CHEST Clinical Trials Opportunities

Sponsoring company: United Therapeutics Corporation
Disease state: pulmonary arterial hypertension (PAH), pulmonary hypertension

This is a multicenter, randomized, double-blind, placebo-controlled study. Participants meeting entry criteria will be randomly allocated 1:1 to receive ralinepag or placebo in addition to their standard of care (SOC) or PAH-specific background therapy. The primary end point is the time from randomization to the first adjudicated protocol-defined clinical worsening event. All primary end point events will be adjudicated by an independent clinical event committee (CEC) in a blinded fashion. Participants with a confirmed primary end point event adjudicated by the CEC at any time during the study, and all subjects on the treatment at the conclusion of the study who have completed the week 28 visit, will have the option to enroll in an open-label extension (OLE) study. Those not participating in the OLE study will discontinue the study drug, remain in the study for long-term follow-up of survival status, and receive SOC PAH treatment at the discretion of the treating physician.

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Sponsoring company: United Therapeutics Corporation
Disease state: pulmonary arterial hypertension (PAH), pulmonary hypertension

The primary objective is to assess the effect of early and rapid treprostinil therapy for mean pulmonary artery pressure (mPAP) reduction to improve right ventricular (RV) function and reverse RV remodeling in participants with PAH.

Participants will receive parenteral treprostinil therapy either intravenously or subcutaneously with rapid-dose titration based on wireless mPAP assessment. After target dose and mPAP level are reached, participants may transition to oral treprostinil and continue up-titration in dose toward further reduction of mPAP until month 12. Treprostinil therapy (parenteral or oral) may continue toward the goal of further reduction of mPAP until month 36.

The primary end point is the change from baseline in RV ejection fraction, as measured by cardiac magnetic resonance imaging at month 12.

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Sponsoring company: Pliant Therapeutics, Inc.
Disease state: idiopathic pulmonary fibrosis

BEACON-IPF is a randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (IPF).

The clinical study will evaluate two doses of bexotegrast (PLN-74809) [160 and 320 mg] taken for 52 weeks by participants with IPF taking and not taking background therapy (ie, nintedanib or pirfenidone). The study will consist of an up to 35-day screening period, a 52-week treatment period, and a 14-day safety follow-up period. Of note, participants who are not taking background therapy at study entry will be allowed to initiate it at any time during the study.

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Sponsoring company: United Therapeutics Corporation
Disease states: interstitial lung disease, pulmonary hypertension, pulmonary hypertension associated with interstitial lung disease (PH-ILD)

This study aims to observe and capture demographic characteristics, treatment patterns, and clinical outcomes for patients with PH-ILD to enhance understanding of the disease and treatment.

Participants will be enrolled into 1 of 3 cohorts: approximately 500 participants not receiving inhaled treprostinil, 150 participants newly initiated on Tyvaso/Tyvaso DPI, and 350 participants receiving Tyvaso/Tyvaso DPI for >60 days.

Data collection will occur approximately every 6 months, allowing for use of standard of care data, if available, and following participants for up to 5 years.

Assessments collected include pulmonary function tests, high-resolution CT scan, vital signs, 6-minute walk test, blood draw for plasma N-terminal pro-brain natriuretic peptide concentration and optional genetics/biomarker analysis, echocardiography, EuroQoL 5 Dimension 5 Level Questionnaire, King’s Brief Interstitial Lung Disease questionnaire, Living with Pulmonary Fibrosis questionnaire, Therapy Administration Questionnaire, health care resource utilization, current medications and rehabilitation, World Health Organization functional class, transplant status, survival data, and right heart catheterization.

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Sponsoring company: MannKind
Disease states: Mycobacterium avium complex (MAC) lung disease, treatment-refractory MAC lung disease, nontuberculous mycobacterium infections

This randomized, double-blind, placebo-controlled study (Part A) is designed to compare the efficacy and safety of clofazimine inhalation suspension vs placebo when added to guideline-based therapy. The primary objective of this study will be to compare the efficacy of clofazimine inhalation suspension vs placebo as assessed by the co-primary end points, sputum culture conversion and change in Quality of Life-Bronchiectasis Respiratory Symptoms Score. An open-label extension study (Part B) will be offered to qualified participants for treatment with clofazimine inhalation suspension.

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Sponsoring company: Genentech, Inc
Disease state: idiopathic pulmonary fibrosis (IPF), systemic sclerosis-associated interstitial lung disease (SSc-ILD)

Moonscape is a 2-cohort, phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled study evaluating the efficacy and safety of vixarelimab compared with placebo in patients with IPF and in patients with SSc-ILD. The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with IPF and in participants with SSc-ILD over a 52-week double-blinded treatment (DBT) period. Participants who complete 52 weeks of treatment in the DBT period can choose to enroll in the optional open-label extension period to receive treatment with vixarelimab for another 52 weeks.

