Analysis of BLyS-dependent signatures and biology in the intestinal mucosa of patients with inflammatory bowel disease

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Ex vivo response to drug of patient intestinal biopsies
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-observational without drug

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  BELIMUMAB
• Medical condition to be studied:
  Inflammatory bowel disease

Population studied

• Short description of the study population:
  Patients’ inclusion criteria; Patients males and females aged 18 years of age or older manifesting a diagnosed IBD (for at least 3 months prior to screening) with active inflammation (UC patients with a Mayo Endoscopic score of ≥2 and CD patients with a SES-CD score ≥7); ; Patients’ exclusion criteria; 1) A diagnosis for an active serious infection, including localized infections; 2) Any condition or disorder that, in the opinion of the investigator, might confound the study results or pose additional risk to the subject; 3) Any contraindications for one or more biopsy collection
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  50

Study design details

• Main study objective:
  The overall objective of this proposal is to lay the groundwork for further clinical investigation of anti-BAFF antibodies for the treatment of IBD.
• Data analysis plan:
  Transcriptional and protein expression data will be collected from each biopsy cultured ex vivo. Comparison of gene and protein expression under different stimulatory or inhibitory conditions will be performed.GraphPad Prism version v8.3 software was used for all statistical analyses. Comparison between two groups was assessed using the Student’s T-test, 2-tailed parametric and unpaired analysis. One-way ANOVA was used for comparisons of more than two groups. For explant culture analysis, fold changes relative to the control condition were transformed to logarithm in base 2, and values were assessed by a parametric One-sample T test. P values < 0.05 were considered statistically significant. Only significant values are labelled in the graphs. Levels of significance are labelled as follows: * = p < 0.05, ** = p < 0.001, *** = p < 0.001, **** p ≤ 0.0001.