Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
NCT06959095 · Pulmonary Disease, Chronic Obstructive
RecruitingDepemokimab is being developed as a treatment for individuals with moderate to severe COPD. The aim of this study is to assess the efficacy and safety of depemokimab as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.
PhasePhase 3
TypeInterventional
Age40 Years – 80 Years
WhereLoxahatchee Groves, Florida, United States + 14 more
SponsorGlaxoSmithKline
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
RecruitingThe purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.
PhasePhase 3
TypeInterventional
Age40 Years – 90 Years
WhereBirmingham, Alabama, United States + 485 more
SponsorHoffmann-La Roche
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)
RecruitingA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
PhasePhase 3
TypeInterventional
Age40 Years – 80 Years
WhereFoley, Alabama, United States + 300 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home
RecruitingParallel-group, prospective, randomized, controlled phase III trial of home High flow Nasal Therapy (HFNT) via myAirvo 3 plus usual COPD medical care vs. usual COPD medical care, for at least 1 year and up to two years in 642 GOLD Grade D, Stages II-IV patients with moderate to very severe COPD at risk for moderate and severe exacerbations with a prior history of severe exacerbation requiring hospitalization within the past 6 weeks.
PhaseNA
TypeInterventional
Age30 Years
WhereBirmingham, Alabama, United States + 26 more
SponsorTemple University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease
NCT06663722 · Chronic Graft Versus Host Disease, cGVHD
RecruitingThe purpose of this study is to see whether giving participants a combination treatment of Axatilimab and Extracorporeal Photopheresis (ECP) is effective against chronic Graft-versus-Host Disease (cGVHD).
PhasePhase 2
TypeInterventional
Age12 Years
WhereMiami, Florida, United States
SponsorUniversity of Miami
▾Tap for detailsClick for full details — eligibility, all locations, contacts Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
RecruitingThis is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation
PhasePhase 2
TypeInterventional
Age40 Years – 80 Years
WhereBirmingham, Alabama, United States + 50 more
SponsorConnect Biopharm LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
NCT07555483 · Alpha 1 Antitrypsin Deficiency
RecruitingThis study is designed to compare two different weekly doses of a medicine called Alpha1-Proteinase Inhibitor given by injection under the skin with the standard doses of the same medicine given through a vein. Adults with Alpha-1 Antitrypsin Deficiency will take part. Participants will be randomly assigned to one of the treatment groups, and both the study doctors and participants will know which treatment is being given. The main goals of the study are to understand how the body processes the medicine (pharmacokinetics) and to assess how safe and well tolerated the different weekly doses are.
PhasePhase 3
TypeInterventional
Age18 Years – 80 Years
WhereBirmingham, Alabama, United States + 18 more
SponsorGrifols Therapeutics LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate Solrikitug in Participants With COPD (ZION)
RecruitingA Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants with Chronic Obstructive Pulmonary Disease (COPD).
PhasePhase 2
TypeInterventional
Age40 Years – 75 Years
WhereBirmingham, Alabama, United States + 117 more
SponsorUniquity One (UNI)
▾Tap for detailsClick for full details — eligibility, all locations, contacts Physiologic Effects of Nasal High Flow on Exercise Tolerance in COPD
RecruitingThis study aims to assess whether to describe the effects of the administration of nasal high flow (NHF) at 70 liters per minute (L/min) in a 6-Minute Walk Test (6-MWT) among Chronic Obstructive Pulmonary Disease (COPD) patients and to characterize the association between self-reported dyspnea with and without NHF at 70 L/min following a 6-MWT.
PhaseNA
TypeInterventional
Age18 Years – 100 Years
WhereMiami, Florida, United States
SponsorUniversity of Miami
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Assess the Efficacy and Safety of Verekitug in Participants With COPD
RecruitingThe purpose of this study is to assess the efficacy and safety of verekitug (UPB-101) in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), an inflammatory lung disease.
PhasePhase 2
TypeInterventional
Age40 Years – 85 Years
WhereBakersfield, California, United States + 324 more
SponsorUpstream Bio Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
RecruitingLPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups. The purpose of this study is to assess the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling including mucus plugging and its association with improvement on lung function, exacerbations, and quality of life improvement in participants aged 40 years of age up to 85 years of age (inclusive). Study details include: The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The number of visits will be 9.
