Trial document




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  DRKS00010101

Trial Description

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Title

A multi-Centre, Exploratory Trial to Assess the Mechanisms of Molecular Activity, Safety and Tolerability of One Dose Level of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD)

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Trial Acronym

Future-010

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URL of the Trial

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Brief Summary in Lay Language

A Clinical Trial to Evaluate Activity, Safety and Tolerability of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD).

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Brief Summary in Scientific Language

exploratory trial to assess the mechanisms of molecular activity, safety and tolerability of one dose level of FE 999301 by i.v. infusions in patients with active Inflammatory Bowel Disease (IBD)

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Organizational Data

  •   DRKS00010101
  •   2016/07/25
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  •   yes
  •   Approved
  •   A102/16, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

  •   2016-000205-36 
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Health Condition or Problem studied

  •   10011401 (Crohn`s disease)
  •   10009900 (Colitis ulcerative)
  •   K50 -  Crohn disease [regional enteritis]
  •   C51 -  Malignant neoplasm of vulva
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Interventions/Observational Groups

  •   FE 999301 (selective IL-6 trans-signalling inhibitor) at one dose level (600mg) in seven infusions over 12 weeks.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   N/A
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Primary Outcome

Change from baseline to Week 14 in genome-wide gene expression of mucosal biopsies as assessed by RNA sequencing (RNAseq).

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Secondary Outcome

• Change from baseline to 4 and 24 hours after first i.v. infusion, Day 3, Weeks 2, 6, 10, and 14 in gene expression in blood and methylation pattern of blood and mucosal biopsies as assessed by RNAseq and reduced representation bisulfite sequencing (RRBS).
• Change from baseline to 4 and 24 hours after first i.v. infusion, Day 3, Weeks 2, 6, and 10 in gene expression of muscosal biopsies as assessed by RNAseq.
• Change from baseline to Week 14 in genome wide gene expression and methylation pattern of mucosal biopsies as assessed by RNA sequencing (RNAseq) and reduced representation bisulfite sequencing (RRBS).
• Descriptive immunophenotyping by fluorescence-activated cell sorting (FACS) at baseline and 4 and 24 hours after first i.v. infusion, Day 3, Weeks 2, 6, 10, and 14.
• Significant changes from baseline to Weeks 4 and 14 in phylogenomic composition of the mucosal and stool microbiome as assessed by 16s rDNA sequencing.
• Descriptive targeted metabolomic profiling (adiponectine, leptin, insulin, wnt5a, fFRP5, Lp(a), glucose, total cholesterol, LDL, HDL,
triglycerides, HbA1c) at baseline and Weeks 4 and 14.
• Decrease in CRP from baseline to Week 14 (% of start); percent of patients with normal CRP in Week 14 (only if increased at baseline)
• Improvement of the quality of life from baseline to week 14 measured by SF-36
• Change from baseline in IBD disease activity scores (Harvey-Bradshaw Index, Crohn's Disease Activity Index [CDAI], percentage of patients with CDAI 100 response, Mayo) over a 14-week time frame.
• Decrease in calprotectin from baseline to Week 14 (% of start); percent of patients with normal calprotectin (only if increased at baseline)
• Percent of patients with endoscopic improvement from baseline to Week 14 (partial Mayo, SES-CD); percent of patients with endoscopic remission
• UC patients only: Change from baseline in histologic activity scores over a 14-week time frame.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2016/08/23
  •   20
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

•The patient is able and willing to give written informed consent
•≥18 years of age
•Negative QuantiFERON-TB Gold In-Tube test within 3 months before
•Diagnosis of IBD >3 months prior to Visit 2
•Active IBD as confirmed by a CRP ≥5 mg/L and/or Calprotectin 250 mg/kg
•Previous treatment for IBD using conventional, non-biologic therapy for at least 3 months which has been stable for at least 14 days prior to Visit 2
•Full colonoscopy with serial biopsies with no signs of malignancy during screening

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Exclusion Criteria

•Current diagnosis of fulminant disease foreseeably needing hospitalization
•Discontinued use of AZA, 6-MP or MTX within 28 days of Visit 2
•Any need of parenteral therapies (except iron infusions).
•Treatment with more than two different types of biologics drugs or any biologic which is not an anti-TNF molecule or vedolizumab.
•Treatment with a biologic agent within 30 days or 5 half-lives prior to Visit 2 (whichever is longer).
•Treatment with cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days prior to Visit 2.
•Treatment with i.v. corticosteroids within 14 days prior to Screening or during the Screening Period.
•More than 20 mg (prednisolone equivalent) of oral corticosteroids within the last 28 days or not on a stable dose at least 14 days prior to Visit 2.
•Infections (including diverticulitis) requiring treatment with i.v. antibiotics, i.v. antivirals, or i.v. antifungals within 60 days prior to Visit 2 or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to Visit 2.
•Disease limited to the rectum, extending <15 cm past the anal verge
•History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC or is planning bowel surgery
•Moderate to severe anaemia (haemoglobin <9 g/dL)
•History of clinically significant drug or alcohol abuse during the previous year, as judged by the Investigator
•Treatment with any investigational medicinal product (IMP) within 30 days or 5 half-lives prior to Visit 2 (whichever is longer).
•Women of childbearing potential who test positive for pregnancy
•Breast-feeding, or lactating woman
•Known hypersensitivity to any component of FE 999301

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Addresses

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    • Universitätsklinikum Schleswig-Holstein (UKSH)
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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    • Klinik für Innere Medizin I
    • Mr.  Dr.  Claudio  Conrad 
    • Anrold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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    • Klinik für Innere Medizin I
    • Mr.  Dr.  Claudio  Conrad 
    • Anrold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Ferring Pharmaceuticals A/S
    • 2300  Copenhagen
    • Denmark
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    • Universitätsklinikum Schleswig-Holstein (UKSH)
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/04/30
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Trial Publications, Results and other Documents

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