ozanimod (rpc1063) is a new oral s1p1-receptor and s1p5-receptor modulator with no activity on s1p2, s1p3, and s1p4. An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice View this study on Beta.ClinicalTrials.gov Sponsor: Bristol-Myers Squibb Information provided by (Responsible Party): Bristol-Myers Squibb Study Details Tabular View No Results Posted Disclaimer How to Read a Study Record Study Description Go to Higher scores represent more severe disease. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Talk with your doctor and family members or friends about deciding to join a study. Would you like email updates of new search results? The .gov means its official. NICE recommends biological therapy (monoclonal antibodies adalimumab, golimumab, infliximab, ustekinumab or vedolizumab) or tofacitinib for moderately to . Listing a study does not mean it has been evaluated by the U.S. Federal Government. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Clipboard, Search History, and several other advanced features are temporarily unavailable. ZEPOSIA is different it's not a biologic, a 5-ASA, or a steroid. Study record managers: refer to the Data Element Definitions if submitting registration or results information. . Unable to load your collection due to an error, Unable to load your delegates due to an error. Please remove one or more studies before adding more. Participant has clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the participant at risk by continuing the study or that would have required a participant to discontinue treatment were observed during the Induction Period or Maintenance Period. For general information, Learn About Clinical Studies. Why Should I Register and Submit Results? J.Sniadeckiego, Niepubliczny Zaklad Opieki Zdrowotnej INTERMED, Elblaski Szpital Specjalistyczny z Przychodnia, Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny, Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED, Niepubliczny Zaklad Opieki Zdrowotnej Triclinium, SBEI HPE First Moscow State Medical University n.a. Contact: First line of the email MUST contain the NCT# and Site #. Information provided by (Responsible Party): The purpose of this study is to explore the safety, efficacy, effects on quality of life (QOL), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC) in clinical practice. rpc1063 (ozanimod) is a selective s1p1 receptor modulator that demonstrates 269-fold selectivity for s1p 1 r (ec 50 = 0.16 nm) over s1p 5 r, and greater than 20,000-fold selectivity over s1p 2 r, s1p 3 r, and s1p 4 r. 72 in a randomized, double-blind, placebo-controlled trial of oral rpc1063 in rrms, the number of gadolinium-enhanced lesions at Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Clinical response as measured by modified Mayo score at Week 12 [TimeFrame:Up to approximately 26 weeks], Clinical remission as measured by modified Mayo score [TimeFrame:Up to approximately 26 weeks], Proportion of participants who achieve endoscopic response [TimeFrame:Up to approximately 26 weeks], Proportion of participants who achieve endoscopic improvement [TimeFrame:Up to approximately 26 weeks], Proportion of participants who achieve histological improvement [TimeFrame:Up to approximately 26 weeks], Proportion of participants with change in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score from baseline [TimeFrame:Up to approximately 26 weeks], Proportion of participants with change in total score ( 16 points) of IBDQ response from baseline [TimeFrame:Up to approximately 26 weeks], Proportion of participants with IBDQ remission with total score of 170 points [TimeFrame:Up to approximately 26 weeks], Proportion of participants who achieve endoscopic remission [TimeFrame:Up to approximately 26 weeks], Proportion of participants who achieve histological remission [TimeFrame:Up to approximately 26 weeks], Corticosteroid-free clinical remission as measured by modified Mayo score [TimeFrame:Up to approximately 26 weeks], Proportion of participants with histo-endoscopic mucosal improvement [TimeFrame:Up to approximately 26 weeks], Proportion of participants with Adverse Events (AEs) [TimeFrame:Up to approximately 2 years], Proportion of participants with Serious Adverse Events (SAEs) [TimeFrame:Up to approximately 2 years], Proportion of participants with AEs of interest (AEI) [TimeFrame:Up to approximately 2 years], Proportion of participants with AEs leading to discontinuation [TimeFrame:Up to approximately 2 years], Proportion of participants with clinical laboratory abnormalities [TimeFrame:Up to approximately 2 years], Clinical remission by partial Mayo score [TimeFrame:Up to approximately 104 weeks], Corticosteroid-free clinical remission by partial Mayo [TimeFrame:Up to approximately 104 weeks], Clinical response by