Clinical trials: sponsored by Chiesi Farmaceutici S.p.A.
Familial Partial Lipodystrophy
Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
This Phase 3 study is an Open Label Extension of the APG-20 Study To Evaluate the Long-term Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects with Partial Lipodystrophy
- Trial name
- NCT06679270
- Testing
- Metreleptin
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Efficacy and Safety of CHF 5993 100/6/12.5 μg HFA-152a pMDI in Patients With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists
This is a study comparing CHF 5993 pMDI HFA-152a with CHF 1535 pMDI HFA-134a in Chinese patients with asthma uncontrolled on medium doses of ICS+LABA.
- Trial name
- TRICHECO (NCT07546981)
- Testing
- Experimental: Participant Group CHF 5993 pMDI HFA-152a, Active Comparator: CHF 1535 100/6 μg pMDI HFA-134a
- Where
- 2 sites in China
- Volunteers
- 554 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Healthy Volunteers
A Study to Compare How CHF10196 (Florensocatib) is Absorbed Into the Blood When Given Alone and With a Drug That Reduces Stomach Acid in Healthy Male Participants
This Phase 1 study evaluates the effect of pantoprazole (a proton pump inhibitor) on the pharmacokinetics (PK) of CHF10196 (Florensocatib) in healthy male participants.
- Trial name
- NCT07683793
- Testing
- CHF10196, Pantoprazole
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA
Evaluate the superiority of CHF 5993 100/6/12.5 µg Pressurised Metered Dose Inhaler (pMDI) (fixed combination of extrafine beclometasone dipropionate (BDP) plus formoterol fumarate (FF) plus glycopyrronium bromide [GB]) versus…
- Trial name
- TRIMARAN (NCT02676076)
- Testing
- CHF 5993 100/6/12.5, CHF 1535 100/6 µg
- Where
- Germany
- Volunteers
- 1,155 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)
Evaluate the superiority of CHF 5993 200/6/12.5 µg pressurised metered dose inhaler (pMDI) (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) versus CHF 1535 200/6 µg…
- Trial name
- TRIGGER (NCT02676089)
- Testing
- CHF 5993 200/6/12.5 µg, CHF 1535 200/6 µg, CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg
- Where
- 244 sites in Argentina, Belarus and 15 more
- Volunteers
- 1,437 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma
This study will compare an asthma inhaler that uses a new climate friendly alternative propellant to an asthma inhaler with an existing propellant.
- Trial name
- TRECONY (NCT07301736)
- Testing
- CHF5993 pMDI with HFA-152a, CHF5993 pMDI with HFA-134a, CHF718 pMDI with HFA-134a
- Where
- 167 sites in Argentina, Bosnia and Herzegovina and 12 more
- Volunteers
- 780 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Bronchiectasis
A Study to Evaluate the Efficacy and Safety of CHF10196 Tablets (Florensocatib) Compared With Placebo in Male and Female Participants 12 to 85 Years of Age With Bronchiectasis
This study aims to find out whether the tablet CHF10196 is safe and effective for people with non-cystic fibrosis bronchiectasis, a long-term lung disease that causes widened airways, mucus buildup, infections, and flare ups of…
- Trial name
- FABLE (NCT07577804)
- Testing
- CHF10196 tablets (florensocatib)
- Volunteers
- 904 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Partial Lipodystrophy
Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL
This is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy.
- Trial name
- METRE-PL (NCT05164341)
- Testing
- metreleptin
- Where
- 31 sites in United States, Belgium and 7 more
- Volunteers
- 69 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Fabry Disease
Open Label Extension of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Every 4 Weeks in Adult Fabry Disease Patients
The objective of CLI-06657AA1-03 (formerly PB-102-F51) is to evaluate the long-term safety, tolerability, and efficacy of 2 mg/kg pegunigalsidase alfa administered intravenously every four weeks in adult Fabry patients who have…
- Trial name
- NCT03614234
- Testing
- pegunigalsidase alfa
- Where
- 14 sites in United States, Belgium and 5 more
- Volunteers
- 29 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient (FORSYYN)
Primary Objective To demonstrate that CHF 1535 pMDI is non-inferior to Symbicort® Turbohaler® in terms of pulmonary function (change from baseline in pre-dose morning FEV1 at Week 24) in patients with COPD.
