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Evaluation of Efficacy and Safety of MEDI2070 in Subjects With Active, Moderate to Severe Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02574637
Recruitment Status : Terminated
First Posted : October 14, 2015
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE September 24, 2015
First Posted Date  ICMJE October 14, 2015
Last Update Posted Date July 26, 2018
Actual Study Start Date  ICMJE January 5, 2016
Actual Primary Completion Date July 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2015)
The primary endpoint of the study is Crohn's Disease Activity Index (CDAI) clinical remission at Week 8, defined by a CDAI score of < 150 [ Time Frame: Week 8 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2015)
  • A decrease in stool frequency from baseline at Week 8, Week 16 and Week 28 [ Time Frame: Week 8, Week 16 and Week 28 ]
  • A reduction of at least 100 points from baseline in Crohn's Disease Activity Index (CDAI) at Week 8, Week 16 and Week 28 [ Time Frame: Week 8, Week 16 and Week 28 ]
  • Crohn's Disease Activity Index (CDAI) clinical remission at Week 16 and Week 28 [ Time Frame: Week 16 and Week 28 ]
  • Simple Endoscopic Score for Crohn's Disease (SES-CD) improvement in gut mucosa at Week 16 and Week 28 [ Time Frame: Week 16 and Week 28 ]
  • Sustained decrease in stool frequency from baseline at Week 8 and Week 28 [ Time Frame: Week 8 and Week 28 ]
  • Crohn's Disease Activity Index (CDAI) Modified sustained clinical remission at Week 8 and Week 28 [ Time Frame: Week 8 and Week 28 ]
  • Simple Endoscopic Score for Crohn's Disease (SES-CD) sustained improvement in gut mucosa at Week 16 and Week 28 [ Time Frame: Week 16 and Week 28 ]
  • Correlate biomarkers with clinical outcomes at Week 8 [ Time Frame: Week 8 ]
  • Serum concentration evaluation of MEDI2070 levels [ Time Frame: Weeks 1-28 ]
  • Number of incidences of Anti-drug antibodies (ADA) against MEDI2070 [ Time Frame: Weeks 4-52 ]
  • Number of incidences of treatment-emergent adverse events [ Time Frame: Weeks 0-80 ]
  • Number of incidences of treatment-emergent serious adverse events [ Time Frame: Weeks 0-80 ]
  • Number of incidences of treatment-emergent adverse events of special interest [ Time Frame: Weeks 0-80 ]
  • Number of incidences of adverse events leading to investigational product discontinuation [ Time Frame: Weeks 0-48 ]
  • Number of incidences of specific laboratory abnormalities [ Time Frame: Weeks 0-80 ]
  • A decrease in abdominal pain from baseline at Week 8, Week 16 and Week 28 [ Time Frame: Week 8, Week 16 and Week 28 ]
  • Sustained decrease abdominal pain from baseline at Week 8 and Week 28 [ Time Frame: Week 8 and Week 28 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Efficacy and Safety of MEDI2070 in Subjects With Active, Moderate to Severe Crohn's Disease
Official Title  ICMJE A Phase 2b Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy
Brief Summary A Phase 2b study to evaluate the efficacy and safety of MEDI2070 in Subjects with Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy
Detailed Description This is a four-part Phase 2b study comprised of a 16-week, double-blind, placebo-controlled, Induction Period, a 12-week double-blind, placebo-controlled, Maintenance Period, a 24-week, Open-label Period and a post-treatment 28 week observational safety follow-up period designed to evaluate the short-term efficacy and the short- and long term safety of MEDI2070 in subjects with moderate to severe, active CD who have failed or are intolerant to anti-TNFα therapy as determined by the Investigator.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: MEDI2070 High dose
    MEDI2070 intravenous (IV)infusion wks 0 & 4 plus placebo SC injection wks 0 & 4, and then subcutaneous (SC) dose of MEDI2070 every 4 wks through week 24. Beginning at wk 28, SC dose of MEDI2070 once every 4 weeks during the Open-label Period.
  • Drug: MEDI2070 High-Med dose
    MEDI2070 intravenous (IV) infusion wk 0 plus placebo SC injection wk 0, and then subcutaneous (SC) dose of MEDI2070 wk 4 plus placebo IV infusion wk 4, and then subcutaneous (SC) dose of MEDI2070 every 4 wks from wk 8 through week 24. Beginning at wk 28, SC dose of MEDI2070 once every 4 weeks during the Open-label Period.
