Study of effect of CSJ117 on symptoms, pharmacodynamics and safety in patients with COPD

Phase 2

• Conditions: Chronic Obstructive Pulmonary Disorder

• Registration Number: JPRN-jRCT2031210454
• Lead Sponsor: Yamada Hiroyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1.Male and female adult patients aged >= 40 years at screening visit
2. Able to perform acceptable and reproducible spirometry with post-bronchodilator FEV1/FVC < 0.7 and post-bronchodilator FEV1>= 25 and < 80% of predicted at Run-In 1 visit
3. CAT >=15 points prior to randomization
4. Patients with a documented physician-diagnosed history of COPD for at least 1 year prior to screening
5. Documented history of at least 2 moderate or 1 severe COPD exacerbations (for FEV1>= 50 and < 80%) OR least 1 moderate or severe COPD exacerbation (for FEV1>= 25 and < 50%) within 12 months prior to screening
6. Availability of HRCT (current or historic) before randomization
7. Current or ex-smokers who have a smoking history of at least 10 pack-years

Exclusion Criteria

1. Patients with a past or current documented medical history of asthma
2. Patients with a current or past medical history of conditions other than COPD or allergic rhinitis that could result in elevated circulating eosinophils levels (e.g., asthma, hypereosinophilic syndrome, Churg-Strauss Syndrome). Patients with known parasitic infestation within 6 months prior to screening are also excluded.
3. Patients with a clinical diagnosis of alpha-1 anti-trypsin deficiency
4. Patients with history of concomitant chronic or severe pulmonary disease (e.g., clinically significant bronchiectasis, lung fibrosis, sarcoidosis, interstitial lung disease, cystic fibrosis, pulmonary hypertension, neuromuscular pulmonary restrictive diseases, tuberculosis). Exception: Patients with concomitant mild or moderate pulmonary hypertension or bronchiectasis are permitted to participate
5. Patients on protocol prohibited concomitant medications
6. Use of other investigational drugs (approved or unapproved) within 30 days or 5 half-lives prior to screening, or until the expected pharmacodynamic effect has returned to baseline (e.g. biologics), whichever is longer; or longer if required by local regulations

Study & Design

• Study Type: Interventional
• Study Design: Not specified