FOIA About Zeposia (ozanimod) Zeposia (ozanimod) is an oral, sphingosine-1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Ozanimod is a sphingosine-1-phosphate (S1P) receptor modulator which has been recently approved for UC therapy. government site. Clinical Remission was based on the 4-component Mayo definition. N Engl J Med. Debreceni Egszsggyi Kzpontja, Severance Hospital, Yonsei University Health System, The Catholic University of Korea, St.Vicent's Hospital, SPZOZ Wojewodzki Szpital Zespolony im. 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. This site needs JavaScript to work properly. This figure shows drugs that are currently in clinical trials for the treatment of ulcerative colitis (UC). Clinical Study for People at Risk of Developing Alzheimer's Disease Recruiting. Bookshelf You have reached the maximum number of saved studies (100). 2021 Sep 30;385(14):1280-1291. doi: 10.1056/NEJMoa2033617. 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. 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. Would you like email updates of new search results? Participants received 0.5 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. 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. 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). 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. Most Common Adverse Reactions that occurred in the MS clinical trials of ZEPOSIA-treated patients ( 4%): upper . The red circles within the figure show the phase of development that the drug is currently in as an UC therapeutic agent. UC is an autoimmune disease characterized by an overproduction of lymphocytes cells involved in the immune response in . Ellen J. Scherl, MD, reviews data from the phase 3 True North study evaluating the use of ozanimod as induction and maintenance therapy for moderate to severe ulcerative colitis, and the panel shares their experience with ozanimod in clinical practice. ZEPOSIA (ozanimod) An Oral Treatment for UC | For HCPs The Only Oral Advanced Therapy a That Can Be Used Before Biologics in Moderate-to-Severe UC Patients 1-3 Another day is dawning in the control of UC Rapid & Sustained Remission 1 Demonstrated Safety Profile 1 One Capsule, Once Daily 1 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 drug is also in late-stage clinical trials for the treatment of Crohn's . For general information, Learn About Clinical Studies. Endoscopy subscores were calculated based on central endoscopy reading. View this study on Beta.ClinicalTrials.gov, U.S. Department of Health and Human Services. Higher scores represent more severe disease. Choosing to participate in a study is an important personal decision. N Engl J Med. 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 . Read our disclaimer for details. 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. The site is secure. Ozanimod works by acting on certain types of immune cells called lymphocytes that are centrally involved in the autoimmune attack on the large intestine. Keywords provided by Bristol-Myers Squibb: Why Should I Register and Submit Results? 2022 Jan 13;386(2):194.doi: 10.1056/NEJMc2117224. 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. 2. and transmitted securely. Identically matching placebo capsules daily for 32 weeks followed by an optional open label treatment period. NICE recommends biological therapy (monoclonal antibodies adalimumab, golimumab, infliximab, ustekinumab or vedolizumab) or tofacitinib for moderately to . ZEPOSIA is different it's not a biologic, a 5-ASA, or a steroid. Treatment with ozanimod led to significant improvements, as compared with placebo, in the incidence of clinical remission (primary end point) and in all key secondary . 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. Ozanimod beats placebo for ulcerative colitis (HealthDay)For patients with moderately to severely active ulcerative colitis, ozanimod is more effective than placebo as induction and. Ozanimod is also in late-stage clinical trials for the treatment of Crohn's disease, another type of inflammatory bowel disease. Be aware that treatment with ozanimod is associated with an increased risk of serious adverse events. The presentations will feature results from the STEPSTONE study and the open-label extension . *Individual results may vary. Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ZEPOSIA is the first and only S1P receptor modulating agent approved for the treatment of ulcerative colitis . Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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. 