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

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

Start date: May 10, 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 participants with moderately to severely active Crohn's disease (CD).

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

FORTIFY
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.

NCT ID: NCT03104400 Active, not 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 (DMARD)

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

This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of upadacitinib 15 mg and 30 mg QD versus placebo for the prevention of structural progression. The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg and 30 mg QD in participants who have completed Period 1.

NCT ID: NCT03104374 Active, not recruiting - Psoriatic Arthritis Clinical Trials

A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)

SELECT - PsA 2
Start date: May 1, 2017
Phase: Phase 3
Study type: Interventional

The study objectives of Period 1 are to compare the efficacy, safety, and tolerability of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo for the treatment of signs and symptoms in adults with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to biologic disease-modifying anti-rheumatic drug (bDMARD). The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants who have completed Period 1.

NCT ID: NCT03101267 Completed - Clinical trials for Rhinitis, Allergic, Seasonal

A Dose-finding Study of ASP4070

Start date: April 13, 2017
Phase: Phase 2
Study type: Interventional

The objective of this study was to evaluate the efficacy, safety, and dose-response of ASP4070 vaccinated in patients with cedar pollinosis.

NCT ID: NCT03100825 Completed - Asthma Clinical Trials

A Long-term Safety Study of QVM149 in Japanese Patients With Asthma

Start date: April 28, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide long term safety data of QVM149 in Japanese patients with asthma for the registration of QVM149 in Japan.

NCT ID: NCT03100500 Completed - Asthma Clinical Trials

A Long-term Safety Study of QMF149 in Japanese Participants With Asthma

Start date: April 25, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study was to provide long term safety data of QMF149 in Japanese participants with inadequately controlled asthma for the registration of QMF149 in Japan.

NCT ID: NCT03100318 Completed - Clinical trials for Hyperuricemia With or Without Gout

Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout

Start date: April 1, 2017
Phase: Phase 3
Study type: Interventional

FYU-981 or Benzbromarone are administrated to hyperuricemia patients with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized, double-blind, ascending dose regimen.

NCT ID: NCT03099174 Completed - Neoplasms Clinical Trials

This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer

Start date: May 4, 2017
Phase: Phase 1
Study type: Interventional

This is a study in adult patients with different types of cancer. The purpose of this study is to find a safe dose of: - Xentuzumab in combination with abemaciclib - Xentuzumab in combination with abemaciclib and hormonal therapies The study also tests whether these medicines make tumours shrink in participants with lung and breast cancer. Participants can stay in the study as long as they benefit from and can tolerate treatment. All participants get xentuzumab infusions and abemaciclib tablets. Participants who have breast cancer get different types of hormonal therapies in addition to xentuzumab and abemaciclib. For all participants, the size of the tumour is measured regularly. Doctors also regularly check the general health of the participants."

NCT ID: NCT03099109 Completed - Solid Tumor Clinical Trials

A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors

Start date: April 12, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety of the study drug known as LY3321367, an anti-T-cell immunoglobulin and mucin-domain domain-containing molecule-3 (TIM-3) antibody administered alone or in combination with LY3300054, an anti-programmed death ligand 1 (PD-L1) antibody, in participants with advanced relapsed/refractory solid tumors.