Clinical Trials

Inclusion Criteria:

• Confirmed diagnosis of CD for at least 3 months prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of CD, as determined by the investigator, must be available.
• SES-CD (excluding the presence of narrowing component) ≥ 6 (or ≥ 4 for subjects with isolated ileal disease), as confirmed by a central reader.
• Average daily very soft or liquid SF ≥ 4.0 AND/OR average daily AP score ≥ 2.0 at Baseline.
• Demonstrated an inadequate response or intolerance to one or more of the following biologic agents:
  • At least one 6-week induction regimen of infliximab (≥ 5 mg/kg intravenous [IV] at Baseline and Weeks 2, and 6);
  • At least one 4-week induction regimen of adalimumab (one 160 mg subcutaneous [SC] dose at Baseline, followed by one 80 mg SC dose at Week 2 [or one 80 mg SC dose at Baseline, followed by one 40 mg SC dose at Week 2, in countries where this dosing regimen is approved]);
  • At least one 4-week induction regimen of certolizumab pegol (400 mg SC at Baseline and Weeks 2, and 4);
  • At least one 6-week induction regimen of vedolizumab (300 mg IV at Baseline and Weeks 2, and 6);
  • At least one 8-week induction regimen of ustekinumab [260 mg (≤ 55 kg) or 390 mg (> 55 to ≤ 85 kg) or 520 mg (> 85 kg) IV, followed by 90 mg SC at Week 8];
  • Recurrence of symptoms during scheduled maintenance dosing following prior clinical benefit of the above biologics;
  • Intolerance to a biologic may include, but not limited to infusion-related reaction, rash, serum sickness, anaphylaxis, elevated liver enzymes, demyelination, congestive heart failure, infection. Demonstration of intolerance requires no minimum dose or duration of use.

Exclusion Criteria:

• Subject with a current diagnosis of ulcerative colitis or indeterminate colitis.
• Subject on CD related antibiotics who:
  • has not been on stable doses of these medications for at least 14 days prior to Baseline; or
  • has discontinued these medications within 14 days of Baseline.
• Subject on oral aminosalicylates who:
  • has not been on stable doses of these medications for at least 14 days prior to Baseline; or
  • has discontinued these medications within 14 days of Baseline.
• Subject on corticosteroids who meet the following:
  • prednisone or equivalent dose > 30 mg/day; or
  • budesonide > 9 mg/day; or
  • has not been on the current course for at least 14 days prior to Baseline and on a stable dose for at least 7 days prior to Baseline.
• Subject on MTX who:
  • has not been on the current course for ≥ 42 days prior to Baseline, and has not been on a stable dose for ≥ 28 days prior to Baseline;
• Subject with the ongoing following known complications of CD:
  • abscess (abdominal or peri-anal);
  • symptomatic bowel strictures,;
  •  > 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum;
  • Confirmed COVID-19: the Baseline visit must be at least 14 days from onset of signs/symptoms or positive SARS-CoV-2 test, symptomatic subjects must have recovered, defined as resolution of fever without use of anti-pyretics and improvement in symptoms; 
  • Suspected COVID-19: subjects with signs/symptoms suggestive of COVID-19, known exposure, or high risk behavior should undergo molecular (e.g., PCR) testing to rule out SARS-CoV-2 infection or must be asymptomatic for 14 days from a potential exposure;
  • fulminant colitis;
  • toxic megacolon;
  • or any other manifestation that might require surgery while enrolled in the study.
• Subject with ostomy or ileoanal pouch.
• Subject diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome. 
• Subject with surgical bowel resection within the past 3 months prior to Baseline, or a history of > 3 bowel resections.
• Laboratory values meeting the following criteria within the Screening period prior to the first dose of study drug:
  • Serum aspartate transaminase (AST) or alanine transaminase (ALT) > 2.0 × upper limit of the reference range (ULN);
  • Total white blood cell count < 2500/µL;
  • Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula < 30 mL/min/1.73 m^2 ;
  • Hemoglobin < 9 g/dL;
  • Platelet count < 100,000/µL;
  • Absolute neutrophil count < 1200/µL;
  • Absolute lymphocyte count < 750/µL.