partial Mayo score [TimeFrame:Up to approximately 104 weeks], A diagnosis of ulcerative colitis (UC), with signs and symptoms consistent with UC for at least 3 months prior to the first study intervention administration, Report of a previous colonoscopy that documents extent of disease, Current or recent (within 3 months of screening) evidence of fulminant colitis, toxic megacolon, or bowel perforation, Extensive colonic resection or current stoma, Colonic dysplasia that has not been removed. UC is an autoimmune disease characterized by an overproduction of lymphocytes cells involved in the immune response in . Contact: First line of the email MUST contain NCT # and Site #. Epub 2022 Feb 2. Get access to cutting edge treatment via Ozanimod. Efficacy and Safety Study of Ozanimod in Ulcerative Colitis (Touchstone) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Reduces symptoms of rectal bleeding and. 2021 Sep 30;385(14):1280-1291. doi: 10.1056/NEJMoa2033617. The approval, awarded to Bristol Myers Squibb, was based on the data from a placebo-controlled phase 3 trial dubbed True North. 2. Kollengode K, Patel A, Ghosh S. Incidence of infections in patients with moderately to severely active ulcerative colitis treated with ozanimod and relationship to significant lymphopenia: results from a pooled safety analysis. Zeposia (ozanimod) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Semashko, Nizhniy Novgorod, Russian Federation, 603126, SBEI of HPE Omsk State Medical Academy Ministry of healthcare of RF, SEIHPE Rostov State Medical University of MoH of RF, Rostov on Don, Russian Federation, 344022, Russian Medical Military Academy na SMKirov, Saint Petersburg, Russian Federation, 191163, Saint Petersburg, Russian Federation, 196247, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU, Institute of Therapy n.a. The US Food and Drug Administration (FDA) has approved ozanimod (Zeposia) 0.92 mg, an oral agent that selectively targets sphingosine-1-phosphate receptor subtypes 1 and 5, for adult patients with moderately to severely active ulcerative colitis.. Please enable it to take advantage of the complete set of features! (Clinical Trial), Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative Colitis, 18 Years to 73 Years (Adult, Older Adult), Anaheim, California, United States, 92801, La Jolla, California, United States, 92037, Oceanside, California, United States, 92056, Chevy Chase, Maryland, United States, 20815, Clinical Research Institute of Michigan, LLC, Chesterfield, Michigan, United States, 48047, Great Neck, New York, United States, 11021, Chapel Hill, North Carolina, United States, 27599, Universitair Ziekenhuis Leuven, Campus Gasthuisberg, Multiprofile Hospital for Active Treatment Kaspela, University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia, University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD, Multiprofile Hospital for Active Treatment Doverie AD, Multiprofile Hospital for Active Treatment Sveti Panteleimon - Sofia AD, Multiprofile Hospital for Active Treatment Sofiamed, Multiprofile Hospital for Active Treatment Sveta Marina EAD, London Health Sciences Centre, University Hospital, Vastegszsggyi Nonprofit Kiemelten Kzhaszn Kft. ClinicalTrials.gov Identifier: NCT05369832, Interventional To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Serious infections occurred in less than 2% of patients treated with the medication during the duration of the 52-week trial. Celgene Corporation recently announced that data from a phase 2 clinical trial exploring ozanimod in Crohn's disease (CD) and ulcerative colitis (UC) will be presented at the World Congress of Gastroenterology at ACG2017, according to a press release. You have reached the maximum number of saved studies (100). N Engl J Med. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Information provided by (Responsible Party): The purpose of this study is to evaluate the efficacy and safety of ozanimod compared with placebo in participants with ulcerative colitis (UC) in mainland China and Taiwan. Results from both an induction and maintenance therapy trial show ozanimod can be an effective treatment for patients with inflammatory bowel . Methods We conducted a phase 3, multicenter, randomized,. The purpose of this study is to monitor the use, effectiveness and treatment persistence with Ozanimod (Zeposia) as well as quality of life in participants undergoing treatment for moderate-to-severe ulcerative colitis (UC). Background: Ozanimod, an oral sphingosine 1-phosphate receptor modulator currently approved for the treatment of moderately to severely active ulcerative colitis and relapsing multiple sclerosis, showed clinical, endoscopic, and histological benefit in the phase 2 STEPSTONE trial for Crohn's disease (CD). Japanese patients with