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NCT ID: NCT04556383 Terminated - Ulcerative Colitis Clinical Trials

A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)

Start date: October 19, 2020
Phase: Phase 2
Study type: Interventional

A 2-part study, comprising of a 36-week placebo-controlled period (PCP) and a 24-week open-label extension (OLE) period, to assess the efficacy and safety of 2 dose regimens of GB004 when added to background UC therapy of 5-aminosalicylate (5-ASA) with or without systemic steroids.

NCT ID: NCT04489537 Terminated - Clinical trials for Hemophilia A With Inhibitor

Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B

Start date: May 4, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the trial is to evaluate the safety and efficacy of MarzAA for on-demand treatment and control of bleeding episodes in hemophilia A or B patients with inhibitors compared with their standard of care (SOC).

NCT ID: NCT04478266 Terminated - Breast Cancer Clinical Trials

Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer

AMEERA-5
Start date: October 14, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease. Secondary Objective: - To compare the overall survival in both treatment arms. - To evaluate the objective response rate in both treatment arms. - To evaluate the duration of response in both treatment arms. - To evaluate the clinical benefit rate in both treatment arms. - To evaluate progression-free survival on next line of therapy. - To evaluate the pharmacokinetics of amcenestrant, and palbociclib. - To evaluate health-related quality of life in both treatment arms. - To evaluate the time to first chemotherapy in both treatment arms. - To evaluate safety in both treatment arms.

NCT ID: NCT04419558 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Start date: September 30, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week randomized treatment phase followed by an optional, open-label extension phase.

NCT ID: NCT04411082 Terminated - ß Thalassemia Clinical Trials

A Study of IMR-687 in Subjects With Beta Thalassemia

Start date: October 16, 2020
Phase: Phase 2
Study type: Interventional

A Study to Evaluate the Safety and Tolerability of IMR-687 in Subjects with Beta Thalassemia

NCT ID: NCT04365400 Terminated - Type 2 Diabetes Clinical Trials

Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes

TRIAGE
Start date: October 13, 2020
Phase: Phase 2
Study type: Interventional

To assess the efficacy and safety of orally administered Epeleuton capsules versus placebo, in the treatment of adult patients with hypertriglyceridemia and type 2 diabetes

NCT ID: NCT04338022 Terminated - Clinical trials for Relapsing Multiple Sclerosis

Study of Evobrutinib in Participants With RMS (evolutionRMS 1)

Start date: June 12, 2020
Phase: Phase 3
Study type: Interventional

The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS). Participants who complete the double-blind treatment period (DBTP) and double-blind extension period (DBEP) prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period.

NCT ID: NCT04200456 Terminated - Clinical trials for Primary Immune Thrombocytopenia

A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

myOpportunITy1
Start date: January 31, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment and assess safety and tolerability of rozanolixizumab in adult study participants with primary immune thrombocytopenia (ITP).

NCT ID: NCT03956550 Terminated - Pain Clinical Trials

A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee

Start date: May 21, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of REGN5069 compared to placebo in patients with pain due to radiographically-confirmed OA of the knee who have a history of inadequate joint pain relief or intolerance to current analgesic therapy. The secondary objectives of the study are: - To characterize the concentrations of functional REGN5069 in serum over time when patients are treated for up to 12 weeks - To assess the safety and tolerability of REGN5069 compared with placebo when patients are treated for up to 12 weeks - To measure levels of anti-drug antibodies (ADAs) against REGN5069 following multiple IV administrations

NCT ID: NCT03943550 Terminated - Ulcerative Colitis Clinical Trials

Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Participants With Ulcerative Colitis (UC)

Start date: May 13, 2019
Phase: Phase 1
Study type: Interventional

The principal aim of this study is to evaluate the safety and tolerability of RO7049665 in participants with active ulcerative colitis (UC).