Actively Recruiting
A Study to Test the Safety and Effects of Inhaled GDC-6988 in Participants With Muco-obstructive Disease
Led by Genentech, Inc. · Updated on 2026-05-05
128
Participants Needed
7
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in participants with muco-obstructive disease.
CONDITIONS
Official Title
A Study to Test the Safety and Effects of Inhaled GDC-6988 in Participants With Muco-obstructive Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Percent predicted FEV1 ≥ 40% by spirometry during screening
- Ability to demonstrate correct use of the smart DPI at screening, in the investigator's judgment
- On a stable treatment regimen for muco-obstructive diseases for ≥ 28 days prior to initiation of study treatment and willingness to remain on the stable treatment regimen through completion of study
- Stable disease for ≥ 28 days prior to screening and through to initiation of study treatment
- Chronic sputum production of ≥1 teaspoon per day as reported in the sputum volume item (Part B participants)
- Ability to produce a sputum sample suitable for central laboratory biomarker research (Part B participants)
- Availability of a representative blood sample for biomarker research (Part B participants)
- Diagnosis of bronchiectasis involving at least 2 lobes with one lobe in the right lung (NCFB participants)
- COPD defined as post-bronchodilator FEV1/FVC ratio of <0.7 (COPD participants)
- Chronic bronchitis with cough and sputum for more than 3 months per year for at least 2 years (COPD participants)
- Former smoker with minimum 10 pack-year history or non-smoker with documented COPD risk factor (COPD participants)
You will not qualify if you...
- Pregnant or breastfeeding, or planning pregnancy during study or contraception period
- Known significant bronchodilator response >10% predicted change in FEV1 or FVC
- Use of any prohibited medications
- Acute respiratory infection within 28 days of screening
- Significant hemoptysis >60 mL within 3 months prior to screening
- Known clinically significant immunodeficiency
- Known substance abuse within 12 months prior to screening
- Poor peripheral venous access
- Receipt of blood products within 120 days prior to screening
- Any medical condition or abnormal lab finding precluding safe participation or affecting results
- History of thoracic or metastatic malignancy within 5 years prior to screening
- Clinically significant abnormal ECG or QTcF >450 ms (males) or >470 ms (females)
- More than 2 chest CTs or lung radiation exposures >100 mSv within 12 months prior to screening (Part B participants)
- Bronchiectasis due to cystic fibrosis, primary ciliary dyskinesia, non-tuberculous mycobacterial infection, chronic aspiration, or traction bronchiectasis due to interstitial lung disease (NCFB participants)
- Diagnosis of asthma as primary respiratory disease (NCFB participants)
- NCFB exacerbation within 28 days prior to screening or not returned to baseline
- Current smoker defined as any inhaled tobacco or marijuana use within 3 months prior to screening (NCFB participants)
- Diagnosis of COPD as primary respiratory disease (NCFB Cohort 3)
- COPD exacerbation within 28 days prior to screening or not returned to baseline (COPD participants)
- Asthma/COPD overlap syndrome (COPD participants)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Accel Research Site - Achieve - Birmingham - ERN - PPDS
Vestavia Hills, Alabama, United States, 35216-1927
Withdrawn
3
Stanford Center for Excellence in Pulmonary Biology
Palo Alto, California, United States, 94304
Actively Recruiting
4
University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd
Kansas City, Kansas, United States, 66160 8500
Actively Recruiting
5
University of North Carolina Clinical Research Center
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
6
UNC Investigational Drug Services
Morrisville, North Carolina, United States, 27560
Actively Recruiting
7
TTS Research
Boerne, Texas, United States, 78006
Completed
Research Team
R
Reference Study ID Number: GB45429 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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