RecruitingPHASE2INTERVENTIONAL

Open Label Extension Study of Brentuximab Vedotin in Early dcSSc

This research is an 'extension study' for a medicine called Brentuximab vedotin, used in people with a severe form of scleroderma called diffuse cutaneous systemic sclerosis (dcSSc). Scleroderma is a long-term condition that causes hardening of the skin and can affect internal organs. This study is for people who took Brentuximab vedotin in a previous study, initially improved, but then found their condition worsened after they stopped the treatment. The main goals are to check if restarting Brentuximab vedotin is safe and how well it works to help manage their symptoms again. This will help researchers understand if this treatment can provide longer-lasting relief for more people.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrolment target

Start

14 Feb 2024

Estimated completion

01 Jul 2026

Diffuse Cutaneous Systemic Sclerosis

What is this study about?

You might have been invited to learn about this study if you have a condition called diffuse cutaneous systemic sclerosis (dcSSc), which is a serious form of scleroderma. Scleroderma is a long-term illness where your body's immune system mistakenly attacks healthy tissues, leading to hardening and tightening of the skin. In the diffuse form, it can also affect internal organs like the lungs, heart, or kidneys.

At the moment, there isn't a perfect treatment for everyone with active diffuse scleroderma. However, a medicine called Brentuximab vedotin has shown some promise in earlier studies. This current study is an extension of a previous one. It's looking at people who previously took Brentuximab vedotin, saw their condition improve, but then experienced a worsening of their symptoms after they stopped taking the medicine. The researchers want to find out if restarting this treatment is safe and effective in helping these people feel better again.

The main idea behind this research is to see if giving Brentuximab vedotin again can help reduce the symptoms of scleroderma and slow down its progression by calming down the overactive immune system. The team will carefully monitor participants to understand the benefits and any potential side effects. This information will help doctors understand better how to use this treatment in the future for people living with diffuse scleroderma.

Key takeaways

This study is for adults with a severe type of scleroderma (dcSSc).
It's an extension for those who previously responded to Brentuximab vedotin but then relapsed.
The main goals are to check safety and effectiveness of restarting treatment.
Participation involves regular monitoring for almost a year.
You can withdraw from the study at any time.
This research helps understand if this treatment offers longer-term relief for scleroderma.

Who may be eligible?

This study is specifically for adults aged 18 or older who have already taken part in a previous Brentuximab vedotin study (BV201708) at St. Joseph's Health Centre. To join, your skin hardening score (mRSS) must have worsened by at least 4 points since you finished the last study.

There are several reasons why someone might not be able to join. For example, if you have severe problems with your lungs or heart, are pregnant or breastfeeding, or have certain active infections like HIV, Hepatitis B or C, or TB. They will also check if you have any other serious health conditions, certain problems with your nerves (peripheral neuropathy), or specific abnormal blood test results.

Also, if you've recently had certain vaccinations, taken another specific medication called rituximab within the last four months, or participated in another clinical trial recently (unless it was the previous Brentuximab vedotin study), you won't be able to join this one.

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?
Did you participate in the previous Brentuximab vedotin study (BV201708) at St. Joseph's Health Centre?
Has your skin hardening score (mRSS) worsened by at least 4 points since that study ended?
Do you have good lung function (e.g., your breathing tests are not severely low)?
Are you able to agree to take part after understanding all the information?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be restarting the Brentuximab vedotin treatment, which has been given to you before. The study is planned to last up to 48 weeks, which is about 11 months. During this time, you would have regular visits where the study team will monitor your health carefully. This will include blood tests to check your inflammatory markers and general health, and assessments of your skin hardening and how you are feeling generally.

Doctors will also look at how your scleroderma is affecting your daily life and your overall health. Some skin samples might be taken (biopsies) to see how the treatment is working at a cellular level, though this is an exploratory part of the study. All these checks help the researchers understand if the treatment is helping you and if it's safe.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that restarting Brentuximab vedotin might help improve your scleroderma symptoms again, especially if they worsened after your previous treatment stopped. However, there's no guarantee it will work for everyone, and like all medications, Brentuximab vedotin can have side effects. These could be similar to what you experienced before. The study team will explain all the known potential risks to you. Remember, joining is completely voluntary, and you can stop participating at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Rheumatology Clinic, St. Joseph's Health Care
Verified postcode
London, Canada· Recruiting

Common questions

What is diffuse cutaneous systemic sclerosis?

It's a serious type of scleroderma where your skin hardens over wide areas and it can also affect parts inside your body.

Why is this study happening?

It's for people whose scleroderma got worse after they stopped a previous Brentuximab vedotin treatment, to see if restarting it is safe and helpful.

How long will the study last?

The study is planned to last for about 48 weeks, which is nearly a year.

What kind of tests will I have?

You'll have regular blood tests, checks of your skin, and general health assessments to see how you're doing.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, and it won't affect your future medical care.

How to find out more

Janet E Pope, PhD

janet.pope@sjhc.london.on.ca 519-646-6332 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.