Now enrolling:
The ASPIRE IPF trial

A Phase 2b trial for people living with idiopathic pulmonary fibrosis (IPF) to learn more about how the new oral investigational drug, buloxibutid, affects lung function, safety, and quality of life.

About the ASPIRE IPF trial

ASPIRE IPF is a late-stage Phase 2b clinical trial to further evaluate the efficacy, safety and best dosages of buloxibutid in patients with idiopathic pulmonary fibrosis (IPF). The trial will evaluate the impact of the trial drug on patients’ ability to breathe, along with other important measures like safety and quality of life. Two different doses of the trial drug will be compared to placebo over a treatment period of one year. In the ASPIRE IPF trial, two of every three participants will take buloxibutid by mouth twice daily.

About the trial drug – buloxibutid

Buloxibutid is a new oral investigational medicine, designed to activate a natural repair system to reduce and resolve scar formation (fibrosis) in the lungs of people with IPF. As an investigational drug, it is not yet approved by any health authority.

The ASPIRE IPF trial follows earlier clinical trials in healthy volunteers as well as patients with IPF, including the Phase 2a AIR trial where buloxibutid was given for a 36-week period. Your doctor may inform you about the reported results from these trials.

Download the ASPIRE IPF trial summary

Who can join the ASPIRE IPF trial?

  • People 40 years or older diagnosed with IPF within the past 5 years
  • Treated with a stable dose of nintedanib (Ofev) or not currently receiving licensed IPF treatment
  • Able to meet other trial requirements explained by the study doctor during screening period

Could I participate?

What to expect

The ASPIRE IPF trial involves three stages: a screening period, a treatment period, and a follow-up after the last dose.

As a participant in the ASPIRE IPF trial, your involvement will include a series of eight scheduled visits to the clinic complemented with eight regular phone or video calls. This approach ensures close monitoring of your health and wellbeing as well as the efficacy and safety of the investigational drug throughout the trial period. The phone or video calls offer some flexibility and will be scheduled to complement the in-person clinic visits.

Participants will be randomly assigned to one of three groups; buloxibutid 50 mg, buloxibutid 100 mg, or a placebo (which looks identical to buloxibutid but contains no active medication), taken twice daily. Two of every three participants will take oral buloxibutid twice daily.

Screening

Up to

6

weeks

Treatment period (52 weeks)

Day

1

Week

4

Week

12

Week

24

Week

36

Week

52

Follow-up

2-4

weeks

Appointments with trial team

  • 8 in-person visits to the clinic for examinations, tests and questionnaires
  • 8 phone or video calls with trial team to monitor your health and wellbeing

Participation includes

  • Trial examinations, tests and treatments
  • Reasonable travel and meal expenses related to clinic visits
  • No cost to patients

Locations in the US

Click ‘Find trial locations’ to find your trial clinic among the many trial locations across the US

Why join the ASPIRE IPF trial?

Joining a clinical trial is an important, personal decision and there are many reasons to consider joining.

  • The possibility of receiving a new, potentially beneficial, treatment in a clinical trial before it is widely available
  • Regular medical evaluations and close monitoring by study doctors and nurses
  • Learn more about your disease and help researchers learn more about IPF, where treatment options are limited

Frequently Asked Questions

What is IPF?

Idiopathic pulmonary fibrosis (IPF) is a rare lung disease characterized by the scarring of lung tissue. The scarring happens around the tiny air sacs in the lungs called alveoli, where oxygen and carbon dioxide are exchanged, often making it difficult for patients to breathe. When the cause of disease is unknown, fibrosis may be termed ‘idiopathic’.

What is buloxibutid?

Buloxibutid is a new oral investigational medicine, designed to activate a natural repair system to reduce scar formation (fibrosis) in the lungs of people with IPF. As an investigational drug it is not approved by any health authority.

How will I know if the treatment is working for me?

You will undergo regular health evaluations, including lung function tests and quality of life assessments among other examinations and tests to assess the effectiveness and safety of the trial drug.

Once the trial is completed and analyses of assessments, examinations and tests have been done for all patients in the trial, the results will be made available to you as a participant.

Can I continue taking my current medicines during the trial?

Patients treated with a stable dose of nintedanib (Ofev) are able to join this trial and continue on treatment. Buloxibutid may affect blood levels of other drugs and therefore patients treated with certain medications (for example pirfenidone, also known as Esbriet) cannot participate in this trial. Your doctor will review your current medication list for further guidance.

Is there any cost to participate?

You will receive the trial drug (or placebo) as well as trial related examinations and tests at no cost. You will be reimbursed for reasonable travel and meal expenses related to attending the trial site clinic visits.

What is ‘informed consent’?

The purpose of the informed consent process is to give you the opportunity to be an informed participant in your healthcare decisions during a clinical trial. You should be aware of all details prior to participating, including what to expect at trial visits, how to take the trial drug, the potential risks and benefits of participation, among other things. Written information will be provided for your review, and you will be able to share this with your family and friends. You will also meet with your trial doctor and the study team to review all details and ask any questions you might have.

Once you agree to join the trial, you will be asked to sign an informed consent form to confirm that you freely agree to taking part in the trial. Even after signing the informed consent form, you are free to leave the trial at any time and for any reason.

Are there any risks with participating?

Regardless of treatment group, your IPF symptoms or condition may not improve or get worse during the trial period. As with any investigational drug, side effects, including those not yet known, may occur. Your safety will be continuously monitored throughout the trial.

What happens if I no longer want to participate?

You are free to withdraw from the trial at any time without any impact on your future medical care. Your doctor will continue to provide care and can advise you about alternative options. If you choose to withdraw, your trial doctor will ask you to attend all the remaining trial visits. However, it is not mandatory that you participate in these visits.

Will expanded access be offered?

The optimal dose of the trial drug cannot be determined until the final analysis of the trial results. Therefore, there are currently no plans on providing access to buloxibutid after the trial. Expanded access may be considered at a later stage of development.

How is patient safety monitored?

Clinical trials follow strict scientific standards to protect you as a participant and help produce reliable trial results. The ASPIRE IPF trial is approved by national health authorities and ethics committees or institutional review boards. Side effects will be continuously monitored to ensure your safety throughout the trial.

How will my privacy be protected during the trial?

Your personal and health information will be kept confidential and secure, in accordance with privacy laws. Data collected will be used for research purposes only, and identifying details will be removed in any shared or published results.

Why is the trial placebo controlled?

One third of trial participants will be randomly selected to take a placebo (which looks identical to the study drug but contains no active medication). Trial participants and staff will not know who is taking the placebo. This is done to prevent bias and to understand if the investigational drug is working.

What is a ‘double-blind’ trial?

To prevent bias and unfairness, neither you as a participant, nor trial doctors or nurses will know if you are taking one of the doses of the investigational drug or placebo until after the trial is finished.

Trial locations

The ASPIRE IPF trial is taking place at locations across the country. If you don’t live close to a trial site, but you want to take part in the trial, then some travel-related costs may be reimbursed. Click the interactive map to see trial locations and click here to view contact details of sites actively enrolling patients in the US.

Learn More

If you think the ASPIRE IPF trial might be an option for you, download this summary or email it to your doctor to discuss it further.

Email: info@aspire-ipf.com
Download the ASPIRE IPF trial summary
Visit ClinicalTrials.gov and search for NCT06588686

If you are a participant in the ASPIRE trial, you should contact your study doctor for any questions. Please refer to our privacy policy to learn how we process personal data in accordance with applicable data protection law and industry standards.

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