Clinical trial NCT02762500: An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative Colitis
Official title: A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Assess the Efficacy and Safety of Induction Therapy With LYC-30937-EC in Subjects With Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colitis, Ulcerative
Lead sponsor: Lycera Corp.
Sponsor class: INDUSTRY
First posted: 2016-05-05
Enrollment: 124
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 purpose of the study is to evaluate the efficacy and safety of LYC-30937-EC given orally once daily in subjects with active ulcerative colitis (UC) defined as a total Mayo score (TMS) of 4-11 inclusive, with an endoscopic score of ≥ 2 and a rectal bleeding score of ≥ 1 at screening.

Detailed description: Approximately 120 subjects will be randomized to receive either enteric-coated (EC) LYC-30937-EC 25 mg PO once daily (QD) or matching placebo PO QD for the duration of 8 weeks. Randomization will be stratified based on previous exposure to anti-tumor necrosis factor (TNF) agents such that at least 50% of the randomized subjects will be anti-TNF naïve .

The study will consist of 3 phases:

* screening phase: up to 4 weeks
* double-blind placebo-controlled phase treatment: 8 weeks
* post-treatment follow-up: 2 weeks

Eligible subjects will be randomized at Week 0 (Study Day 1) to either LYC-30937-EC 25 mg or placebo. Screening will occur from Study Days -28 to -1. Randomization and first dosing will occur at Week 0/Study Day 1. Double-blind study visits will occur at Weeks 2, 4, and 8, with the last dose at Week 8/Study Day 57. Subjects will return at Week 10 for a post-treatment safety follow-up visit.

Eligibility criteria: Inclusion Criteria:

* Clinical UC diagnosis ≥ 6 months prior to screening with minimum disease extent of ≥ 15cm from anal verge.
* Active UC defined as a TMS of 4-11 (inclusive) with endoscopic subscore of ≥ 2 and rectal bleeding subscore of ≥ 1 at screening.
* Females of childbearing potential must have a negative pregnancy test at screening and baseline visits and must agree to use acceptable methods of birth control while in the trial and for 30 days after taking the last dose of study drug.
* May be currently receiving treatment with oral aminosalicylates (ASA) for ≥ 6 weeks at a stable dose for ≥ 3 weeks prior to the screening screening endoscopy and/or thiopurine at a stable dose ≥ 8 weeks prior to the screening endoscopy and/or prednisone (dose 20 mg daily) or equivalent for ≥ 4 weeks and receiving stable dose for ≥ 2 weeks prior to screening endoscopy
* able to provide written informed consent and be compliant with study procedures.

Exclusion Criteria:

* History of Crohn's disease (CD) or indeterminate colitis or the presence or history of fistula consistent with CD.
* Presence of colon polyps.
* Severe extensive disease that in the investigators discretion is likely to require colonic surgery during the 8 week double-blind portion of the trial (eg, fulminant colitis, toxic megacolon, bowel perforation, evidence of acute abdomen).
* History of alcohol or drug abuse within 1 year of randomization.
* History of cancer including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been adequately treated with no recurrence for ≥ 1 year prior to screening.
* History or currently active primary or secondary immunodeficiency.
* Clinically relevant hepatic, neurologic, pulmonary, ophthalmological, gastrointestinal, endocrine, psychiatric, or other major systemic disease making implementation of the study difficult or that would put the subject at risk by participating in the study
* Positive test for Clostridium difficile or positive stool culture for enteric pathogens or presence of ova or parasites at screening.
* Liver function tests \> 1.5 x upper limit of normal (ULN) or direct bilirubin \> 1.5 x ULN
* Hemoglobin \< 8.5 g/dl
* Neutrophils \< 1500/mm3
* White blood cell (WBC) count \< 3000/mm3
* Platelets \< 80000 mm3
* International normalized ratio (INR) \> 1.5
* Treatment with an immunosuppressant agent within 8 weeks of screening.
* Previous exposure to ≥ 2 approved or investigational biologic agents to treat UC.
* History of UC treatment with a biologic agent within 12 weeks of screening.
* Treatment with rectal steroids within 2 weeks of screening.
* Treatment with an investigational agent within 30 days of screening.

