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

Gilead Sciences

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Ulcerative Colitis

Treatments: Biological: Placebo; Biological: Andecaliximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02520284

GS-US-326-1100

2014-005217-24 (EudraCT Number)

Details and patient eligibility

About

The primary objectives of this study are as follows: 1) To evaluate the efficacy of andecaliximab to induce endoscopy, rectal bleeding, and stool frequency (EBS) clinical remission at Week 8 (Cohort 1); 2) To evaluate the efficacy of andecaliximab to maintain EBS clinical remission at Week 52 (Cohort 2); and 3) To evaluate the safety and tolerability of andecaliximab. The study will consist of 3 parts: Induction Phase (Cohort 1), Maintenance Phase (Cohort 2), and an optional Extended Treatment Phase.

Enrollment: 165 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and 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 (TNFα) 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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165 participants in 3 patient groups, including a placebo group

Andecaliximab Every 2 Weeks

Experimental group

Description:

Participants will receive andecaliximab 150 mg administered via subcutaneous (SC) injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab. Based on Week 8 assessment results, participants will either continue in Blinded Maintenance Treatment phase or will be offered Open-Label andecaliximab 150 mg administered via SC injection weekly for up to Week 51.

Treatment:

Biological: Placebo

Biological: Andecaliximab

Andecaliximab Weekly

Experimental group

Description:

Participants will receive andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses. Based on Week 8 assessment results, participants will either continue in Blinded Maintenance Treatment phase or will be offered Open-Label andecaliximab 150 mg administered via SC injection weekly for up to Week 51.

Treatment:

Biological: Andecaliximab

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses. Based on Week 8 assessment results, participants will either continue in Blinded Maintenance Treatment phase or will be offered Open-Label andecaliximab 150 mg administered via SC injection weekly for up to Week 51.

Treatment:

Biological: Placebo

Biological: Andecaliximab