Phase 2
Completed N=65
A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease
Crohn Disease
Source: ClinicalTrials.gov NCT02513459 ↗
Enrolled (actual)
65
Serious AEs
34.3%
Results posted
Apr 2020
Primary outcomePrimary: Number of Participants With Adverse Events — 2; 60; 60 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
2; 60; 60 | — |
| SECONDARY Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit |
25.00; 72.31; 25.00; 25.00; 73.85; 71.88 | — |
| SECONDARY Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit |
50.00; 90.77; 75.00; 100.00; 98.46; 92.19 | — |
| SECONDARY Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit |
25.00; 73.85; 25.00; 50.00; 80.00; 78.13 | — |
| SECONDARY Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit |
50.00; 83.08; 50.00; 50.00; 86.15; 90.63 | — |
| SECONDARY Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Remission by Visit |
42.86; 56.45; 62.79; 58.97; 85.71 | — |
| SECONDARY Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Response by Visit |
58.73; 72.58; 81.40; 82.05; 100.00 | — |
| SECONDARY Percentage of Participants With Mucosal Healing by Visit |
29.69; 35.48; 39.53; 43.59; 42.86 | — |
| SECONDARY Percentage of Participants Achieving Deep Remission by Visit |
34.92; 47.54; 53.49; 42.86; 0.00 | — |
| SECONDARY Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit |
62.50; 58.46; 70.00; 69.23; 72.55; 70.83 | — |
| SECONDARY Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit |
92.19; 89.23; 95.00; 88.46; 90.20; 95.83 | — |
| SECONDARY Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) by Visit |
-50.70; -198.47; -92.68; -119.40; -206.75; -205.93 | — |
| SECONDARY Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit |
-27.75; -105.46; -35.25; -53.75; -109.53; -108.32 | — |
| SECONDARY Mean Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) by Visit |
-8.08; -9.32; -9.24; -9.75; -10.76 | — |
| SECONDARY Mean Change From Baseline in Simple Endoscopic Score (SES-CD) by Visit |
-9.63; -12.35; -11.56; -12.63; -13.36 | — |
| SECONDARY Mean Change From Baseline in Stool Frequency (SF) By Visit |
-0.46; -4.13; -0.46; -1.07; -4.22; -4.10 | — |
| SECONDARY Mean Change From Baseline in Abdominal Pain (AP) Score By Visit |
-0.61; -1.36; -0.82; -1.11; -1.44; -1.45 | — |
| SECONDARY Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit |
62.48; 58.72; 64.03; 64.14; 62.38; 67.28 | — |
| SECONDARY Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit |
20.44; 18.26; 20.29; 20.64; 19.12; 22.25 | — |
| SECONDARY Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit |
9.9; 9.1; 9.6; 10.1; 10.3; 9.8 | — |
| SECONDARY Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit |
11.04; 10.57; 11.64; 11.20; 10.59; 11.92 | — |
| SECONDARY Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit |
21.09; 20.79; 22.55; 22.23; 22.41; 23.35 | — |
| SECONDARY Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit |
-14.64; -15.84; -12.76; -14.32; -16.11; -14.40 | — |
| SECONDARY Mean Change From Baseline in Fecal Calprotectin (FCP) Profile by Visit |
-1983.9; -2166.4; -2277.8; -2485.9; -2031.9; -2631.5 | — |
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:
- 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 /=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.
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
Data sourced from ClinicalTrials.gov (NCT02513459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.