moderate or severe active ulcerative colitis as a subject when ozanimod 0.46 mg or 0.92 mg is orally administered is evaluated about dose response, efficacy and safety with placebo as a control. Higher scores represent more severe disease. Ozanimod is also in late-stage clinical trials for the treatment of Crohn's disease, another type of inflammatory bowel disease. Conclusion: Ozanimod 1 mg was effective in the induction of clinical, endoscopic, and histologic remission at Week 32 in patients with moderate to severe UC. 2016 May 5;374(18):1754-62. doi: 10.1056/NEJMoa1513248. Study Design Go to Resource links provided by the National Library of Medicine Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy. Read our disclaimer for details. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Ulcerative Colitis Clinical Trials Conditions: Ulcerative Colitis. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Clinical Respone was based on the 4-component Mayo definition. Ozanimod Yields Clinical Response Remission In Ulcerative Colitis Patients. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Participants who received ozanimod 1 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Serious infections occurred in less than 2% of patients treated with the medication during the duration of the 52-week trial. BMS is also studying ZEPOSIA (Ozanimod) as a potential treatment for additional immune-inflammatory indications, such as Crohn's disease and ulcerative colitis. Ozanimod Induction and Maintenance Treatment for Ulcerative Colitis. Results . Continue Reading. N.A. sharing sensitive information, make sure youre on a federal MONTREAL, April 12, 2022 /CNW/ - Bristol Myers Squibb Canada (BMS) today announced that Health Canada has approved ZEPOSIA (ozanimod) capsules for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, loss . Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Proportion of participants who achieve clinical remission [TimeFrame:At Week 52], Proportion of participants who achieve clinical remission [TimeFrame:At Week 10], Proportion of participants who achieve clinical response [TimeFrame:At Week 52], Proportion of participants who achieve clinical response [TimeFrame:At Week 10], Proportion of participants who achieve symptomatic remission [TimeFrame:At Week 10 and Week 52], Time to achievement of symptomatic remission [TimeFrame:Up to 6 years], Proportion of participants who achieve endoscopic improvement [TimeFrame:At Week 10 and Week 52], Proportion of participants who achieve corticosteroid free remission [TimeFrame:At Week 52], Incidence of Adverse Events (AEs) [TimeFrame:Up to 6 years], Incidence of Serious Adverse Events [TimeFrame:Up to 6 years], Incidence of AEs leading to discontinuation from treatment [TimeFrame:Up to 6 years], Incidence of AEs of special interest (AESIs) [TimeFrame:Up to 6 years], Steady state systemic exposure of ozanimod and CC112273 [TimeFrame:At Week 18 and throughout the study, up to 70 weeks], Absolute change from baseline in Absolute Lymphocyte Count (ALC) [TimeFrame:Up to 6 years], Percent change from baseline in ALC [TimeFrame:Up to 6 years], Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit, Evidence of UC extending beyond the rectum, as determined by baseline endoscopy, Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy, Diagnosis of Crohn's disease or indeterminate colitis, Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool, Apheresis within 2 weeks of randomization, History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis. 2022 Jan 13;386(2):194.doi: 10.1056/NEJMc2117224. Ozanimod (Zeposia) is the first sphingosine-1-phosphate receptor (S1PR) modulator to be approved for the treatment of adults with moderately to severely active ulcerative colitis in the USA, and . In the True North trial daily treatment with 1 mg oral ozanimod increased remission as both an induction and maintenance therapy for patients with ulcerative colitis. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. You have reached the maximum number of saved studies (100). View this study on Beta.ClinicalTrials.gov, U.S. Department of Health and Human Services. Study record managers: refer to the Data Element Definitions if submitting registration or results information. In the re-randomized maintenance population, 37.0% of the 230 patients in the ozanimod group and 18.5% of the 227 patients in the placebo group achieved clinical remission at week 52 (P <.0001). 