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Trial record 1 of 1 for:    D5170C00002
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Evaluation of Efficacy and Safety of MEDI2070 in Subjects With Active, Moderate to Severe Crohn's Disease

This study is currently recruiting participants.
Verified March 2017 by Allergan
Sponsor:
ClinicalTrials.gov Identifier:
NCT02574637
First Posted: October 14, 2015
Last Update Posted: April 4, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
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

Condition Intervention Phase
Crohn's Disease Drug: MEDI2070 High dose Drug: MEDI2070 High-Med dose Drug: MEDI2070 Low-Med dose Drug: MEDI2070 Low dose Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 342
Actual Study Start Date: January 5, 2016
Estimated Study Completion Date: June 18, 2019
Estimated Primary Completion Date: January 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574637


Contacts
Contact: Clinical Trials Registry Team 1-877-277-8566 IR-CTRegistration@allergan.com

  Show 159 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Carl Gommoll, MS Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02574637     History of Changes
Other Study ID Numbers: D5170C00002
2015-000609-38 ( EudraCT Number )
First Submitted: September 24, 2015
First Posted: October 14, 2015
Last Update Posted: April 4, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Allergan:
MEDI2070
inflammatory bowel disease
moderate to severe Crohn's Disease
IL-23

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases


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