Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis

NCT02337608 | Completed Phase 2 DMC

• 2 other identifiers: GLPG1205-CL-2112014-001893-32
• Study Type: interventional
• Target: 64
• Locations: 6 countries
• Sites: 39

Brief Summary

• Approximately 60 patients suffering from moderate to severe ulcerative colitis will be evaluated for improvement of disease activity (efficacy) when taking GLPG1205 or matching placebo once daily for 12 weeks in addition to their stable background treatment.
• During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG1205 present in the blood (Pharmacokinetics) as well as the effects of GLPG1205 on disease- and mechanism of action-related parameters (Pharmacodynamics) in blood, stool and colonic biopsies will be determined.

Conditions

Ulcerative Colitis

Keywords

moderate to severe ulcerative colitis; GLPG1205

Outcome Measures

Primary Outcomes (1)

• Changes in Mayo score at Week 8

  To evaluate the efficacy of GLPG1205 in terms of changes in Mayo score comparing results at Week 8 with baseline between GLPG1205 treated subjects and placebo subjects

  Screening and Week 8

Secondary Outcomes (11)

• Changes in partial Mayo score

  From Screening to Week 12

• Histological response rate

  Screening and Week 8

• Number of subjects with adverse events

  From Screening to Week 16

• Number of subjects with abnormal laboratory parameters

  From Screening to Week 16

• Number of subjects with abnormal vital signs

  From Screening to Week 16

Study Arms (2)

GLPG1205 100mg QD

EXPERIMENTAL

GLPG1205 100mg daily dosing in the morning

Drug: GLPG1205

Placebo

PLACEBO COMPARATOR

Placebo daily dosing in the morning

Drug: Placebo

Interventions

GLPG1205 DRUG

GLPG1205 daily dosing in the morning for 12 weeks

GLPG1205 100mg QD

Placebo DRUG

placebo daily dosing in the morning daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects between 18 and 75 years
• Documented history of UC
• Presence of active UC for a minimum period of 14 days prior to screening and spread beyond the rectum, Mayo score ≥ 6 with rectal bleeding score ≥ 1 and endoscopy score ≥ 2
• Absence of infectious colitis
• Tumor necrosis factor alpha (TNFα) inhibitor-naive subjects should have failed at least 1 prior conventional therapy
• Continuation of concurrent treatment with oral steroids (≤30 mg prednisolone eq/day), immunosuppressants and 5-aminosalicylates at stable dose is allowed
• Female subjects must have a negative blood pregnancy test, unless they are surgically sterile, had a hysterectomy, or have been postmenopausal for at least 1 year
• Subjects will have to use highly effective contraceptive methods

You may not qualify if:

• History of sensitivity to any component of the study drug, or a history of drug or other allergy
• Any concurrent illness, condition, disability, or clinically significant abnormality that, in the investigator's opinion, represents a safety risk for the subject's participation, may affect the interpretation of data, or may prevent the subject from safely completing the assessments
• History of significant psychological, neurologic, hepatic, renal, endocrine, cardiovascular, GI (other than UC), pulmonary, or metabolic disease
• History of active infections requiring intravenous antibiotics within the past 4 weeks prior to screening.
• History of malignancy within the past 5 years; presence or history of intestinal malignancy
• History of bowel surgery within 6 months prior to screening; history of colon resection with \< 30 cm of the colon remaining
• Suspicion of Crohn's disease, indeterminate colitis, microscopic colitis, ischemic colitis, diverticular disease-associated colitis, or radiation-induced colitis
• Subject who has received non-permitted UC therapies within specified timeframes, depending on the medication, as stated in the protocol
• Subject who is pregnant or lactating

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (39)

St. Pierre University Hospital Center

Brussels, Belgium

Location

Leuven University Hospital

Leuven, Belgium

Location

Clinic Saint-Joseph

Liège, Belgium

Location

Hepato-Gastroenterology HK Ltd.

Hradec Králové, Czechia

Location

Outpatient Clinic of Internal Medicine and Gastroenterology

Pilsen, Czechia

Location

Orlickoustecka Hospital, Inc.

Ústí nad Orlicí, Czechia

Location

Regional Hospital T. Bata, Clinic of Internal Medicine

Zlín, Czechia

Location

Hospital Znojmo

Znojmo, Czechia

Location

Gastroenterology Specialist Practice

Berlin, Germany

Location

Asklepios West Hospital Hamburg, Clinic of Internal Medicine

Hamburg, Germany

Location

Hannover Medical School

Hanover, Germany

Location

University Hospital Jena

Jena, Germany

Location

Gastroenterology Group Practice Minden

Minden, Germany

Location

Gastroenterology Practice at Germania-Campus

Münster, Germany

Location

Internal Medicine Group Practice Oldenburg

Oldenburg, Germany

Location

Clinexpert Medical Center

Budapest, Hungary

Location

Hungarian Center for Obesity Ltd.

Budapest, Hungary

Location

Medical Centre, Hungarian Defence Forces

Budapest, Hungary

Location

Szent Margit Hospital

Budapest, Hungary

Location

Main Railway Outpatient Clinic Debrecen

Debrecen, Hungary

Location

Javorszky Odon Hospital

Vác, Hungary

Location

Healthcare Center Orkan Med Stec Michalska Spolka Jawna

Ksawerów, Poland

Location

Saint Family Hospital Medical Center

Lodz, Poland

Location

Sopmed Llc

Sopot, Poland

Location

H-T Medical Center

Tychy, Poland

Location

Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults

Warsaw, Poland

Location

Vivamed

Warsaw, Poland

Location

Active Health Center, Non-Public Healthcare Facility Zawidawie Center

Wroclaw, Poland

Location

Kazan State Medical University

Kazan', Russia

Location

Territorial Clinical Hospital

Krasnoyarsk, Russia

Location

Central Research Institute of Gastroenterology

Moscow, Russia

Location

Moscow Vladimirsky Regional Clinical Research Institute

Moscow, Russia

Location

Semashko Nizhny Novgorod Regional Clinical Hospital

Nizhny Novgorod, Russia

Location

City Clinical Hospital #12

Novosibirsk, Russia

Location

Penza Regional Clinical Hospital n.a. N. N. Burdenko

Penza, Russia

Location

City Clinical Hospital #31

Saint Petersburg, Russia

Location

City General Hospital #2

Saint Petersburg, Russia

Location

St. Venerable Martyress Elizabeth Municipal Hospital

Saint Petersburg, Russia

Location

Stavropol State Medical University

Stavropol, Russia

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

GLPG1205

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Frédéric Vanhoutte, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 13, 2015
• Study Start: December 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

HU (6); CZ (5); RU (11); BE (3); PL (7); DE (7)