OATS:

• Diet as an additional therapy alongside the initiation of advanced medication with biologics or small molecules in active Crohn’s disease (no placebo)

• Randomization to receive advanced medication with or without diet for 8 weeks

• The patient may choose which medication they will be treated with; the dietary intervention is randomized

• Key inclusion criteria:
Fecal calprotectin > 250 mg/kg
Sufficient inflammation visible at endoscopy

TAK-279-CD-2001:

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

• Investigates the efficacy and safety of TAK-279 in patients with active Crohn’s disease

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

• Oral administration once daily

• Key inclusion criteria:

  Sufficient gastrointestinal symptoms and inflammation visible at endoscopy

  No primary sclerosing cholangitis

  No high blood pressure

  History of maximum 2 prior classes of advanced Crohn’s disease medications

CALLESTO

• Phase 2 double-blind placebo-controlled study (1 in 3 chance of placebo)

• Investigates the efficacy and safety of AZD7798 in patients with active Crohn’s disease and an ileostomy

• AZD7798 depletes CCR9-positive immune cells and has anti-inflammatory effects

• Subcutaneous injections every 4 weeks

• Key inclusion criteria:

  Active inflammation in the terminal portion (between 5 and 25 cm) of the small   intestine

  Patients with an ileostomy

AMALTHEA:

• Phase 2 double-blind placebo-controlled study (2 in 5 chance of placebo)

• Investigates the efficacy and safety of AZD7798 in patients with active Crohn’s disease

• AZD7798 depletes CCR9-positive immune cells and has anti-inflammatory effects

• Subcutaneous injections every 4 weeks

• Key inclusion criteria:

  Sufficient gastrointestinal symptoms and inflammation visible at endoscopy

  History of no maximum 3 prior classes and 4 prior medications of advanced   therapies

SOPRANO:

• Phase 4 open label study (no placebo)

• Compares disease relapse in Crohn’s disease patients who have undergone an ileocaecal resection (removal of the transition between the small and large intestine), followed by either immediate initiation of medication or delayed initiation based on an endoscopy six months after the procedure. Both strategies are currently used in clinical practice, but this government-sponsored study aims to determine which approach is most appropriate.

• The patient may choose the advanced therapy to be used, but the computer system determines whether this therapy starts immediately or only after the first endoscopic evaluation.

• Key inclusion criteria:

  Crohn’s disease patients who recently (< 40 days ago) underwent an ileocaecal   resection

  At least one risk factor for disease relapse

  Entitlement to reimbursement for advanced therapy for Crohn’s disease

M24-885:

• Phase 2 open label study (no placebo)

• Investigates the efficacy and safety of lutikizumab and ABBV-382 in patients with active Crohn’s disease

• Lutikizumab is an IL-1 inhibitor with anti-inflammatory effects
ABBV-382 is an anti-integrin agent that blocks immune cell migration to the gut

• Lutikizumab: subcutaneous injections every 2 weeks

ABBV-382: 1 intravenous infusion every 4 weeks (3 in total), followed by subcutaneous     injections every 4 weeks

• Key inclusion criteria:

  Sufficient intestinal symptoms and inflammation visible at endoscopy

  History of no maximum 2 prior advanced Crohn’s disease medications

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

VECTORS:

• Phase 4 open label study (no placebo)

• Compares the treatment goal of “ultrasound, clinical, and biological remission” versus “clinical and biological remission” in patients with active Crohn’s disease.

• Treatment consists of vedolizumab (Entyvio®) administered over one year

• Vedolizumab is an anti-integrin agent that blocks immune cell migration to the gut

• Key inclusion criteria:

      History of maximum one prior advanced Crohn’s disease medication

      Sufficient intestinal symptoms and inflammation visible at endoscopy

ABX464-202

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

• Investigates the efficacy and safety of obefazimod in patients with active Crohn’s disease

• Obefazimod increases the expression of micro-RNA-124 and has anti-inflammatory effects

• Oral administration once daily

• Key inclusion criteria:

  Sufficient gastrointestinal symptoms and inflammation visible at endoscopy

  Mandatory sun protection

  History of maximum 2 prior classes and 3 prior medications of advanced Crohn’s    disease medications

  No history of colonic dysplasia

  No primary sclerosing cholangitis

VICTRIVA

• Phase 3 double-blind controlled study (no placebo)

• Compares the efficacy and safety of combination therapy with vedolizumab (Entyvio®) and upadacitinib (Rinvoq®) versus vedolizumab monotherapy.

Vedolizumab is an anti-integrin that blocks immune cell migration to the gut

Upadacitinib is a JAK1 inhibitor with anti-inflammatory effects

Upadacitinib or placebo: oral administration once daily the first 12 weeks
Vedolizumab infusions at weeks 0, 2, 6, 10, and 14, followed by infusions every 8 weeks

• Key inclusion criteria:

  Aged between 18 and 65 years

  Sufficient gastrointestinal symptoms and inflammation visible on at endoscopy

MK7240-008

• Phase 3 double-blind placebo-controlled study (1 in 4 chance of placebo)

• Investigates the efficacy and safety of tulisokibart in patients with active Crohn’s disease

• Tulisokibart is an anti-TL1a and has anti-inflammatory effects

• Intravenous infusions at weeks 0, 2, 6, and 10, followed by subcutaneous injections every 2 weeks

• Key inclusion criteria:

  Sufficient gastrointestinal symptoms and inflammation visible at endoscopy

  History of maximum 2 prior advanced Crohn’s disease medications

EXTENT

• Investigates whether an MRI scan can be replaced by ultrasound for evaluating small and large bowel involvement in active Crohn’s disease

• Patients receive an ultrasound, MRI, and (in case of colonic involvement) colonoscopy as part of standard care

• Key inclusion criteria:

  No patients with disease activity limited only to the rectum, anal canal, or upper gastrointestinal tract

OMICROHN

• Compares treatment outcomes based on epigenetic marker-guided therapy versus standard practice therapy selection in patients with active Crohn’s disease (no placebo)

• Treatment selection between vedolizumab (Entyvio®) — an anti-integrin agent that blocks immune cell migration to the gut — and ustekinumab (Stelara®) — an IL-12/23 inhibitor with anti-inflammatory effects — is made either based on epigenetic markers or according to standard clinical practice

• Key inclusion criteria:
Sufficient gastrointestinal symptoms and inflammation visible at endoscopy
History of maximum one prior advanced Crohn’s disease medication