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

NCT07577804 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CLI-10196AA1-022026-525467-41-00
• Study Type: interventional
• Target: 1,808
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 symptoms. The main goal is to see whether CHF10196 can reduce the number of lung flareups each year compared with placebo. The study will also assess whether it can improve lung function, quality of life, and overall safety. The study has two phases. In the first phase, participants receive either CHF10196 tablets or placebo without knowing which one they are taking. In the second phase, all participants receive CHF10196 so its long-term safety can be further studied. Adults aged 18 to 85 years and adolescents aged 12 to under 18 years can take part, while continuing their usual stable bronchiectasis treatment. Up to about 2.5 years of participation are planned. Around 900 participants will be enrolled, with regular clinic visits and phone check ins. In the first phase, participants take either CHF10196 or inactive tablets once daily; in the second phase, everyone takes CHF10196 once daily. Temporary treatment interruptions are allowed if needed, and participants who stop treatment early may still continue study visits, depending on the study phase.

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• The annualised rate of adjudicated pulmonary exacerbations

  Up to 78 weeks

Secondary Outcomes (11)

• Time to first adjudicated pulmonary exacerbation

  Up to 78 weeks

• Change from baseline in SGRQ (Saint George Respiratory Questionnaire) total score

  Week 52

• Change from baseline in post-bronchodilator in FEV1 (forced expiratory volume in the first second)

  Week 52

• Change from baseline in post-bronchodilator in FVC (forced vital capacity)

  Week 52

• Annualised rate of severe adjudicated pulmonary exacerbations

  Up to 78 weeks

Study Arms (2)

Main Part and Extension Part of the Study: CHF10196 tablets (florensocatib)

EXPERIMENTAL

Drug: CHF10196 tablets (florensocatib)

Main Part of the Study: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CHF10196 tablets (florensocatib) DRUG

40mg tablets taken once daily.

Main Part and Extension Part of the Study: CHF10196 tablets (florensocatib)

Placebo DRUG

Tablets taken once daily.

Main Part of the Study: Placebo

Eligibility Criteria

• Age: 12 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent obtained prior to any study-related procedure; Adolescents: Written informed consent obtained from the parent(s)/legally authorised representative(s) (according to the local regulation) and written or verbal assent by the participant (when appropriate), obtained prior to any study-related procedures;
• Adults: Male or female participant ≥18 and ≤85 years of age; Adolescents: Male or female participant ≥12 and \<18 years of age;
• Adults: BMI (body mass index) \>18.5 kg/m² at screening; Adolescents: Body weight \>30 kg at screening;
• Clinical history consistent with bronchiectasis (cough, chronic sputum production, and/or recurrent respiratory infections) confirmed by centralised reading of a chest CT, not more than 5 years old demonstrating bronchiectasis affecting 1 or more lobes; Note: If no recent chest CT is available, or if the records/report is not available, a new CT chest will be performed during the screening period;
• A history of at least 2 pulmonary exacerbations treated with antibiotics, or 1 pulmonary exacerbation treated with antibiotics with additional risk factors (SGRQ Symptoms score at screening \>40) in the past 12 months prior to screening; Adolescents: A history of at least 1 pulmonary exacerbation in the 12 months prior to screening;
• Post-bronchodilator FEV1 ≥30% of the predicted value, calculated using the Global Lung Function Initiative 2012 reference equations; Note: in case post-bronchodilator spirometry quality is not judged satisfactory as per ATS/ERS acceptability and usability criteria\*, it may be re-checked on the same day (after a sufficient period of rest) or once before randomisation if it cannot be performed on the same day;
• Participants may either be:
• on stable background therapy for at least 3 months prior to screening;
• not on background therapy at screening and not planning to start background therapy;
• Able to provide sputum at screening (adults only);
• Cooperative attitude and ability to read/write, perform all study-related procedures, and use electronic device, ability to understand the risks involved;
• If female, the participant must be of non-childbearing potential, surgically sterile, postmenopausal, or she and her partner must use adequate methods of contraception\*\* during the study and for 90 days after the last dose of study intervention. Participants must not donate eggs during the study and for 90 days after the last dose of IMP (investigational medicinal product); Note: In case of hormonal contraception, an additional non-hormonal method (barrier method, preferably male condom) is required. The status of adolescent females being not of childbearing potential at screening will be monitored at each further visit (except the Follow-up visit);
• If male, the participant and his partner must agree to use adequate methods of contraception\*\* during the study and for at least 90 days after the last dose of study intervention.
• Participant's written informed consent for the OLE Phase obtained prior to any study-related procedures of the OLE Phase; Adolescents: Written informed consent for the OLE Phase obtained from the parent(s)/legal representative(s) (according to the local regulation) and written or verbal assent by the participant (when appropriate), obtained prior to any study-related procedures of the OLE Phase;
• Participants (adults or adolescents) who completed the treatment period of the Main Phase

