Phase 2
Completed N=254
Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease
Source: ClinicalTrials.gov NCT01696396 ↗Enrolled (actual)
254
Serious AEs
21.0%
Results posted
Jun 2019
Primary outcomePrimary: Percentage of Participants With Remission at Week 8 — 13.3; 23.1; 14.3; 19.5 percentage of participants — p=0.76
Summary
The primary objective of this study is to evaluate the efficacy of abrilumab as measured by the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission (CDAI < 150) after treatment for 8 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Remission at Week 8 |
13.3; 23.1; 14.3; 19.5; 12.8; 23.1 | 0.76 |
| SECONDARY Percentage of Participants With Remission at Week 12 |
18.1; 33.3; 25.3; 27.0; 20.1; 43.8 | 0.16 |
| SECONDARY Percentage of Participants With Response at Week 12 |
27.7; 41.7; 45.3; 43.2; 35.3; 50.4 | 0.021 sig |
| SECONDARY Percentage of Participants With Response at Week 8 |
26.4; 33.3; 42.9; 30.6; 30.6; 33.8 | 0.047 sig |
| SECONDARY Percentage of Participants With Sustained Remission at Both Week 12 and Week 24 |
8.2; 19.2; 11.9; 17.1; 9.0; 25.0 | 0.34 |
| SECONDARY Percentage of Participants With Sustained Remission at Both Week 8 and Week 24 |
7.1; 15.4; 9.5; 12.2; 5.9; 14.3 | 0.47 |
| SECONDARY Change From Baseline in CDAI Score at Week 12 |
-55.32; -92.16; -97.41; -96.11 | 0.006 sig |
| SECONDARY Change From Baseline in CDAI Score at Week 8 |
-64.05; -80.42; -91.52; -87.64 | 0.045 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 6 months prior to baseline
- Moderately to severely active Crohn's disease defined by a CDAI score ≥ 220 and ≤ 450 at baseline
- Evidence of active inflammation within 12 weeks prior to baseline
- Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following agents: Immunomodulators and/or anti-tumor necrosis factor (TNF) agents or to corticosteroids (non-US sites only).
- Neurological exam free of clinically significant, unexplained signs or symptoms during screening and no clinically significant change prior to randomization
- Subject has no known history of active tuberculosis and has a negative test for tuberculosis during screening
Exclusion Criteria
- Short bowel syndrome
- Stricture with obstructive symptoms within 3 months
- Bowel surgery within 12 weeks prior baseline, or has planned bowel surgery within 24 weeks from baseline
- Ileostomy and/or colostomy
- Any gastric or intestinal pouch
- Evidence of an infected abscess
- Bowel perforation or evidence of non-inflammatory obstruction during the 6 months prior to baseline
- Stool positive for C. difficile toxin at screening
- Any uncontrolled or clinically significant systemic disease
- Known to have tested positive for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV)
- Any underlying condition that predisposes subject to infections
- Subject has malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of baseline
- Received an anti-TNF agent, cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus, topical (rectal) aminosalicylic acid (eg, mesalamine) or topical (rectal) steroids, intravenous or intramuscular corticosteroids within protocol-specified time periods.
- Any prior exposure to antagonists of integrins or integrin ligands (eg, natalizumab, efalizumab, or vedolizumab), rituximab, or TNF kinoid immunotherapies, AMG 181, or any form of cell-based transplantation
- Received treatment of infection with intravenous (within 30 days of baseline) or oral (within 14 days prior to baseline) antibiotics, antivirals, or antifungals
- Significant laboratory abnormalities
- Pregnant or breast feeding
Data sourced from ClinicalTrials.gov (NCT01696396). 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.