Crohn’s disease - Moderate to severe
You may be reimbursed for any reasonable expenses incurred including travel and £89 for your time attending the site for each colonoscopy
About This clinical research study
MAC Clinical Research is currently conducting a clinical study to test a new investigational medication for Crohn’s disease (CD). CD is a chronic inflammatory disease where parts of the digestive system become inflamed, it is characterised by periods of remission and relapse, or ‘flare-ups’. Symptoms include diarrhoea or soft/liquid stools, stomachache/cramps, blood in your poo, tiredness and weight loss.
The investigational medication, BMS-986165, has been developed as a variation of a protein in our bodies known as tyrosine kinase 2 (TYK-2). Previous studies have shown that BMS-986165 may help to control the part of the immune system responsible for CD. The purpose of this clinical study is to further assess the safety and effectiveness of BMS-986165 compared to placebo in participants with moderate to severe Crohn’s disease. Administration is by tablet, taken orally, twice a day (morning and evening).
Eligible participants may enter a 12-week Induction period where they will have a 3 in 4 chance (75%) of receiving BMS-986165, the investigational medication, and a 1 in 4 chance (25%) chance of receiving the placebo (a ‘dummy drug’). Following week 12; if you respond to the treatment you may continue to receive the same study treatment. If you experience a loss of response, you may be offered to switch to open label treatment, where you will receive the investigational medication (no possibility for placebo).
If you contact us, it does not mean you have to decide at that point whether to participate.
If you do decide to participate you are free to withdraw at any time.
If you choose to participate you may be involved in the clinical study’s 5 phases, for a duration of up to 112 weeks (just over 2 years) which may include up to 25 outpatient visits.
At the end of the Open Label treatment period, you may also be eligible to continue receiving BMS-986165 during a separate Long Term Extension (LTE) study, this can be discussed later in the study and there will be no obligation to participate.
Reimbursement: You may be reimbursed for any reasonable expenses incurred including travel and £89 for your time attending the site for each colonoscopy
Key Inclusion Criteria
Key Exclusion Criteria
Other eligibility criteria will apply. Please contact MAC for more information.
If you are eligible you will receive a comprehensive health screen. Your GP will be fully informed of your participation and provided with any information relevant to your healthcare.
ABOUT CLINICAL RESEARCH STUDIES
Clinical research studies are performed as a way of bringing about progress in medicine and research. Clinical research studies make it possible to scientifically assess the properties of a drug, to demonstrate the effectiveness and safety of a treatment or a medical device, or to learn more about a disease and methods to diagnose and monitor it.
If the study is successful, it may be an important step towards developing a promising new treatment.
MAC Clinical Research is conducting a trial to evaluate a potential new treatment for Crohn’s Disease.
If you would like more information, please fill in the form below and we will be in touch…
Alternatively, please call our recruitment team on freephone 0800 633 5507.
Frequently Asked Questions
Crohn’s disease is a lifelong condition that causes inflammation in the digestive system, and is one of the two main forms of inflammatory bowel disease (IBD), the second being ulcerative colitis. It is often characterised by periods of remission and relapse, or “flare ups”, however, some may experience constant symptoms. Severity of symptoms will vary but those commonly experienced are stomach pains/cramps, diarrhoea, often containing blood, mucus or pus, fatigue and weight loss. Those diagnosed with Crohn’s disease tend to have symptoms on and off for life, the correct treatments can control, but not cure, the condition.
Medical treatments for Crohn’s disease aim to decrease the severity and frequency of “flare-ups”. Options will vary from patient to patient, depending on the severity and frequency of their symptoms, and may involve short or long-term treatment using conventional or advanced therapies, and sometimes a combination of all. Medications used to treat the symptoms of Crohn’s disease include: Aminosalicylates (5-ASAs), Corticosteroids (steroids), Immunosuppressants, and advanced therapies such as biologics, janus kinase (JAK) inhibitors or Sphingosine-1-phosphate receptor 1 (S1PR1) inhibitors.
Currently there is no cure, Crohn’s disease 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”. Treatments also help to improve the long-term prognosis of Crohn’s disease by limiting complications, such as colorectal cancer, deep vein thrombosis, or other complications. Whilst living with Crohn’s disease can be difficult at times, there is no reason why patients cannot enjoy a normal life if their symptoms are well controlled with the right treatment.
Volunteers are vital for the success of clinical trials, to help test new medicines and find better treatments for the future for medical conditions such as Crohn’s disease. Taking part in a clinical trial offers an opportunity to be a part of the development of treatments and help future sufferers of Crohn’s disease. Clinical trials test the safety and efficacy of new medicines and may involve potential risks, it is, therefore, crucial that you fully understand what is involved in the clinical trial before agreeing to take part. Volunteers for clinical trials are always screened to assess their suitability for the trial and will be fully informed of the risks associated with the trial during this screening process.
All clinical trials must be reviewed and authorised by various governing bodies and committees before they can go ahead to minimise any risks. The Medicines and Healthcare products Regulatory Agency (MHRA) ensures that medicines meet applicable standards of safety, quality and efficacy, meaning a trial must be thought to be safe before it is approved. The Health Research Authority (HRA) is responsible for research ethics committees across the UK. Independent research ethics committees work to protect the interests and rights of volunteers who take part in the trial, adding another layer of protection to the process.
If you have a diagnosis of Crohn’s disease 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.
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