Rosnilimab for Ulcerative Colitis
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: AnaptysBio, Inc.
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing a new medication called Rosnilimab to see if it can help people with moderate to severe ulcerative colitis. The study will check if the medication is safe and if it works well to reduce inflammation in the colon. Researchers want to find out if Rosnilimab can improve symptoms for those who haven't had success with other treatments.
Is the drug Rosnilimab a promising treatment for Ulcerative Colitis?The provided research articles do not contain information about Rosnilimab or its effectiveness for Ulcerative Colitis. Therefore, we cannot determine if Rosnilimab is a promising treatment for this condition based on the given data.1341011
What safety data is available for Rosnilimab in treating ulcerative colitis?The provided research does not contain any safety data for Rosnilimab (also known as ANB-030 or ANB030) in the treatment of ulcerative colitis. The studies focus on other treatments such as vedolizumab, golimumab, and tofacitinib.5691213
What data supports the idea that Rosnilimab for Ulcerative Colitis is an effective drug?The available research does not provide specific data on Rosnilimab for Ulcerative Colitis. Instead, it focuses on other drugs like golimumab, vedolizumab, and tofacitinib, which have shown effectiveness in treating the condition. For example, golimumab has been effective in both new and experienced patients with ulcerative colitis, and tofacitinib has shown positive results in real-world settings. Without specific data on Rosnilimab, we cannot compare its effectiveness to these other treatments.2781213
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, it excludes those with a history of inadequate response or intolerance to certain UC therapies, which might imply some restrictions. Please consult with the trial coordinators for specific guidance.
Eligibility Criteria
This trial is for adults over 18 with moderate to severe active ulcerative colitis, confirmed by a recent colonoscopy. Participants should have been diagnosed before Day 1 of the study and show specific scores on medical scales that measure UC severity.Inclusion Criteria
I was diagnosed with ulcerative colitis before the study start date.
My ulcerative colitis is active and severe, confirmed by a test.
Treatment Details
The ROSETTA study is testing Rosnilimab's effectiveness and safety in treating ulcerative colitis compared to a placebo. The goal is to see if Rosnilimab can help manage symptoms better than no treatment at all.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Rosnilimab SC Dose 2Experimental Treatment1 Intervention
This arm will receive low dose Rosnilimab SC
Group II: Rosnilimab SC Dose 1Experimental Treatment1 Intervention
This arm will receive High dose Rosnilimab SC
Group III: PlaceboPlacebo Group1 Intervention
This arm will receive Placebo SC
Find a clinic near you
Research locations nearbySelect from list below to view details:
AnaptysBio Investigative Site 10-108San Jose, CA
AnaptysBio Investigative Site 10-113Garland, TX
AnaptysBio Investigative Site 10-106Miami, FL
AnaptysBio Investigative Site 10-114Sun City, AZ
More Trial Locations
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Who is running the clinical trial?
AnaptysBio, Inc.Lead Sponsor
References
Phase II study of capecitabine, oxaliplatin, and erlotinib in previously treated patients with metastastic colorectal cancer. [2018]To investigate the combination of erlotinib, capecitabine, and oxaliplatin in patients who were previously treated for metastatic colorectal cancer.
IBD: Golimumab in ulcerative colitis: a 'ménage à trois' of drugs. [2021]Golimumab, a human anti-TNF antibody, is effective in patients with ulcerative colitis, according to new findings from an international phase III double-blind trial. The addition of this drug makes a ménage à trois of available drugs--comprising infliximab, adalimumab and golimumab--for the treatment of ulcerative colitis.
PEAK: a randomized, multicenter phase II study of panitumumab plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or bevacizumab plus mFOLFOX6 in patients with previously untreated, unresectable, wild-type KRAS exon 2 metastatic colorectal cancer. [2022]To evaluate panitumumab plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or bevacizumab plus mFOLFOX6 in patients with previously untreated wild-type (WT) KRAS exon 2 (codons 12 and 13) metastatic colorectal cancer (mCRC). A prespecified secondary objective was to assess treatment effects in an extended RAS analysis that included exons 2, 3, and 4 of KRAS and NRAS.
5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus sunitinib or bevacizumab as first-line treatment for metastatic colorectal cancer: a randomized Phase IIb study. [2020]Sunitinib is an oral inhibitor of tyrosine kinase receptors implicated in tumor proliferation, angiogenesis, and metastasis. In this randomized, multicenter, open-label Phase IIb study, sunitinib plus mFOLFOX6 (oxaliplatin plus leucovorin plus 5-fluorouracil) was compared with bevacizumab plus mFOLFOX6 as first-line therapy in patients with metastatic colorectal cancer.
Maintenance of Efficacy and Continuing Safety of Golimumab for Active Ulcerative Colitis: PURSUIT-SC Maintenance Study Extension Through 1 Year. [2018]The safety and efficacy of subcutaneous golimumab through 2 years of maintenance therapy was evaluated in patients with moderate-to-severe ulcerative colitis (UC).
Safety Profile of Biologic Drugs in the Therapy of Ulcerative Colitis: A Systematic Review and Network Meta-Analysis. [2018]We compared the safety profile of biologic drugs in patients with moderately to severely active ulcerative colitis (UC).
Short-term effectiveness of golimumab for ulcerative colitis: Observational multicenter study. [2022]To evaluate the real-world effectiveness of golimumab in ulcerative colitis (UC) and to identify predictors of response.
Clinical efficacy and safety of golimumab in biologically experienced and naive patients with active ulcerative colitis: A real-life experience from two Italian IBD centers. [2019]To evaluate the efficacy and safety of golimumab in biological naive and experienced patients with moderately to severely active ulcerative colitis (UC) treated at two Italian IBD centers.
Indirect comparison of vedolizumab and adalimumab for biologic-naive patients with ulcerative colitis. [2020]Indirect comparison of efficacy and safety of vedolizumab with adalimumab in biologic-naïve patients with moderate to severe ulcerative colitis (UC).
Phase II Study of Ensituximab, a Novel Chimeric Monoclonal Antibody, in Adults with Unresectable, Metastatic Colorectal Cancer. [2021]Label="PURPOSE">Patients with metastatic colorectal cancer refractory to chemotherapy have limited treatment options. Ensituximab (NEO-102) is a novel chimeric mAb targeting a variant of MUC5AC with specificity to colorectal cancer.
Regorafenib Plus Nivolumab in Patients With Advanced Gastric or Colorectal Cancer: An Open-Label, Dose-Escalation, and Dose-Expansion Phase Ib Trial (REGONIVO, EPOC1603). [2021]This is a phase Ib trial of regorafenib plus nivolumab for gastric and colorectal cancer.
The real-world outcomes of vedolizumab in patients with ulcerative colitis in Korea: a multicenter retrospective study. [2022]This study examined the real-world effectiveness and safety outcomes of vedolizumab in ulcerative colitis (UC) patients who had failed anti-tumor necrosis factor (anti-TNF) therapy in Korea.
Short-term effectiveness and safety of tofacitinib in ulcerative colitis - real world data from tertiary medical centers in Israel. [2022]We sought to define the effectiveness and safety of tofacitinib in a real-world (RW) cohort of Israeli patients with moderate to severe ulcerative colitis (UC).