PHASE Ib, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY OF SELNOFLAST IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Completed

• Conditions: COPD; lung disease; 10006436

• Registration Number: NL-OMON51550
• Lead Sponsor: F.Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

- Between 35 and 75 years of age (inclusive)
- Patients with a >= 12-month diagnosis of COPD
- Radiologic evidence of air trapping at screening based on chest HRCT
conducted per imaging acquisition protocol and reviewed by the imaging central
reader
- Extent of emphysema on HRCT at screening is < 25%
- GOLD 2020 Grade 2/3, characterized by a post-bronchodilator forced
expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio <= 0.70
and a post-bronchodilator FEV1 of >= 30% and =< 79% of predicted at screening
and with an exacerbation history >= 2 or >= 1 leading to hospitalization
within the last 12 months
- COPD assessment test (CAT) score >=10 and with a clinical diagnosis of
chronic bronchitis, characterized by cough and sputum production on most days
for a minimum of 3 months during the last year
- Participant must have a body mass index (BMI) between 18 and 35 kg/m^2
- Abnormal laboratory values: high sensitivity CRP (hs-CRP) >= 3 mg/L at
screening AND absolute neutrophil count >= 6.0 x 10 high 9 /L in whole blood
at screening
- Vital signs (body temperature, systolic and diastolic blood pressure, pulse
rate, and respiratory rate) will be assessed in the sitting position after the
subject has rested for at least 3 minute
- Unchanged standard regimen of care for >= 4 weeks prior to screening
- Ex-smokers with at least a 10-pack year smoking history or current smokers
with at least a 10 pack-year smoking history who smoke =< 1 pack-year on
average in the last 3 months as reported at screening
- Able to perform reliable, reproducible pulmonary function test maneuvers per
American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines
- Female participants: female participant is eligible to participate if she is
not pregnant, not breastfeeding, and at least one of the following conditions
applies: Women of non-childbearing potential or Women of childbearing
potential who Agree to remain abstinent or use at least acceptable
contraceptive methods during the treatment period and for at least 14 days
after the final dose of selnoflast/placebo
- Male participants: No contraception required for male participants

Exclusion Criteria

- Any condition or disease detected during the medical interview/physical
examination that would render the patient unsuitable for the study, place the
patient at undue risk, or interfere with the ability of the patient to complete
the study
- Known active or uncontrolled bacterial, viral, fungal, mycobacterial, or
other infection, excluding fungal infection of nail beds, including
participants exhibiting symptoms consistent with SARS-CoV-2 within 2 weeks
prior to screening
- Positive polymerase chain reaction (PCR) test for SARS-CoV-2 within 6 weeks
prior to Day 1
- Diagnosis of severe bronchiectasis in chart or history
- Patients with another concomitant pulmonary disease, including but not
exclusive of, interstitial pulmonary fibrosis, sarcoidosis, or other
granulomatous or infectious process
- Patients treated for active asthma within 2 years prior to the screening visit
- Any COPD exacerbation or upper or lower respiratory tract infection requiring
antibiotics, oral steroids, or hospitalization within 2 weeks prior to
screening, during the screening period, or during the run-in period
- Patients requiring long-term oxygen therapy for daytime hypoxemia
- Patients with a diagnosis of alpha-1 antitrypsin deficiency
- History of lung transplant or malignancy of any organ system (other than
localized basal cell carcinoma of the skin) within the past 5 years
- Any surgical or medical condition which might significantly alter the
absorption, distribution, metabolism, or excretion of drugs, or which may
jeopardize the subject in case of participation in the study
- History of clinically significant ECG abnormalities, or ECG abnormalities at
screening or baseline
- Known family history or known presence of long QT syndrome
- Patients with a history of acute coronary syndrome in 3 months prior to the
screening visit
- Patients with a history of coronary artery bypass surgery or other major
vascular surgery within 6 months prior to the screening visit
- Evidence of urinary obstruction or difficulty in voiding
- History of any clinically significant hepatic disease or cirrhosis
- Significant illness not resolved within 2 weeks prior to screening
- Use of systemic steroids, ICS, theophylline, and phosphodiesterase 4 (PDE4)
inhibitors within 4 weeks of screening
- Vaccines within 4 weeks prior to the first dose
- Current treatment with medications that are well known to prolong the QT
interval
- Donation or loss of 450 mL or more of blood within 8 weeks prior to initial
dosing, or longer if required by local regulation
- Plasma donation > 150 mL within 7 days prior to first dosing
- Use of other investigational drugs at the time of enrollment, or within 5
half-lives of enrollment, or within 30 days, whichever is longer; or longer if
required by local regulations
- History of hypersensitivity to the study drugs or to drugs of similar
chemical classes or excipients
- QTcF > 450 ms in male participants and > 470 ms in female participants
demonstrated by at least two ECGs > 30 minutes apart
- Liver function test abnormalities at screening. Re-testing during the
screening period is possible once. This laboratory assessment may be repeated
once during the screening period, if necessary
- Anemia (hemoglobin levels > 10.0 g/dL at screening). This laboratory
assess

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Incidence, severity, and causal relationship ofadverse events (AEs),<br /><br>incidence of serious AEs (SAEs) and AEs leading to treatment discontinuation<br /><br>- Incidence of abnormal laboratory findings<br /><br>- Incidence of abnormal vital signs and electrocardiogram (ECG) parameters</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Change in:<br /><br>o Pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)<br /><br>o Post-bronchodilator (post-BD) FEV1<br /><br>o Pre-BD FEV1 percentage of predicted<br /><br>o Post-BD FEV1 percentage of predicted<br /><br>o Pre-BD total lung capacity (TLC)<br /><br>o Pre-BD residual volume (RV)<br /><br>o Pre-BD functional residual capacity (FRC)<br /><br>o RV/TLC ratio<br /><br>o Pre-BD forced expiratory flow over the middle<br /><br>o one half of the FVC (FEF25-75)<br /><br>o Post-BD FEF25-75<br /><br><br /><br>Pharmacokinetic parameters of RO7486967 in blood by PK population analysis.</p><br>