You may not qualify if:

• Participants who have experienced any degree of pulmonary exacerbation or are experiencing a pulmonary exacerbation within 4 weeks prior to screening or during the screening period; Note: Participants can be rescreened only after recovery and 4 weeks after the last dose of antibiotic treatment;
• Current diagnosis of CF (cystic fibrosis) as determined by Investigator;
• Known history of invasive opportunistic infections (such as but not limited to histoplasmosis, pneumocystosis, or aspergillosis) and/or abnormally frequent or prolonged infections suggesting an immunocompromised status judged incompatible with the introduction of a DPP1 inhibitor by the Investigator;
• Diagnosis of A1ATD -Alpha-1-antitrypsin deficiency- (defined as A1AT serum level \<110 mg/dL) currently being treated with augmentation therapy; Note: A prior test result of A1AT serum level to confirm the diagnosis will be acceptable;
• Participants with a diagnosis of non-tuberculosis mycobacteria, pulmonary infection or TB (tuberculosis), or allergic bronchopulmonary aspergillosis currently being treated or requiring treatment as determined by the Investigator;
• Participants receiving a systemic immunosuppressive therapy for the treatment of an autoimmune disease;
• History of malignancy in the past 5 years (excluding cured basal cell carcinoma of the skin, carcinoma in situ and papillary thyroid carcinoma) or treatment of malignancy in the past 5 years;
• Have significant haemoptysis (≥300 mL or requiring blood transfusion) within 4 weeks prior to screening or during the screening period;
• Participants with a severe concomitant disease or disorder that, in the opinion of the Investigator, may put the participant at risk by participating in the study, or interfere with the participant's treatment, assessment, or influence the results of the study, or have compliance issues with the study. Examples include, but are not limited to, cardiovascular conditions (e.g. NYHA Class III or IV cardiac failure), pulmonary conditions (e.g. severe pulmonary fibrosis or lung transplantation), infectious diseases (e.g. severe COVID-19 infection), gastrointestinal conditions, hepatobiliary conditions (e.g. Child-Pugh class B or C), severe renal conditions (e.g. severe nephrotic syndrome), neurological conditions (e.g. demyelinating diseases), musculoskeletal, endocrine, metabolic or psychiatric conditions;
• Have elevated liver function test results (ALT or AST \>2x ULN) or have a bilirubin \>1.5x ULN at screening (isolated bilirubin \>1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%);
• Have an abnormal renal function test result (eGFR \<60 mL/min by CKD-EPI formula for adults or CKiD-U25 formula for adolescents) at screening
• Participants with an absolute blood neutrophil count \<1000/ mm3 at screening;
• Participants with a history of alcohol or drug abuse within 6 months prior to screening as per DSM V criteria;
• Clinically significant abnormal laboratory values at screening that, in the opinion of the Investigator, may put the participant at risk by participating in the study, or interfere with the participant's treatment or assessment, or influence the results of the study;
• Blood donation or blood loss (≥450 mL) less than 2 months prior to screening;

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Pablo Iveli

  Chiesi Farmaceutici S.p.A.

  STUDY DIRECTOR

Central Study Contacts

Chiesi Clinical Trial info

CONTACT

+ 39 0521 2791; clinicaltrials_info@chiesi.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 11, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share