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 adults with moderately to severely active ulcerative colitis who have had an inadequate or lost response to, or were intolerant of, either Methods: We conducted a double-blind, placebo-controlled phase 2 trial of ozanimod in 197 adults with moderate-to-severe ulcerative colitis. Talk with your doctor and family members or friends about deciding to join a study. Relevance to patient care and clinical practice: Ozanimod is the first sphingosine 1-phosphate modulator to be approved for UC and is administered orally. Read our, ClinicalTrials.gov Identifier: NCT01647516, Interventional Results from both an induction and maintenance therapy trial show ozanimod can be an effective treatment for patients with inflammatory bowel . The study was funded by Bristol Myers Squibb, True North. While ulcerative colitis affects the colon and rectum, Crohn's disease may act on any part of the gastrointestinal tract and also affect the entire thickness of the bowel wall. Contact: First line of the email MUST contain the NCT# and Site #. All subjects will receive orally administered ozanimod HCl 1 mg. You have reached the maximum number of saved studies (100). Read our disclaimer for details. Apply to this Phase 4 clinical trial treating Colitis, Colitis, Ulcerative, Ulcer. Results . PMID: 35020994 DOI: Gastroenterology. 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. Keywords provided by Bristol-Myers Squibb: Why Should I Register and Submit Results? For general information, Learn About Clinical Studies. 2015the international organization for the study of IBDIOIBD""selecting therapeutic targets in inflammatory bowel diseaseSTRIDEIBD [] 62021STRIDE IBD . N Engl J Med. IBD. Ozanimod Therapy for Ulcerative Colitis. 2022 Jun;162(7):2104-2106. doi: 10.1053/j.gastro.2022.01.033. official website and that any information you provide is encrypted Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05076175. Sandborn WJ, Feagan BG, Wolf DC, D'Haens G, Vermeire S, Hanauer SB, Ghosh S, Smith H, Cravets M, Frohna PA, Aranda R, Gujrathi S, Olson A; TOUCHSTONE Study Group. Before However, its safety profile is unique, requiring extensive assessments prior to initiation of and during treatment. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Proportion of participants with clinical remission as measured by the 3-component Mayo Score [TimeFrame:At week 10], Proportion of participants with clinical remission as measured by the 3-component Mayo Score [TimeFrame:At week 52], Proportion of participants with clinical response as measured by the 3-component Mayo Score [TimeFrame:At week 10 and at week 52], Proportion of participants with endoscopic improvement [TimeFrame:At week 10 and at week 52], Proportion of participants achieving histologic remission [TimeFrame:At week 10 and at week 52], Proportion of participants with mucosal healing [TimeFrame:At week 10 and at week 52], Proportion of participants in remission as measured by the 3-component Mayo Score while off corticosteroids for 12 weeks [TimeFrame:At week 52], Proportion of participants with Treatment Emergent Adverse Events (TEAEs) [TimeFrame:Up to 78 weeks], Proportion of participants with Serious Adverse Events (SAEs) [TimeFrame:Up to 78 weeks], Proportion of participants with TEAEs leading to discontinuation of investigational product [TimeFrame:Up to 78 weeks], Proportion of participants with TEAEs of special interest [TimeFrame:Up to 78 weeks], Proportion of participants with clinical laboratory abnormalities [TimeFrame:Up to 78 weeks], Proportion of participants with vital sign abnormalities [TimeFrame:Up to 78 weeks], Proportion of participants with electrocardiogram (ECG) abnormalities [TimeFrame:Up to 78 weeks], Proportion of participants with pulmonary function test abnormalities [TimeFrame:Up to 78 weeks]. At the end of the 10-week induction period, ozanimod outperformed placebo on every measure of clinical effectiveness: clinical remission (23.4% vs. 8.9%), clinical response (53.7% vs. 30.7%), endoscopic improvement (35.6% vs. 14.9%) and mucosal healing (18% vs. 5%). ClinicalTrials.gov Identifier: NCT01647516 Featured Trials. Results were similar between the treatment/placebo and open-label arms. Moderately to severely active ulcerative colitis (UC) in adults. Information provided by (Responsible Party): The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC). View this study on Beta.ClinicalTrials.gov, U.S. Department of Health and Human Services. Ulcerative colitis, part of a group of conditions known as inflammatory bowel diseases, is the result of the immune system's overactive response. This mechanism. N Engl J Med. 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. