Clinical trials: open to volunteers, sponsored by Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)
The aim of this Post Authorisation Safety Study (PASS) is to assess the incidence of adverse cardiovascular and cerebrovascular events in COPD patients who are new to inhaled fixed triple therapy (dual bronchodilator plus…
- Trial name
- TRIBE (NCT05652439)
- Testing
- Observational retrospective data collection
- Where
- United Kingdom
- Volunteers
- 25,000 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Idiopathic Pulmonary Fibrosis
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Doses of Inhaled CHF10073 in Participants With Idiopathic Pulmonary Fibrosis
The objective of the study is to assess the safety and tolerability of repeated doses of CHF10073 and to characterise cough-related safety outcomes associated with CHF10073 administration.
- Trial name
- NCT07876284
- Testing
- CHF10073 low dose, CHF10073 high dose
- Volunteers
- 18 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Idiopathic Pulmonary Fibrosis
A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability at Week 24 of 2 doses of CHF10067 (zampilimab) in participants with idiopathic pulmonary fibrosis (IPF).
- Trial name
- ZAPPHIRE (NCT07516951)
- Testing
- CHF10067
- Where
- 19 sites in United States, North Macedonia and 2 more
- Volunteers
- 240 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma, Healthy Volunteers
Evaluation of Safety, Side Effects, and How the Drug, Inhaled CHF10136, Is Absorbed, Modified and Removed From the Body in Healthy Adults and Adults With Asthma
This study evaluates the safety and tolerability of CHF10136 administered by inhalation in healthy adults and adults with asthma.
- Trial name
- NCT07851623
- Testing
- CHF10136
- Where
- 3 sites in United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Safety and Efficacy Comparison Between CHF5993 100/6 12.5µg pMDI to Seretide Evohaler 125/25µg pMDI in Adolescent Subjects With Asthma
The CLI-05993AA5-06 study is an interventional study designed to investigate the safety and efficacy of a new experimental drug called CHF5993 pMDI compared to the currently approved Seretide 125 Evohaler pMDI in adolescent…
- Trial name
- TRIADES (NCT07858123)
- Testing
- CHF5993 100/6/12.5 μg pMDI HFA-152a, Seretide Evohaler
- Where
- 25 sites in Germany, Italy and 1 more
- Volunteers
- 700 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Epidermolysis Bullosa, Dystrophic, Epidermolysis Bullosa, Junctional
A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez
In patients with epidermolysis bullosa (EB), collagen does not form properly, so their skin is very fragile and blisters easily. Such patients are also at greatly increased risk of developing skin cancers.
- Trial name
- FOSteR (NCT06423573)
- Testing
- Filsuvez
- Where
- 12 sites in United States, France and 4 more
- Volunteers
- 170 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Healthy Volunteers
Evaluation of Safety, Side Effects and How the Drug CHF6467 Administered Via Intranasal Route is Absorbed, Modified and Removed in Healthy Subjects
A clinical trial to investigate the safety and tolerability of single and multiple intranasal (through the nose) dosing with the study drug CHF6467 in 68 healthy adult subjects.
- Trial name
- NCT07163182
- Testing
- CHF6467 Part 1 (SAD), CHF6467 Part 2 (MAD)
- Where
- Bulgaria
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Fabry Disease
A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents With Fabry Disease
A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents with Fabry Disease.
- Trial name
- FLY (NCT06328608)
- Testing
- PRX-102 1 mg/kg every two weeks
- Where
- 12 sites in United States, Austria and 4 more
- Volunteers
- 22 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Healthy Male Volunteers
A Study in Healthy Male Participants to Compare How CHF10196 Affects How the Body Absorbs and Processes Two Commonly Used Medicines: Dabigatran, a Blood Thinner, and Rosuvastatin, a Medicine Used to Lower Cholesterol
The purpose of this study is to assess the potential drug-drug interaction of CHF10196 (a dipeptidyl peptidase 1 inhibitor) and its metabolite on the pharmacokinetics of dabigatran (a P-glycoprotein substrate) and Rosuvastatin (a…
- Trial name
- NCT07744386
- Testing
- Dabigatran Etexilate, Rosuvastatin, CHF10196
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
BETRI-Prospective: Asthma Control in Single Inhaler ICS/LABA/LAMA (87/5/9 pMDI [BDP/FF/GB - 100/6/12.5 μg]) vs Single Inhaler ICS/LABA (200/6 pMDI [BDP/FF - 200/6 μg])
This study will evaluate the effect of triple ICS/LAMA/LABA therapy with a BDP/FF/GB 100/6/12.5 µg on asthma control outcomes relative to ICS/LABA therapy with BDP/FF 200/6 μg in a population with asthma poorly controlled.
- Trial name
- BETRI (NCT07666490)
- Testing
- Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (100/6/12.5 µg per actuation), Foster® 200/6 pMDI (BDP/FF-200/6 µg)
- Where
- Bulgaria
- Volunteers
- 644 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Generalised Lipodystrophy, Partial Lipodystrophy
MEASuRE: Metreleptin Effectiveness And Safety Registry
The study is a post-authorization, prospective, voluntary registry of patients treated with commercial metreleptin including, but not limited to, patients in the US and EEA.
- Trial name
- MEASuRE (NCT02325674)
- Testing
- Metreleptin
- Where
- 28 sites in United States, France and 3 more
- Volunteers
- 100 people
- Sponsor
- 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
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.
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.
Epidermolysis Bullosa, Junctional Epidermolysis Bullosa
A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa
The goal of this clinical trial is to learn if Oleogel-S10 gel works to treat skin wounds from two types of inherited epidermolysis bullosa (EB): junctional EB (JEB) or dystrophic EB (DEB) in the Japanese population.
- Conditions
- Epidermolysis Bullosa, Junctional Epidermolysis Bullosa, Epidermolysis Bullosa, Dystrophic, Epidermolysis Bullosa, Junctional
- Trial name
- REVIVE (NCT06917690)
- Testing
- Oleogel-S10
- Where
- 6 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Chiesi Farmaceutici S.p.A.