Safety and Efficacy of Andecaliximab (GS-5745) in Adults With Moderately to Severely Active Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02520284
• Date of registration: 07/08/2015
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences
• Public title: Safety and Efficacy of Andecaliximab (GS-5745) in Adults With Moderately to Severely Active Ulcerative Colitis
• Scientific title: A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Ulcerative Colitis
• Date of first enrolment: September 2015
• Target sample size: 165
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02520284
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Czechia, France, Germany, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Korea, Republic of, Latvia, Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Gilead Study Director
• Affiliation: Gilead Sciences

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Ulcerative Colitis (UC) confirmed on endoscopy

- Moderately to severely active UC (Mayo Score 6-12)

- May be receiving oral 5-aminosalicylate (ASA), oral corticosteroid, azathioprine,
6-mercaptopurine (MP), or methotrexate

- Treatment failure with at least one of the following agents received: corticosteroids,
immunomodulators, tumor necrosis factor-alpha (TNFa) antagonists, vedolizumab

Key Exclusion Criteria:

- Diagnose of Crohn's disease or indeterminate colitis

- Pregnant or lactating females

- Any chronic medical condition (including, but not limited to cardiac or pulmonary
disease, alcohol or drug abuse)

- Exhibit severe UC / clinically significant active infection

- History of malignancy in the last 5 years

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

Ulcerative Colitis

Intervention(s)

Biological: Andecaliximab

Biological: Placebo

Primary Outcome(s)

For Cohort 1, Percentage of Participants With EBS Clinical Remission at Week 8 [Time Frame: Week 8]

Secondary Outcome(s)

For Cohort 1, Percentage of Participants With Mucosal Healing as Determined by the Geboes Histologic Scoring System at Week 8 [Time Frame: Week 8]

For Cohort 1, Percentage of Participants With MCS Remission at Week 8 [Time Frame: Week 8]

For Cohort 1, Percentage of Participants With MCS Remission (Alternative Definition) at Week 8 [Time Frame: Week 8]

For Cohort 1, Percentage of Participants With Endoscopic Remission at Week 8 [Time Frame: Week 8]

For Cohort 1, Percentage of Participants With Endoscopic Response at Week 8 [Time Frame: Week 8]

For Cohort 1, Percentage of Participants With MCS Response at Week 8 [Time Frame: Week 8]

Secondary ID(s)

GS-US-326-1100

2014-005217-24

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/04/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02520284