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 Crohn’s Disease

INTERVENTION: Product Name: GLPG1205 Product Code: G321605 Pharmaceutical Form: Capsule, hard Current Sponsor code: G321605 Other descriptive name: GLPG1205 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: Crohn’s Disease ; MedDRA version: 17.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 ‐ Gastrointestinal disorders Therapeutic area: Diseases [C] ‐ Digestive System Diseases [C06] PRIMARY OUTCOME: Main Objective: To demonstrate efficacy in terms of the change in Crohn’s Disease Activity Index (CDAI) score compared with baseline following 12 weeks of treatment with GLPG1205 100 mg once daily (qd) versus placebo in subjects with active moderate Crohn’s Disease (CD). Primary end point(s): Difference in CDAI change from baseline between GLPG1205‐ and placebo‐treated subjects at Week 12 Secondary Objective: ‐To evaluate the safety and tolerability of GLPG1205 given to CD subjects for 12 weeks compared with placebo.; ‐To evaluate the efficacy in terms of percentage of subjects achieving CDAI clinical response and/or clinical remission with GLPG1205 given qd compared with placebo.; ‐To characterize the pharmacokinetics (PK) of GLPG1205 in CD subjects.; ‐To explore the effects of GLPG1205 on selected biomarkers (e.g., fecal calprotectin and C reactive protein [CRP]).; Timepoint(s) of evaluation of this end point: at Week 12 SECONDARY OUTCOME: Secondary end point(s): Safety Endpoints: ; ‐ Frequency of Serious adverse events in GLPG1205 versus placebo ; group. ; ‐ Frequency of Adverse events in GLPG1205 versus placebo group. ; ‐ Changes in physical examinations, vital signs, 12‐lead ECG and ; laboratory parameters over the duration of the study in GLPG1205 ; versus placebo group. ; Efficacy endpoints: ; ‐ CDAI score at week 4, 8 and 12 ; ‐ CDAI response at week 4, 8 and 12 ; ‐ CDAI remission at week 4, 8 and 12 ; ; PK parameters: ; GLPG1205 in blood at week 4, 8, 12 ; ; PD assessments: ; ‐ serum CRP in blood samples at baseline, week 4, 8 and 12 and FU ; ‐ fecal calprotectin in stool samples at screening, baseline, week 4, 8 and 12 Timepoint(s) of evaluation of this end point: Weeks 4, 8, and 12; Fo Safety week 2 screening visit. INCLUSION CRITERIA: 1.Male or female between 18 and 75 years of age inclusive, on the day of signing the informed consent form. 2.Documented history of colonic or ileocolonic CD (at least 6 months prior to baseline) as assessed by colonoscopy and supported by histological assessment. 3.Crohn’s Disease Activity Index score during screening = 220 to = 450. 4.Evidence of active disease as demonstrated by a simplified endoscopic activity score (SES‐CD) > 7 with Presence of Ulcers subscore = 1 in at least 1 segment (confirmed by the Core Imaging Laboratory). 5.Absence of infectious colitis as evidenced by negative stool culture for enteric pathogens, negative Clostridium difficile cytotoxin assay, and negative microscopic stool examination for intestinal parasites. 6.Allowed current CD treatment: a.5‐Aminosalicylates ([5‐ASAs]; mesalazine, olsalazine, or sulfasalazine) for at least 12 weeks and at a stable dosage for > 4 weeks and will be maintained at this dosa