Insmed Inc
INSMHealthcare|Biotechnology|USA
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Clinical Trials (52)
| Trial | Conditions | Phase | Status | Enrollment | Design | Drug |
|---|---|---|---|---|---|---|
| NCT07481981 A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | P3 | Recruiting | 344 | RCT, Double-blind | Treprostinil Palmitil Inhalation Powder, Placebo |
| NCT07179380 Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) | Pulmonary Hypertension, Interstitial Lung Disease | P3 | Recruiting | 344 | RCT, Double-blind | Treprostinil Palmitil Inhalation Powder, Placebo |
| NCT05649748 An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | P2P3 | Active | 91 | Open-label | Treprostinil Palmitil, Placebo |
| NCT07290062 A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | P1 | Recruiting | 23 | Open-label | — |
| NCT06817382 A Study to Investigate the Safety and Biodistribution of a Single Intrathecal (IT) Injection of INS1201 in Ambulatory Males With Duchenne Muscular Dystrophy (DMD) | Duchenne Muscular Dystrophy | P1 | Recruiting | 12 | Open-label | — |
| NCT06144996 Development of a Canadian Bronchiectasis and NTM Database | Bronchiectasis, Non-Tuberculous Mycobacterial Pneumonia | Recruiting | 2,000 | — | — | |
| NCT00368173 IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome | Growth Hormone Insensitivity Syndrome (GHIS), Laron Syndrome | P2P3 | Completed | — | Open-label | rhIGF-I/rhIGFBP-3 |
| NCT04677569 Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex | Mycobacterium Infections, Nontuberculous | P3 | Completed | 425 | RCT, Double-blind | ALIS, Azithromycin, Ethambutol, ELC (matching placebo for ALIS) |
| NCT04817332 STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19 | Covid19 | P3 | Completed | 406 | RCT, Double-blind | Brensocatib, Placebo |
| NCT07234032 An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) | Pulmonary Hypertension, Interstitial Lung Disease | P3 | Not Yet Recruiting | 344 | Open-label | Treprostinil Palmitil Inhalation Powder, Placebo |
| NCT01315691 Study to Evaluate Arikace™ in CF Patients With Chronic Infection Due to Pseudomonas Aeruginosa | Cystic Fibrosis | P3 | Withdrawn | — | RCT, Double-blind | Liposomal amikacin for inhalation, Placebo for liposomal amikacin for inhalation |
| NCT04594369 A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis | Non-Cystic Fibrosis Bronchiectasis | P3 | Completed | 1,767 | RCT, Double-blind | Brensocatib 10 mg, Brensocatib 25 mg, Placebo |
| NCT02344004 Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone | Mycobacterium Infections, Nontuberculous | P3 | Completed | 336 | RCT, Open-label | LAI (Liposomal Amikacin for Inhalation) 590 mg |
| NCT02628600 Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212 | NTM Lung Infection Due to MAC | P3 | Completed | 163 | Open-label | LAI 590 mg, Multi-drug regimen |
| NCT05649722 An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) | Pulmonary Hypertension, Interstitial Lung Disease | P2P3 | Completed | 31 | Open-label | Treprostinil Palmitil Inhalation Powder, Placebo |
| NCT04677543 Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex | Mycobacterium Infections, Nontuberculous | P3 | Completed | 99 | RCT, Double-blind | ALIS, Azithromycin, Ethambutol, ELC |
| NCT01315678 Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections | Pseudomonas Aeruginosa Infection | P3 | Completed | 302 | RCT, Open-label | Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer., Tobramycin inhalation solution using a PARI LC® Plus nebulizer. |
| NCT01316276 Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection | Cystic Fibrosis | P3 | Completed | 206 | Open-label | Liposomal amikacin for inhalation |
| NCT00351221 Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan Syndrome | Noonan Syndrome | P2 | Terminated | 24 | Open-label | rhIGF-1/rhIGFBP-3 |
| NCT06013241 A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) | Chronic Rhinosinusitis Without Nasal Polyps | P2 | Completed | 288 | RCT, Double-blind | Brensocatib, Placebo, Mometasone furoate nasal spray (MFNS) |
| NCT04791514 A Study of Treprostinil Palmitil Inhalation Powder (TPIP) In Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | P2 | Terminated | 1 | Open-label | Treprostinil Palmitil |
| NCT00577577 Safety and Efficacy Study of Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3) In Myotonic Dystrophy Type 1 | Myotonic Dystrophy Type 1 | P2 | Completed | 69 | RCT, Double-blind | rhIGF-I/rhIGFBP-3, placebo |
| NCT06685835 A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS) | Hidradenitis Suppurativa | P2 | Terminated | 214 | RCT, Double-blind | Brensocatib, Placebo |
| NCT05176951 A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease | Pulmonary Hypertension | P2 | Completed | 39 | RCT, Double-blind | Treprostinil Palmitil, Placebo |
| NCT03218917 Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis | Non-Cystic Fibrosis Bronchiectasis | P2 | Completed | 256 | RCT, Double-blind | Brensocatib 10 mg, Brensocatib 25 mg, Placebo |
| NCT00102531 Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung | Osteosarcoma Metastatic | P1P2 | Completed | 19 | Open-label | Cisplatin liposomal |
