In short
MTX-474 is an investigational substance being studied for diffuse cutaneous systemic sclerosis (dcSSc), a rare autoimmune condition that causes hardening and thickening of the skin. One Phase 2 clinical trial is currently authorised in the EU, planning to enrol 78 participants to test whether MTX-474 can reduce skin thickening over 24 weeks. The trial compares MTX-474 given by intravenous infusion against placebo infusions.
Key points
- MTX-474 is an investigational substance with no marketing authorisation in these records.
- It is being studied in diffuse cutaneous systemic sclerosis (dcSSc), a rare autoimmune disease affecting the skin.
- The single registered trial is a Phase 2 study with a planned enrolment of 78 participants.
- The trial is currently authorised and has not yet reported results.
- The main outcome measure is the change in the modified Rodnan skin score (mRSS) from baseline to week 24.
- MTX-474 is given as an intravenous infusion at a dose of 4 mg per kilogram of body weight.
What is MTX-474?
MTX-474 is an investigational substance that is being developed for the treatment of diffuse cutaneous systemic sclerosis (dcSSc), a rare autoimmune condition in which the immune system attacks the body's own tissues, leading to hardening and thickening of the skin. The substance is currently under investigation and has no marketing authorisation in the records available, meaning it is not yet an approved medicine. It is being studied in a Phase 2 clinical trial to evaluate whether it can reduce skin thickening in people with dcSSc.
How does MTX-474 work?
The registry data do not describe the mechanism of action of MTX-474. The trial is designed to assess the change from baseline on skin thickening, which suggests that the substance is intended to affect the processes that cause the skin to thicken in dcSSc, but no further details are given in the available sources.
Which conditions is it studied for?
- Diffuse cutaneous systemic sclerosis (dcSSc) — a form of systemic sclerosis, a rare autoimmune disease in which the immune system attacks healthy tissue, causing hardening and thickening of the skin over large areas of the body. The trial is investigating whether MTX-474 can reduce this skin thickening.
How is MTX-474 given?
In the registered trial, MTX-474 is given as an intravenous infusion, which means it is delivered directly into a vein. The dose used in the trial is 4 mg per kilogram of body weight. The comparison arms receive placebo infusions of either sodium chloride 0.9% solution or dextrose 5% solution, both given intravenously.
What do the clinical trials show?
One clinical trial of MTX-474 is registered in the EU Clinical Trials Information System. The trial is a Phase 2 study, which means it is testing the substance in a larger group of people than earlier phase trials, to gather more information about its effects and safety. The trial is currently authorised, meaning it has received approval to begin but has not yet reported results. It plans to enrol 78 participants with diffuse cutaneous systemic sclerosis.
What are the trials measuring?
The main outcome measure in the trial is the mean change from baseline to week 24 on the modified Rodnan skin score (mRSS) in each study arm. The mRSS is a standard tool used by doctors to assess skin thickness in systemic sclerosis; a lower score indicates less skin thickening. The trial compares the change in mRSS in the group receiving MTX-474 with the change in the groups receiving placebo.
Who can take part in these trials?
The trial is open to participants with diffuse cutaneous systemic sclerosis (dcSSc). The registry record does not provide further details about specific inclusion or exclusion criteria, such as age limits or how long a person must have had the condition. The planned number of participants is 78.
What side effects are known?
No side effects of MTX-474 are reported in the available registry data. Since the trial is still in the authorised stage and has not reported results, information about side effects is not yet available from this source.