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Efficacy, Safety and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Patients With Active, Moderate-to-severe Crohn's Disease.

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02031276
First received: December 16, 2013
Last updated: November 30, 2016
Last verified: November 2016
  Purpose
This study is a proof of concept, multi-center, randomized, double-blind, placebo-controlled, parallel-group phase 2 dose-ranging study of BI 655066/ABBV-066 (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease.

Condition Intervention Phase
Crohn Disease Drug: ABBV-066 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Randomized, Double-blind, Multiple Dose, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of BI 655066/ABBV-066 (Risankizumab), an IL-23 p19 Antagonist Monoclonal Antibody, in Patients With Moderately to Severely Active Crohn's Disease, Who Are naïve to, or Were Previously Treated With Anti-TNF Therapy

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Proportion of patients achieving clinical remission at week 12, defined as a CDAI score of < 150 [ Time Frame: week 12 ]

Secondary Outcome Measures:
  • CDEIS remission, defined as a score of 4 or less at week 12 (for patients with initial isolated ileitis a score of 2 or less) [ Time Frame: week 12 ]
  • CDEIS response, defined as a score of 7 or less at week 12 (for patients with initial isolated ileitis >50% reduction from baseline) [ Time Frame: week 12 ]
  • Mucosal healing, defined as the absence of mucosal ulceration at week 12 [ Time Frame: week 12 ]
  • Deep remission, defined as clinical remission and endoscopic remission (CDEIS) at week 12 [ Time Frame: week 12 ]
  • Proportion of patients achieving clinical response at week 12 defined by either a CDAI score of < 150 or a CDAI reduction from baseline of at least 100 points [ Time Frame: week 12 ]

Enrollment: 121
Study Start Date: February 2014
Study Completion Date: November 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABBV-066 Low Dose IV (Double Blind Period 1)
Multiple, low doses of ABBV-066 by intravenous infusion
Drug: ABBV-066
ABBV-066 administered by IV infusion
Other Names:
  • BI 655066
  • risankizumab
Experimental: ABBV-066 High Dose IV (Double Blind Period 1)
Multiple, high doses of ABBV-066 by intravenous infusion
Drug: ABBV-066
ABBV-066 administered by IV infusion
Other Names:
  • BI 655066
  • risankizumab
Placebo Comparator: Placebo (Double Blind Period 1)
Multiple doses of placebo for ABBV-066 by intravenous infusion
Drug: Placebo
Placebo for ABBV-066
Experimental: ABBV-066 IV (Open-label Period 2)
Multiple, high doses of ABBV-066 by intravenous infusion
Drug: ABBV-066
ABBV-066 administered by IV infusion
Other Names:
  • BI 655066
  • risankizumab
Experimental: ABBV-066 SC (Open-label Period 3)
Multiple, low doses of ABBV-066 by subcutaneous injection
Drug: ABBV-066
ABBV-066 administered by SC injection
Other Names:
  • BI 655066
  • risankizumab

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Men or women 18-75 years at the time of consent.
  2. Diagnosis of Crohn's disease at least 3 months prior to screening.
  3. Moderate to severe active Crohn's disease, defined as CDAI >or=220 and <or=450.
  4. Presence of mucosal ulcers in at least one segment of the ileum or colon and a CDEIS score >4, as assessed by ileocolonoscopy and confirmed by central independent reviewer before randomization
  5. Patients who are naive or experienced to 1 or more TNF antagonists (infliximab, adalimumab, or certolizumab pegol) at a dose approved for Crohn's Disease.TNF antagonist experienced patients may have stopped anti-TNF treatment due to primary or secondary non-responsiveness, intolerance or for other reasons.
  6. Female patients:

    Women of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause), that, if sexually active agree to use one of the appropriate medically accepted methods of birth control in addition to the consistent and correct use of a condom from date of screening until 15 weeks after last administration of study medication. Medically accepted methods of contraception are: ethinyl estradiol containing contraceptives, diaphragm with spermicide substance, and intra-uterine-device, or

    1. Surgically sterilized female patients with documentation of prior hysterectomy, tubal ligation or complete bilateral oophorectomy, or
    2. Postmenopausal women with postmenopausal is defined as permanent cessation = 1 year of previously occurring menses, and
    3. Negative serum ß-Human Chorionic Gonadotrophin (ß-HCG) test at screening and urine pregnancy test prior to randomization.

