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
Up to £3915 plus reasonable travel expenses
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 speak with 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
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.
– An inadequate response, loss of response or intolerance to at least one previous UC treatment (additional criteria may apply).
– Male or female aged 18 to 80 inclusive.
– Diagnosis of ulcerative colitis for at least 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.
– 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.
– Codeine or other opiates, including anti-diarrhoeal treatments, e.g loperamide (Imodium etc.), or atropine, as part of your standard treatment that you are unable to pause – short term use MAY be permitted.
– Fear of needles/injections.
Other eligibility criteria will apply. Please contact MAC for more information.
This trial will test the safety and efficacy of PT101, compared to placebo (dummy medication). During the trial, eligible participants will receive the study drug or placebo by subcutaneous (under the skin) injection and have a 4 in 5 chance (80%) of receiving PT101 and a 1 in 5 chance (20%) of receiving placebo.
Eligible participants will attend up to 24 outpatient visits, including 2 endoscopies, over a period of up to 19 weeks. After this period, eligible patients can choose to participate in an additional study period of 40 weeks which would involve up to 23 outpatient visits.
A full description of the study will be given before you decide to take part, both over the phone and during an appointment at a MAC clinic. This will include you receiving the full patient information sheet (PIS).
Up to £3915 plus reasonable travel expenses
Frequently Asked Questions
Ulcerative colitis is an inflammatory bowel disease (IBD) that causes inflammation and ulcers within the colon (also known as the bowel or long intestine), and the rectum. It is a long-term condition characterised by periods of remission and relapse, or “flare ups”. The severity of symptoms will vary but those commonly experienced are repeated diarrhoea, often containing blood, mucus or pus, stomach pains, and the need to empty bowels more frequently. Those diagnosed with ulcerative colitis tend to have symptoms on and off for life, the correct treatments can control, but not cure, the disease.
The exact cause of ulcerative colitis is unknown but is thought to be the result of a problem with the immune system. Many experts believe it is an autoimmune condition (when the immune system mistakenly attacks healthy tissue). A leading theory is the immune system mistakes “friendly bacteria” in the colon, which aid digestion, as a harmful infection resulting in inflammation of the bowel and rectum. Other factors, including inherited genes and environmental conditions are also believed to have an impact on the prevalence of ulcerative colitis.
Currently there is no cure, ulcerative colitis tends to be a progressive condition, meaning symptoms will get worse without treatment. Medical treatments aim to decrease the severity and frequency of “flare-ups”.
Clinical trials test investigational medications, but there is no guarantee that the medication being investigated will improve your condition. Currently, there is no cure for ulcerative colitis, medications can help to relieve and manage symptoms of the condition and treatments currently being investigated are hoped will help more people in the future. Medications believed to bring a balance back to the immune system and help reduce acute inflammation in ulcerative colitis are currently being investigated.
If you have a diagnosis of ulcerative colitis that has been confirmed by colonoscopy and/or a gastroenterologist and are aged 18 or above, you may be eligible to take part. Age ranges and length of diagnosis will vary between clinical trials and other eligibility criteria will apply.
Clinical trials may include reimbursement for the time and commitment of participants, as well as travel expenses for required visits. The amount can vary, depending on the condition being investigated, the length of time of visits and the type of treatment, this will usually be discussed after registering your interest. It is important volunteers fully understand the commitment and any risks involved in a clinical and these will be discussed at numerous stages with participants, only those eligible to participate in a clinical trial will receive any payments applicable.
