Mild to moderate Ulcerative Colitis MedDRA version: 16.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: GLPG0974
Pharmaceutical Form: Capsule
INN or Proposed INN: GLPG0974
Current Sponsor code: G279874
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Sponsors
Galapagos NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Men or women between 18 to 75 years of age inclusive, on the day of signing the informed consent. 2.Documented history of UC (at least 6 months prior to randomization) with histological confirmation of diagnosis. 3.Presence of mild-to-moderately active ulcerative colitis for a minimum period of 14 days and spread beyond the rectum (inflammation extending =15 cm from anal verge) as evidenced by clinical signs and endoscopy. 4.Medication: 5-ASA for at least 12 weeks and stable dose for > 4 weeks or discontinued for> 4 weeks prior to randomization. Rectal medications stopped for > 2 weeks prior to randomization. 5.Baseline Mayo score 4-10 (inclusive) with rectal bleeding sub-score of = 1, endoscopy score = 1 and Physician’s rating of disease activity =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1.History of sensitivity to any component of the study drug, or a history of drug or other allergy that, in the Investigator’s opinion, contraindicates subject’s participation in the study. 2.Any concurrent illness, condition, disability or clinically significant abnormality (including laboratory tests) that, in the Investigator’s opinion, represents a safety risk for subject’s participation in the study, may affect the interpretation of clinical safety or efficacy data, or may prevent the subject to safely complete the assessments required by the protocol, including: a.Hemoglobin 1.5 x upper limit of normal (ULN) f.HbA1c > 6% g.Total bilirubin level >1.25 x ULN h.Creatinine clearance <80 mL/min using the Cockroft-Gault formula 3.Positive serology for human immunodeficiency virus (HIV)1 or 2 or hepatitis B or C, or any history of HIV or hepatitis from any cause with the exception of hepatitis A. 4.History of active infections requiring intravenous antibiotics within the past four weeks prior to randomization. 5.History of malignancy within the past five years (except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been treated with no evidence of recurrence). 6.History of bowel surgery within 12 months prior to screening, or presence or history of intestinal malignancy (if any unexpected lesion is observed during screening endoscopy, additional biopsies should be taken for histopathological assessment in the local lab to and recruitment into the study must be deferred until the results are available). 7.Suspicion of Crohn’s disease, indeterminate colitis, microscopic colitis, ischaemic colitis or radiation-induced colitis, based on medical history, endoscopy and/or histological findings. For subjects with a documented history of UC of = 8 years a total colonoscopy should have been done within the 2 years prior to screening or performed at Day 1 prior to randomization. to exclude the aforementioned conditions. 8.History of lower GI bleeding disorder, other than UC. 9.A history of significant psychological, neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal (other than UC), pulmonary or metabolic disease. 10.History of tuberculosis (TB) infection as determined by: a.positive diagnostic TB test result (defined as a positive QuantiFERON TB Gold test), OR b.a chest radiograph (both posterior-anterior and lateral views), taken within three months prior to screening and read by a qualified radiologist, with evidence of current active TB or old inactive TB. i.e. both tests must be negative for thesubject to be eligible. 11.Treatment with systemic corticosteroids within 1 week prior to randomization. 12.If topical corticosteroids are being used for other chronic inflammatory conditions, the subject may be included at the discretion of the Investigator after discussion with the medical monitor. 13.Treatment with TNF-a inhibitors or other biologics within 2 months prior to randomization. 14.Treatment with immunosuppressants (azathioprine or 6-mercaptopurine or methotrexate), if initiated within 3 months prior to randomization, or if changed in terms of drug or dose within 3 months prior to randomization . 15.Current use of probiotic or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1.To explore the efficacy of GLPG0974 versus placebo in mild to moderate Ulcerative Colitis (UC) by use of efficacy measures such as the Mayo score, Partial Mayo Score and histopathological Geboes index 2.To characterize the PK of GLPG0974 in UC subjects. 3.To explore the effects of GLPG0974 on selected biomarkers (e.g. faecal calprotectin, MPO in biopsy and serum CRP) and on microbiota. ;Primary end point(s): Safety Endpoints: - Frequency of Serious adverse events in GLPG0974 versus placebo group. - Frequency of Adverse events in GLPG0974 versus placebo group. - Changes in physical examinations, vital signs, 12-lead ECG and laboratory parameters over the duration of the study in GLPG0974 versus placebo group. ;Timepoint(s) of evaluation of this end point: At different timepoints from signing informed consent until follow-up visit : (S)AE, laboratory parameters Scr., D1, D8, D29 and D43: ECG and Vital signs Scr., D1, D29 and D43: Physical exam;Main Objective: To evaluate the safety and tolerability of GLPG0974 given to UC subjects for 28 days compared to placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Endpoints: - Mayo score - Partial Mayo Score - Geboes Index PK parameters: - GLPG0974 in blood PD parameters: - fecal calprotectin analysis on stool samples - MPO measurement on biopsy samples - serum CRP analysis - microbiota analysis on stool and biopsy samples;Timepoint(s) of evaluation of this end point: Efficacy Endpoints: - Mayo score: D1 and D29 - Partial Mayo score: D8 and D15 - Geboes Index: D1 and D29 PK parameters: D8, D15 and D29 PD parameters: - fecal calprotectin analysis on stool samples: D1, D8, D15 and D29 - MPO measurement on biopsy samples: D1 and D29 - serum CRP analysis: Scr., D1, D8, D15, D29 and D43 - microbiota analysis on stool and biopsy samples D1 and D29 | — |
Countries
Belgium, Czech Republic, Latvia
Contacts
Public ContactClinical Trial Information Desk
Galapagos NV
Outcome results
None listed