An Open Label, Single Group, Long Term Safety Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 28
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
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.
详细描述
This was a single group, open-label long-term extension study that assessed the long-term safety, efficacy, and pharmacokinetics of risankizumab in participants with moderately to severely active Crohn's disease. This study was terminated early by AbbVie to enable participants who completed the study to rollover into Study NCT03105102 (AbbVie M16-000 Sub-Study 3 [Phase 3 OLE study]) for further OLE treatment within the Phase 3 program, which allows for risankizumab dose escalation if needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Risankizumab
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.
干预措施: Risankizumab 600 mg IV (Drug)
Risankizumab
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.
干预措施: Risankizumab 180 mg SC (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 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
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.
次要结局
- Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit(Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192)
- Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) 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)
- Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores 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)
- Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit(Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192)
- Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit(Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192)
- Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit(Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192)
- Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit(Weeks 0, 8, 24, 40, 56, 72, 88, 104, 120, 128, 136, 152, 160, 176, and 184)
- Mean Change From Baseline in Fecal Calprotectin (FCP) Profile by Visit(Weeks 0, 24, 56, 88, 120, 152, and 184)
- 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 Crohn's Disease Endoscopic Index of Severity (CDEIS) Response by Visit(Weeks 0, 48, 104, 152, and 200)
- Percentage of Participants With Mucosal Healing by Visit(Weeks 0, 48, 104, 152, and 200)
- Percentage of Participants Achieving Deep Remission by Visit(Weeks 0, 48, 104, 152, and 200)
- 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)
- Mean Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) by Visit(Weeks 0, 48, 104, 152, and 200)
- Mean Change From Baseline in Simple Endoscopic Score (SES-CD) by Visit(Weeks 0, 48, 104, 152, and 200)
- Mean Change From Baseline in Stool Frequency (SF) 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)
- Mean Change From Baseline in Abdominal Pain (AP) Score 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)
- Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit(Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192)
- Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit(Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192)
- Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit(Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192)