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ClinicalTrial.gov Identifier : NCT02513459

A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab) in Patients With Moderately to Severely Active Crohn's Disease

    Status Active, not recruiting
    Related Conditions
    Crohn's Disease

Enrollment Details

65 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type II phase trial.

Protocol ID
M15-989

Brief summary

Top

This is an open label, single group, long term safety extension trial to provide a long-term treatment option for subjects who responded to treatment with BI 655066/ABBV-066 (risankizumab) in a preceding trial.

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 75 Years

Canada: 1

0
Hamilton, ON
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Study Design

  • A target outcome that the study’s protocol aims to evaluate - things like: the occurrence of a disease, a symptom, sign, or lab abnormality, among others.
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    Endpoint Classification

    Safety Study

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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    Intervention Model

    Single Group Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Masking

    Open Label

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
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    Purpose

    Treatment

    • Patients with Crohn`s disease, who have successfully completed the preceding trial 1311.6. Successful treatment is defined as:
      1. Completion of period 2 in 1311.6 with a clinical response (drop in Crohn's Disease Activity Index from baseline by >/=100) but no remission (Crohn's Disease Activity Index < 150) at Visit E1; or
      2. Completion of period 3 in 1311.6 with a clinical response (drop in Crohn's Disease Activity Index from baseline by >/=100) and/or remission (Crohn's Disease Activity Index < 150) at Visit E5; or
      3. Completion of period 2 or 3 in 1311.6 per protocol with a clinical response or remission before initiation of 1311.20/M15989 may roll-over either directly if that response/remission is maintained or through an open-label i.v. re-induction phase if they have lost their previous response/remission.
    • Female patients:
      1. 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 20 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
      2. Surgically sterilized female patients with documentation of prior hysterectomy, tubal ligation or complete bilateral oophorectomy, or
      3. Postmenopausal women with postmenopausal is defined as permanent cessation >/=1 year of previously occurring menses, and
      4. Negative serum ß-Human Chorionic Gonadotrophin 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 20 weeks after last administration of study medication.
    • Be able to adhere to the study visit schedule and other protocol requirements.
    • Patients who were not compliant with key study procedures (colonoscopy, treatment compliance, endpoint assessment, contraception measures) in preceding trial 1311.6
    • Patients who could not tolerate BI 655066/ABBV-066 (Risankizumab) treatment for tolerability or safety reasons in the preceding trial
    • Are pregnant, nursing, or planning pregnancy while enrolled in the study, or within 20 weeks after receiving the last dose of study medication.
    • Patients must agree not to receive a live virus or bacterial or Bacille Calmette-Guérin vaccination during the study or up to 12 months after the last administration of study drug.
    • Patients who have developed malignancy, or suspicion of active malignant disease during the preceding trial
    • Are intending to participate in any other study using an investigational agent or procedure during participation in this study.
    • Cannot adhere to the concomitant medication requirements

More on this trial

ClinicalTrials.gov