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

11 marca 2019 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

124

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: LYC-30937-EC 25 mg PO QD
LYC-30937-EC 25 mg by mouth once daily for 8 weeks
Lek: LYC-30937-EC
Komparator placebo: Placebo PO QD
Matching placebo by mouth once daily for 8 weeks
Lek: Placebo

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Subjects Who Achieve Clinical Remission at Week 8 Using Modified Mayo Score.
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Subjects Who Achieve Clinical Remission at Week 8 Using the Total Mayo Score.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Number of Subjects With Type of Adverse Events (AEs) Serious Adverse Events (SAEs) and AEs That Led to Discontinuation of Treatment.
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Lycera Corp.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 lipca 2016

Zakończenie podstawowe (Rzeczywisty)

1 maja 2018

Ukończenie studiów (Rzeczywisty)

1 maja 2018

Daty rejestracji na studia

Pierwszy przesłany

3 maja 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 maja 2016

Pierwszy wysłany (Oszacować)

5 maja 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 kwietnia 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 marca 2019

Ostatnia weryfikacja

1 marca 2019

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

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

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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