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AstraZeneca CLEAR AZD0292

Ph2b, randomized (1:1:1), double blind, placebo-controlled, parallel, multidose study to evaluate the efficacy and safety of 2 dose levels of  AZD0292 administered every 4 weeks; Variable Treatment Duration Design: minimum 24 and maximum of 48 weeks.

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The treatment period ranges from 24-48 weeks.

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Follow-up: 28 weeks post-last dose.

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Inclusion criteria: positive sputum culture for PsA at Screening, ≥ 2 moderate or ≥ 1 severe exacerbations in past 24 months.

Exclusion criteria: primary lung diagnosis other than BE (exceptions: stable COPD/Asthma); active TB, NTM, ILD.

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Boehringer Ingelheim AIRTIVITY 1397-0014

A Phase III, randomized, double-blind, placebo-controlled study to assess the Efficacy, Safety, and Tolerability of BI 1291583 2.5 mg administered once daily for up to 76 weeks in patients with Bronchiectasis (The AIRTIVITY® Study).

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The treatment period ranges from 52-76 weeks.

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Main inclusion criteria: ≥12 years of age. Participants aged ≥12 to <18 years (adolescents) need to weigh at least 35 kg at Visit 1; Clinical history consistent with bronchiectasis and investigator confirmed diagnosis by computed tomography (CT) scan where bronchiectasis has been documented by a radiologist; History of pulmonary exacerbations requiring antibiotic  treatment in the last 12 months before Visit 1 o at least 2 pulmonary exacerbations, or o at least 1 exacerbation and an SGRQ Symptoms score of 
>40 (adults only) o at least 1 exacerbation and high symptom burden according to the investigator’s judgement (adolescents only).
 

Main exclusion criteria: Any new or newly diagnosed condition of primary or secondary 
immunodeficiency within 1 year before randomisation; Allergic bronchopulmonary aspergillosis being treated or requiring treatment; Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment.

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GSK 223957 Asthma Low Carbon Ventilation

A randomized, double-blind, 2-way crossover, multicenter study to evaluate the safety of test propellant HFA-152a and reference propellant HFA134a when administered via metered dose inhaler.

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Treatment period: 5 days and up to 7 days between the treatment periods.

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Follow up: 5 to 7 days post-last dose of treatment period 2.

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Inclusion Criteria: Participants may be eligible if they are 18 years of age or older and have had asthma for at least 6 months with stable asthma treatment for at least 12 weeks before screening. Participants must have adequate lung function and controlled asthma, be non-smokers with limited prior tobacco exposure, and be able to correctly and consistently use a pressurized inhaler. Both male and female participants may be eligible. Women who may become pregnant must have a negative pregnancy test as required by the study.

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Exclusion Criteria: Participants may not be eligible if they have a history of life-threatening asthma, other significant lung diseases, a recent respiratory infection, or a severe asthma exacerbation requiring systemic corticosteroids, hospitalization, or emergency treatment within the previous 3 months. Other significant or uncontrolled medical conditions, certain medications or medication allergies, recent participation in another clinical trial, or a history of alcohol or drug abuse may also prevent participation. Additional exclusion criteria include factors that may affect compliance with study procedures, planned changes in asthma treatment or environmental exposure, significant ECG abnormalities, certain abnormal liver test results or liver disease, or a prolonged QTc interval on ECG.

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GSK 223957 Asthma Low Carbon Ventilation

A Phase 2 randomized, double-blind, placebo-controlled study to investigate efficacy, safety, immunogenicity, and pharmacokinetics, of GSK3862995B in participants with Bronchiectasis.

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24-48 weeks treatment duration period with dosing every 12 weeks.

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Follow-up: 24 weeks after the treatment period.

Inclusion criteria: Bronchiectasis diagnosis; Non-smokers or former cigarette smokers​; Males and females of childbearing and non-childbearing potential​; Stable background SOC for bronchiectasis.

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Exclusion criteria: Participants with a primary diagnosis of asthma or COPD as judged by the investigator; Other clinically significant lung disease​; Significant allergies to humanized monoclonal antibodies; Initiation of pulmonary rehabilitation during the clinical period is prohibited; Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled and, which in the judgment of the Investigator, may affect participant safety or affect study endpoints. ​

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GSK 222725 ENDURA

A randomized, double-blind, placebo-controlled, parallel-group, multicenter study of the efficacy and safety of depemokimab in adult participants with COPD with Type 2 inflammation.

