Weekly Top News – IBD – May 4, 2020

May 4, 2020
Inflammatory Bowel Disease

mirikizumab (LY3074828) / Eli LillyA Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (clinicaltrialsregister.eu) - Apr 28, 2020 - P3; N=778; Ongoing; Sponsor: Eli Lilly and Company

Stelara (ustekinumab) / J&JNICE recommends Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis (PharmiWeb) - Apr 28, 2020 - "The Janssen Pharmaceutical Companies of Johnson & Johnson welcomes the National Institute for Health and Care Excellence (NICE) positive Final Appraisal Document (FAD) recommending Stelara (ustekinumab) as an option for treating moderately to severely active ulcerative colitis (UC) in adults when conventional therapy or a biological agent cannot be tolerated, or the disease has responded inadequately or lost response to treatment, only if: a tumour necrosis factor (TNF)-alpha inhibitor has failed (that is the disease has responded inadequately or has lost response to treatment) or a TNF-alpha inhibitor cannot be tolerated or is not suitable."

Entyvio (vedolizumab) / TakedaEfficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological Therapy (clinicaltrials.gov) - Apr 27, 2020 - P; N=100; Not yet recruiting; Sponsor: Pontifícia Universidade Católica do Paraná

ontamalimab (SHP647) / TakedaEfficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 305) (clinicaltrials.gov) - Apr 28, 2020 - P3; N=1032; Active, not recruiting; Sponsor: Shire; Recruiting --> Active, not recruiting

ontamalimab (SHP647) / TakedaFIGARO UC 302: Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - Apr 28, 2020 - P3; N=740; Active, not recruiting; Sponsor: Shire; Recruiting --> Active, not recruiting

ontamalimab (SHP647) / TakedaEfficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306) (clinicaltrials.gov) - Apr 28, 2020 - P3; N=1032; Active, not recruiting; Sponsor: Shire; Recruiting --> Active, not recruiting

ontamalimab (SHP647) / TakedaFIGARO UC 301: Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - Apr 28, 2020 - P3; N=740; Active, not recruiting; Sponsor: Shire; Recruiting --> Active, not recruiting

A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease (clinicaltrials.gov) - May 1, 2020 - P; N=1056; Not yet recruiting; Sponsor: Janssen Scientific Affairs, LLC