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Sponsoring company: United Therapeutics Corporation
Disease state: interstitial lung disease (ILD), pulmonary hypertension (PH), pulmonary hypertension associated with interstitial lung disease

The primary objective is to collect clinical parameters in patients with ILD for exploratory and post hoc analyses to identify and weigh specific parameters for their prognostic significance for PH, aiming to develop a screening algorithm for PH in patients with ILD.

Participants will undergo various clinical assessments that are potentially associated with PH. Data will be used to identify and weigh specific clinical parameters based on their prognostic significance for right heart catheterization (RHC)-confirmed PH. No study drug is under investigation. The study includes 2 study visits: Screening and Visit 1.

Assessments include pulmonary function tests; high-resolution CT scan; physical examination; 6-minute walk test; blood draw for clinical laboratory parameters; plasma brain natriuretic peptide and plasma N-terminal pro-brain natriuretic peptide concentrations; echocardiography; University of California, San Diego Shortness of Breath Questionnaire; King’s Brief Interstitial Lung Disease questionnaire; 36-Item Short Form Survey; PH Functional Classification Self-Report; Investigator's Suspicion of PH Questionnaire; adverse event monitoring; and RHC.

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Sponsoring company: Chiesi Farmaceutici, S.P.A
Disease state: COPD

Chiesi Farmaceutici S.p.A. is conducting a phase 3, four-arm, parallel, placebo and active-controlled (roflumilast), clinical study (PILLAR) for adults with severe to very severe COPD to assess efficacy and safety of two doses of CHF6001 (tanimilast), an inhaled investigational study drug (PDE4i), as add-on to maintenance triple therapy. The study will randomize approximately 3,980 individuals with COPD at approximately 450 global study centers worldwide.

PILLAR is a clinical research study for adults with COPD diagnosis for at least 12 months prior to screening, post-BD FEV₁ <50% of the patient predicted normal value, with chronic bronchitis or mixed phenotype. Subjects should be on background triple therapy at least 3 months prior to the screening visit and have at least one moderate or severe COPD exacerbation in the previous year.

Contact information, Chiesi Farmaceutici: clinicaltrials_info@chiesi.com

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Sponsoring company: Tvardi Therapeutics, Inc.
Disease state: idiopathic pulmonary fibrosis

The REVERT_IPF clinical trial evaluates the safety and effectiveness of TTI-101 alone or with nintedanib in adults with idiopathic pulmonary fibrosis (IPF).

TTI-101 is a selective inhibitor of STAT3, a key promotor in the maladaptive fibrotic cascade of IPF.

The REVERT_IPF clinical trial lasts approximately 21 weeks, including a 12-week treatment period. Participants will be randomized in a 1:1:1 ratio to receive one of two doses of TTI-101 or placebo. TTI-101 (or placebo) is in tablet form and is self-administered twice daily.

Key eligibility criteria include:

• ≥40 years of age
• >40% predicted FVC
• ≥25% predicted DLCO
• ≥88% SpO2 with up to 4L O2/min
• IPF diagnosed within the last 7 years
• If currently receiving nintedanib, must be on a stable dose for ≥3 months
• 6-week washout period for prior antifibrotic therapy

Other inclusion and exclusion criteria apply for participating in the REVERT_IPF Clinical Trial.

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Sponsoring company: United Therapeutics Corporation
Disease state: pulmonary fibrosis, interstitial lung disease (ILD)

This phase 3, multinational, randomized, double-blind, placebo-controlled study evaluates the safety and efficacy of inhaled treprostinil in participants with progressive pulmonary fibrosis over 52 weeks. Participants will be randomly allocated 1:1 to receive inhaled treprostinil or placebo, starting at 3 breaths administered 4 times daily (QID) and titrating to a target of 12 breaths QID or the maximum tolerated dose. Six treatment period visits to the clinic are required at weeks 4, 8, 16, 28, 40, and 52.

Efficacy assessments include FVC, time to clinical worsening, time to first acute exacerbation of ILD, overall survival, King’s Brief Interstitial Lung Disease questionnaire, plasma N-terminal pro-brain natriuretic peptide concentration, supplemental oxygen use, and lung diffusion capacity. Safety assessments include adverse events/serious adverse events, vital signs, clinical laboratory parameters, and electrocardiogram parameters.

Participants completing the week 52 visit may enter an open-label extension study after completing the final study visit.

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Sponsoring company: Chiesi Farmaceutici S.P.A
Disease state: COPD

Chiesi Farmaceutici S.p.A. is conducting a phase 3 clinical research study (TRITON) for adults with moderate to severe COPD to compare CHF 5993 with CHF 1535 in improving lung function, reducing moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes. The study will enroll approximately 2,900 individuals with COPD at approximately 360 global centers.

TRITON is a clinical research study for adults with a COPD diagnosis for at least 12 months, and a post-BD FEV₁ <50% predicted normal and a history of ≥1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator FEV₁ ≥50% and <80% of predicted normal and a documented history of ≥2 moderate COPD exacerbations or ≥1 severe COPD exacerbation in the previous 12 months.

Contact information, Chiesi Farmaceutici: clinicaltrials_info@chiesi.com

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