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

11 de marzo de 2019 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

124

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: LYC-30937-EC 25 mg PO QD
LYC-30937-EC 25 mg by mouth once daily for 8 weeks
Droga: LYC-30937-EC
Comparador de placebos: Placebo PO QD
Matching placebo by mouth once daily for 8 weeks
Droga: Placebo

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Subjects Who Achieve Clinical Remission at Week 8 Using Modified Mayo Score.
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Subjects Who Achieve Clinical Remission at Week 8 Using the Total Mayo Score.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Subjects With Type of Adverse Events (AEs) Serious Adverse Events (SAEs) and AEs That Led to Discontinuation of Treatment.
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Lycera Corp.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2016

Finalización primaria (Actual)

1 de mayo de 2018

Finalización del estudio (Actual)

1 de mayo de 2018

Fechas de registro del estudio

Enviado por primera vez

3 de mayo de 2016

Primero enviado que cumplió con los criterios de control de calidad

3 de mayo de 2016

Publicado por primera vez (Estimar)

5 de mayo de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de abril de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

11 de marzo de 2019

Última verificación

1 de marzo de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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