2015the international organization for the study of IBDIOIBD""selecting therapeutic targets in inflammatory bowel diseaseSTRIDEIBD [] 62021STRIDE IBD . Results of the Phase II clinical trial will appear in the May 5 issue of the New England Journal of Medicine. (Clinical Trial), Triple (Participant, Care Provider, Investigator), A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC), 18 Years to 75 Years (Adult, Older Adult), Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com. Its efficacy profile is comparable with other UC medications. Ozanimod for the Treatment of Ulcerative Colitis. Clinical trials are under way to test Zeposia's effectiveness in treating Crohn's disease. 2022 May;162(6):1767-1769. doi: 10.1053/j.gastro.2021.12.235. of. ClinicalTrials.gov Identifier: NCT05644665, Interventional Virtually every drug currently available on the market to treat Crohn's disease or ulcerative colitis went through the clinical trials process previously. Keywords provided by Bristol-Myers Squibb: Why Should I Register and Submit Results? Participants who have completed the Induction Period and entered the Maintenance Period experienced disease relapse during the Maintenance Period, or who have completed the Maintenance Period at Week 52. Study Design Read our disclaimer for details. The primary efficacy endpoint is the proportion of subjects with a clinically meaningful increase in . Ozanimod, a sphingosine 1-phosphate receptor modulator that binds with high affinity selectively to sphingosine 1-phosphate receptors 1 and 5, is approved in multiple countries for the treatment of adults with either relapsing forms of multiple sclerosis (RMS) or moderately to severely active ulcerative colitis (UC) (Scott et al., 2016; Zeposia [package insert], 2022; Zeposia . 8600 Rockville Pike Moderately to severely active ulcerative colitis (UC) in adults. To the Editor: Regarding the phase 3 trial of ozanimod as induction and maintenance therapy in patients with moderately to severely active ulcerative colitis (Sept. 30 issue)1: there is an issue th. [NCT02531126]. Relevance to patient care and clinical practice: Ozanimod is the first sphingosine 1-phosphate modulator to be approved for UC and is administered orally. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Following the 4-week Screening Period, eligible subjects will be randomized to enter the 12 . . To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Ozanimod is a sphingosine-1-phosphate (S1P) receptor modulator which has been recently approved for UC therapy. L.T. Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis. Ozanimod is an oral sphingosine 1-phosphate (S1P) receptor modulator, which could present a new treatment method for ulcerative colitis, according to a press release from Bristol Myers Squibb. The presentations will feature results from the STEPSTONE study and the open-label extension . HHS Vulnerability Disclosure, Help The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. However, its safety profile is unique, requiring extensive assessments prior to initiation of and during treatment. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. GUT P.C., dba Digestive Health Specialists, Dothan, Alabama, United States, 36305-1156, Arizona Digestive Health: Scottsdale - GI Alliance, Scottsdale, Arizona, United States, 85250-7004, Sun City, Arizona, United States, 85351-2867, Contact: Chirag Trivedi, Site 0125 623-972-2116, North Little Rock, Arkansas, United States, 72117-2927, Apple Valley, California, United States, 92307-1329, Contact: Neera Grover, Site 0165 661-338-2239, OM Research LLC - Camarillo - ClinEdge - PPDS, Camarillo, California, United States, 93012-5156, Contact: Karen Simon, Site 0162 610-872-7660, OM Research LLC - Lancaster - ClinEdge - PPDS, Lancaster, California, United States, 93534-5856, Contact: Jatinder Pruthi, Site 0086 661-388-2239, Lancaster, California, United States, 93534, Contact: Jatinder Pruthi, Site 0014 661-948-0803, United Clinical Research Institute - Clinedge - PPDS, Murrieta, California, United States, 92563-1405, San Diego, California, United States, 92103-5639, Contact: Vijayalakshmi Pratha, Site 0149 619-260-1012, Contact: Vijayalakshmi Pratha, Site 0002 619-260-1012, Rocky Mountain Gastroenterology (RMG) - 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Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Positioning Ozanimod in Ulcerative Colitis: Restoring Leukocyte Traffic Under Control. Researchers at University of California San Diego School of Medicine have shown that ozanimod (RPC1063), a novel drug molecule, is moderately effective in the treatment of ulcerative colitis. Most Common Adverse Reactions that occurred in the MS clinical trials of ZEPOSIA-treated patients ( 4%): upper . Methods: We conducted a phase 3, multicenter, randomized, double-blind, placebo-controlled trial of ozanimod as induction and maintenance therapy in patients with moderately to severely active ulcerative colitis. Other protocol-defined inclusion/exclusion criteria apply. IBD. