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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02405442
• Date of registration: 27/03/2015
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences
• Public title: Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease
• Scientific title: A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Crohn's Disease
• Date of first enrolment: April 30, 2015
• Target sample size: 187
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02405442
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Australia, Canada, Czech Republic, Czechia, France, Germany, Hungary, Iceland, Italy, New Zealand, Poland, South Africa, Spain, United Kingdom, United States

Contacts

• Name: Gilead Study Team
• Affiliation: Gilead Sciences

Key inclusion & 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 (TNFa) 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Andecaliximab

Drug: Placebo

Primary Outcome(s)

Percentage of Participants Achieving Clinical Response (PRO2 Score = 8) at Week 8 of the Double-Blind Phase [Time Frame: Week 8]

Percentage of Participants Achieving Endoscopic Response (= 50% Reduction From Baseline SES-CD) at Week 8 of the Double-Blind Phase [Time Frame: Week 8]

Secondary Outcome(s)

Percentage of Participants Achieving CDAI Remission (CDAI = 150) at Week 8 of the Double-Blind Phase [Time Frame: Week 8]

Percentage of Participants Achieving Mucosal Healing (SES-CD Size-of-Ulcer Subscore = 0) at Week 8 of the Double-Blind Phase [Time Frame: Week 8]

Secondary ID(s)

2015-001249-10

GS-US-395-1663

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02405442