GDC-6599 for Chronic Cough

No longer recruiting at 12 trial locations

Overseen By Reference Study ID Number: GA43590, https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Genentech, Inc.

Must be taking: ICS therapy

Must not be taking: ACE inhibitors, Opioids

Disqualifiers: Pregnancy, Hepatic impairment, Pneumonia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new treatment, GDC-6599, for individuals with a chronic cough that persists despite other treatments. Researchers compare GDC-6599 to a placebo (a harmless pill with no effect) to determine its impact on reducing coughing. The trial includes different groups, such as those with asthma-related coughs and those with chronic obstructive pulmonary disease (COPD) and chronic bronchitis. It may suit individuals who have experienced a persistent cough for over a year that disrupts daily life, even after trying other treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as ACE inhibitors, opioids, pregabalin, gabapentin, amitriptyline, nortriptyline, and cough suppressants, before and during the study. If you are on these medications, you will need to stop them for a specific period before joining the trial.

Is there any evidence suggesting that GDC-6599 is likely to be safe for humans?

Research has shown that GDC-6599 has been tested for safety in people with chronic cough. Although specific side effects are not detailed, the treatment is currently in the middle stage of clinical testing. This stage evaluates how well people tolerate the treatment and identifies any common side effects. Earlier stages typically confirm basic safety, suggesting that GDC-6599 has been deemed safe enough to proceed. However, as with any new treatment, risks remain, and side effects can vary among individuals. Researchers will closely monitor trial participants to manage any side effects that may occur. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic cough?

GDC-6599 is unique because it targets chronic cough by focusing on a potential underlying mechanism that isn't addressed by most current treatments. While standard options like antitussives and bronchodilators primarily aim to suppress cough reflex or dilate airways, GDC-6599 works differently, potentially targeting specific pathways involved in chronic cough conditions such as chronic bronchitis and asthma. Researchers are excited about GDC-6599 because it may offer a new approach for patients who don't respond well to existing therapies, providing quicker relief and improved quality of life.

What evidence suggests that this trial's treatments could be effective for chronic cough?

Studies have shown that GDC-6599 may reduce the frequency and severity of chronic cough. Early results suggest this treatment could benefit those whose coughs haven't improved with other treatments. Research indicates that GDC-6599 targets specific pathways in the body involved in causing coughs. In this trial, participants with various types of chronic cough, including those linked to asthma and chronic obstructive pulmonary disease (COPD), will receive either GDC-6599 or a placebo. Although data collection is ongoing, the mechanism of this treatment offers hope for addressing various types of chronic cough. These early results provide a promising start for this treatment. ^{1 3 4 6 7}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Genetech

Are You a Good Fit for This Trial?

Adults with chronic cough and a physician's diagnosis of asthma or COPD, who are not current smokers and have used bronchodilator medication for at least 12 weeks. They must not be pregnant, breastfeeding, or planning to become pregnant soon. Participants should not have had respiratory infections recently or been treated with certain medications like opioids for cough within the last two weeks.

Inclusion Criteria

Your lung function test shows that you can breathe out at least 60% of the air you're supposed to.

I have had colorectal cancer, asthma, COPD, or upper cervical cancer for over a year.

I have never smoked or quit smoking more than 6 months ago, with less than 20 pack-years of history.

Exclusion Criteria

I am not pregnant, breastfeeding, nor planning to become pregnant soon.

I haven't taken strong CYP3A affecting drugs in the last month.

Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive GDC-6599 or placebo for 14 days

2 weeks

3 visits (in-person)

Washout

A 14-day washout period between treatment periods

2 weeks

Treatment Period 2

Participants receive the alternate treatment (GDC-6599 or placebo) for 14 days

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GDC-6599
• GDC-6599-matching placebo

Trial Overview The trial is testing GDC-6599 against a placebo to see if it helps people with chronic cough. It's a Phase IIa study where patients will randomly receive either the drug or placebo in different periods without knowing which one they're taking (double-blind). The effects on coughing, safety, how the body processes the drug (pharmacokinetics), and its biological actions (pharmacodynamics) are being studied.

How Is the Trial Designed?

Group I: Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis Experimental Treatment 3 Interventions

Patients with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5.

Group II: Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease Experimental Treatment 3 Interventions

Patients with Chronic Obstructive Pulmonary Disease will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5.

Group III: Part A: Unexplained Chronic Cough Experimental Treatment 3 Interventions

Patients with Unexplained Chronic Cough will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5

Group IV: Part A: CRC Asthma non-atopic Experimental Treatment 3 Interventions

Patients with CRC non-atopic asthma will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5

Group V: Part A: CRC Asthma atopic Experimental Treatment 3 Interventions

Patients with CRC atopic asthma will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05660850

NCT05660850 | A Study To Evaluate The Efficacy, Safety ... A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough. ClinicalTrials.gov ID ...

2. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/respiratory-disorder/unexplained-chronic-cough/a-study-to-evaluate-the-efficacy--safety--pharmacokinet-62935.html

Clinical trial for CRC With Atopic Asthma, CRC With Chron... A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough · Respiratory Disorder.

3. withpower.com withpower.com/trial/phase-2-bronchitis-2023-c0618

GDC-6599 for Chronic Cough · Info for Participants This trial is testing a new drug called GDC-6599 to see if it can help people with chronic coughs that haven't been cured by other treatments.

4. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/a-phase-iia-study-to-evaluate-the-efficacy-and-safety-of-gdc-6599-in-patients-with-chronic-cough/

A Phase IIa study to evaluate the efficacy and safety of ... The purpose of this study is to compare the effects of GDC-6599 versus placebo on patients with chronic cough. Patients with refractory chronic cough (RCC) ...

5. rrlab.healthsci.mcmaster.ca rrlab.healthsci.mcmaster.ca/research/cough/

Chronic Cough & Bronchitis - Respiratory Research Lab This study is evaluating the effectiveness of GDC-6599 to reduce cough frequency and severity in patients with a diagnosis chronic cough. Cough: Refractory ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-the-efficacy-safety-pharmacokinetics-and-pharmacodynamic-effects-of-gdc6599

A Study To Evaluate The Efficacy, Safety, Pharmacokinetics ... A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough · Timeline.

7. sigma.larvol.com sigma.larvol.com/ott.php?e1=1031559&sourcepg=TZ

Online Trial Tracker RG6341 / Roche ; NCT05660850: A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough ...