Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Crohn’s Disease
• Age: Between 18 years - 80 years
• Gender: Male

• Other Inclusion Criteria:
  

  1. Subjects who are between the ages of 18-80 years old and able to provide written consent and to comply with the requirements of this study protocol.
  2. Subjects with confirmed diagnosis of CD for at least 3 months prior to Baseline
  3. Subjects whose crohn's disease activity index (CDAI) score 220 – 450 at Baseline
  4. Subjects with endoscopic evidence of mucosal inflammation as documented by an SES-CD of ≥3.
  5. Subjects with average daily SF ≥4 and/or average daily AP score ≥2 at Baseline
  6. Subjects who demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates, oral locally acting steroids, systemic steroids, immunomodulators, and/or biologic therapies
  7. Female subjects of childbearing potential must have a negative serum pregnancy test result during Screening, and a negative urine pregnancy at Baseline and use the birth control methods listed in the protocol

  
  

You may not be eligible for this study if the following are true:

• 1. Subjects with a current diagnosis of ulcerative colitis or indeterminate colitis
  2. Subjects on CD-related antibiotics who has not been on stable doses for greater than, or discontinued within, 14 days prior to Baseline
  3. Subjects on oral aminosalicylates
  4. Subjects taking oral corticosteroids
  5. Subjects on immunomodulators (AZA, 6-MP, MTX)as per the protocol
  6. Subjects who received IV anti-infectives within 35 days prior to Baseline visit or oral/intramuscular anti-infectives (non-CD-related) within 14 days prior to the Baseline visit
  7. Subjects who received exclusive enteral nutrition or any parenteral nutrition within 35 days prior to Baseline.
  8. Subjects who received any live bacterial or viral vaccination within 30 days prior to Screening or during the Screening Period.
  9. Subjects who received cyclosporine, tacrolimus, or mycophenolate mofetil within 35 days prior to Baseline
  10. Subject who received fecal microbial transplantation within 35 days prior to Baseline
  11. Subjects who received any approved biologic agents or any investigational biologic or other agent or procedure
  12. Subjects with prior exposure to p19 inhibitors
  13. Subject has been taking combination of two or more of the following: oral budesonide, or oral beclomethasone and/or oral prednisone (or equivalent) simultaneously, with the exception of inhalers, within 14 days prior to Screening or during the Screening period
  14. Subject who received IV/intramuscular corticosteroids within 14 days prior to Screening or during the Screening period
  15. Subject who received therapeutic enema or suppository, other than required for endoscopy, within 14 days prior to endoscopy used for Screening or during the Screening period
  16. Subjects who received apheresis ≤60 days prior to Screening or during the Screening period.
  17. Subject who has concomitant cannabis use either recreational or for medical reasons within 14 days of Baseline or any history of clinically significant drug, or alcohol abuse in the last 12 months.
  18. Subjects with currently known complications of CD
  19. Subjects with ostomy or ileoanal pouch
  20. Subjects diagnosed with short gut or short bowel syndrome
  21. Subjects with surgical bowel resection within the past 3 months prior to Baseline, or a history of ≥3 bowel resections
  22. Subjects who are pregnant or breastfeeding
  23. Subjects with history of dysplasia of the gastrointestinal tract or lymphoproliferative disease, malignancy or has servere, progressive or uncontrolled renal, hepatic, hematological, endocrine, disorder or symptoms thereof.
  24. Subjects with any condition, including any physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study