Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— ORIGIN  

Official title:

Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients With Moderate to Severe Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02337608
• Other study ID #: GLPG1205-CL-211
• Secondary ID: 2014-001893-32
• Status: Completed
• Phase: Phase 2
• First received: January 9, 2015
• Last updated: November 18, 2015
• Start date: December 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 (TNFa) 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• GLPG1205
GLPG1205 daily dosing in the morning for 12 weeks
• Placebo
placebo daily dosing in the morning daily for 12 weeks

Locations

Country	Name	City	State
Belgium	St. Pierre University Hospital Center	Brussels
Belgium	Leuven University Hospital	Leuven
Belgium	Clinic Saint-Joseph	Liege
Czech Republic	Hepato-Gastroenterology HK Ltd.	Hradec Kralove
Czech Republic	Outpatient Clinic of Internal Medicine and Gastroenterology	Pilsen
Czech Republic	Orlickoustecka Hospital, Inc.	Usti nad Orlici
Czech Republic	Regional Hospital T. Bata, Clinic of Internal Medicine	Zlin
Czech Republic	Hospital Znojmo	Znojmo
Germany	Gastroenterology Specialist Practice	Berlin
Germany	Asklepios West Hospital Hamburg, Clinic of Internal Medicine	Hamburg
Germany	Hannover Medical School	Hannover
Germany	University Hospital Jena	Jena
Germany	Gastroenterology Group Practice Minden	Minden
Germany	Gastroenterology Practice at Germania-Campus	Muenster
Germany	Internal Medicine Group Practice Oldenburg	Oldenburg
Hungary	Clinexpert Medical Center	Budapest
Hungary	Hungarian Center for Obesity Ltd.	Budapest
Hungary	Medical Centre, Hungarian Defence Forces	Budapest
Hungary	Szent Margit Hospital	Budapest
Hungary	Main Railway Outpatient Clinic Debrecen	Debrecen
Hungary	Javorszky Odon Hospital	Vac
Poland	Healthcare Center Orkan Med Stec Michalska Spolka Jawna	Ksawerow
Poland	Saint Family Hospital Medical Center	Lodz
Poland	Sopmed Llc	Sopot
Poland	H-T Medical Center	Tychy
Poland	Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults	Warsaw
Poland	Vivamed	Warsaw
Poland	Active Health Center, Non-Public Healthcare Facility Zawidawie Center	Wroclaw
Russian Federation	Kazan State Medical University	Kazan
Russian Federation	Territorial Clinical Hospital	Krasnoyarsk
Russian Federation	Central Research Institute of Gastroenterology	Moscow
Russian Federation	Moscow Vladimirsky Regional Clinical Research Institute	Moscow
Russian Federation	Semashko Nizhny Novgorod Regional Clinical Hospital	Nizhny Novgorod
Russian Federation	City Clinical Hospital #12	Novosibirsk
Russian Federation	Penza Regional Clinical Hospital n.a. N. N. Burdenko	Penza
Russian Federation	City Clinical Hospital #31	Saint Petersburg
Russian Federation	City General Hospital #2	Saint Petersburg
Russian Federation	St. Venerable Martyress Elizabeth Municipal Hospital	Saint Petersburg
Russian Federation	Stavropol State Medical University	Stavropol

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Germany,  Hungary,  Poland,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Changes in partial Mayo score	To evaluate the efficacy of GLPG1205 in terms of changes in partial Mayo score comparing results with baseline between GLPG1205 treated subjects and placebo subjects at every visit up to Week 12	From Screening to Week 12	No
Secondary	Histological response rate	To evaluate the efficacy of GLPG1205 in terms of histological response rate by use of the histopathological Geboes index comparing results at Week 8 with baseline between GLPG1205 treated subjects and placebo subjects	Screening and Week 8	No
Secondary	Number of subjects with adverse events	To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of adverse events at every visit	From Screening to Week 16	Yes
Secondary	Number of subjects with abnormal laboratory parameters	To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal laboratory parameters at every visit	From Screening to Week 16	Yes
Secondary	Number of subjects with abnormal vital signs	To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal vital signs at every visit	From Screening to Week 16	Yes
Secondary	Number of subjects with abnormal electrocardiogram	To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal electrocardiograms at every visit	From Screening to Week 16	Yes
Secondary	Number of subjects with abnormal physical examination	To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal physical examination at every visit	From Screening to Week 16	Yes
Secondary	The plasma levels of GLPG1205	To characterize the pharmacokinetics (PK) of GLPG1205 by measuring the amount in plasma at Week 4, 8 and 12	Week 4, 8 and 12	No
Secondary	Changes in serum C-reactive protein (CRP) levels	To characterize the pharmacodynamics (PD) of GLPG1205 by measuring the levels of C-reactive protein in serum at every visit	From Screening to Week 16	No
Secondary	Changes in faecal calprotectin levels	To characterize the pharmacodynamics (PD) of GLPG1205 by measuring the levels of faecal calprotectin in stool at every visit up to Week 12	From Screening to Week 12	No
Secondary	Changes in myeloperoxidase (MPO) levels in colonic biopsies	To characterize the pharmacodynamics (PD) of GLPG1205 by measuring the levels of myeloperoxidase (MPO) in colonic biopsies at Screening and Week 8	Screening and Week 8	No