AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

A multicenter double-blind, randomized, placebo-controlled phase I/II study to determine the safety, tolerability, potential efficacy and dose finding of INP20, an oral formulation for treatment of immunotherapy in peanut-allergic patients.

This research is a trial for a new medicine called INP20, designed as an oral treatment for people who are allergic to peanuts. The main goals are to check how safe the medicine is and if people can take it without too many problems. Researchers also want to find the most effective dose and see if it can help reduce allergic reactions to peanuts. This study is being carefully done in different places, and some participants will receive the active medicine while others receive a dummy pill (placebo). This helps the researchers understand the true effects of INP20. It's an early-stage study, meaning it's among the first times it's being tested in humans.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Innoup Farma S.L.

Enrolment target

Start

31 Oct 2024

Peanut allergy

What is this study about?

This clinical trial is looking into a new oral medicine, INP20, for individuals living with peanut allergies. The main idea behind this type of treatment, called immunotherapy, is to help a person's body become less sensitive to the substance they are allergic to over time. For peanut allergy, this could mean reducing the severity of reactions or even increasing the amount of peanut a person can tolerate without experiencing an allergic reaction.

The study has two main parts. The first part focuses on understanding the safety of INP20 and finding the right dose. Researchers will start with small doses and gradually increase them, carefully watching for any side effects. The second part will then look more closely at how well the chosen dose works and how safe it is over a longer period. Throughout the study, some people will get the active medicine, INP20, and others will get a placebo (a dummy pill with no active ingredient). This helps the researchers compare the effects accurately without knowing who is getting which treatment.

Trials like this are really important because they help develop new and better ways to manage conditions like peanut allergy. Developing new treatments involves many careful steps, and this study is an early but crucial part of that journey, focusing on initial human safety and effectiveness. It's all about gathering solid evidence to ensure potential new medicines are both safe and helpful for patients.

Key takeaways

This study evaluates a new oral medicine (INP20) for peanut allergy.
It aims to find a safe dose and see if it reduces allergic reactions.
Some participants will receive INP20, others a dummy pill (placebo).
It's an early-stage study focusing on safety and initial effectiveness.
Participation involves regular clinic visits for monitoring and tests.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, participants generally need to be adults, specifically 18 years old or older. The study is open to both men and women.

Beyond age and sex, specific health information will also be important. For example, you would need to have a confirmed peanut allergy. The research team will review your medical history and conduct tests to make sure the study medication is suitable for you and that you meet all the necessary health requirements.

It's important to remember that not everyone who meets the initial age and sex criteria will be eligible. The research team will go through a detailed screening process to ensure the study is safe for you and that you are a good fit for the research goals.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a confirmed peanut allergy?
Are you able to visit the study clinic regularly for appointments?
Are you comfortable with the possibility of taking either the study medicine or a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure it's right for you. This would involve medical checks and tests. If you qualify, you would be randomly assigned to either receive the new medicine, INP20, or a placebo (a dummy pill) by mouth. Neither you nor the study team would know which one you are getting initially.

You would have regular visits to the study clinic where the research team would monitor your health very closely. These visits would include physical exams, checking your vital signs (like blood pressure and heart rate), taking blood and urine samples for lab tests, and checking your peak flow (how quickly you can breathe air out).

Initially, in Part A of the study, the dose of the medicine for some participants may be gradually increased over time, under close medical supervision, to find the safest and most effective amount. In Part B, you would continue to take your assigned treatment and attend regular follow-up appointments. The total duration of your participation in the study, including all visits and follow-ups, would be explained in full detail by the study team, but typically these kinds of integrated Phase I/II studies can last for several months to a year or more.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. You might benefit from receiving a new experimental treatment for your peanut allergy that is not yet widely available, and your participation helps advance medical understanding that could help others in the future. However, there's no guarantee that INP20 will work for you, and like all medicines, it can cause side effects. These could range from mild discomfort to more serious reactions, especially given it's for an allergy. The research team will monitor you closely for any adverse effects. You are always free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is INP20?

INP20 is a new oral medicine being tested to see if it can help people with peanut allergies.

What does 'peanut allergy immunotherapy' mean?

It means the treatment aims to slowly train your body to be less sensitive to peanuts, hopefully reducing allergic reactions.

Why is there a 'placebo' group?

A placebo is a dummy pill. Comparing results from those taking INP20 to those taking the placebo helps researchers see if INP20 is truly effective.

What 'phase' is this study in?

This is an early-stage study (Phase I/II), meaning it's among the first times the medicine is being tested in humans to check its safety and early effectiveness.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'double-blind' study, so neither you nor the study team will know who is getting which treatment until the study is over.