Weekly Top News – IBD – August 17, 2020

August 17, 2020
Inflammatory Bowel Disease

llllllllllXeljanz (tofacitinib) / Pfizer, Marche Polytechnic UniversityA Fasting Mimicking Diet on Ulcerative Colitis Patients Undergoing Tofacitinib Induction (clinicaltrials.gov) - Aug 10, 2020 - P3; N=76; Not yet recruiting; Sponsor: University of Miamilllllllllletrolizumab (RG7413) / RocheA Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors (clinicaltrials.gov) - Aug 9, 2020 - P3; N=397; Completed; Sponsor: Hoffmann-La Roche; Active, not recruiting --> Completedlllllllllletrolizumab (RG7413) / RocheRoche provides update on phase III studies of etrolizumab in people with moderately to severely active ulcerative colitis (GlobeNewswire) - Aug 10, 2020 - "In the HIBISCUS I induction study...etrolizumab met the primary endpoint. In contrast, the HIBISCUS II induction study...did not meet its primary endpoint. In the HICKORY study...etrolizumab met the primary endpoint at induction but not at maintenance. In the LAUREL maintenance study...etrolizumab failed to meet its primary endpoint. The safety profile of etrolizumab was consistent with previous studies and no major safety issues were identified in the four phase III clinical trials reported to date....Further analyses of the data, including secondary endpoints, are ongoing and will be submitted for presentation at upcoming medical meetings....Pivotal phase III study of etrolizumab in Crohn’s disease is ongoing..."llllllllllJyseleca (filgotinib) / GileadMANTA: Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease (clinicaltrials.gov) - Aug 10, 2020 - P2; N=250; Active, not recruiting; Sponsor: Gilead Sciences; Recruiting --> Active, not recruitingllllllllllEntyvio (vedolizumab) / TakedaTakeda expects more effective IBD treatment with Kynteles' expanded reimbursement (Korea Biomedical Review) - Aug 12, 2020 - "Takeda Korea is strengthening its position in the domestic inflammatory bowel disease (IBD) market with Kynteles receiving expanded reimbursement as a first-line treatment, the company said in a news conference Wednesday."llllllllllGattex (teduglutide) / Takeda20 most expensive drugs in the US (Becker's Hospital Review) - Aug 12, 2020 - "For its list, published Aug. 11, GoodRx excluded drugs that have to be administered by a healthcare provider. The prices reflect list prices for the drug's most common 30-day prescription. The 20 most expensive drugs based on their monthly list prices: 10. Gattex — $40,450 (Takeda)."llllllllllZeposia (ozanimod) / BMSA Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - Aug 11, 2020 - P3; N=535; Recruiting; Sponsor: Celgene; Trial completion date: Jun 2023 --> Sep 2024; Trial primary completion date: Mar 2023 --> Jun 2024llllllllllZeposia (ozanimod) / BMSInduction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - Aug 11, 2020 - P3; N=600; Recruiting; Sponsor: Celgene; Trial completion date: Jun 2022 --> Jun 2023; Trial primary completion date: Mar 2022 --> Jun 2023llllllllllZeposia (ozanimod) / BMSAn Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - Aug 11, 2020 - P3; N=1040; Recruiting; Sponsor: Celgene; Trial completion date: Jun 2024 --> Jun 2026; Trial primary completion date: Mar 2024 --> Jun 2026llllllllllZeposia (ozanimod) / BMSInduction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - Aug 14, 2020 - P3; N=600; Recruiting; Sponsor: Celgene; Trial completion date: Apr 2024 --> Jul 2023; Trial primary completion date: Apr 2024 --> Apr 2023