Primary outcomes:
measure: Number of Subjects Who Achieve Clinical Remission at Week 8 Using Modified Mayo Score.
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of Subjects Who Achieve Clinical Remission at Week 8 Using the Total Mayo Score.
timeFrame: 8 weeks
measure: Number of Subjects With a Clinical Response on the Modified Mayo Score at Week 8.
timeFrame: 8 weeks
measure: Number of Subjects With a Clinical Response on the Total Mayo Score at Week 8.
timeFrame: 8 weeks
measure: Percent Change From Baseline to Week 8 in Fecal Calprotectin in Subjects With Baseline Fecal Calprotectin ≥ 250 µg/g
timeFrame: Baseline to Week 8
measure: Percent Change From Baseline in Total Mayo Score at Week 8.
timeFrame: Baseline to Week 8
Other outcomes:
measure: Number of Subjects With Type of Adverse Events (AEs) Serious Adverse Events (SAEs) and AEs That Led to Discontinuation of Treatment.
timeFrame: 10 weeks
Locations:
city: Little Rock
country: United States
facility: Lycera Investigational Site
state: Arkansas
city: Long Beach
country: United States
facility: Lycera Investigational Site
state: California
city: Mission Hills
country: United States
facility: Lycera Investigational Site
state: California
city: Rialto
country: United States
facility: Lycera Investigational Site
state: California
city: Hollywood
country: United States
facility: Lycera Investigational Site
state: Florida
city: Miami
country: United States
facility: Lycera Investigational Site
state: Florida
city: Decatur
country: United States
facility: Lycera Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Lycera Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Lycera Investigational Site
state: Illinois
city: Louisville
country: United States
facility: Lycera Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Lycera Investigational Site
state: Louisiana
city: Ann Arbor
country: United States
facility: Lycera Investigational Site
state: Michigan
city: Bronx
country: United States
facility: Lycera Investigational Site
state: New York
city: Brooklyn
country: United States
facility: Lycera Investigational Site
state: New York
city: New York
country: United States
facility: Lycera Investigational Site
state: New York
city: Greenville
country: United States
facility: Lycera Investigational Site
state: North Carolina
city: Flourtown
country: United States
facility: Lycera Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Lycera Investigational Site
state: Pennsylvania
city: Sayre
country: United States
facility: Lycera Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: Lycera Investigational Site
state: Tennessee
city: Union City
country: United States
facility: Lycera Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Lycera Investigational Site.
state: Texas
city: Houston
country: United States
facility: Lycera Investigational Sites
state: Texas
city: Houston
country: United States
facility: Lycera Investigational Site
state: Texas
city: Houston
country: United States
facility: Lycera Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Lycera Investigational Site
state: Texas
city: Victoria
country: Canada
facility: Lycera Investigational Site
state: British Columbia
city: Toronto
country: Canada
facility: Lycera Investigational Site
state: Ontario
city: Ostrava
country: Czechia
facility: Lycera Investigational Site
city: Praha 3
country: Czechia
facility: Lycera Investigational Site
city: Praha
country: Czechia
facility: Lycera Investigational Site
city: Slany
country: Czechia
facility: Lycera Investigational Site
city: Usti nad Labem
country: Czechia
facility: Lycera Investigational Site
city: Budapest
country: Hungary
facility: Lycera Investigational Site
city: Budapest
country: Hungary
facility: Lycera Investigational Site
city: Debrecen
country: Hungary
facility: Lycera Investigational Site
city: Debrecen
country: Hungary
facility: Lycera Investigational Site
city: Hatvan
country: Hungary
facility: Lycera Investigational Site
city: Amsterdam
country: Netherlands
facility: Lycera Investigational Site
city: Rotterdam
country: Netherlands
facility: Lycera Investigational Site
city: Bydgoszcz
country: Poland
facility: Lycera Investigational Site
city: Bydgoszcz
country: Poland
facility: Lycera Investigational Site
city: Katowice
country: Poland
facility: Lycera Investigational Site
city: Katowice
country: Poland
facility: Lycera Investigational Site
city: Katowice
country: Poland
facility: Lycera Investigational Site
city: Kielce
country: Poland
facility: Lycera Investigational Site
city: Krakow
country: Poland
facility: Lycera Investigational Site
city: Krakow
country: Poland
facility: Lycera Investigational Site
city: Ksawerów
country: Poland
facility: Lycera Investigational Site
city: Lublin
country: Poland
facility: Lycera Investigational Site
city: Lublin
country: Poland
facility: Lycera Investigational Site
city: Nowa Sól
country: Poland
facility: Lycera Investigational Site
city: Piaseczno
country: Poland
facility: Lycera Investigational Site
city: Poznan
country: Poland
facility: Lycera Investigational Site
city: Skierniewice
country: Poland
facility: Lycera Investigational Site
city: Sopot
country: Poland
facility: Lycera Investigational Site
city: Staszów
country: Poland
facility: Lycera Investigational Site
city: Szczecin
country: Poland
facility: Lycera Investigational Site
city: Warszawa
country: Poland
facility: Lycera Investigational Site
city: Warszawa
country: Poland
facility: Lycera Investigational Site
city: Wloclawek
country: Poland
facility: Lycera Investigational Site
city: Wroclaw
country: Poland
facility: Lycera Investigational Site
city: Wroclaw
country: Poland
facility: Lycera Investigational Site
city: Wrocław
country: Poland
facility: Lycera Investigational Site
city: Wrocław
country: Poland
facility: Lycera Investigational Site
city: Łódź
country: Poland
facility: Lycera Investigational Site
city: Belgrade
country: Serbia
facility: Lycera Investigational Site
city: Belgrade
country: Serbia
facility: Lycera Investigational Site
city: Kragujevac
country: Serbia
facility: Lycera Investigational Site
city: Niš
country: Serbia
facility: Lycera Investigational Site
city: Subotica
country: Serbia
facility: Lycera Investigational Site
city: Zrenjanin
country: Serbia
facility: Lycera Investigational Site
Study officials:
affiliation: Lycera Corp.
name: H. Jeffrey Wilkins, MD
role: STUDY_DIRECTOR
References: