A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis.
The purpose of the AURORA Clinical Trial is to better understand the safety and effectiveness of ST-0529 for people with moderate to severely active ulcerative colitis.
To enter the study, you must:
- Be between 18 and 75 years of age
- Have a diagnosis of ulcerative colitis for at least 3 months
- Have been previously treated with any of the following conventional therapies for ulcerative colitis (oral or IV corticosteroids, budesonide, azathioprine or 6-mercaptopurine, anti-TNF agents, or vedolizumab) and have shown an inadequate response, loss of response or intolerance/medical contraindication during treatment
- Be currently experiencing an active flare of your ulcerative colitis
- Be on a dose of ≤ 40 mg/day (prednisolone or equivalent) or ≤ 9mg budesonide if currently taking oral corticosteroids
- Be willing to undergo two endoscopies: one at screening and one at the end of study treatment, according to the protocol requirements
You CANNOT have any of the following:
- Ulcerative proctitis or a diagnosis of Crohn's colitis, ischemic colitis, NSAID-induced colitis, idiopathic colitis or radiation colitis
- Previous surgery for ulcerative colitis
- Malignancy or history of malignancy within the last 5 yrs
- Active tuberculosis or a history of treated/untreated tuberculosis
The AURORA Clinical Trial is investigating ST-0529 and its potential for reducing symptoms related to moderately to severely active ulcerative colitis.
Participants will be randomized to receive ST-0529 in doses of 18.75 mg twice a day, or 37.5 mg twice a day, or 75 mg twice a day, or matching placebo twice a day
- This study will last a maximum of 20 weeks and includes an initial Screening Period (up to 4 weeks) requiring 2 clinic visits, a 12 week Study Treatment Period requiring 5 clinic visits, and a Follow Up Visit at Week 16.
Description of Treatment or Intervention (Mechanism of Action)
- ST-0529 is an oral calcineurin inhibitor that can be used to reduce inflammation and the activity of your immune system in certain diseases as well as to prevent organ rejection in people who receive transplants.
- Calcineurin inhibitors work by preventing certain white blood cells from causing inflammation in your tissues. For patients with Ulcerative Colitis, this inflammation is seen in the large colon.
Patient Participation Requirements
- All participants in the AURORA study are required to attend all clinic visits, undergo two endoscopies (one at the start and one at the end of the study), and take study drug as directed by study staff.
- Participants will be given an electronic diary to take home during the study, where they will record on a daily basis their self-dosing of medication, and report on stool frequency (how often they pass stool) and any signs of bleeding.
Possible Risks & Side Effects
Any medication can cause side effects.
- Based on previous studies of ST-0529 in healthy volunteers, the most common side effects were abdominal pain, diarrhea, abdominal discomfort, headache, dizziness, and cough.
- In a previous study of patients with mild to moderate UC who took ST-0529, the most common side effects were abdominal pain, abdominal distension (feeling bloated), respiratory infection, headache, cough, nasal cavity pain and fatigue (tiredness) compared with people who took placebo.
- Since ST-0529 targets the large intestine, it is expected that the levels of the active drug in the rest of the body will be low.
- For that reason, previous studies of ST-0529 did not result in the common side effects seen with other marketed calcineurin inhibitors. The common side effects related to other drugs in this class may not necessarily occur after taking ST-0529 and may depend on the dose, how long you take the medication, and what medications you are taking at the same time.
Also, new side effects may appear that are not listed below.
- The most commonly reported side effects reported with the treatment of commercially available calcineurin inhibitors include renal disorders, tremor, male-pattern hair grown in women, increased blood pressure, abnormal sensations (burning, tingling or numbness) and increased cholesterol levels, cramps, acne, convulsion (involuntary contraction of muscles), headache, increase in the size of your gums, diarrhea, nausea/vomiting, liver toxicity, abdominal discomfort, flushing, reduced white blood cells, cancer of the white blood cells, sinus infection, gynecomastia (swelling of breast tissue in males), fatigue, and increased body temperature.