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NCT ID: NCT02379793 Completed - Clinical trials for Skin and Connective Tissue Diseases

Skin Irritation Test of LEO 80185 Gel in Healthy Japanese Subjects

Start date: March 2015
Phase: Phase 1
Study type: Interventional

The purpose of the study is to investigate skin irritation of LEO 80185 gel, gel vehicle and Liquid Paraffin in healthy Japanese male subjects.

NCT ID: NCT02379091 Completed - Clinical trials for Rheumatoid Arthritis

Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

NEXUS
Start date: December 17, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to establish proof of concept and identify the optimal efficacious dose for namilumab in RA in patients with an inadequate response to methotrexate (MTX-IR) and in patients with an inadequate response to one tumor necrosis factor (TNF)-inhibitor (TNF-IR).

NCT ID: NCT02378688 Completed - Crohn's Disease Clinical Trials

Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease

Start date: March 2015
Phase: Phase 2
Study type: Interventional

The primary objectives of the study are: - To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease(CD) - To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active CD.

NCT ID: NCT02377752 Completed - Neoplasm Clinical Trials

A Study of Olaratumab in Japanese Participants With Advanced Cancer

Start date: March 23, 2015
Phase: Phase 1
Study type: Interventional

This study consists of 2 parts (Part A and Part B). The main purpose of Part A is to evaluate safety and side effects of olaratumab in combination with doxorubicin in Japanese participants with a group of rare cancers (advanced solid tumors, especially advanced soft tissue sarcoma [STS].) The main purpose of Part B is to evaluate how much olaratumab gets into the blood stream of Japanese participants with advanced solid tumors and how long it takes the body to get rid of it.

NCT ID: NCT02377713 Completed - Alzheimer's Disease Clinical Trials

A Single Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease.

Start date: March 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a single dose in Japanese patients with Mild to Moderate Alzheimer's Disease.

NCT ID: NCT02377427 Completed - Asthma Clinical Trials

Pharmacokinetics and Pharmacodynamics of Mepolizumab Administered Subcutaneously in Children

Start date: August 25, 2015
Phase: Phase 2
Study type: Interventional

Mepolizumab is a humanized immunoglobulin G (IgG1) monoclonal antibody (mAb) that exhibits dose proportional and time-independent pharmacokinetics. The study will be conducted in 2 parts. Part A: it will be pharmacokinetic (PK) and pharmacodynamic (PD) study conducted to support the use of mepolizumab in children aged 6 to 11 years with severe eosinophilic asthma and characterize the PK/PD of mepolizumab 40 milligrams (mg) or 100 mg administered subcutaneously depending on participant body weight. Part B: It is a long-term safety / pharmacodynamic phase in which extended treatment for a further 52 weeks will be offered on an optional basis to those subjects eligible for continued treatment. Participants with bodyweight <40 kilogram (kg) will be dosed with mepolizumab 40 mg and participants with body weight >=40 kg will be dosed with mepolizumab 100 mg subcutaneously in upper arm or thigh at Visit 2 (Week 0). Approximately 40 male or female participants aged 6 to 11 years will be screened to achieve approximately 28 eligible participants entering the treatment phase to allow availability of 20 evaluable participants, with a minimum of six participants enrolled in the <40 kg bodyweight group. The total duration of the study will be 22 weeks and will include a run-in period of 1-2 weeks, a treatment period of 12 weeks and a follow-up phase of 8 weeks. A participant will be considered having completed the study if the participant completes all phases of the study including the follow-up phase (Week 20 [visit 8]).

NCT ID: NCT02376985 Completed - Breast Cancer Clinical Trials

Evaluation of Oral Care to Prevent Oral Mucositis in ER Positive MBC Patients Treated With Everolimus: Phase 3 RCT

Start date: March 26, 2015
Phase: Phase 3
Study type: Interventional

To examine whether the occurrence of oral mucositis can be reduced by dental oral management in patients by comparing the use of dental oral management through instruction by dental and oral surgeons (dental oral management group) and an observation group (brushing instruction only group) in a randomized, controlled study in females that are using everolimus for estrogen receptor-positive, hormone therapy-resistant refractory breast cancer.

NCT ID: NCT02375971 Completed - Clinical trials for Retinopathy of Prematurity

RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity

RAINBOW
Start date: December 30, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (ROP).

NCT ID: NCT02375958 Completed - Esophageal Cancer Clinical Trials

PCA062 in pCAD-positive Tumors.

Start date: April 15, 2015
Phase: Phase 1
Study type: Interventional

A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.

NCT ID: NCT02373202 Completed - Clinical trials for Rheumatoid Arthritis

A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)

Start date: February 2015
Phase: Phase 3
Study type: Interventional

Primary Objective: To document the long-term safety of sarilumab added to non-methotrexate (non-MTX) disease-modifying antirheumatic drugs (DMARDs) or as monotherapy. Secondary Objective: To document the long term efficacy of sarilumab added to non-MTX DMARDs or as monotherapy.