Efficacy and Safety Trial of a New Drug for Ulcerative Colitis

Researchers are looking for patients who have been diagnosed with Ulcerative Colitis for at least 3 months with moderate-to-severe active Ulcerative Colitis to take part in a 16-week placebo-controlled study to evaluate the efficacy and safety of a new drug called ST-0529.

Study Concept

The active component of ST-0529 is called cyclosporine, which is an immunosuppressant. It works by preventing certain white blood cells from causing inflammation in your tissues. Cyclosporine has been approved in other forms and is prescribed by doctors for certain diseases and conditions. In previous UC studies, systemically administered cyclosporine reduced ulcerative colitis disease activity, but also increased the risk of other side effects.

ST-0529 is designed to deliver cyclosporine only to the lower digestive tract. It is believed that this will reduce the side effects caused by other types of cyclosporine because this new drug directly delivers it to the large intestine and so it is not absorbed in the whole body.

Study Design

This new international clinical trial, funded by Sublimity Therapeutics (Hold Co) Ltd, will seek to answer the following questions:

  • How well does ST-0529 help patients with active Ulcerative Colitis?
  • What dose of ST-0529 is most helpful for patients?
  • Does ST-0529 cause any side effects?

The UK study is being led by Professor Tariq Iqbal, a Consultant Gastroenterologist at Queen Elizabeth Hospital, Birmingham.

Taking Part

To take part you need to travel to one of the following treatment sites (your costs will be reimbursed):

  • Barnsley Hospital (Contact: barnsley.researchnurses@nhs.net)
  • Addenbrooke's Hospital, Cambridge (Contact: 01223 596 461)
  • Queen Elizabeth Hospital, Birmingham
  • Ulster Hospital, Belfast
  • Royal Liverpool Hospital,
  • King's College London Hospital (Contact: kch-tr.ibdtrials@nhs.net)

You can find the latest list of participating sites at the bottom of their study webpage.

To enter the study you must:

  • Be 18 - 75 years of age
  • Have been diagnosed with Ulcerative Colitis for at least 3 months
  • Have taken, but not had a good response to, a conventional therapy for Ulcerative Colitis (corticosteriods, budesonide, azathioprine/6-mercaptopurine, anti-TNF agents, vedolizumab)
  • Be currently experiencing a flare, resulting in increasing trips to the bathroom or seeing blood in your poo
  • Be willing to have two endoscopies: one at the screening stage and one at the end of the treatment

Unfortunately, we will be unable to accept volunteers who have:

  • Ulcerative proctitis, Crohn's colitis, ischemic colitis, NSAID-induced colitis, idiopathic colitis, or radiation colitis
  • Had previous surgery for Ulcerative Colitis
  • Any history of malignancy (cancer)
  • Active or a history of tuberculosis

To take part and for more information, please directly contact your local participating hospital site.

This research study is NOT funded or organised by Crohn's & Colitis UK and, therefore, we cannot take responsibility for your involvement in the research. It is a patient’s choice to take part.