Clinical trial NCT02520284: Safety and Efficacy of Andecaliximab (GS-5745) in Adults With Moderately to Severely Active Ulcerative Colitis
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-08-11
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: For Cohort 1, Percentage of Participants With EBS Clinical Remission at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: For Cohort 1, Percentage of Participants With MCS Remission at Week 8
timeFrame: Week 8
measure: For Cohort 1, Percentage of Participants With MCS Response at Week 8
timeFrame: Week 8
measure: For Cohort 1, Percentage of Participants With Endoscopic Remission at Week 8
timeFrame: Week 8
measure: For Cohort 1, Percentage of Participants With Endoscopic Response at Week 8
timeFrame: Week 8
measure: For Cohort 1, Percentage of Participants With Mucosal Healing as Determined by the Geboes Histologic Scoring System at Week 8
timeFrame: Week 8
measure: For Cohort 1, Percentage of Participants With MCS Remission (Alternative Definition) at Week 8
timeFrame: Week 8
Other outcomes:
Locations:
city: Dothan
country: United States
state: Alabama
city: Wheat Ridge
country: United States
state: Colorado
city: Lauderdale Lakes
country: United States
state: Florida
city: Miramar
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Zephyrhills
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Topeka
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Monroe
country: United States
state: Louisiana
city: Ann Arbor
country: United States
state: Michigan
city: Plymouth
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Egg Harbor Township
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Mentor
country: United States
state: Ohio
city: Rochester
country: United States
state: Ohio
city: Germantown
country: United States
state: Tennessee
city: Hermitage
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Baytown
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Southlake
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Chesapeake
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Wauwatosa
country: United States
state: Wisconsin
city: Footscray
country: Australia
city: Herston
country: Australia
city: Malvern
country: Australia
city: Melbourne
country: Australia
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Mouscron
country: Belgium
city: Pleven
country: Bulgaria
city: Victoria
country: Canada
state: British Columbia
city: Vaughan
country: Canada
state: Ontario
city: Hradec Kralove
country: Czechia
city: Nantes
country: France
city: Bekescsaba
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Dublin
country: Ireland
state: Leinster
city: Rozzano
country: Italy
city: San Giovanni Rotondo
country: Italy
city: Seoul
country: Korea, Republic of
city: Suwon-si
country: Korea, Republic of
city: Daugavpils
country: Latvia
city: Amsterdam
country: Netherlands
city: Christchurch
country: New Zealand
state: Canterbury Region
city: Auckland
country: New Zealand
city: Wellington
country: New Zealand
city: Bialystok
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Piaseczno
country: Poland
city: Poznan
country: Poland
city: Sopot
country: Poland
city: Sroda Wielkopolska
country: Poland
city: Tychy
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Bucharest
country: Romania
city: Timisoara
country: Romania
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Rostov-on-Don
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Trencin
country: Slovakia
city: Claremont
country: South Africa
state: Western Cape
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Taichung
country: Taiwan
city: Kharkov
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Vinnitsa
country: Ukraine
city: Cambridge
country: United Kingdom
city: Oxford
country: United Kingdom
city: Prescot
country: United Kingdom
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: