At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 250 enrolled
Drug / intervention
PF-04236921 SC injection +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)
In Brief
A Phase 2 clinical trial evaluating PF-04236921 SC injection for Crohn's Disease. Completed, enrolled 250 participants across 193 sites in 18 countries.
Detailed Summary
This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustralia, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, New Zealand, Romania, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2011
First PostedFeb 2011
Primary CompletionSep 2014
Study CompletionFeb 2015
TodayJul 2026
First PostedFeb 2, 2011
Enrollment StartFeb 1, 2011
Primary CompletionSep 1, 2014
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 15.4 years ago
Interventions
PF-04236921 SC injectiondrug
Placebo delivered SC, 2 doses separated by 4 weeks
PF-04236921 SC injectiondrug
Drug dose level 1 delivered SC, 2 doses separated by 4 weeks
PF-04236921 SC injectiondrug
Drug dose level 2 delivered SC, 2 doses separated by 4 weeks