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

Completed · Phase 2

Conditions studied: Crohn Disease

In brief

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.

Key facts

Study ID

NCT02513459

Run by

AbbVie

People needed

65

Starts

2015-09-16

Expected to finish

2019-06-19

Last updated by the study team

2020-04-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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
• 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
• 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:
• 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
• Surgically sterilized female participants with documentation of prior hysterectomy, tubal ligation or complete bilateral oophorectomy, or
• Postmenopausal women with postmenopausal is defined as permanent cessation >/=1 year of previously occurring menses, and
• Negative serum ß-Human Chorionic Gonadotrophin test at screening and urine pregnancy test prior to randomization.
• Male participants:
• Who are documented to be sterile, or
• 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.

You may not qualify if…

• 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

Where it is running

• MGG Group, Inc.Chevy Chase Clinical Research /ID# 155068 — Chevy Chase, Maryland, United States
• Clin Res Inst of Michigan, LLC /ID# 155066 — Chesterfield, Michigan, United States
• Cliniques Universitaires Saint Luc /ID# 154985 — Woluwe-Saint-Lambert, Brussels Capital, Belgium
• CHU de Liege /ID# 154988 — Liège, Liege, Belgium
• Imelda Ziekenhuis /ID# 154984 — Bonheiden, Belgium
• ULB Erasme /ID# 154987 — Brussels, Belgium
• AZ Groeninge /ID# 154989 — Kortrijk, Belgium
• UZ Leuven /ID# 154986 — Leuven, Belgium
• AZ-Delta /ID# 154983 — Roeselare, Belgium
• McMaster University Med Cent /ID# 155019 — Hamilton, Ontario, Canada
• Universitaetsklinikum Erlangen /ID# 155039 — Erlangen, Bavaria, Germany
• Med Hochschule Hanover /ID# 155041 — Hanover, Germany
• Academisch Medisch Centrum /ID# 155058 — Amsterdam, North Holland, Netherlands
• Maastricht Universitair Medisch Centrum /ID# 155059 — Maastricht, Netherlands
• NZOZ Vivamed /ID# 155061 — Warsaw, Poland
• Lexmedica /Id# 155062 — Wroclaw, Poland
• Yeungnam University Med Ctr /ID# 155056 — Daegu, Daegu Gwang Yeogsi, South Korea
• Kangbuk Samsung Hospital /ID# 155054 — Jongno-Gu, Seoul Teugbyeolsi, South Korea
• Severance Hospital /ID# 155055 — Seoul, Seoul Teugbyeolsi, South Korea
• Asan Medical Center /ID# 155053 — Seoul, South Korea
• Hospital Duran i Reynals /ID# 155063 — L'Hospitalet de Llobregat, Barcelona, Spain
• Hospital Clinic de Barcelona /ID# 155064 — Barcelona, Spain
• Hospital Univ de la Princesa /ID# 155065 — Madrid, Spain
• Guy's and St Thomas' NHS Found /ID# 155046 — London, London, City of, United Kingdom
• Addenbrookes Hospital /ID# 155047 — Cambridge, United Kingdom

Full record on ClinicalTrials.gov

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