Ulcerative Colitis
Clinical Trial
MAC Clinical Research are currently conducting a trial to test a potential new treatment for ulcerative colitis (UC).
Improving quality of life
Key Information
Reimbursement
Receive up to £2,670 plus reasonable travel
Gender and Age
Males and Females aged 18 - 80
Clinics
Greater Manchester, Lancashire, Merseyside, South Yorkshire, and West Yorkshire
Health Check
Receive a free comprehensive health check
Register Your Interest
What Happens Next?
1. Sign Up
Register your interest on our website or over the phone
2. We'll Call You
Our study specialists will call you to discuss your health and check if the trial is suitable for you
3. Eligible?
If eligible, you will be booked in for a 'CHAT' where you'll receive a Patient Information Sheet (PIS)
4. Medical History
If you decide to take part, our medical team will obtain a copy of your medical history from your GP
5. Health Check
You will attend a free comprehensive health check with a MAC doctor and your eligibility will be confirmed
6. Enrollment
You will be enrolled onto the clinical trial and attend scheduled visits (Travel expenses or transport to clinic provided)
About this Ulcerative Colitis Clinical Trial
Ulcerative Colitis (UC) is a chronic inflammatory disease of the rectal & colonic mucosa which is characterised by periods of remission and relapse, or ‘flare-ups’. Autoimmune and inflammatory diseases such as UC can happen when a person’s immune system becomes unbalanced. The study medicine, PT101, has been developed as a variation of a protein in our bodies known as interleukin-2 (IL-2). In previous studies PT101 has been shown to increase a type of immune cell in the body called regulatory T cells (Tregs), which are believed to bring balance back to the immune system and help reduce acute inflammation, a cause of UC flare-ups.
– Age 18 – 80
– Diagnosis of ulcerative colitis for at least the past 3 months
– BMI of 18 – 35; minimum weight of 50kg
– Active ulcerative colitis
– Currently experiencing increased stool frequency
– Currently passing at least some blood during bowel movements
– Currently taking and unable to pause advanced treatments for UC – Biologic agents e.g infliximab, JAK inhibitors e.g tofactinib or S1P1 inhibitors e.g Fingolimod
– Previous or planned surgery for ulcerative colitis (including colostomy, ileostomy, proctocolectomy or total colectomy.
– Diagnosis of Crohn’s disease or indeterminant colitis
– Active clinically significant infection
– Fear of needles/injections
Other eligibility criteria will apply. Please contact MAC for more information.
The study will run for approximately 16 weeks. This includes taking the study drug or matching placebo (a ‘dummy medication’ containing no active ingredient or drug) by subcutaneous (under the skin) injection, and requires a total of 15 outpatient visits, including 2 endoscopies. The purpose of this study is to:
– Determine further whether PT101 is safe, and what side effects it may have.
– Measure how much PT101 gets into the blood stream and how long it takes the body to clear it.
– Measure how PT101 effects your body, especially immune cells that help to control inflammation.
– Examine further whether PT101 may be an effective treatment for UC.
A full description of the study will be given before you decide to take part. This will include receiving the full patient study information sheet (PIS). Your GP will also be notified of your participation.
Up to £2,670 plus reasonable travel.
After the 16-week study period, eligible patients can choose to participate in an additional study period of 40 weeks which would involve an additional 10 outpatient visits.