  • Drug: MEDI2070 Low-Med dose
    Subcutaneous (SC) low-med dose of MEDI2070 wk 0 & wk 4 plus placebo intravenous (IV) infusion wk 0 & wk 4, then subcutaneous (SC) low-med dose of MEDI2070 every 4 wks wk 8 through week 24. Beginning at wk 28, SC dose of MEDI2070 once every 4 weeks during the Open-label Period.
  • Drug: MEDI2070 Low dose
    Subcutaneous (SC) low dose of MEDI2070 Wk 0 & Wk 4 plus intravenous (IV) Placebo dose Wk 0 & Wk 4, then subcutaneous (SC) low dose of MEDI2070 every 4 wks wk 8 through week 24. Beginning at wk 28, SC dose of MEDI2070 once every 4 weeks during the Open-label Period.
  • Drug: Placebo
    Placebo SC and IV infusion wks 0 & 4 and then SC dose of placebo every 4 weeks wk 8 through wk 24. then SC dose of MEDI2070 once every 4 weeks during Open Label period.
Study Arms  ICMJE
  • Experimental: MEDI2070 High dose
    MEDI2070 intravenous (IV) infusion and Placebo SC injection weeks 0 and 4 wks. Then subcutaneous (SC) dose of MEDI2070 every 4 wks through week 24. Beginning at wk 28, SC dose of MEDI2070 once every 4 weeks during the Open-label Period.
    Intervention: Drug: MEDI2070 High dose
  • Experimental: MEDI2070 High-Med dose
    MEDI2070 intravenous (IV) infusion wk 0 and then subcutaneous (SC) dose of MEDI2070 every 4 wks through week 24. Beginning at wk 28, SC dose of MEDI2070 once every 4 weeks during the Open-label Period.
    Intervention: Drug: MEDI2070 High-Med dose
  • Experimental: MEDI2070 Low-Med dose
    Subcutaneous (SC) dose of MEDI2070 every 4 wks through week 24. Beginning at wk 28, SC dose of MEDI2070 once every 4 weeks during the Open-label Period.
    Intervention: Drug: MEDI2070 Low-Med dose
  • Experimental: MEDI2070 Low dose
    Subcutaneous (SC) dose of MEDI2070 every 4 wks through week 24. Beginning at wk 28, SC dose of MEDI2070 once every 4 weeks during the Open-label Period.
    Intervention: Drug: MEDI2070 Low dose
  • Placebo Comparator: Placebo
    Placebo SC and IV infusion wks 0 & 4 and then SC dose of placebo every 4 weeks through wk 24. SC dose of MEDI2070 once every 4 weeks during Open Label period.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 28, 2017)
29
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2015)
342
Actual Study Completion Date  ICMJE January 29, 2018
Actual Primary Completion Date July 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of ileal, ileo-colonic, or colonic Crohn's Disease (CD) for > 3 months prior to screening - Men or women age 18 - 80 years at the time of screening - Moderate to severely active CD, as defined by Crohn's Disease Activity Index (CDAI) AND endoscopic demonstration of inflammation - Stable dose of medications for Crohn's disease therapy -Prior treatment failure or intolerance with at least one Anti Tumor Necrosis Factor-Alpha Therapy (anti-TNF α) agent. -Effective contraception from screening, and for 36 weeks after the last dose of investigational product -No known history of active tuberculosis (TB) & negative assessment for TB/latent TB

Exclusion Criteria:

  • Severe underlying immunosuppression
  • Severe gastrointestinal complications; e.g., short bowel syndromes, obstructing strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation
  • Significant infections at screening; Infected abscess, positive for Clostridium difficile, recent infectious hospitalization,
  • Recent treatment with approved or investigational biologic therapy for Crohn's disease
  • Recent or planned live attenuated vaccine
  • History of cancer, except for basal cell carcinoma or CIS of the cervix with apparent cure ≥ 12 months before screening
  • Pregnancy/breast feeding
  • Drug abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Russian Federation,   Spain,   United States
Removed Location Countries Bulgaria,   Czech Republic,   Korea, Republic of,   Poland,   Turkey,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT02574637
Other Study ID Numbers  ICMJE D5170C00002
2015-000609-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Carl Gommoll, MS Allergan
PRS Account Allergan
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP