and then followed up for a further 8 weeks to study completion at Week 60. This is a LAP to support provision of open-label mepolizumab on an individual basis to eligible subjects who participated in clinical study MEA115921 and who require a dose of prednisolone (or equivalent) of >=5 milligrams per day (mg/day) for adequate control of their EGPA. Eligible subjects can initiate mepolizumab under this LAP within a 6-month period starting from completion of study MEA115921 (that is, at Week 60) or, in case of premature discontinuation from study MEA115921, the subjects will initiate mepolizumab at the time point that would have been Week 60 if the subject had completed the study. Eligible subjects will receive subcutaneously administered mepolizumab at a dose of 300 mg SC every 4 weeks. Eligible subjects will continue to receive mepolizumab under this LAP until mepolizumab is commercially licensed for the treatment of EGPA in the relevant country or until GlaxoSmithKline (GSK) discontinues the program or until the subject meets any of the withdrawal/stopping criteria.