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: Crohn’s Disease With Evidence of Mucosal Ulceration; MedDRA version: 17.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-07
• Last Update Posted: 25 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 of Ulcers subscore of the Simplified Endoscopy Score for CD (SES CD) and total score of at least 7.
5. Treatment with oral steroids (= 30 mg prednisolone equivalent/day or budesonide dose = 9 mg/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 (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 anti-TNF treatment, where treatment was stopped for other reasons (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 in male subjects.
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 (and agreed by the subject) at least 25 days prior to the first dose of the study drug. Subjects whose immunomodulators (e.g. thiopurines and methotrexate) were discontinued prior to Screening are also permitted to participate. In these cases documented evidence for the reasons of discontinuation should be provided.
9. The results of the following laboratory tests during 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 = 1.0 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. 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 wi

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, 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 test positive for stool culture of enteric pathogens, ova or parasites during the screening period.
7. Subject has received nonsteroidal anti-inflammatory drugs within 14 days prior to Screening or during screening period.
8. Subject has received therapeutic enema or suppository, other than required for colonoscopy, within 7 days prior to screening or 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. Subjects who have previously received either lymphocyte apheresis or selective monocyte granulocyte apheresis within 12 months prior to Screening or during screening period.
13. Subjects who have previously received fecal microbiota transplants or stem cell transplantation.
14. Subjects who have received previous treatment with investigational chemical agents within 4 weeks prior to Screening or during screening period.
15. Subjects who have previously received treatment with biological IMPs including murine, chimeric or humanized monoclonal antibodies or a chemokine receptor blocker within less 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 GI tract (high or low grade, flat or raised including discrete adenoma-like dysplasia or indefinite dysplasia) or found to have above described dysplasia in any biopsy performed during the screening colonoscopy.
18. Concurrent 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, or signs and symptoms suggestive of, lymphoproliferative disease including lymphadenopathy or splenomegaly.
20. Positive serology for 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 (excluding fungal infections of nail beds), 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 (except Crohn’s disease related antibiotics). Im

Study & Design

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