A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Intervention: Risankizumab 600 mg IV; Risankizumab 180 mg SC
Intervention description: Re-induction treatment; 3 infusions every 4 weeks, after which eligibility was assessed if clinical response was re-gained; Maintenance treatment every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who re-gained their clinical response following the re-induction treatment could continue with maintenance treatment beginning at Visit 5.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Participants with clinical response or remission at the end of Study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993) or at screening for this study were rolled over directly into this study and received maintenance therapy of risankizumab 180 mg administered subcutaneously (SC) every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who lost response or remission between the completion of Study NCT02031276 and enrollment in this study received open-label intravenous (IV) re-induction treatment with risankizumab consisting of 3 infusions of 600 mg IV every 4 weeks (q4w), after which eligibility was assessed if clinical response was re-gained. If clinical response or remission was achieved, participants continued with maintenance treatment of risankizumab 180 mg SC q8w beginning at Visit 5.
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ABBV-066; BI 655066; Risankizumab

Summary:

      The primary objective of the study was to investigate long-term safety of risankizumab (BI
      655066/ABBV-066) in participants with moderately to severely active Crohn's disease who
      showed a clinical response or remission on previous treatment with risankizumab in Study
      NCT02031276 (BI trial 1311.6/ AbbVie M15-993) and were now receiving long-term treatment.
      Additional objectives of this study were to further investigate long-term efficacy,
      tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of risankizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with Crohn's disease, who had successfully completed the preceding trial
             NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Successful treatment
             is defined as:

               1. Completion of period 2 in 1311.6 with a clinical response (drop in Crohn's
                  Disease Activity Index (CDAI) from baseline by ≥100) but no remission (CDAI <
                  150) at Visit E1; or

               2. Completion of period 3 in 1311.6 with a clinical response (drop in CDAI from
                  baseline by ≥100) and/or remission (CDAI < 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 can 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 participants:

               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 intrauterine device, or

               2. Surgically sterilized female participants 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 participants:

               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.

        Exclusion Criteria:

          -  Participants who were not compliant with key study procedures (colonoscopy, treatment
             compliance, endpoint assessment, contraception measures) in preceding trial 1311.6

          -  Participants who could not tolerate risankizumab (BI 655066/ ABBV-066) 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.

          -  Participants 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.

          -  Participants 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