Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Andecaliximab; Placebo
Intervention description: Andecaliximab administered via subcutaneous (SC) injection; Placebo to match andecaliximab administered via SC injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will primarily evaluate the safety and efficacy of andecaliximab in adults with
      active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by
      an Open-Label Extension. Participants who complete the Double-Blind Phase will be eligible to
      enroll in the optional Open-Label Extension for an additional 44 weeks. Participants who
      complete Week 52 assessments will be eligible to enter the Extended Treatment Phase to
      continue treatment with andecaliximab for an additional 156 weeks.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Ability to provide a written informed consent

          -  Females of childbearing potential must have a negative pregnancy test at screening and
             baseline

          -  Documented diagnosis of Crohn's disease with a minimum disease duration of 6 months
             with involvement of the ileum and/or colon at a minimum

          -  Moderately to severely active Crohn's disease as defined by a Crohn's Disease Activity
             Index (CDAI) total score between 220-450 (inclusive) AND with evidence of active
             disease as measured by ileocolonoscopy

          -  Within the previous 5 years, demonstrated an inadequate clinical response or
             intolerance of at least one of the following agents:

               -  Corticosteroids

               -  Immunomodulators

               -  Tumor necrosis factor-alpha (TNFα) antagonists

               -  Vedolizumab

          -  May be receiving the following drugs:

               -  Oral 5-aminosalicylate (5-ASA)

               -  Oral corticosteroid therapy

               -  Antidiarrheals for chronic diarrhea

               -  Azathioprine or 6-mercaptopurine (6-MP) or methotrexate

               -  Antibiotics for the treatment of Crohn's disease

          -  Able to comply with the dosing instructions for study drug and able to comply with the
             study visits and requirements

        Key Exclusion Criteria:

          -  Evidence of abscess at screening

          -  Extensive colonic resection (subtotal or total colectomy) or history of > 2 small
             bowel resections

          -  Ileostomy, colostomy, or symptomatic stenosis of the intestine

          -  Current use of oral corticosteroids at a dose equivalent to > 30 mg/day of prednisone

          -  Ulcerative colitis or indeterminate colitis

          -  Short bowel syndrome

          -  Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli,
             Salmonella, Shigella, Campylobacter or Yersinia

          -  Treatment with any monoclonal antibody within 4 weeks of screening

          -  History or evidence of colonic mucosal dysplasia

          -  HIV, hepatitis B, hepatitis C, or tuberculosis (TB) infection

          -  Participated in a clinical study with an investigational drug or biologic within the
             last 30 days

          -  Any chronic medical condition (including, but not limited to, cardiac or pulmonary
             disease) that, in the opinion of the investigator, would make the individual
             unsuitable for the study or would prevent compliance with the study protocol

        Note: Other protocol defined Inclusion/ Exclusion criteria may apply.