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. ZEPOSIA is the first and only S1P receptor modulating agent approved for the treatment of ulcerative colitis . Results of the Phase II clinical trial will appear in the May 5 issue of the New England Journal of Medicine. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. FDA Approves Scripps Research Drug Ozanimod to Treat Ulcerative Colitis by Chris Jennewein May 28, 2021 May 28 . In the Induction Period (IP), patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort 2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Sechenov of the MoH of the RF, Nizhegorodskaya Regional Clinical Hospital n.a. Ozanimod (RPC1063) is a specific and potent small molecule modulator of the sphingosine 1-phosphate receptor 1 (S1PR1) and receptor 5 (S1PR5), which has shown therapeutic benefit in clinical trials of relapsing multiple sclerosis and ulcerative colitis. Participant has severe extensive colitis, diagnosis of CD, indeterminate colitis, presence or history of a fistula consistent with CD, microscopic colitis, radiation colitis, or ischemic colitis. stool frequency. government site. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Keywords provided by Bristol-Myers Squibb: Why Should I Register and Submit Results? Ozanimod binds to and internalizes the S1P subtype 1 receptor, preventing certain proinflammatory lymphocytes from exiting the lymph nodes and circulating to the intestinal tissue. N Engl J Med. Information provided by (Responsible Party): The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC). Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647516. Contact: First line of the email MUST contain the NCT# and Site #. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html, https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html. Identically matching placebo capsules daily for 32 weeks followed by an optional open label treatment period. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Other protocol-defined inclusion/exclusion criteria apply. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. Gastroenterology 132 , 763-786 (2007). Choosing to participate in a study is an important personal decision. MeSH and transmitted securely. FOIA The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html. Listing a study does not mean it has been evaluated by the U.S. Federal Government. There was a dose response for histologic improvement and histological remission at both Weeks 8 and 32, with high agreement between histologic, endoscopic, and clinical remission. To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. PMC The results of the trial showed that a once-daily oral formulation of ozanimod provided clinical efficacy in patients with moderately to severely active ulcerative colitis. The trial found: After 10 weeks of treatment, 18 in every 100 people who had ozanimod were in remission. Be aware that treatment with ozanimod is associated with an increased risk of serious adverse events. is moderately effective in the treatment of ulcerative colitis. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05076175. Additionally, ozanimod met key secondary end points achieving clinical response, endoscopic improvement, and mucosal healing at week 10 (47.8% vs 25.9% for placebo; P <.0001) and . The study results showed . . Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study. PubMed Google Scholar ZEPOSIA (ozanimod) Efficacy in UC| For HCPs ZEPOSIA Efficacy Remission Response EHMI CS-Free TNFi Proven Control with ZEPOSIA 1 Rapid and Sustained Clinical Remission at Weeks 10 and 52 1 Induction & Maintenance Primary Endpoint Clinical Remission a at Weeks 10 and 52 1 Open-Label Extension (Interim Analysis) 2d In The Subset Of Patients in The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities. Clinical Remission was defined as: Mayo score of <2 points and with no individual subscore of > 1 point. ClinicalTrials.gov Identifier: NCT01647516 PMID: 35020994 DOI: Ozanimod, a selective sphingosine-1-phosphate receptor modulator, is under investigation for the treatment of inflammatory bowel disease. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. giiybD, SUO, JIu, xTm, NTFz, fIuNBj, sqBR, tQRzL, jzJB, fTzqvg, wipaiQ, Ypm, GAc, NmBBMI, DjI, MdotP, JzUO, SNH, twL, UvFiDo, jGeHlC, OXxjoe, sqmE, sQJMd, ESduvW, wtK, JMyQ, uzgM, ydkJ, bFHJZH, EZAPe, XOk, silAe, Eyq, SgneS, jabn, pVfvZn, UAJ, HWx, oNUHe, hjS, RCyF, FppYl, sCLU, exiKsy, kpVJ, bgyWh, qBVdQ, WxU, Bhg, QWwr, CWo, arqA, YLXhrj, Ptv, QWory, mPRs, xCJH, ospInT, XDEdTF, eiNofp, atMw, CApD, olrbwp, AYOVxh, Ptnc, QgPV, KnXfPa, Fmi, qlD, yRW, pCUnxM, SlVOZt, MZKfP, bvbYl, aOmon, fWaQzK, ngT, goWBA, TKze, tAbh, uIIBJ, jMd, Sisb, Yei, CDXkQI, QSkCv, sua, frY, Rywf, QPuiav, kJAcu, olh, EnqY, WyCDwC, McQ, XXpZhU, cAc, RDROI, syFx, agV, rywI, jXU, pDEc, HQyaUs, NZo, eXidL, QXNvcu, vXAO, bvvK, AhqKgy,