Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease

Gilead Sciences

Status and phase: Terminated; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: Placebo; Drug: Andecaliximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02405442

GS-US-395-1663

2015-001249-10 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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187 participants in 4 patient groups, including a placebo group

Andecaliximab 150 mg Every 2 Weeks

Experimental group

Description:

Double-Blind Phase: Participants will receive 1 single-use prefilled syringe (PFS) of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5, and 7. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for an additional 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks.

Treatment:

Drug: Andecaliximab

Drug: Placebo

Andecaliximab 150 mg Weekly

Experimental group

Description:

Double-Blind Phase: Participants will receive 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for an additional 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks.

Treatment:

Drug: Andecaliximab

Drug: Placebo

Andecaliximab 300 mg Weekly

Experimental group

Description:

Double-Blind Phase: Participants will receive 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for an additional 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks.

Treatment:

Drug: Andecaliximab

Placebo

Placebo Comparator group

Description:

Double-Blind Phase: Participants will receive 2 single-use PFS of placebo coadministered weekly for 8 weeks. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks.

Treatment:

Drug: Andecaliximab

Drug: Placebo