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An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative Colitis

11 maart 2019 bijgewerkt door: Lycera Corp.

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

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

124

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 3M9
        • Lycera Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Lycera Investigational Site
  • Hongarije
      • Budapest, Hongarije, 1088
        • Lycera Investigational Site
      • Budapest, Hongarije, 1125
        • Lycera Investigational Site
      • Debrecen, Hongarije, 4031
        • Lycera Investigational Site
      • Debrecen, Hongarije, 4032
        • Lycera Investigational Site
      • Hatvan, Hongarije, 3000
        • Lycera Investigational Site
  • Nederland
      • Amsterdam, Nederland, 1081 HZ
        • Lycera Investigational Site
      • Rotterdam, Nederland, 3015 CE
        • Lycera Investigational Site
  • Polen
      • Bydgoszcz, Polen, 85-168
        • Lycera Investigational Site
      • Bydgoszcz, Polen, 85-681
        • Lycera Investigational Site
      • Katowice, Polen, 40-211
        • Lycera Investigational Site
      • Katowice, Polen, 40-659
        • Lycera Investigational Site
      • Katowice, Polen, 40-752
        • Lycera Investigational Site
      • Kielce, Polen, 25 364
        • Lycera Investigational Site
      • Krakow, Polen, 30-415
        • Lycera Investigational Site
      • Krakow, Polen, 31-009
        • Lycera Investigational Site
      • Ksawerów, Polen, 95-054
        • Lycera Investigational Site
      • Lublin, Polen, 20-362
        • Lycera Investigational Site
      • Lublin, Polen, 20-008
        • Lycera Investigational Site
      • Nowa Sól, Polen, 67-100
        • Lycera Investigational Site
      • Piaseczno, Polen, 05-500
        • Lycera Investigational Site
      • Poznan, Polen, 61-113
        • Lycera Investigational Site
      • Skierniewice, Polen, 96-100
        • Lycera Investigational Site
      • Sopot, Polen, 81-756
        • Lycera Investigational Site
      • Staszów, Polen, 28-200
        • Lycera Investigational Site
      • Szczecin, Polen, 71-270
        • Lycera Investigational Site
      • Warszawa, Polen, 02-507
        • Lycera Investigational Site
      • Warszawa, Polen, 04-749
        • Lycera Investigational Site
      • Wloclawek, Polen, 87-800
        • Lycera Investigational Site
      • Wroclaw, Polen, 50-053
        • Lycera Investigational Site
      • Wroclaw, Polen, 54-144
        • Lycera Investigational Site
      • Wrocław, Polen, 53-333
        • Lycera Investigational Site
      • Wrocław, Polen, 50-449
        • Lycera Investigational Site
      • Łódź, Polen, 93-034
        • Lycera Investigational Site
  • Servië
      • Belgrade, Servië, 11000
        • Lycera Investigational Site
      • Belgrade, Servië, 11080
        • Lycera Investigational Site
      • Kragujevac, Servië, 34000
        • Lycera Investigational Site
      • Niš, Servië, 18000
        • Lycera Investigational Site
      • Subotica, Servië, 24000
        • Lycera Investigational Site
      • Zrenjanin, Servië, 23000
        • Lycera Investigational Site
  • Tsjechië
      • Ostrava, Tsjechië, 722 00
        • Lycera Investigational Site
      • Praha, Tsjechië, 130 00
        • Lycera Investigational Site
      • Praha 3, Tsjechië, 130 00
        • Lycera Investigational Site
      • Slany, Tsjechië, 274 01
        • Lycera Investigational Site
      • Usti nad Labem, Tsjechië, 401 13
        • Lycera Investigational Site
  • Verenigde Staten
    • Arkansas
      • Little Rock, Arkansas, Verenigde Staten, 72212
        • Lycera Investigational Site
    • California
      • Long Beach, California, Verenigde Staten, 90822
        • Lycera Investigational Site
      • Mission Hills, California, Verenigde Staten, 91345
        • Lycera Investigational Site
      • Rialto, California, Verenigde Staten, 92377
        • Lycera Investigational Site
    • Florida
      • Hollywood, Florida, Verenigde Staten, 33021
        • Lycera Investigational Site
      • Miami, Florida, Verenigde Staten, 33176
        • Lycera Investigational Site
    • Georgia
      • Decatur, Georgia, Verenigde Staten, 30033
        • Lycera Investigational Site
      • Marietta, Georgia, Verenigde Staten, 30060
        • Lycera Investigational Site
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60637
        • Lycera Investigational Site
    • Kentucky
      • Louisville, Kentucky, Verenigde Staten, 40202
        • Lycera Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, Verenigde Staten, 70809
        • Lycera Investigational Site
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
        • Lycera Investigational Site
    • New York
      • Bronx, New York, Verenigde Staten, 10461
        • Lycera Investigational Site
      • Brooklyn, New York, Verenigde Staten, 11230
        • Lycera Investigational Site
      • New York, New York, Verenigde Staten, 10024
        • Lycera Investigational Site
    • North Carolina
      • Greenville, North Carolina, Verenigde Staten, 27834
        • Lycera Investigational Site
    • Pennsylvania
      • Flourtown, Pennsylvania, Verenigde Staten, 19031
        • Lycera Investigational Site
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • Lycera Investigational Site
      • Sayre, Pennsylvania, Verenigde Staten, 18840
        • Lycera Investigational Site
    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37212
        • Lycera Investigational Site
      • Union City, Tennessee, Verenigde Staten, 38261
        • Lycera Investigational Site
    • Texas
      • Houston, Texas, Verenigde Staten, 77030
        • Lycera Investigational Site
      • Houston, Texas, Verenigde Staten, 76092
        • Lycera Investigational Site.
      • Houston, Texas, Verenigde Staten, 77004
        • Lycera Investigational Sites
      • Houston, Texas, Verenigde Staten, 77004
        • Lycera Investigational Site
      • San Antonio, Texas, Verenigde Staten, 78229
        • Lycera Investigational Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: LYC-30937-EC 25 mg PO QD
LYC-30937-EC 25 mg by mouth once daily for 8 weeks
Geneesmiddel: LYC-30937-EC
Placebo-vergelijker: Placebo PO QD
Matching placebo by mouth once daily for 8 weeks
Geneesmiddel: Placebo

