Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease
(OPERA Trial)
Recruiting in Palo Alto (17 mi)
+136 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Shire
Prior Safety Data
Trial Summary
What is the purpose of this trial?
Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.
Research Team
SD
Study Director
Principal Investigator
Takeda
Eligibility Criteria
Inclusion Criteria
Subjects must have failed or are intolerant to anti-TNFs and/or immunosuppressants (AZA, 6-MP, and/or MTX).
hsCRP greater than 3mg/L
Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening
Treatment Details
Interventions
- PF-00547659 (Monoclonal Antibodies)
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Drug Dose level 3- SC injectionExperimental Treatment1 Intervention
Drug dose level 3 delivered SC, 3 doses separated by 4 weeks.
Group II: Drug Dose level 2-SC injectionExperimental Treatment1 Intervention
Drug dose level 2 delievered SC, 3 doses separated by 4 weeks.
Group III: Drug Dose level 1- SC injectionExperimental Treatment1 Intervention
Drug dose level 1 delivered SC, 3 doses separated by 4 weeks.
Group IV: Placebo-SC InjectionPlacebo Group1 Intervention
Placebo delivered SC, 3 doses separated by 4 weeks.
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Who Is Running the Clinical Trial?
Shire
Lead Sponsor
Trials
457
Recruited
96,000+
Pierre S. Sayad
Shire
Chief Medical Officer
MD from Loma Linda University
Flemming Ornskov
Shire
Chief Executive Officer since 2013
PhD in Medicine from Aarhus University