ADX-629 for Chronic Cough

No longer recruiting at 14 trial locations
BC
Overseen ByBILL CAVANAGH
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of a new oral treatment called ADX-629 for individuals with chronic cough. Chronic cough is a persistent cough that persists without explanation by other lung issues. Participants will receive either ADX-629 tablets or a placebo (a pill with no active medication) twice daily for 14 days. This trial may suit adults with a stubborn chronic cough not explained by other conditions and who do not smoke. Participants must stop using cough medicines during the trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial requires you to stop taking antitussive medications (cough suppressants) for the duration of the study. If you are currently taking an ACE inhibitor, you must have stopped it at least 3 months before the screening.

Is there any evidence suggesting that ADX-629 is likely to be safe for humans?

Research has shown that ADX-629 is generally safe for people. In earlier studies, neither ADX-629 nor a placebo (a harmless pill with no active drug) raised major safety concerns. People taking ADX-629 did not experience more side effects than those taking the placebo. Another study suggested that ADX-629 might help reduce certain types of inflammation, offering protective benefits. Overall, the evidence so far indicates that ADX-629 is safe to use, with no major negative effects reported.12345

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

Unlike standard treatments for chronic cough, which often include cough suppressants and antihistamines, ADX-629 is unique because it targets the underlying inflammation that can cause persistent coughing. This treatment works by modulating the immune response, potentially reducing inflammation more effectively than current options. Researchers are excited about ADX-629 because it could offer faster relief and address the root cause of chronic cough, providing a new avenue for patients who haven't found success with existing treatments.

What evidence suggests that ADX-629 might be an effective treatment for chronic cough?

Research has shown that ADX-629, a type of medication, has potential in treating various conditions by reducing inflammation. Studies found that ADX-629 significantly improved liver function in patients with liver issues. By lowering certain levels in the body, ADX-629 may help reduce inflammation, a major problem in chronic cough. Although limited data exists specifically for chronic cough, the mechanism of ADX-629 suggests it could be effective. Early results from other trials indicate it might help conditions involving excessive inflammation. Participants in this trial will receive either ADX-629 or a placebo to further evaluate its effectiveness.26789

Are You a Good Fit for This Trial?

Inclusion Criteria

You have a history of an ongoing cough that hasn't gone away despite treatment or doesn't have an obvious cause.
Agree to discontinue antitussive medications for the trial duration
Historical Chest radiograph or CT scan that does not demonstrate any abnormality considered to be significantly contributing to chronic cough
See 1 more

Exclusion Criteria

You smoke or have a history of smoking heavily (more than 20 packs of cigarettes).
Recent history of drug or alcohol abuse or a positive urine drug test at screening
You had cancer in the past five years, except for certain types of non-invasive skin and cervical cancers that have been treated and have not come back.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive either ADX-629 or placebo orally twice a day for 14 days

2 weeks
Daily administration

Washout

A washout period between treatment periods to clear the drug from the system

2-4 weeks

Treatment Period 2

Participants crossover to receive the alternate treatment (ADX-629 or placebo) for 14 days

2 weeks
Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ADX-629
  • Placebo
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ADX-629Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aldeyra Therapeutics, Inc.

Lead Sponsor

Trials
34
Recruited
4,700+

Citations

Aldeyra Therapeutics Announces Positive Results from ...Relative to Baseline, Signal-Finding Molecule ADX‑629 Demonstrated Statistically Significant Improvement in Liver Function in Patients with ...
Aldeyra reshuffles pipeline, culling asset despite Phase II ...The biotech announced the Phase II data showing that ADX-629, a signal-finding RASP modulator, significantly improved markers of hepatic ...
A Clinical Trial to Evaluate the Safety and Efficacy of ADX-629 in ...The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.
ADX-629 Therapy for Sjogren-Larsson SyndromeThis research study will determine whether orally administered ADX-629 is safe and has biochemical efficacy in participants with Sjögren-Larsson syndrome ...
Aldeyra Therapeutics Enrolls First Patient in Phase 2 Clinical ...By lowering RASP levels, ADX‑629 may diminish the inflammation associated with atopic dermatitis. ADX‑629 has previously demonstrated immune- ...
Aldeyra Therapeutics' Investigational RASP Modulator ADX ...Both ADX-629 and placebo were well tolerated, and no safety concerns were noted. Most assessments were statistically similar between treatment ...
A Clinical Trial to Evaluate the Safety and Efficacy of ADX ...A Clinical Trial to Evaluate the Safety and Efficacy of ADX-629 in in Subjects With Elevated Ethanol Levels ... Plan for Individual Participant Data (IPD). Plan ...
Aldeyra Therapeutics Advances Investigational Oral RASP ...The adaptive, multicenter, two-part Phase 2 clinical trial will evaluate the safety and efficacy of ADX‑629 over 12 weeks of treatment. Part ...
ADX-629, A Reactive Aldehyde Species (RASP) Inhibitor ...This clinical trial suggests that ADX-629 was well-tolerated and may provide a protective effect by reducing EOS infiltration.
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