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Brodalumab in Moderate to Severe Crohn's Disease
NCT01150890Phase 2
Key facts
- Status
- Terminated
- Start
- Nov 2010
- Primary completion
- Oct 2011
- Countries
- 8
- Sponsor
- Amgen
- Modality
- Monoclonal Antibodies
- Drugs
- brodalumab
- Conditions
- Crohn's disease
01
Overview
Phase 2, randomised, double-blind trial of brodalumab in Crohn's disease (4 arms), sponsored by Amgen. Primary endpoint: Percentage of Participants Who Achieved Clinical Remission at Week 6. Started Nov 2010; status: terminated.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo IV at Baseline and Week 4
Brodalumab 210 mg
210 mg IV at Baseline and Week 4
Brodalumab 350 mg
350 mg IV at Baseline and Week 4
Brodalumab 700 mg
700 mg IV at Baseline and Week 4
03
Who it enrols
Adult patients with moderately to severely active Crohn's disease (CDAI 250-450) and evidence of active inflammation. Excludes patients with short bowel syndrome, strictures, recent bowel surgery, ostomies, ulcerative colitis, active infections, or recent use of anti-TNF agents, biologics, or immunosuppressants.
04
Endpoints
Primary
Percentage of Participants Who Achieved Clinical Remission at Week 6
Secondary
Percentage of Participants Who Achieved a CDAI Response at Week 6
Change From Baseline in CDAI at Week 6
Number of Participants With Treatment-emergent Adverse Events
Maximum Observed Concentration of Brodalumab
Time to Maximum Observed Concentration of Brodalumab
Area Under the Serum Concentration Versus Time Curve
05
Results
Not all primary endpoints met
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