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study. Participants who have completed the Week 10 Visit and are non-responders at Week 10. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. earlier. stool frequency. Ozanimod for the Treatment of Ulcerative Colitis. 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. Sechenov of the MoH of the RF, Nizhegorodskaya Regional Clinical Hospital n.a. If you're living with ulcerative colitis, you may have a new treatment option. of. View this study on Beta.ClinicalTrials.gov. Higher scores represent more severe disease. Contact: First line of the email MUST contain NCT # and Site #. Please remove one or more studies before adding more. Methods We conducted a phase 3, multicenter, randomized,. Virtually every drug currently available on the market to treat Crohn's disease or ulcerative colitis went through the clinical trials process previously. Clinical trials are under way to test Zeposia's effectiveness in treating Crohn's disease. Federal government websites often end in .gov or .mil. Learn More. A large clinical trial looked at how well ozanimod works in adults with moderately or severely active Ulcerative Colitis. Zeposia (ozanimod), an investigational anti-inflammatory medicine, significantly increased clinical remission and mucosal healing in patients with ulcerative colitis (UC), a form of inflammatory bowel disease (IBD), Bristol Myers Squibb announced in a press release. Individual Participant Data (IPD) Sharing Statement: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html. The approval, awarded to Bristol Myers Squibb, was based on the data from a placebo-controlled phase 3 trial dubbed True North. 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. 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. . The applicable drug, drug target, and relevant company are indicated parallel to the red circles within the figure. Shupyk NMA of PGE, Order of the Red Star MMMCC MMCH Clinic of Gastroenterology, CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv, Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU, Medical Clinical Research Center "Health Clinic", Zaporizhzhya city multidisciplinary clinical hospital #9, Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8 [TimeFrame:Week 8], Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8 [TimeFrame:Week 8], Change From Baseline in Mayo Score at Week 8 [TimeFrame:Baseline to Week 8], Percentage of Participants With Mucosal Healing at Week 8 [TimeFrame:Week 8], = Mild disease (erythema, decreased vascular pattern, mild friability), = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions), = Severe disease (spontaneous bleeding, ulceration), Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32 [TimeFrame:Week 32], Percentage of Participants Who Achieved Clinical Response at Week 32 [TimeFrame:Week 32], Percentage of Participants With Mucosal Healing at Week 32 [TimeFrame:Week 32], Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction Period [TimeFrame:From the first dose of investigational product (IP) up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 52.8 days, 56.1 days and 50.8 days respectively for 0.5 mg, 1 mg ozanimod and placebo], Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Maintenance Period [TimeFrame:From the first dose of IP up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 156.3 days, 171.1 days and 154.5 days respectively for 0.5 mg, 1 mg ozanimod and placebo. (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. Careers. Background: Ozanimod, a selective sphingosine-1-phosphate receptor modulator, is under investigation for the treatment of inflammatory bowel disease. ClinicalTrials.gov Identifier: NCT05076175, Interventional Talk with your doctor and family members or friends about deciding to join a study. The primary efficacy endpoint is the proportion of subjects with a clinically meaningful increase in . Individual Participant Data (IPD) Sharing Statement: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. I.M. Epub 2021 Dec 8. There was a high rate of continued study participation and long-term benefit with ozanimod HCl 1 mg daily based on clinical, histological and biomarker measures in patients with moderately to severely active UC in the TOUCHSTONE OLE. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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. Ozanimod in Ulcerative Colitis. 