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NCT ID: NCT03598751 Active, not recruiting - Psoriatic Arthritis Clinical Trials

Clinical Study of Efficacy and Safety of BCD-085 (Monoclonal Anti-IL-17 Antibody) in Psoriatic Arthritis

PATERA
Start date: July 25, 2018
Phase: Phase 3
Study type: Interventional

Study BCD-085-8/PATERA is a multicentre double-blind placebo-controlled Phase 3 study in patients with psoriatic arthritis (PsA). The objective of the study is to evaluate the efficacy and safety of BCD-085 comparing to placebo in patients with PsA.

NCT ID: NCT03492177 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension

Start date: July 23, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (>=) 2 to less than (˂) 18 years of age with Pulmonary Arterial Hypertension (PAH), by investigating the PK of selexipag and its active metabolite ACT-333679 in this population.

NCT ID: NCT03473743 Active, not recruiting - Clinical trials for Urothelial Carcinoma

A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer

Start date: April 5, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease.

NCT ID: NCT03466411 Active, not recruiting - Crohn's Disease Clinical Trials

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

GALAXI
Start date: April 13, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.

NCT ID: NCT03456076 Active, not recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer

Start date: August 16, 2018
Phase: Phase 3
Study type: Interventional

This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months. Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.

NCT ID: NCT03390686 Active, not recruiting - Lung Cancer Clinical Trials

A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients

Start date: November 15, 2019
Phase: Phase 3
Study type: Interventional

In the SAMSON-2 study, the proposed biosimilar HD204 will be compared to its reference product EU-licensed Avastin®. The aim of the study is to demonstrate equivalence of HD204 and EU-licensed Avastin® in terms of efficacy, safety, pharmacokinetics and immunogenicity.

NCT ID: NCT03332017 Active, not recruiting - Clinical trials for Relapsed/Refractory Follicular Non-Hodgkin Lymphoma

A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma

ROSEWOOD
Start date: November 14, 2017
Phase: Phase 2
Study type: Interventional

he purpose of the study is to evaluate the efficacy, safety, and tolerability BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymphoma.

NCT ID: NCT03288870 Active, not recruiting - Clinical trials for Non-Small Cell Carcinoma of Lung, TNM Stage 4

Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)

DOMINUS
Start date: September 19, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

International multi-center open-label randomized clinical trial of efficacy, safety and pharmacokinetics of BCD-100 (JSC BIOCAD, Russia) monotherapy compared to docetaxel as second-line therapy of patients with advanced inoperable or metastatic non-small cell lung cancer

NCT ID: NCT03183895 Active, not recruiting - Heart Failure Clinical Trials

Evaluate the Safety and Performance of the AccuCinch® Ventricular Repair System - The CorCinch-EU Study

Start date: January 15, 2019
Phase: N/A
Study type: Interventional

This is prospective, non-randomized, single-arm, international, multicenter, clinical safety and performance clinical investigation to evaluate the AccuCinch® Ventricular Repair System for the treatment of heart failure, with or without functional mitral regurgitation due to dilated ischemic or non-ischemic cardiomyopathy

NCT ID: NCT03105102 Active, not recruiting - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease

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

The study consists of 4 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 participants with moderately to severely active Crohn's disease (CD) who responded to intravenous 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 participants 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 participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab; - Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab. - OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.