PhasePhase 4
TypeInterventional
Age40 Years – 85 Years
WhereBirmingham, Alabama, United States + 60 more
SponsorSanofi
▾Tap for detailsClick for full details — eligibility, all locations, contacts Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
NCT07199361 · Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
RecruitingThis research aims to uncover the Mechanisms of pain relief through the FDA-cleared peripheral transcutaneous magnetic stimulation (pTMS) device by MagVenture. 50 people with chronic pain (post-surgical or post-traumatic) will be identified and recruited. The eligibility for participation in the study will be evaluated by a series of pain and mental health questionnaires followed by quantitative sensory testing (QST) to assess response to noxious heat, cold, and pressure stimuli. Blood will be drawn to isolate plasma, serum, and leukocytes. Participants will then undergo pTMS at the site of pain for four consecutive days. At the end of the therapy, pain testing will be done again, followed by blood withdrawal to assess the changes in plasma and leukocyte levels of mediators of pain. It is anticipated that pTMS will increase mediators of pain relief and reduce inflammatory mediators. Risks: It is possible that a few participants may not respond to pTMS therapy. However, plasma analysis of mediators of pain may help stratify these participants into responders vs. non-responders. Risks associated with the study are minimal and mainly involve discomfort associated with pain testing. The importance of knowledge gained includes understanding pain relief mechanisms by medical devices such as pTMS, which will result in better pain management.
PhaseNA
TypeInterventional
Age19 Years – 80 Years
WhereMiami, Florida, United States
SponsorFlorida International University
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
NCT06585774 · Chronic Graft-versus-host-disease
RecruitingThis study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
PhasePhase 3
TypeInterventional
Age12 Years
WhereBirmingham, Alabama, United States + 121 more
SponsorIncyte Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts STRIVE Post-Market Registry Study
NCT04302272 · Emphysema
RecruitingThis is a single-arm, prospective, multi-center, Registry study to evaluate the long-term safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe emphysema in a post-market setting.
Phase—
TypeObservational
Age18 Years
WherePhoenix, Arizona, United States + 13 more
SponsorOlympus Corporation of the Americas
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
RecruitingA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
PhasePhase 3
TypeInterventional
Age40 Years – 80 Years
WhereCullman, Alabama, United States + 267 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease
RecruitingThe purpose of this clinical trial is to learn about the effects and safety of the study medicine PF-07275315 for the potential treatment of COPD. COPD is a condition that makes it difficult to breathe, which negatively impacts the quality of life and functioning of people who are affected. This study is seeking participants who: * Are 35 to 80 years old * Have had moderate-to-severe COPD for at least 12 months * Have a documented history of at least 2 moderate or severe exacerbations within the last 12 months * Have been continuously taking their regular maintenance treatment(s) for COPD over at least 6 months at a stable dose for 3 months All participants will receive PF-07275315 or a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-07275315 or placebo will be given as multiple shots in the clinic over the course of 24 weeks for the Phase 2 part and 52 weeks for the Phase 3 part. We will compare the results of people receiving PF-07275315 to those of the people who do not. This will help us determine if PF-07275315 is safe and effective. Participants who will be involved in the Phase 2 part of the study for about 40 weeks. During this time, they will have 11 visits at the study clinic. Participants who will be involved in the Phase 3 part of the study for about 68 weeks. During this time, they will have 18 visits at the study clinic.
PhasePhase 2 / Phase 3
TypeInterventional
Age35 Years – 80 Years
WhereDothan, Alabama, United States + 31 more
SponsorPfizer
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)
NCT06615050 · Graft-versus-host Disease (GVHD)
RecruitingThe purpose of this study is to assess Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation
PhasePhase 3
TypeInterventional
Age18 Years
WherePalo Alto, California, United States + 29 more
SponsorIncyte Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts An Efficacy and Safety Study of DFL24498 in the Treatment of AKC
NCT07395232 · Atopic Keratoconjunctivitis
RecruitingThis is a phase 3, multicenter, randomized, double-masked, parallel-group, vehicle-controlled study to evaluate the safety and efficacy of DFL24498 compared with vehicle ophthalmic solution, in participants with AKC. Approximately 138 participants who meet all eligibility criteria will be enrolled in the study.
PhasePhase 3
TypeInterventional
Age18 Years – 65 Years
WhereJacksonville, Florida, United States + 18 more
SponsorDompé Farmaceutici S.p.A
▾Tap for detailsClick for full details — eligibility, all locations, contacts Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
RecruitingThis is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: * Screening period of up to 4 weeks * Randomized intervention period of approximately 48 weeks * Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.
PhasePhase 3
TypeInterventional
Age40 Years – 80 Years
WhereChandler, Arizona, United States + 195 more
SponsorSanofi
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
RecruitingThis Phase IIb dose-ranging study will evaluate the efficacy and safety of 2 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.
PhasePhase 2
TypeInterventional
Age40 Years
WhereBirmingham, Alabama, United States + 365 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts