RLS-0071 for COPD

Not currently recruiting at 5 trial locations
CW
Overseen ByClaire Whitaker
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: ReAlta Life Sciences, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests RLS-0071, a new peptide treatment, for individuals with moderate COPD flare-ups (sudden worsening of symptoms). The goal is to determine its safety and tolerability. Participants will receive either RLS-0071 or a placebo three times a day for up to five days. Ideal candidates are those hospitalized with COPD who have a history of heavy smoking (at least 10 pack-years) and are experiencing increased breathlessness or mucus production. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that RLS-0071 is likely to be safe for humans?

Researchers are investigating the safety and tolerability of RLS-0071 for treating adults with moderate COPD flare-ups. This new treatment aims to reduce inflammation, a major issue during COPD flare-ups. Although RLS-0071 is still under study, safety data from research on other conditions, such as a type of brain injury in newborns, have shown that the drug behaves predictably in the body. This helps researchers understand its potential effects and safety in humans. However, as this study is in the early stages for COPD, more data is needed to fully assess its safety.12345

Why do researchers think this study treatment might be promising?

Unlike the standard COPD treatments that primarily focus on bronchodilating effects or reducing inflammation, RLS-0071 offers a unique approach by targeting the underlying inflammatory pathways more directly and efficiently. This innovative action could potentially offer quicker relief, as it is administered three times daily for a short period of 3 to 5 days, contrasting with the longer treatment durations typically required by other medications. Researchers are excited about RLS-0071 because of its potential to significantly improve symptoms in a shorter time frame, which could enhance patient compliance and overall quality of life.

What evidence suggests that RLS-0071 might be an effective treatment for COPD?

Research has shown that RLS-0071, which participants in this trial may receive, is a promising treatment because it targets inflammation in two ways. It helps reduce inflammation caused by neutrophils, white blood cells that can worsen COPD symptoms. Other studies found that RLS-0071 was safe and well tolerated by patients. It effectively reduced lung inflammation in humans, suggesting it could help manage COPD flare-ups. These findings support its potential to improve lung function and quality of life for people with COPD.13678

Are You a Good Fit for This Trial?

This trial is for adults with moderate COPD flare-ups, who've smoked at least the equivalent of a pack a day for 10 years. They must have been diagnosed with COPD previously, shown by specific lung function tests within the last year and be hospitalized due to their current flare-up.

Inclusion Criteria

You have smoked the equivalent of 10 packs of cigarettes per year for at least one year.
I have COPD, confirmed by a lung function test in the last year.
I have been diagnosed with a severe COPD flare-up without any other known cause.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive RLS-0071 or placebo three times a day for at least 3 days and up to 5 days

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 days

What Are the Treatments Tested in This Trial?

Interventions

  • RLS-0071
Trial Overview The study is testing RLS-0071, a new peptide treatment for COPD exacerbations. Participants will either receive RLS-0071 or a placebo to assess the safety and how well it works in improving symptoms compared to not receiving the active drug.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RLS-0071Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

RLS-0071 is already approved in United States for the following indications:

🇺🇸
Approved in United States as RLS-0071 for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

ReAlta Life Sciences, Inc.

Lead Sponsor

Trials
6
Recruited
220+

Citations

Safety, PK and PD Relationships of RLS-0071 in Patients ...This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of adults with moderate exacerbations of COPD.
ReAlta begins enrolment in Phase II trial of AE-COPD ...ReAlta has enrolled the first subject in a Phase II trial of RLS-0071 for acute exacerbations of chronic obstructive pulmonary disease.
RLS-0071, A Novel Dual-targeting Anti-inflammatory Agent ...CONCLUSION: Overall, these results demonstrate that RLS-0071 met proof of mechanism in humans and can decrease neutrophil-mediated inflammation ...
RLS-0071, a novel anti-inflammatory agent, significantly ...This clinical trial demonstrated that RLS-0071 was safe and well tolerated and modulated neutrophil-mediated inflammation in humans after inhaled LPS challenge.
ReAlta Life Sciences Publishes Data Demonstrating RLS ...ReAlta Life Sciences Publishes Data Demonstrating RLS-0071 (pegtarazimod) Reduces Brain Inflammation in Preclinical Hypoxic Ischemic ...
News ReleaseData confirm elevated inflammatory biomarkers in newborns with Hypoxic Ischemic Encephalopathy (HIE) and demonstrate a predictable pharmacokinetic profile for ...
Safety, PK and PD Relationships of RLS-0071 in Patients ...This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of adults with moderate exacerbations of COPD.
Chronic Obstructive Pulmonary Disease With Acute ...NCT06175065. Safety, PK and PD Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease. RLS-0071. treatment, 2 ...
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