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The treatment period ranges from 52-104 weeks.

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Follow-Up period: 9 weeks after exit visit.

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Inclusion criteria: Age: ≥40 to ≤80 years of age, at the time of ICF; Blood Eosinophil Count (BEC); COPD diagnosis at least 1 year clinically 
documented; COPD assessment test (CAT) ≥10; Current or former cigarette smokers with history of cigarette smoking≥10 years; Optimized inhaler therapy;  Adjunctive COPD therapies; Weight: BMI ≥ 16 kg/m2; Male or eligible Female;  Capable of giving informed consent.

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Exclusion criteria:  Asthma diagnosis; COPD stability; Lung resection; Pulmonary rehabilitation;  Oxygen; Cor Pulmonale; Chronic hypercapnia; Unstable cardiovascular disease or arrhythmia;  Vasculitis; Eosinophilic disease; Parasitic Infection;  Malignancy; . Immunodeficiency; Liver Disease;  Other concurrent medical condition; Previous exposure; Previous failure or nonresponse to antiIL5/5R or anti IL-4R/IL-13 treatment; . Other mAbs; Investigational medications;  Oral corticosteroids; Previous randomization; Concurrent enrollment in another clinical trial;  12-lead ECG at Screening V1; . Hypersensitivity; Non-compliance; Questionable validity of consent; Drug or alcohol abuse; Affiliation with investigator site;  Liver Safety exclusion.

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GSK 221672 BEconneCTD-ILD CTD

A Phase 3, randomized, double-blind, placebocontrolled, parallel group study to evaluate the efficacy and safety of belimumab administered subcutaneously in adults with interstitial lung disease (ILD) associated with connective tissue disease (CTD).

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The treatment period 52 weeks.

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Follow-Up Period: 8 weeks after exit visit.

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Inclusion criteria: Participant is 18 years of age inclusive, or older at the time of signing the informed consent; Documented diagnosis of RA, SLE, IIM, pSS, mCTD; Diagnosis of ILD on HRCT with disease extent of ≥10% of the whole lung (WL-ILD), as confirmed by central reader at screening; Evidence of ILD progression in the previous 24 months; Participant is capable and willing to self-administer the study medication.

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Exclusion criteria: Participants will be excluded if they have ILD other than CTD-ILD, systemic sclerosis, rapidly progressive disease, severe pulmonary impairment, significant pulmonary or systemic comorbidities, active or recent serious infections, tuberculosis, recent malignancy, major surgery, severe allergies or hypersensitivity reactions, neurological disorders such as PML, or significant psychiatric conditions including depression or suicide risk.

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GSK 223977 VENTO Bronchiectasis Phase II

 A Phase 2 randomized, double-blind, placebo-controlled study to investigate efficacy, safety, immunogenicity, and pharmacokinetics, of GSK3862995B in participants with bronchiectasis” (“Study”) 

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The treatment period: 48 weeks.

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Inclusion criteria: Participants must be adults 18–85 years of age with a diagnosis of bronchiectasis confirmed by chest CT, a BMI between 18 and 35 kg/m², current sputum production, and adequate lung function (FEV₁ ≥30% predicted). Participants must also have a history of pulmonary exacerbations or uncontrolled respiratory symptoms and be able to provide informed consent.

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Exclusion criteria: Participants may not have a primary diagnosis of asthma or COPD or certain causes of bronchiectasis, including cystic fibrosis. Individuals with active respiratory infections, tuberculosis, or certain fungal or nontuberculous mycobacterial (NTM) infections, as well as those with a recent pulmonary exacerbation or acute respiratory infection, may be excluded. Other exclusions include certain uncontrolled medical conditions or significant heart, liver, or immune disorders, long-term oxygen therapy for more than 12 hours per day, and other conditions or treatments that may affect participant safety or study results.

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Novo Nordisk NN9490-8293 AMAZE 4

AMAZE 4 is a randomised, double blinded, placebo-controlled, phase 3a study designed to investigate the potential benefits of zenagamtide in promoting significant weight loss and improvement of obstructive sleep apnoea (OSA).​

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Treatment period: 80-weeks.

