What next?
What next?
About this study
The WISPer study is looking at a new drug called MTX-463.
WISP1 is a protein that plays an important role in the development and progression of fibrosis (scarring). Because of this, it is being studied as a possible target for new treatments.
MTX-463 is a new type of drug designed to block the harmful effects of WISP1. This may act to help treat different types of fibrosis, such as in the lungs and liver. Researchers will look at the impact of this for people with IPF. This study aims to look at the effect of the drug and the impact it has on the body to see if it is safe and effective.
There are many different types of research. These studies might ask participants to test different treatments, devices, or complete questionnaires. Some studies may not require any involvement from people affected by PF, but instead look at cells in a lab environment, animal models, or utilise computer modelling.
A study involving people can be:
- Interventional – participants are given an active treatment decided by researchers. This could be a change in medication or lifestyle (e.g. exercise, diet, complementary wellbeing therapy, or symptom management). These are commonly known as clinical trials.
- Observational – participants are assessed for specific changes over time, but researchers do not alter their standard treatment or care (e.g. questionnaires to understand the impact of symptom, or patient registries that track trends in how disease affects people or the services that are provided).
There are 3 main phases of clinical trials:
- Phase 1 is the earliest stage of research, where there is often a focus on understanding if the treatment is safe or if it causes any side effects.
- Phase 2 still focuses on safety and side effects, but also tries to find out more about what is the best dose.
- Phase 3 often compares the new treatment to existing treatments or lookalike medications.
As drugs or interventions move into the different phases, the number of people taking part will increase. Not all studies will make it to the later phases, especially if the intervention is not found to be safe or effective in phase 1 and 2.
The recruitment aim is the number of people that researcher want to take part in the research study.
What is involved?
You will be randomly assigned to one of two groups. One group will receive an intravenous infusion of the study drug, MTX-463, and the other group will receive a matching placebo, which does not contain any active medication.
You will receive infusions every four weeks for 5 months, after this you will have monitoring appointments for 8 weeks. At each hospital visit you will also have various medical assessments and tests to see how your body responds to the drug. This will include blood tests every 4 weeks, lung function tests at each hospital visit and questionnaires at the start and end of the study.
You are still able to continue taking antifibrotic drugs (pifenidone or nintedanib) whilst taking part in this study.
Summary of involvement
Taking part in the study for up to 32 weeks
Taking either the study drug or a placebo via an infusion every four weeks
Medical assessments including lung function tests
Questionnaires
Can I take part?
You may be able to take part if you are over the age of 40 years and have a diagnosis of IPF.
In research studies, there are lots of different reasons why you may or may not be able to take part. These are known as inclusion and exclusion criteria (see the main criteria list below). Only the research team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point without this effecting your usual care or treatment.
If you are not able to take part in this research study, there may be other opportunities for you to take part in different studies.
To find out more about other research opportunities visit our research finder main page.
You are age 40 years or older
You have a diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
If you are taking pirfenidone or nintedanib, the dose of the medication must be stable for the last 90 days
If you are not taking nintedanib or pirfenidone you must have stopped this at least 30 days before the study, or have never taken it
There are also specific lung function requirements, which will be assessed by the research team
You have had an acute exacerbation of IPF within the last 6 months
You require continuous supplemental oxygen therapy
What difference could taking part make?
Taking part in this study may not bring direct benefit to you, but the information researchers learn from the study will help to understand the impact of the drug for people with IPF.
Where does the study take place?
Study locations
Birmingham
Cambridge
Edinburgh
Oxford
How to take part
If you are interested in taking part in this study, please speak to your healthcare team to express your interest in research. You can also take a look at the WISPer Study website for more information or email WISPer@mediartx.com
Further information
This page is a summary which provides information about an opportunity to participate in research. More detailed information about the study can be found via the following the links and through contacting the research team.
If you have any questions about this research study, please speak to your medical team.
WISPer@mediartx.comThis study is supported by
This page provides a lay summary of the research study and does not contain all the information needed to inform decisions about taking part. Please speak to your medical team or the study research team in relation to specific details about the study.
Action for Pulmonary Fibrosis does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators. Every effort is made to ensure that these details are correct and are kept up to date. If you are aware of any inaccuracies, please email research@actionpf.org