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Subjects Who Achieve Clinical Remission at Week 8 Using Modified Mayo Score.
Tijdsspanne: 8 weeks

The modified Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 9 points and consists of 3 subscores (stool frequency, rectal bleeding, endoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally.

Clinical remission on the modified Mayo score was defined as a Mayo stool frequency subscore of ≤ 1, Mayo rectal bleeding subscore of 0 and a Mayo endoscopy subscore of ≤ 1.
8 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Subjects Who Achieve Clinical Remission at Week 8 Using the Total Mayo Score.
Tijdsspanne: 8 weeks

The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, endoscopy, physicians global assessment), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally.

Clinical remission on the total Mayo Score is defined as a total Mayo score of ≤ 2, with no individual subscore > 1.
8 weeks
Number of Subjects With a Clinical Response on the Modified Mayo Score at Week 8.
Tijdsspanne: 8 weeks

The modified Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 9 points and consists of 3 subscores (stool frequency, rectal bleeding, endoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally.

Clinical response on the modified Mayo score at Week 8 was defined as a reduction from the baseline modified Mayo score of ≥ 2 points and ≥ 25%, and a decrease from baseline in rectal bleeding score of ≥ 1 point or absolute rectal bleeding score of ≤ 1 point.
8 weeks
Number of Subjects With a Clinical Response on the Total Mayo Score at Week 8.
Tijdsspanne: 8 weeks

The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, endoscopy, physicians global assessment), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally.

Clinical response on the total Mayo score at Week 8 was defined as a reduction from baseline total Mayo score of ≥ 3 points and ≥ 30%, and a decrease from baseline in rectal bleeding score of ≥ 1 point or absolute rectal bleeding score of ≤ 1 point.
8 weeks
Percent Change From Baseline to Week 8 in Fecal Calprotectin in Subjects With Baseline Fecal Calprotectin ≥ 250 µg/g
Tijdsspanne: Baseline to Week 8
Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.
Baseline to Week 8
Percent Change From Baseline in Total Mayo Score at Week 8.
Tijdsspanne: Baseline to Week 8

Analyzes the change in total Mayo score score between baseline and Week 8 for all randomized subjects who had total Mayo score scores at both baseline and Week 8.

The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, endoscopy, physicians global assessment), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally.
Baseline to Week 8

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Subjects With Type of Adverse Events (AEs) Serious Adverse Events (SAEs) and AEs That Led to Discontinuation of Treatment.
Tijdsspanne: 10 weeks
Adverse events (AEs) were collected from the time a subject signed the informed consent. Treatment-emergent adverse events (TEAEs) are AEs occurring or worsening after the first dose of study drug (LYC-30937-EC 25 mg or placebo). Adverse event severity was assessed by the Investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03, with grading as follows: Grade 1 = mild (asymptomatic or mild symptoms), Grade 2 = moderate (minimal, local intervention, or noninvasive intervention indicated); Grade 3 = severe (or medically significant but not life-threatening); Grade 4 = life-threatening; Grade 5 = death.
10 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Lycera Corp.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2016

Primaire voltooiing (Werkelijk)

1 mei 2018

Studie voltooiing (Werkelijk)

1 mei 2018

Studieregistratiedata

Eerst ingediend

3 mei 2016

Eerst ingediend dat voldeed aan de QC-criteria

3 mei 2016

Eerst geplaatst (Schatting)

5 mei 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 april 2019

Laatste update ingediend die voldeed aan QC-criteria

11 maart 2019

Laatst geverifieerd

1 maart 2019

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • LYC-30937-2001
  • 2016-000518-31 (EudraCT-nummer)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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