    Male patients:

    1. Who are documented to be sterile, or
    2. Who consistently and correctly use effective method of contraception (i.e. condoms) during the study and 15 weeks after last administration of study medication.
  7. Have the capacity to understand and sign an informed consent form.
  8. Be able to adhere to the study visit schedule and other protocol requirements.

Exclusion criteria:

  1. Have complications of Crohn´s Disease such as strictures, stenoses, short gut syndrome, or any other manifestation that might require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the evaluation of benefit from treatment with BI 655066.
  2. Have any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to randomization and are not anticipated to require surgery. Patients with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses present.
  3. Have had any kind of bowel resection or diversion within 6 months or any other intra-abdominal surgery within 3 months prior to screening. Patients with a current ileostomy or colostomy are excluded.
  4. Have received treatment with:

    • Total parenteral nutrition (TPN) within 2 weeks of screening.
    • Any dose of ustekinumab (Stelara®).
    • Anti-TNF therapy = 8 weeks prior to the first administration of study medication or any other biologic = 8 weeks prior to the first administration of study drug or within 5 times the half-life of the biologic prior to the first administration of study agent, whichever is longer.
    • Natalizumab, efalizumab, or agents that deplete B or T cells (e.g., rituximab, alemtuzumab, or visilizumab) within 6 months of screening, or, if after receiving these agents, evidence is available at screening of persistent depletion of the targeted lymphocyte population.
    • Any investigational drug within the previous 4 weeks or 5 times the half-life of the investigational agent prior to the first administration of study agent, whichever is longer.
    • Regular daily use of opioids for medical reasons within previous 3 months prior to the first administration of study agent.
    • Rectal 5-ASA compounds, parenteral or rectal corticosteroids must have been discontinued at least 4 weeks prior to visit 2.
    • Cannot adhere to the concomitant medication requirements specified in section 4.2.2.
  5. Are pregnant, nursing, or planning pregnancy (both men and women) while enrolled in the study, or within 15 weeks after receiving the last dose of study medication.
  6. Have used apheresis (e.g., Adacolumn apheresis) = 2 weeks prior to screening.
  7. Have received any live bacterial or viral vaccination = 12 weeks prior to Day 1. Patients must agree not to receive a live virus or bacterial vaccination during the study or up to 12 months after the last administration of study drug.
  8. Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening. Patient must agree not to receive a BCG vaccination during the study or up to 12 months after the last study drug administration.
  9. Have signs or symptoms of infection, history of chronic or recurrent infection, have evidence of active herpes zoster infection <8 weeks of screening, have a sool culture or other examination positive for an enteric pathogen, have a history of latent or active granulomatous infection, infected with HIV virus, HepB or HepC virus, established nonserious infections
  10. Are not eligible accorging to TB screening criteria
  11. Have severe, progressive or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral or psychiatric disease or signs and symptoms.
  12. Have a transplanted organ
  13. Have known history of lymphoproliferative disease
  14. Have any malignancy or history of malignancy
  15. Have previously undergone allergy immunotherapy
  16. Are unable or unwilling to undergo multiple venipunctures
  17. Are known to have substance abuse
  18. Are currently or intending to participate in any other study
  19. Have screening laboratory test results within the protocol stated parameters
  20. Have a known hypersensitivity to study drug
  21. Have evidence of current or previous clinically significant disease, medical condition other than CD, finding of the medical examination or lab value.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02031276

  Show 44 Study Locations
Sponsors and Collaborators
AbbVie
Boehringer Ingelheim
Investigators
Study Chair: AbbVie Inc AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02031276     History of Changes
Other Study ID Numbers: M15-993
2013-002902-29 ( EudraCT Number )
1311.6 ( Other Identifier: Boehringer Ingelheim )
Study First Received: December 16, 2013
Last Updated: November 30, 2016

Keywords provided by AbbVie:
ABBV-066
BI 655066
risankizumab

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

ClinicalTrials.gov processed this record on September 21, 2017