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NCT ID: NCT03485365 Completed - Pain, Inflammatory Clinical Trials

A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA)

Start date: May 17, 2018
Phase: Phase 1
Study type: Interventional

This study is the first administration of GSK3858279 in humans and will be conducted in two parts: Part A will consist of a single ascending dose escalation design to evaluate safety, tolerability, PK, TE and immunogenicity of either a single intravenous (IV) or a single subcutaneous (SC) dose. Approximately 48 healthy participants will be enrolled in 6 cohorts and randomized to 3:1 ratio (GSK3858279 or placebo). Part B will evaluate safety, tolerability, efficacy (pain), PK, TE and immunogenicity after repeat SC dosing. Approximately 50 OA participants will be randomized in a parallel group design to receive either GSK3858279 or placebo in a 1:1 ratio.

NCT ID: NCT03484065 Completed - Clinical trials for Afibrinogenemia, Congenital

Quality of Life in Patients With Congenital Afibrinogenemia

QualyAFIB
Start date: June 2016
Phase:
Study type: Observational

The aim of this observational study is to evaluate the quality of life in patients with congenital afibrinogenemia using the Haemo-QoL SF for kids and the Haem-A-QoL for adult patients.

NCT ID: NCT03482635 Completed - Colitis, Ulcerative Clinical Trials

BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis

Start date: March 27, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are - to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II) - to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III) - To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.

NCT ID: NCT03482037 Completed - Clinical trials for Neurogenic Detrusor Overactivity

Effects of Rec 0/0438 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury

Start date: June 7, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Rec 0/0438 in subjects with neurogenic detrusor overactivity due to spinal cord injury

NCT ID: NCT03482011 Completed - Psoriasis Clinical Trials

A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis

OASIS-1
Start date: April 24, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of mirikizumab in participants with moderate to severe plaque psoriasis.

NCT ID: NCT03481660 Completed - Clinical trials for Diabetic Macular Edema

A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

KITE
Start date: July 27, 2018
Phase: Phase 3
Study type: Interventional

This was a Phase III, randomized, double-masked, multi-center, active-controlled, two-arm study designed to evaluate the efficacy and safety of brolucizumab 6 mg compared to the active control, aflibercept 2 mg used per authorized label, in subjects with visual impairment due to diabetic macular edema (DME).

NCT ID: NCT03479619 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of Three Lancing Devices Regarding Capillary Blood Volume and Lancing Pain Intensity.

Start date: March 6, 2018
Phase: N/A
Study type: Interventional

A randomized single-blind study with the use of three lancing devices equipped with personal lancets. Every device will be studied for three lancet sizes: 28G, 30G, and 33G with the minimum and maximum puncture depth setting.

NCT ID: NCT03478969 Completed - Clinical trials for Diabetes Mellitus, Type 1

Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System

PRO Solo
Start date: May 17, 2018
Phase: N/A
Study type: Interventional

This interventional device study aims to compare mainly standard Multiple Daily Injection (MDI) therapy vs. Accu-Chek® Solo Micropump System and investigates participant satisfaction. In addition, a third arm is included to compare to only similar product on the market which is OmniPod. The third arm is for data collection purpose.

NCT ID: NCT03478930 Completed - Nasal Polyps Clinical Trials

An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps

Start date: May 9, 2018
Phase: Phase 3
Study type: Interventional

The overall purpose of this study is to evaluate the safety, efficacy, and durability of response of omalizumab in an open-label setting in adult participants with chronic rhinosinusitis with nasal polyps who completed the double-blind, placebo-controlled, Phase III studies GA39688 (NCT03280550) or GA39855 (NCT03280537). Participants will be eligible for enrollment in the study at, or within 28 days after, the Week 24 visit of Studies GA39688/GA39855. After enrollment into this open-label extension (OLE) study, participants will receive 28 weeks of dosing of omalizumab before entering a 24-week off-treatment observation phase of the study. Baseline in this OLE study is defined as the last pre-treatment measurement prior to randomization in Studies GA39688/GA39855 (i.e., baseline of Studies GA39688/GA39855). The data that will be reported from baseline to Week 24 inclusive will come from Studies GA39688/GA39855.

NCT ID: NCT03478787 Completed - Psoriasis Clinical Trials

Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis

Start date: May 8, 2018
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.