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

NCT02513459 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: M15-9892015-001834-151311.2
• Study Type: interventional
• Target: 65
• Locations: 9 countries
• Sites: 28

Brief 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.

Conditions

Crohn Disease

Keywords

ABBV-066; BI 655066; Risankizumab

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  A treatment emergent adverse event was defined as an event that occurred or worsened on or after the first dose of study drug through 140 days after the last dose in the current study for participants not rolling over into M16-000 Sub-study 3 or until the first dose of study drug in NCT03105102. All treatment-emergent serious and nonserious adverse events were collected, whether elicited or spontaneously reported by the participant.

  From the time of study drug administration until 140 days after the last dose of study drug in the current study or until the first dose of study drug in NCT03105102 (AbbVie M16-000 Sub-study 3), up to 4 years for participants who rolled-over

Secondary Outcomes (23)

• Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit

  Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184

• Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit

  Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184

• Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit

  Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184

• Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit

  Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184

• Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Remission by Visit

  Weeks 0, 48, 104, 152, and 200

Study Arms (1)

Risankizumab

EXPERIMENTAL

Maintenance treatment with risankizumab 180 mg administered subcutaneously (SC) 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.

Drug: Risankizumab 600 mg IV; Drug: Risankizumab 180 mg SC

Interventions

Risankizumab 600 mg IV DRUG

Re-induction treatment; 3 infusions every 4 weeks, after which eligibility was assessed if clinical response was re-gained

Also known as: BI 655066, ABBV-066

Risankizumab

Risankizumab 180 mg SC DRUG

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.

Also known as: BI 655066, ABBV-066

Risankizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• AbbVie: lead
• Boehringer Ingelheim: collaborator

Study Sites (28)

MGG Group, Inc.Chevy Chase Clinical Research /ID# 155068

Chevy Chase, Maryland, 20815, United States

Location

Clin Res Inst of Michigan, LLC /ID# 155066

Chesterfield, Michigan, 48047, United States

Location

Cliniques Universitaires Saint Luc /ID# 154985

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

Location

CHU de Liege /ID# 154988

Liège, Liege, 4000, Belgium

Location

Imelda Ziekenhuis /ID# 154984

Bonheiden, 2820, Belgium

Location

ULB Erasme /ID# 154987

Brussels, 1070, Belgium

Location

AZ Groeninge /ID# 154989

Kortrijk, 8500, Belgium

Location

UZ Leuven /ID# 154986

Leuven, 3000, Belgium

Location

AZ-Delta /ID# 154983

Roeselare, 8800, Belgium

Location

McMaster University Med Cent /ID# 155019

Hamilton, Ontario, L8S 4K1, Canada

Location

Universitaetsklinikum Erlangen /ID# 155039

Erlangen, Bavaria, 91054, Germany

Location

Med Hochschule Hanover /ID# 155041

Hanover, 30625, Germany

Location

Academisch Medisch Centrum /ID# 155058

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Maastricht Universitair Medisch Centrum /ID# 155059

Maastricht, 6229 HX, Netherlands

Location

NZOZ Vivamed /ID# 155061

Warsaw, 03-580, Poland

Location

Lexmedica /Id# 155062

Wroclaw, 53-114, Poland

Location

Yeungnam University Med Ctr /ID# 155056

Daegu, Daegu Gwang Yeogsi, 42415, South Korea

Location

Kangbuk Samsung Hospital /ID# 155054

Jongno-Gu, Seoul Teugbyeolsi, 03181, South Korea

Location

Severance Hospital /ID# 155055

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Asan Medical Center /ID# 155053

Seoul, 05505, South Korea

Location

Hospital Duran i Reynals /ID# 155063

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Clinic de Barcelona /ID# 155064

Barcelona, 08036, Spain

Location

Hospital Univ de la Princesa /ID# 155065

Madrid, 28006, Spain

Location

Guy's and St Thomas' NHS Found /ID# 155046

London, London, City of, SE1 9RT, United Kingdom

Location

Addenbrookes Hospital /ID# 155047

Cambridge, CB2 0SP, United Kingdom

Location

St. James University Hospital /ID# 155050

Leeds, LS9 7TF, United Kingdom

Location

The Newcastle Upon Tyne Hospitals NHS Foundation Trust' /ID# 155049

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

John Radcliffe Hospital /ID# 155048

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

• Ferrante M, Feagan BG, Panes J, Baert F, Louis E, Dewit O, Kaser A, Duan WR, Pang Y, Lee WJ, Gustafson D, Liao X, Wallace K, Kalabic J, D'Haens GR. Long-Term Safety and Efficacy of Risankizumab Treatment in Patients with Crohn's Disease: Results from the Phase 2 Open-Label Extension Study. J Crohns Colitis. 2021 Dec 18;15(12):2001-2010. doi: 10.1093/ecco-jcc/jjab093.

  PMID: 34077509 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: July 31, 2015
• Study Start: September 16, 2015
• Primary Completion: June 19, 2019
• Study Completion: June 19, 2019
• Last Updated: April 24, 2020
• Results First Posted: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

Locations

DE (2); KR (4); CA (1); BE (7); PL (2); NL (2); GB (5); ES (3); US (2)