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NCT ID: NCT04643158 Terminated - Asthma Clinical Trials

Efficacy and Safety of Inhaled AZD1402 Administered for Four Weeks in Adults With Asthma on Medium-to-High Dose Inhaled Corticosteroids

APATURA
Start date: March 12, 2021
Phase: Phase 2
Study type: Interventional

This is a randomised, placebo-controlled, double-blinded, multi-centre, 2-part study to assess the efficacy and safety of inhaled AZD1402. Part 1 will be performed in a Lead-in Cohort for each dose level to evaluate the safety and pharmacokinetics (PK) in a population with asthma controlled on medium dose inhaled corticosteroids (ICS)-long acting beta agonists (LABA) before progressing to dosing in adults with asthma who are uncontrolled on medium-to-high dose ICS-LABA in Part 2. The study will recruit participants receiving treatment with medium dose ICS with LABA for Part 1 and participants receiving treatment with medium-to-high dose ICS with LABA for Part 2 (separate inhalers or combination product). Part 2 will be initiated following evaluation of safety and PK at the relevant dose level in Part 1a. The entire study period for each participant in both Parts 1 and 2, is approximately 3.5 months; a 2-week Screening Period, a 4 week Run-in Period, 4 weeks of Treatment Period, and 4 weeks of Follow-Up Period.

NCT ID: NCT04642911 Active, not recruiting - Diabete Type 2 Clinical Trials

Longterm Follow-up of Subjects With Diabetes 2 Type Treatment With ex Vivo Gene Therapy

AUB001
Start date: October 15, 2020
Phase:
Study type: Observational

This is a multicenter, long term safety and efficacy follow up study for with insulin dependent diabetes 2 type who have been treated with ex vivo gene therapy product in Ukraine Association of Biobank bio-sponsored clinical studies. After completing the parent clinical study (2 years),eligible subjects will be followed for an additional 8 years for total 10 years post-drugproduct infusion. No investigation drug product will be administered in the study

NCT ID: NCT04640623 Recruiting - Clinical trials for Urinary Bladder Neoplasms

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

SunRISe-1
Start date: December 18, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).

NCT ID: NCT04640142 Recruiting - Clinical trials for Primary Immune Deficiency

Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases

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

Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with primary immunodeficiency diseases

NCT ID: NCT04636814 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)

PILLAR
Start date: July 12, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and the safety of two doses of CHF6001 (Tanimilast) as add-on to maintenance triple therapy in the target patient population.

NCT ID: NCT04636801 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER)

PILASTER
Start date: July 14, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population.

NCT ID: NCT04634877 Active, not recruiting - Clinical trials for Endometrial Neoplasms

Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

Start date: January 10, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.

NCT ID: NCT04634825 Terminated - Clinical trials for Head and Neck Cancer

Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer

Start date: March 17, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2 study of enoblituzumab combined with either retifanlimab or tebotelimab administered as first-line treatment to patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

NCT ID: NCT04633564 Completed - NSCLC Stage IV Clinical Trials

MYL-1402O Compared With Avastin®, in Patients With Stage IV nsNSCLC

Start date: January 21, 2017
Phase: Phase 3
Study type: Interventional

Assess the Efficacy and Safety of MYL-1402O Compared with Avastin®, in the First-line Treatment of Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer

NCT ID: NCT04629339 Terminated - Clinical trials for Hepatocellular Carcinoma

Study of INCB086550 in Select Solid Tumors

Start date: September 2, 2021
Phase: Phase 2
Study type: Interventional

An open-label, nonrandomized study to evaluate the efficacy and safety of INCB086550, a first-in-class oral inhibitor of PD-L1, as initial immune checkpoint inhibitor therapy in participants with select solid tumors