Actively including ulcerative colitis studies

Amaretto

• Phase 4 open label study (no placebo)
• Compares weekly versus biweekly subcutaneous infliximab (Remsima®) treatment in Crohn’s disease and ulcerative colitis patients who switched from a high-dose intravenous infliximab regimen
• Patients who wish to continue intravenous infliximab may also participate.

• Key inclusion criteria:

  Crohn’s disease or ulcerative colitis in clinical and biological remission (CRP < 10   mg/L and fecal calprotectin < 250 mg/kg) 

  On a high and stable (>6 months) intravenous infliximab dose

Galocean:

• Phase 4 non-interventional open label study (no placebo)

• Evaluates the effectiveness, treatment patterns, quality of life, and safety in patients with active ulcerative colitis treated with filgotinib (Jyseleca®) in real-world clinical practice

• Filgotinib is a JAK1 inhibitor with anti-inflammatory effects

• Oral administration once daily

• Two-year follow-up including questionnaires and blood samples

• Key inclusion criteria:

  Patients who initiated treatment with filgotinib

Palekona:

• Phase 2 double-blind placebo-controlled study (1 in 4 chance of placebo)

• Evaluates the efficacy and safety of GS-5290 in patients with active ulcerative colitis.

• GS-5290 is an anti-TPL2 agent with anti-inflammatory effects.

• Oral administration once daily

• Key inclusion criteria:

  Sufficient intestinal symptoms and inflammation visible at endoscopy

  No patients with inflammation limited to the rectum

  History of minimum 1 and maximum 3 prior classes of advanced therapies

M23-703:

• Phase 2 double-blind controlled study (no placebo)

• Evaluates the efficacy and safety of lutikizumab compared to adalimumab in patients with active ulcerative colitis.

• Lutikizumab is an IL-1 inhibitor with anti-inflammatory effects

    Adalimumab is a TNFα inhibitor with anti-inflammatory effects

• One intravenous infusion, followed by subcutaneous injections at week 1 and 2, then every 2 weeks thereafter

• Key inclusion criteria:

  Significant intestinal symptoms and inflammation visible at enodscopy

  No prior treatment with adalimumab

  No patients with inflammation limited to the rectum

BI 1486-0006

• Phase 2 open label studie (no placebo)

• Evaluates the efficacy and safety of BI 3032950 in patients with active ulcerative colitis

• BI 3032950 is an anti-TREM1 agent with anti-inflammatory effects

• Three intravenous infusions every 4 weeks, followed by subcutaneous injections every 4 weeks

• Key inclusion criteria:

  Sufficient gastrointestinal symptoms and inflammation visible at endoscopy

  History of minimum 1 and maximum 3 prior classes of advanced therapies

  No primary sclerosing cholangitis

  No patients with inflammation limited to the rectum

TAK-279-UC-2001:
• Phase 2 double-blind placebo-controlled study (1 in 3 chance of placebo)

• Investigates the efficacy and safety of TAK-279 in patients with active ulcerative colitis

• TAK-279 is a TYK2 inhibitor with anti-inflammatory properties

• Oral administration once daily

• Key inclusion criteria:

  Sufficient gastrointestinal symptoms and inflammation visible on endoscopy

  No primary sclerosing cholangitis

  No patients with inflammation limited to the rectum

  History of no more than 2 prior classes of advanced Crohn’s disease medications

DRI 17822

• Phase 2 double-blind placebo-controlled study (1 in 6 chance of placebo)

• Evaluates the efficacy and safety of SAR441566 in patients with active ulcerative colitis

• SAR441566 is a TNFα inhibitor with anti-inflammatory effects

• Oral administration twice daily

• Key inclusion criteria:

  Sufficient gastrointestinal symptoms and inflammation visible at endoscopy

  History of maximum 3 prior classes of advanced therapies

  No use of antidiarrheal medications (e.g., Imodium®)

  No patients with inflammation limited to the rectum

TABASCO

• Evaluates the role of intestinal ultrasound in the context of acute severe ulcerative colitis

• Stool samples and intestinal ultrasound will be performed daily for one week. If the patient does not undergo surgery, a follow-up stool sample and ultrasound will be repeated on day 30.

• Key inclusion criteria:

  Patients hospitalized with acute severe ulcerative colitis

  No Clostridioides difficile infection

  No patients with a stoma or pouch