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NCT ID: NCT03972280 Completed - Clinical trials for Hidradenitis Suppurativa

Safety and Pharmacokinetics of Repeat Doses of CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis

Start date: July 4, 2019
Phase: Phase 1
Study type: Interventional

Study CSL324_1002 will investigate the safety and pharmacokinetics of repeat doses of CSL324 in subjects with hidradenitis suppurativa and palmoplantar pustulosis. CSL324 is a novel, recombinant therapy that may treat diseases caused by increased numbers of neutrophils at sites of inflammation.

NCT ID: NCT03971123 Completed - Alzheimer Disease Clinical Trials

Study to Compare the Pharmacokinetics of Tricaprilin Formulations and a Placebo on Ketone Body Production

Start date: August 30, 2019
Phase: Phase 1
Study type: Interventional

Phase 1, Single-center, Open-label Study, Healthy Adult Male Subjects. Part 1:Single-dose, Placebo-controlled, 3-Way Crossover PK Study Part 2: Single dose 2-way comparator PK Study

NCT ID: NCT03971071 Completed - Migraine Headache Clinical Trials

A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache

Start date: October 7, 2019
Phase: Phase 4
Study type: Interventional

Study 20170703 is a phase 4, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of erenumab against placebo in participants with chronic migraine (CM) who have a history of at least 1 preventive treatment failure and are diagnosed with medication overuse headache (MOH).

NCT ID: NCT03969225 Completed - Clinical trials for Vascular Access Complication

Vascular Access Outcome Measure for Function: a vaLidation Study In haemoDialysis

VALID
Start date: December 6, 2019
Phase:
Study type: Observational

A functioning vascular access provides a lifeline for patients requiring haemodialysis but vascular access dysfunction remains one of the leading causes of excessive morbidity, mortality and healthcare costs in this group. Despite increasing numbers of vascular access trials, successful interventions to improve vascular access function have been sparse and compromised by highly variable, often selectively reported outcome measures of limited relevance to patients and health professionals. Through engagement of all relevant stakeholders including patients and caregivers, vascular access function, defined by the need for interventions to enable and maintain the use of a vascular access for haemodialysis, has been identified as one of the most critically important outcome measures for trials in haemodialysis. This prospective, multi-centre, multinational validation study aims to assess the accuracy and feasibility of measuring vascular access function part of routine clinical practice and across different clinical settings to ensure successful global implementation of this core outcome measure in future trials in haemodialysis.

NCT ID: NCT03969121 Completed - Clinical trials for Breast Cancer Female

Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer

Start date: July 16, 2019
Phase: Phase 3
Study type: Interventional

The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the efficacy of palbociclib in combination with Endocrine therapy over Endocrine therapy alone measured by PEPI and EndoPredict™ EPclin Score in women with operable HR+, HER2 negative breast cancer . The Clinical Response Rate, drop in Ki67 index ≤ 2.7% and Breast conserving rate will be compared between two arms.

NCT ID: NCT03963401 Completed - Psoriatic Arthritis Clinical Trials

A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis

Start date: June 13, 2019
Phase: Phase 2
Study type: Interventional

This is a 52 week Phase 2b study designed to evaluate the efficacy at 16 weeks and to evaluate the safety and efficacy up to 1 year in subjects with active psoriatic arthritis.

NCT ID: NCT03961204 Completed - Clinical trials for Multiple Sclerosis (MS)

Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)

Start date: August 15, 2019
Phase: Phase 4
Study type: Interventional

The objective of this study was to collect data both retrospectively and prospectively in order to evaluate the long-term outcomes, durability of effect, and real-world treatment patterns following treatment with Cladribine Tablets or placebo in participants with multiple sclerosis (MS) who were previously participated in the parent studies (ORACLE MS and CLARITY/CLARITY-EXT).

NCT ID: NCT03960580 Completed - Clinical trials for Chronic Rhinosinusitis

Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis Without the Presence of Nasal Polyps

Start date: June 6, 2019
Phase: Phase 3
Study type: Interventional

This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic Rhinosinusitis (CRS) without nasal polyps

NCT ID: NCT03960450 Completed - Psoriasis Clinical Trials

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Topical Administration of BOS-475 in Healthy Subjects and Patients With Psoriasis

Start date: April 23, 2019
Phase: Phase 1
Study type: Interventional

This study was conducted to evaluate the safety and tolerability of BOS-475 following single and repeat topical administration to healthy participants (Part A), and to evaluate the safety and tolerability of 42-day repeat topical administration of BOS-475 to participants with plaque psoriasis (Part B).

NCT ID: NCT03950856 Completed - Clinical trials for Pneumococcal Infections

Lot-to-Lot Consistency of V114 in Healthy Adults (V114-020)

PNEU-TRUE
Start date: June 12, 2019
Phase: Phase 3
Study type: Interventional

The primary objectives are to evaluate the safety and tolerability of V114 and to compare the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) across 3 different lots of V114. The primary hypothesis is that all 3 lots of V114 are equivalent as measured by the serotype-specific OPA GMTs for 15 serotypes in V114 at 30 days postvaccination.