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NCT ID: NCT03290781 Not yet recruiting - Ulcerative Colitis Clinical Trials

Study of the Effect of SHP647 as Maintenance Treatment in Participants With Moderate to Severe Ulcerative Colitis Who Achieved Clinical Response in Induction Studies

FIGARO UC 303
Start date: February 22, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of SHP647 as maintenance therapy in participants with moderate to severe ulcerative colitis (UC) who achieved clinical response in induction studies. This is a phase 3, randomized, double-blind, placebo-controlled, parallel-group efficacy and safety study.

NCT ID: NCT03283085 Not yet recruiting - Ulcerative Colitis Clinical Trials

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis (AIDA)

Start date: January 22, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with SHP647 in participants with moderate to severe Ulcerative Colitis (UC).

NCT ID: NCT03282045 Recruiting - Sore Throat Clinical Trials

Efficacy and Safety of the Lysobact Complete Spray®, Tantum Verde® and Pharyngal® Oromucosal Spray in the Treatment of Acute Sore Throat

Start date: October 2016
Phase: Phase 3
Study type: Interventional

The primary objective of this multicenter, single-blind, randomized, placebo-controlled, prospective, comparative study with parallel design and 4-arms is to evaluate superiority of Lysobact Complete Spray® against placebo and non inferiority of Lysobact Complete Spray® against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).

NCT ID: NCT03259308 Not yet recruiting - Ulcerative Colitis Clinical Trials

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Start date: November 30, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).

NCT ID: NCT03161457 Recruiting - Clinical trials for Rheumatoid Arthritis

A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid Arthritis

Start date: February 27, 2017
Phase: Phase 1
Study type: Interventional

This is a multicentre, randomised, double-blind, parallel group study to compare the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, safety, tolerability and efficacy of JHL1101 versus MabThera in subjects with moderate to severe RA who have previously failed at least 1 tumour necrosis factor alpha (TNF) inhibitor (i.e., intolerance or documented active disease despite at least 12 weeks treatment according to the TNF inhibitor-approved treatment and dosage), and are on concomitant treatment with MTX.

NCT ID: NCT03131336 Recruiting - Bleeding Clinical Trials

PeproStat as a Topical Agent Used to Stop Bleeding in Patients Undergoing Surgery

Start date: March 31, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the effectiveness and safety of a new peptide-based coagulant, PeproStat. The study drug will be applied to patients undergoing liver/soft tissue surgery, vascular surgery or spine surgery. The speed of action of the new coagulant, that is applied with a gelatin sponge, will be compared to the same sponge but with saline (a commonly used standard of care).

NCT ID: NCT03105128 Recruiting - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease

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

The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active Crohn's disease (CD).

NCT ID: NCT03105102 Not yet recruiting - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991

Start date: March 29, 2018
Phase: Phase 3
Study type: Interventional

The study consists of 3 sub-studies, as follows: - Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991 - Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in subjects who responded to induction treatment in Study M16-006 or Study M15-991; - Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in subjects who completed Sub-study 1 or 2.

NCT ID: NCT03104413 Not yet recruiting - Crohn's Disease Clinical Trials

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

Start date: December 29, 2017
Phase: Phase 3
Study type: Interventional

The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.

NCT ID: NCT03104400 Recruiting - Psoriatic Arthritis Clinical Trials

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug

SELECT - PsA 1
Start date: April 27, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to compare the safety, tolerability, and efficacy of ABT-494 Dose A once daily (QD) and Dose B QD versus placebo and versus adalimumab every other week (eow) in participants with moderately to severely active Psoriatic Arthritis (PsA) and have an inadequate response to non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of ABT-494 Dose A QD and Dose B QD versus placebo for the prevention of structural progression. Period 2 evaluates the safety, tolerability and efficacy of ABT-494 Dose A QD and Dose B QD in participants with PsA who have completed Period 1.