| NCT00678015 Pharmacokinetic and Efficacy Study of Nordihydroguaiaretic Acid (NDGA) in Non Metastatic Recurrent Prostate Cancer | Prostate Cancer | P2 | Terminated | 12 | Open-label | Nordihydroguaiaretic Acid (NDGA) |
| NCT00777296 Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™) | Cystic Fibrosis | P1P2 | Completed | 66 | RCT, Open-label | ARIKACE™, Placebo |
| NCT05147805 A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | P2 | Completed | 102 | RCT, Double-blind | Treprostinil Palmitil, Placebo |
| NCT05090904 A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis | Cystic Fibrosis | P2 | Completed | 29 | RCT, Double-blind | Brensocatib, Placebo |
| NCT03905642 Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase | Cystic Fibrosis | P2 | Completed | 49 | Open-label | Arikayce™ |
| NCT00775138 Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa. | Bronchiectasis | P2 | Completed | 64 | RCT, Double-blind | 280 mg Arikayce™, Matching Placebo for Cohort 1, 560 mg Arikayce™, Matching Placebo for Cohort 2 |
| NCT01315236 Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria | Mycobacterium Infections, Nontuberculous | P2 | Completed | 90 | RCT, Double-blind | Liposomal amikacin for inhalation (LAI), placebo |
| NCT00558844 Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa | Cystic Fibrosis | P1P2 | Completed | 41 | RCT, Double-blind | Arikayce™ 560 mg, Placebo for 560 mg, Arikayce™ 70 mg, Arikayce™ 140 mg, Placebo for 70 mg / 140 mg |
| NCT03038178 Liposomal Amikacin for Inhalation (LAI) in the Treatment of Mycobacterium Abscessus Lung Disease | Mycobacterium Infections, Nontuberculous, Mycobacteria, Atypical | P2 | Completed | 30 | Open-label | LAI plus multi-drug regimen |
| NCT06178783 A Study of the Palatability and Acceptability of Different Brensocatib Oral Liquid Formulations in Healthy Participants | Healthy Volunteers | P1 | Completed | 20 | RCT, Double-blind | Brensocatib |
| NCT07643155 A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic Impairment | Hepatic Impairment | P1 | Not Yet Recruiting | 30 | Open-label | Treprostinil Palmitil Inhalation Powder |
| NCT06238856 Single Dose Escalation Study of TR02 (Sustained Lipid Inhalation Technology [SLIT™] Amikacin) in Participants With Cystic Fibrosis (CF) Having Chronic Infections of Pseudomonas Aeruginosa | Cystic Fibrosis | P1 | Completed | 18 | RCT, Double-blind | SLIT™ Amikacin, Placebo |
| NCT05999942 A Study to Investigate Lung Deposition of Inhaled Amikacin-loaded Liposomes in Healthy Male Participants | Healthy Volunteers | P1 | Completed | 6 | Open-label | Liposomal Amikacin for Inhalation |
| NCT05965570 A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants | Healthy Volunteers | P1 | Completed | 22 | Open-label | Brensocatib, Clarithromycin |
| NCT05673603 A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal Impairment | Renal Impairment | P1 | Completed | 28 | Open-label | Brensocatib |
| NCT05652257 A Study of the Absorption, Metabolism, and Excretion of [14C]-Brensocatib Following a Single Oral Administration in Healthy Male Participants | Healthy Volunteers | P1 | Completed | 7 | Open-label | [14C]-brensocatib |
| NCT05355935 A Study to Investigate the Effects of Brensocatib on QT Interval in Healthy Participants | Healthy Volunteer | P1 | Completed | 48 | RCT, Double-blind | Brensocatib, Moxifloxacin, Placebo |
| NCT07102316 A Study to Assess the Relative Bioavailability After a Single Inhalation Administration of Treprostinil Palmitil Inhalation Powder (TPIP) Formulation 2 (F2) to TPIP Formulation 3 (F3) in Healthy Participants | Healthy Volunteers | P1 | Completed | 42 | RCT, Open-label | TPIP F2, TPIP F3 |
| NCT06091579 A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder (TPIP) in Healthy Participants | Healthy Volunteers | P1 | Completed | 42 | RCT, Double-blind | Treprostinil Palmitil Inhalation Powder, Placebo |
| NCT05927597 A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of INS1007 in Healthy Japanese and Caucasian Participants | Healthy Volunteers | P1 | Completed | 82 | RCT, Double-blind | INS1007, Placebo |
| NCT05826574 A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy Participants | Healthy Volunteers | P1 | Completed | 32 | Open-label | Brensocatib, Rifampin, Esomeprazole |
| NCT06344728 A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy Participants | Healthy Participants | P1 | Completed | 24 | RCT, Open-label | Brensocatib Oral Solution, Brensocatib Oral Tablet |
| NCT06193031 A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of C16TR for Inhalation With Tyvaso® Cohort in Healthy Participants | Healthy Volunteers | P1 | Completed | 24 | RCT, Double-blind | C16TR, Placebo, Tyvaso® |
| NCT05517525 A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Brensocatib in Participants With Normal Hepatic Function and Participants With Hepatic Impairment | Hepatic Impairment | P1 | Completed | 30 | Open-label | Brensocatib |
| NCT06939647 An Expanded Access Study to Assess Treprostinil Palmitil Inhalation Powder (TPIP) for Participants With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) | Pulmonary Arterial Hypertension, Pulmonary Hypertension, Interstitial Lung Disease | AVAILABLE | — | — | Treprostinil Palmitil | |
| NCT05344508 An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis | Non-Cystic Fibrosis Bronchiectasis | APPROVED_FOR_MARKETING | — | — | Brensocatib |