A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients with Moderately to Severely Active Crohn's Disease

Date Added
October 27th, 2020
PRO Number
Pro00101185
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease
Summary

The purpose of this study is to determine if an additional intravenous (IV) dose of Ustekinumab is safe and effective in helping Crohn's disease patients, whose initial response to Ustekinumab was followed by loss of response to Ustekinumab, to regain response to Ustekinumab for the treatment of their disease.

This study is designed to last 10 months. Eligible participants will have 2 screening visits, 3 drug administration visits, and 2 follow-up visits.

Participants have a 50% chance of being randomized (like drawing names out of a hat) into either the Ustekinumab re-induction group or the continuous maintenance group. Participants in the Ustekinumab re-induction group will receive intravenous Ustekinumab at the baseline visit. Participants in the continuous maintenance group will receive subcutaneous Ustekinumab at the baseline visit. All participants will receive subcutaneous Ustekinumab 90 mg for subsequent visits.

Institution
MUSC
Recruitment Contact
Minjun Feng
843-876-2184
fengm@musc.edu

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Date Added
July 9th, 2019
PRO Number
Pro00088643
Researcher
Brenda Hoffman

List of Studies


Keywords
Crohn's Disease
Summary

Study M16-006 is a randomized, double blind, placebo-controlled 12-week induction study for those subjects with Moderately to Severely Active Crohn's Disease.
This study will evaluate two IV doses of Risankizumab (600 mg and 1200 mg). The selection of the doses in this study was selected by the data provided from the phase II study that was completed previously. The results from the Phase 2 study suggest a potential for increased benefit with 1200 mg administration.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-8439
forstere@musc.edu

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

Date Added
July 9th, 2019
PRO Number
Pro00088554
Researcher
Brenda Hoffman

List of Studies


Keywords
Crohn's Disease
Summary

Study M15-991 is a randomized, double blind, placebo-controlled 12-week induction study. This study is for those subjects with moderately to severely Active Crohn's Disease Who Failed Prior Biologic Treatment.
This study will evaluate two IV doses of Risankizumab (600 mg and 1200 mg). The selection of the doses in this study was selected by the data provided from the phase II study that was completed previously. The results from the Phase 2 study suggest a potential for increased benefit with 1200 mg administration.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-8439
forstere@musc.edu



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