Status:
COMPLETED
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 (Andecaliximab) in Adults With Moderate to Severe Active Ulcerative Colitis
Lead Sponsor:
Gilead Sciences
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The primary objectives of this study are as follows: * To assess the safety and tolerability of escalating single and multiple doses of GS-5745 (andecaliximab) in participants with moderate to severe...
Detailed Description
The study will test the safety of the drug. Participants will be given different concentrations of the drug in Cohorts, starting from a lower dose to a higher dose. Single-Dose Treatment: A thorough...
Eligibility Criteria
Inclusion
- Key
- Male or Female, 18 to 65 years of age
- Negative pregnancy test at screening
- Documented diagnosis of UC with a minimum disease extent of 15 centimeters (cm) from the anal verge
- Mayo Score of at least 3 for the SAD cohort and Mayo Score of at least 6 for the MAD cohorts
- Hepatic panel (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin, direct bilirubin, alkaline phosphatase, lactate dehydrogenase \[LDH\] ≤ 2 times the upper limit of the normal range \[ULN\])
- Serum creatinine ≤ 1.5 times the ULN
- Hemoglobin ≥ 10 grams per deciliter (g/dL) (both males and females)
- Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (1,500 milli meters \[mm\]\^3)
- Platelets ≥ 100 x 10\^9/L.
- Key
Exclusion
- Pregnant or lactating females
- Exhibit severe UC/ clinically significant active infection
- Current use of oral corticosteroids at a dose equivalent to \> 20 mg/day of prednisone
- Any dose adjustment in oral corticosteroids or oral immunosuppressants (6-MP, Azathioprine), or oral 5-aminosalicylate (5-ASA) compounds within 30 days of Baseline
- Use of rectal formulations of 5-ASA compounds or corticosteroids within 2 weeks prior to randomization
- Crohn's disease or indeterminate colitis
- History of colectomy, partial colectomy, or dysplasia on biopsy
- Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli, Salmonella, Shigella, Campylobacter or Yersinia
- Treatment with Infliximab, Adalimumab, Natalizumab, Golimumab, Vedolizumab or Certolizumab within 8 weeks of randomization
- 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.
Key Trial Info
Start Date :
March 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2015
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01831427
Start Date
March 28 2013
End Date
February 6 2015
Last Update
February 1 2021
Active Locations (16)
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1
Delta Research Partners LLC
Monroe, Louisiana, United States, 71201
2
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
3
Clinical Research Institute of Michigan
Chesterfield Township, MI 48047, Michigan, United States, 48047
4
Ehrhardt Clinical Research, LLC
Belton, Missouri, United States, 64012