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Follow-up period: 4-weeks.

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Inclusion criteria: individuals with obesity (BMI ≥27 kg/m²); Age 18 years or above at the time of signing the informed consent; Participant must have a desire and be committed to lose at least 25% of their body weight; Previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with polysomnography (PSG), home sleep apnoea test (HSAT), or other method that meets local guidelines prior to screening; The baseline PSG must indicate an AHI value ≥ 15 events/hour for confirming eligibility into the study; Currently using positive airway pressure for at least 3 consecutive months prior to screening and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits.​

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Exclusion criteria: Glycated haemoglobin (HbA1c) ≥ 6.5 % (48 mmol/mol) as measured by the central laboratory at screening; History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records; Any planned or previous surgery within 90 days prior to screening for sleep apnoea, including septoplasty, turbinoplasty, or other ear, nose, and throat surgeries, including tonsillectomy and adenoidectomy; Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence; Treatment with GLP-1 RAs, dual GLP-1/GIP RAs (or any other GLP-1 based treatment) or amylin analogues within 1 year before screening.

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Insmed INS1009-311 Pulmonary Hypertension PH-ILD

Phase 2, double-blind, placebo-controlled trial.

Objective: To evaluate the safety and tolerability of TPIP in patients with PH-ILD over 16 weeks.

The treatment period: 16 weeks.

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Follow-Up period: 4 weeks after exit visit.

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Inclusion criteria: Adults with WHO Group 3 pulmonary hypertension associated with fibrotic ILD confirmed by CT scan and right heart catheterization, including conditions such as IIP, chronic HSP, CTD-ILD, or CPFE. Participants must meet defined hemodynamic and exercise capacity criteria, have stable background treatment for ILD and/or PH prior to screening, and, for CTD-ILD patients, have FVC <70% predicted. Participants must also be able to provide informed consent, comply with study requirements, and use appropriate contraception when applicable.

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Exclusion criteria: Participants will be excluded if they have pulmonary hypertension groups other than PH-ILD, COPD, predominant emphysema, significant left heart disease, severe hepatic dysfunction, HIV, chronic thromboembolic disease, recent pulmonary embolism, active respiratory infection, recent ILD exacerbation, severe concomitant illness, recent malignancy, substance abuse, or current tobacco, e-cigarette, or inhaled marijuana use. Additional exclusions include recent use of investigational therapies or PAH-approved medications (except PDE5 inhibitors), high oxygen requirements, abnormal coagulation or blood pressure findings, physical limitations affecting the 6MWT or inhaler use, hypersensitivity to study drugs, organ transplantation, pregnancy or breastfeeding, and any condition that may interfere with study participation or interpretation of results.​​

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Insmed INS1009-312 Pulmonary Hypertension PH-ILD (EXTENSION)

A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease.

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Participants who complete treatment in the Phase 3 lead-in study INS1009-311 may enroll in this Open-Label Extension (OLE) study to evaluate the long-term safety and efficacy of TPIP in participants with PH-ILD.

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Most Enrollment assessments may utilize the Week 24 assessments from the lead-in study. These assessments will only need to be repeated if:

• More than 14 days have elapsed since the Week 24 End-of-Treatment (EOT) visit, or

• The assessment was not performed during the Week 24 visit.

If the OLE Enrollment visit occurs within 14 days of the Week 24 (EOT) visit from the lead-in study, the Week 24 assessments will serve as the Enrollment assessments for the OLE study.

The first dose of the OLE study drug may be administered as early as the day following the Week 24 visit, since the final dose of the lead-in study treatment is administered at Week 24 to support post-dose assessments.

CSL Behring CSL787_2001 Site #84000652

A Phase 2b, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Range Finding Study to Evaluate the Efficacy, Safety, and Tolerability of Nebulized CSL787 in Adults (18 to 85 years) with Non-cystic Fibrosis Bronchiectasis.​

Kinaset Asthma Frevencitinib Phase II Site #SN0120267 / KN2147

A Phase 2 Randomized Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Three Doses of Frevecitinib (KN-002) in Patients with Severe Asthma not Adequately Controlled with Medium to High Dose ICS/LABA Therapy (PANAIRAMA)

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