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. The drug works by acting on certain types of immune cells called lymphocytes that are centrally involved in the autoimmune attack on the large intestine. Listing a study does not mean it has been evaluated by the U.S. Federal Government. An official website of the United States government. Bethesda, MD 20894, Web Policies 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. Clinical response was defined as a reduction from baseline in Mayo score 3 points and 30%, and a decrease from baseline in the rectal bleeding subscore of 1 point or an absolute rectal bleeding subscore of 1 point. In this review, we focus on the mechanism of action of ozanimod hydrochloride in preclinical studies of intestinal inflammation as well as its clinical effectiveness and safety in moderate to severe UC patients. 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). Why Should I Register and Submit Results? Ozanimod Induction and Maintenance Treatment for Ulcerative Colitis. 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). Results of the Phase II clinical trial will appear in the May 5 issue of the New England Journal of Medicine. ZEPOSIA is a once-daily pill for UC not an injection or an infusion. Participant has had moderately to severely active UC diagnosed at least 3 months prior to first investigational product administration. L.T. 2022 May;162(6):1767-1769. doi: 10.1053/j.gastro.2021.12.235. Moderate to severely active UC disease activity, defined as a modified Mayo score of 4 through 9, inclusive, with the following minimum subscores: i) An SF subscore 1, AND ii) An RB subscore 1, AND iii) An ES 2 (endoscopy performed within 60 days of the first study intervention administration). Ozanimod is an oral sphingosine 1-phosphate receptor modulator. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Clinical trials on ZEPOSIA The safety and efficacy of ZEPOSIA were demonstrated in two randomised, double-blind, double-dummy, parallel-group, active comparator-controlled clinical . Ozanimod is an oral sphingosine 1-phosphate receptor modulator, which could present a new treatment method for ulcerative colitis, according to a press release from Bristol Myers Squibb. . Main Study and Open-label Extension Period: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Ozanimod, a selective sphingosine-1-phosphate receptor modulator, is under investigation for the treatment of inflammatory bowel disease. Zeposia reduces the capacity of lymphocytes to egress from lymph nodes, reducing the number of circulating lymphocytes in peripheral blood. You have reached the maximum number of saved studies (100). A significantly greater proportion of patients with moderate to severe ulcerative colitis achieved clinical remission at 32 weeks with Ozanimod 1 mg versus placebo Clinical response and mucosal healing also significantly improved with Ozanimod 1 mg compared to placebo at week 32 Week 32 safety results consistent with those at week 8 Celgene Corporation (NASDAQ: CELG) today announced detailed . MeSH Continue Reading. Choosing to participate in a study is an important personal decision. Results from both an induction and maintenance therapy trial show ozanimod can be an effective treatment for patients with inflammatory bowel . N.A. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Clinical Remission was defined as: Mayo score of <2 points and with no individual subscore of > 1 point. Mucosal healing is defined as an endoscopy subscore 1 point. Reduces symptoms of rectal bleeding and. Ozanimod for Ulcerative Colitis Ozanimod for Ulcerative Colitis N Engl J Med. Sandborn WJ, Feagan BG, D'Haens G, Wolf DC, Jovanovic I, Hanauer SB, Ghosh S, Petersen A, Hua SY, Lee JH, Charles L, Chitkara D, Usiskin K, Colombel JF, Laine L, Danese S; True North Study Group. 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. . 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. Ozanimod Yields Clinical Response Remission In Ulcerative Colitis Patients. (Clinical Trial), Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy, Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com. Ozanimod appears to be an effective treatment for moderate to severe ulcerative colitis (UC), according to research presented at the Advances in Inflammatory Bowel Diseases (AIBD) 2021 Annual Meeting, held from December 9 to 11, 2021, in Orlando, Florida and virtually. Contact: First line of the email MUST contain the NCT# and Site #. 1.Introduction. PMC [NCT02531126]. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Talk with your doctor and family members or friends about deciding to join a study. Please remove one or more studies before adding more. The mechanism of action for ozanimod is unknown, although investigators believe that it may work by reducing lymphocyte migration into the intestines. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. 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