Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.

Phase 2 Terminated 20 enrolled Pfizer

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine if PF-06687234 is effective and safe as add-on therapy to infliximab in subjects with active ulcerative colitis who are not in remission.

Timeline

Start: 2017-12-20
Primary completion: 2021-01-07
Completion: 2021-01-07

Outcome

Missed primary endpoint

Stopped (Business): “The Sponsor changed R\&D strategy and priority.”

paper There were no statistically significant differences between groups for any efficacy endpoint (all p > 0.05), although numerical trends towards efficacy were observed in some secondary endpoints. PMID 41684726 ↗

paper PF-06687234 was well tolerated, but when combined with background infliximab, did not meet the primary efficacy endpoint in this cohort of participants with active UC. PMID 41684726 ↗

Publications

Schreiber S, Danese S, Vermeire S, Leong RW, Pradhan V, Singh RSP, Yu D, Messing D, Neubert H, Palandra J, Tehlirian C, Gale JD. Efficacy and safety of the interleukin-10-fragment F8 fusion protein PF-06687234 as add-on therapy to infliximab in patients with active ulcerative colitis: a randomized, phase IIa clinical trial. Ther Adv Gastroenterol. 2026 Feb 10;19:17562848251410784. doi: 10.1177/17562848251410784. eCollection 2026.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PF-06687234	Protein / enzyme biologic	20 mg	Subcutaneous