CM-101 in PSC Patients -The SPRING Study
The SPRING Study is a research project investigating a new medicine, CM-101, for people living with Primary Sclerosing Cholangitis (PSC). PSC is a chronic liver disease that can lead to serious health problems. The study wants to find out if CM-101 is safe to use, how people tolerate it, and if it could help manage their PSC. Around 68 adults with PSC will take part, some receiving CM-101 and others a dummy drug (placebo). This research is important to potentially find new and better ways to treat PSC. Participants will be closely monitored by doctors throughout the study.
At a glance
What is this study about?
This study, known as The SPRING Study, is focused on a liver condition called Primary Sclerosing Cholangitis (PSC). PSC is a disease that affects the bile ducts in the liver, which are tiny tubes that carry digestive fluid. Over time, these ducts can become inflamed and scarred, leading to serious liver damage. Currently, there isn't a cure for PSC, so finding new treatments is really important.
Researchers are investigating a new medication called CM-101. This medicine is a type of antibody, which are special proteins that target specific things in the body. In this case, CM-101 is designed to work against a particular protein called CCL24, which is thought to play a role in PSC.
The main goals of The SPRING Study are to see if CM-101 is safe for people with PSC, how well they tolerate it (meaning if they have uncomfortable side effects), and if it shows any signs of improving their condition. This is a "Phase 2" study, which means it builds on earlier research and aims to get a better understanding of the drug's effects in a larger group of patients. If CM-101 proves promising in this study, it could move on to further research stages.
Key takeaways
- The study is for adults with Primary Sclerosing Cholangitis (PSC).
- It's testing a new medication called CM-101.
- The main goals are to check safety and if the drug helps PSC.
- Participation involves regular clinic visits and medication doses.
- You might receive CM-101 or a placebo during the first part.
- You can stop participating at any time.
Who may be eligible?
To join The SPRING Study, you need to be an adult between 18 and 75 years old and have been diagnosed with PSC for at least 24 weeks. Your doctor must also agree that there are no serious concerns about another liver condition called cholangiocarcinoma (a type of bile duct cancer). Additionally, a specific liver enzyme in your blood, called Alkaline Phosphatase (ALP), needs to be above a certain level during screening.
If you're already taking medication for PSC, like ursodeoxycholic acid (UDCA), you need to have been on a steady dose for at least 3 months before starting the study. If you also have inflammatory bowel disease (like ulcerative colitis or Crohn's disease), it needs to be well-controlled. For women who could become pregnant, it's essential to use effective contraception throughout the study and for a period afterwards. Men must also use barrier contraception if they are not vasectomized.
Some things would prevent you from joining. For example, if you have another type of sclerosing cholangitis, a different serious liver disease, or a condition where your immune system attacks your liver (called autoimmune hepatitis), you wouldn't be able to participate. The medical team will check all these details carefully to make sure the study is right and safe for you.
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 between 18 and 75 years old?
- Have you been diagnosed with PSC for at least 6 months?
- Is your ALP blood test level higher than normal?
- If taking PSC medication (like UDCA), has your dose been stable for 3 months?
- If you have inflammatory bowel disease, is it well-controlled?
- Are you able to use effective contraception if needed?
What does participation involve?
If you decide to take part in The SPRING Study, it will involve several stages. First, there's a screening period to check if you're suitable. Then, for the main part of the study, you'll receive the study drug (CM-101) or a placebo (a dummy drug). This will happen through an injection once every three weeks, for a total of five doses over 15 weeks. You won't know if you're getting CM-101 or the placebo, and neither will your local doctor.
After these 15 weeks, you might be able to continue receiving CM-101 in an 'open-label' period, where everyone knows they are getting the active drug. This involves another 11 doses over 33 weeks. So, you could be taking part for up to 48 weeks receiving the study drug. Throughout the study, you'll have regular visits to the clinic for check-ups, blood tests, and to make sure you're doing well. There will also be follow-up calls and visits after you finish taking the medication to monitor your health. The total time for follow-up could extend to about 60 weeks from when you first start.
Potential risks and benefits
Locations (33)
- Scripps Clinic Torrey Pines - site P83Verified postcodeLa Jolla, United States
- UC Davis Health System - Midtown Ambulatory Care Center - site P79Verified postcodeSacramento, United States
- Northwestern University - site P77Verified postcodeChicago, United States
- Massachusetts General Hospital - site P95Verified postcodeBoston, United States
- Harvard Medical School - Beth Israel Deaconess Medical Center (BIDMC) - Liver Center - site P81Verified postcodeBoston, United States
- Gastro One - GI Diagnostic and Therapeutic Endoscopy Center - 1310 Wolf Park - site P82Verified postcodeGermantown, United States
- Methodist Dallas Medical Center - site P72Verified postcodeDallas, United States
- Virginia Commonwealth - site P94Verified postcodeRichmond, United States
- Klinikum der Johann Wolfgang Goethe-Universitaet - site P42Verified postcodeFrankfurt am Main, Germany
- Universitätsklinikum Hamburg-Eppendorf (UKE) - site P47Verified postcodeHamburg, Germany
- Medizinische Hochschule Hannover (MHH) - site P41Verified postcodeHanover, Germany
- Soroka MC - site P23Verified postcodeBeersheba, Israel
Common questions
What is Primary Sclerosing Cholangitis (PSC)?
PSC is a long-term liver disease that causes inflammation and scarring in the bile ducts, which are tubes that carry bile from your liver. This can lead to liver damage over time.
What is CM-101?
CM-101 is a new, experimental medication being tested in this study. It's designed to target a specific protein in the body that researchers believe is involved in PSC.
What is a 'placebo'?
A placebo is adummy treatment that looks exactly like the study drug but doesn't contain any active medicine. It helps researchers compare the effects of the new drug against no treatment.
How long will I be in the study?
You could be in the study for up to 48 weeks receiving treatment, plus additional follow-up periods, possibly extending to around 60 weeks in total.
Will I know if I'm getting the real drug or the placebo?
During the first part of the study, neither you nor your doctor will know if you're receiving CM-101 or the placebo. This is called 'double-blind' and helps ensure fair results. Later, you might have the option to receive the active drug open-label.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.