A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceratio

• Conditions: Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; Crohn’s Disease With Evidence of Mucosal Ulceration; MedDRA version: 17.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders

• Registration Number: EUCTR2013-002857-32-HU
• Lead Sponsor: Galapagos NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-04
• Last Update Posted: 18 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Male or female subjects between the ages of 18 and 75 years, on the day of signing informed consent.
2. Documented history of ileal, colonic, or ileocolonic CD (at least 3 months prior screening) as assessed by colonoscopy, and supported by histological assessment.
3. Crohn’s Disease Activity Index (CDAI) score during screening = 220 to = 450.
4. Evidence of active inflammation at screening as demonstrated by endoscopic confirmation of active disease (based on central reading) with evidence of ulceration corresponding to a score of 1 in at least 1 of the 5 ileocolonic segments on the Presence Ulcers subscore of the Simplified Endoscopy Score for CD (SES CD) and total score (excluding narrowing sub score) of at least 7.
5. Treatment with oral steroids (= 30 mg prednisolone equivalent/day or budesonide dose =9mg/day) is allowed, if at a stable dose since at least 2 weeks prior to the first dose of study drug.
6. Subjects previously not exposed to anti-TNF treatment (eg, TNF-naïve) or subjects previously exposed to anti-TNF therapy (eg, a single course of anti-TNF therapy with agents such as infliximab, adalimumab or certolizumab pegol) at a dose registered for the treatment of CD that has been discontinued at least 8 weeks prior to Baseline. Subjects deemed by the treating physician as a primary or secondary non-responder or intolerant to anti-TNF treatment or responders to anto-TNF treatmen, where treatment was stopped for other reason (TNF-experienced) can also be included.
7. Subjects are allowed to continue on concurrent treatment with the following agents:
a) Mesalazine and olsalazine if stable dosage for at least 4 weeks prior to Screening (same dosage to be maintained throughout the study). Previous exposure to sulfasalazine is permitted but must be discontinued at least 4 weeks prior to Screening.
b) Crohn’s Disease-related antibiotics if stable dosage for at least 4 weeks prior to Screening and no discontinuation in the 14 days prior to the first dose of study drug
c) Probiotics if stable dosage for 2 weeks prior to the first dose of study drug.
8. Previous exposure to immunomodulators (eg, thiopurines and methotrexate) is permitted, but must be discontinued at least 4 weeks prior to Screening. Documented evidence for the reasons of discontinuation should be provided.
9. The results of the following laboratory tests at screening must be as specified below:
a) Haemoglobin = 9 g/dL (International System of Units [SI]: = 90 g/L)
b) White blood cells (WBCs) = 3.0 x 109 cells/L
c) Neutrophils = 2.0 x 109 cells/L
d) Lymphocytes = 0.5 x 109 cells/L
e) Platelets = 100 x 109 cells/L
f) Serum alanine transaminase (ALT) and aspartate transaminase (AST) = 1.5 x ULN
g) Total bilirubin level = 1.5 x ULN
h) Alkaline phosphatase =1.5 x ULN
i) Lipase = 1.5 x ULN and amylase = 1.5 x ULN
j) Creatinine clearance > 60 mL/min and blood urea nitrogen (BUN) within normal ranges. Creatinine clearance will be calculated using the Cockroft-Gault formula.
10. Women of childbearing potential must have a negative blood pregnancy test, unless they are surgically sterile, had a hysterectomy, or have been postmenopausal for at least 1 year (12 consecutive months without menses); in case of doubt a determination of serum follicle-stimulating hormone (FSH) can be done with FSH levels > 35 mIU/mL confirming menopause status.
11. Subjects willing to use highly effective contraceptive methods prior to the first dose of the study

Exclusion Criteria

1. Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC.
2. Stoma, gastric or ileanal pouch, proctocolectomy or total colectomy, symptomatic stenosis or obstructive strictures, abscess or suspected abscess, history of bowel perforation.
3. Subject who has had surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study.
4. Subject who has short bowel syndrome.
5. Subject who is receiving tube feeding, defined formula diets, or total parenteral alimentation.
6. Subject with positive Clostridium difficile toxin stool assay or evidence of any other gastrointestinal infection (GI) (bacterial, viral, or parasitic) during the screening period.
7. Subject has received nonsteroidal anti-inflammatory drugs within 14 days prior to Screening.
8. Subject has received therapeutic enema or suppository, other than required for colonoscopy, within 7 days prior to and during screening period.
9. Subject has received intravenous corticosteroids within 14 days prior to Screening or during screening period.
10. If nonsystemic steroids are being used for other conditions than CD, subjects may be included at the discretion of the Investigator after discussion with the Medical Monitor.
11. Treatment with cyclosporine, mycophenolate mofetil, tacrolimus, or interferon within 10 weeks prior to Screening or during screening period.
12. Any prior treatment with lymphocyte-depleting agents. 13. Subjects who received treatment with more than one anti-TNF agent.
14. Subjects who have previously received fecal microbiota transplants or stem cell transplantation.
15. Subjects who have received previous treatment with investigational chemical agents withinless than 5 half-lives prior to Baseline. Previous treatment with a janus kinase inhibitor is prohibited.
16. Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the Investigator, such as anaphylaxis requiring hospitalization
17. Subject with a previous history of dysplasia of the gastrointestinal tract or found to have above described dysplasia in any biopsy performed during the Screening colonoscopy.
18. Concurrent gastro-intestinal (GI) malignancy or a history of cancer elsewhere (other than basal cell carcinoma or carcinoma in situ of the cervix successfully treated more than 5 years prior to the initial study drug administration).
19. History of lymphoproliferative disease; or signs and symptoms suggestive of possible lymphoproliferative disease including lymphadenopathy or splenomegaly
20. 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.
21. Known active infection of any kind or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks of the Screening visit or completion of oral anti-infectives within 2 weeks of the Screening visit Immunocompromised subjects who in the opinion of the investigator are at an unacceptable risk for participating in the study.
22. Previous history of symptomatic herpes zoster or herpes simplex infection within 12 weeks prior to Screening or have a history of disseminated/complicated herpes zoster infection
23.History of invasive infection
24.Significant blood loss (> 500 mL) or transfusion of any blood produ

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified