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NCT ID: NCT05540717 Completed - Clinical trials for Seasonal Allergic Rhinitis

Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen

Start date: October 11, 2022
Phase: Phase 3
Study type: Interventional

The PQGrass306 (G306) clinical trial is the pivotal Phase III efficacy clinical trial of PQ Grass. The aim of the G306 pivotal clinical trial is to confirm the efficacy and safety of the optimal effective dose of PQ Grass 27600 SU. This will be determined through the measurements of the effect of PQ Grass on the symptoms of seasonal allergic rhinitis (SAR)/rhinoconjunctivitis and the use of relief medications to control these symptoms during the peak grass pollen season (GPS).

NCT ID: NCT05538715 Recruiting - Partial-edentulism Clinical Trials

Reconstruction of Localized Alveolar Ridge Defects

Start date: November 8, 2019
Phase: Phase 4
Study type: Interventional

The aim of the present prospective randomized controlled study is to compare the clinical, radiological, micro-circulation, and histology of a novel, semi-thick, and conventional full-thickness mucoperiosteal flap technique during horizontal alveolar ridge augmentation.

NCT ID: NCT05538702 Completed - Clinical trials for Nicotine Dependence, Cigarettes

Acute Oral Effects of Heated Tobacco Products

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Heated tobacco products (HTP) are devices which heat, but not burn tobacco. They do not produce cigarette smoke but rather an aerosol. HTPs are marketed as less harmful alternatives to smoking. Use and awareness of these devices have grown exponentially in recent years, with probably millions of people currently using them. There is very little literature about them, so it is quite important to study the effects caused on the human body by these products. The benefits and risks of HTP use are uncertain. There is no research on the acute oral effects of HTPs in the scientific literature.

NCT ID: NCT05537142 Recruiting - Clinical trials for Healthy Participants

A Study to Assess the Phamacokinetics of BV100 in Participants With Varying Degrees of Hepatic Impairment

Start date: September 2, 2022
Phase: Phase 1
Study type: Interventional

To investigate the pharmacokinetics (PK) of rifabutin in subjects with hepatic impairment after single intravenous (IV) infusion of BV100

NCT ID: NCT05537090 Completed - Healthy Volunteers Clinical Trials

A Study to Assess Effect of BV100 on the Pharmacokinetics of Midazolam in Healthy Participants

Start date: September 1, 2022
Phase: Phase 1
Study type: Interventional

To evaluate the effect of repeated doses of intravenous BV100 on the pharma-cokinetics of midazolam and 1-hydroxymidazolam.

NCT ID: NCT05536297 Active, not recruiting - Clinical trials for Age-Related Macular Degeneration

Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

Start date: September 26, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess long-term safety of avacincaptad pegol intravitreal administration for patients with geographic atrophy (GA) who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham).

NCT ID: NCT05535946 Recruiting - Ulcerative Colitis Clinical Trials

ABTECT - Maintenance

Start date: January 16, 2023
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors]. This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106. All eligible subjects who have completed either one of the induction studies above mentioned, will be given the opportunity to take part in the present ABX464-107 maintenance study and will be randomized to either a double blind, placebo-controlled part (Part #1) or allocated to ABX464 50mg or 25mg open label treatment arms (Part #2) depending on their clinical response at the end of induction. This study consists of a 44-week treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit.

NCT ID: NCT05531565 Recruiting - Clinical trials for Subacute Cutaneous Lupus Erythematosus

A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

AMETHYST
Start date: September 13, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B].

NCT ID: NCT05531149 Recruiting - COVID-19 Clinical Trials

Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia

TRICOVID
Start date: December 22, 2022
Phase: Phase 3
Study type: Interventional

The main objectives of the trial are to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with non-severe community-acquired pneumonia (CAP) or moderate / severe Coronavirus Disease 2019 (COVID-19) pneumonia. Other objectives are to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties of trimodulin.

NCT ID: NCT05530070 Recruiting - Coeliac Disease Clinical Trials

Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies

ARCTIC
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

This investigation examines the most important cardiovascular risk factors (e.g., metabolic parameters, body composition) and their changes in coeliac disease. The series of studies allow to assess body composition and cardiovascular risk-related metabolic parameters of newly diagnosed and treated coeliac patients in their complexity and to test if they change during therapy. The interventional part of the investigation aims to answer the question if a dietary intervention mitigates the unfavorable effects of unbalanced diet.