- Trial name
- FORSYYN (NCT03888131)
- Where
- 53 sites in China
- Volunteers
- 750 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Study on Foster Efficacy Maintenance and Reliever vs Foster Maintenance + Salbutamol Reliever in Asthmatics (MART2)
Primary objective: The primary objective of the study was to compare the efficacy of Maintenance and Reliever Therapy (MART) with Foster® 100/6 μg (one inhalation bid) plus additional inhalations as needed, with the standard…
- Trial name
- NCT00861926
- Testing
- Salbutamol, Beclomethasone dipropionate + Formoterol
- Where
- 206 sites in Bulgaria, Croatia and 12 more
- Volunteers
- 1,714 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Efficacy of LAMA Added to ICS in Treatment of Asthma (ELITRA)
Primary objective The primary objective was to evaluate the superiority of CHF 5259 (glycopyrronium bromide [GB]) in a pressurised metered dose inhaler (pMDI) (50 μg total daily dose) versus placebo in terms of forced expiratory…
- Trial name
- ELITRA (NCT02296411)
- Testing
- CHF 5259 12.5 µg + Qvar
- Where
- 28 sites in Bulgaria, Germany and 3 more
- Volunteers
- 98 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Triple in Asthma Dose Finding
Primary objective The primary objective was to evaluate the efficacy of a free combination of CHF 5259 at 3 dose levels plus Foster® 100/6 μg in a pMDI by comparison with Foster® 100/6 μg in terms of forced expiratory volume in…
- Trial name
- Triskel (NCT02127866)
- Testing
- CHF 5259 plus Foster 100/6 µg, Foster 100/6 µg (four puffs BID)
- Where
- 44 sites in Bulgaria, Germany and 4 more
- Volunteers
- 211 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
Functional Respiratory Imaging Study (DARWiIN)
The objective of this clinical study was to evaluate the tolerability, safety, and efficacy of stepping up from fluticasone propionate (FP)/salmeterol (SLM) dry-powder inhaler (DPI) (SERETIDE™ DISKUS™) to extrafine beclometasone…
- Trial name
- DARWiIN (NCT04876677)
- Testing
- Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium (BDP/FF/GB)
- Where
- 8 sites in Belgium, Hungary
- Volunteers
- 25 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Study in Adult Patients With Moderate to Severe Asthma
This study assessed the influence of pink vs. white pressurized metered-dose inhaler (pMDI) actuators on asthma symptoms perception. There was no prespecified primary objective.
- Trial name
- FEEL (NCT04886999)
- Testing
- Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A), Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B)
- Where
- 10 sites in Italy
- Volunteers
- 78 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Fabry Disease
Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease
The objective of CLI-06657AA1-04 (formerly PB-102-F60) was to evaluate the long-term safety, tolerability, and efficacy parameters of 1 mg/kg pegunigalsidase alfa administered intravenously every other week in adult Fabry…
- Trial name
- NCT03566017
- Testing
- pegunigalsidase alfa
- Where
- 30 sites in United States, Australia and 11 more
- Volunteers
- 97 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients
Primary objective To show the superiority of CHF 1535 (BDP/FF) pMDI (800/24 μg per day) over BDP HFA pMDI (800 μg per day) in terms of change from baseline to the entire treatment period in average pre-dose morning peak…
- Trial name
- FORCE (NCT01577082)
- Testing
- CHF1535 200/6 µg pMDI, BDP HFA 100 µg pMDI
- Where
- 66 sites in Bulgaria, Czechia and 7 more
- Volunteers
- 542 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Fabry Disease, Pregnancy
Maternal and Postnatal Outcomes Study (MOS): A Global Observational Registry Assessing the Safety of Elfabrio® in Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding
The goal of this observational registry is to evaluate the safety and outcomes of pregnancy and lactation in women with Fabry disease who are exposed to pegunigalsidase alfa within 30 days prior to conception and/or during…
- Conditions
- Fabry Disease, Pregnancy, Pregnancy Complications
- Trial name
- MOS (NCT06941025)
- Testing
- Not applicable- observational study
- Where
- 5 sites in United States, Germany and 3 more
- Volunteers
- 10 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Fabry Disease
Study to Evaluate the Safety, PK, PD, and Efficacy of PRX-102 in Japanese Patients With Fabry Disease
The aim of this study is to evaluate the safety and efficacy of pegunigalsidase alfa in Japanese patients (adults and adolescents) affected by Fabry disease.
- Trial name
- RISE (NCT05710692)
- Testing
- PRX-102 1 mg/kg every 2 weeks, PRX-102 2 mg/kg every 4 weeks
- Where
- 10 sites in Japan
- Volunteers
- 16 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Bronchiectasis
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled CHF6333 After Single Doses in Healthy Volunteers and After Single and Repeated Doses in Subjects With Bronchiectasis
The aim of this clinical trial is to assess the safety of: single doses of the study drug CHF6333 in Healthy Volunteers (HVs) and in subjects with Bronchiectasis (BE) - Part I repeated doses of the study drug CHF6333 in subjects…
- Trial name
- NCT06166056
- Testing
- CHF6333
- Where
- 9 sites in United Kingdom
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.