Oral Etrasimod for Crohn's Disease (CULTIVATE Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Pfizer
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing a new oral medication called etrasimod for adults with severe Crohn's disease who haven't had success with other treatments. The medication aims to reduce gut inflammation by calming the immune system. The study will last several years and includes different stages to determine the best dosage and long-term effects. Etrasimod is also being tested for ulcerative colitis and may avoid issues that can lead to treatment failure with other therapies.
What safety data is available for Etrasimod in treating Crohn's Disease?The provided research does not contain specific safety data for Etrasimod in the treatment of Crohn's Disease. The studies focus on other treatments such as adalimumab, risankizumab, and vedolizumab, as well as general adverse events in IBD therapies. Further research specifically on Etrasimod is needed to answer this question.78121314
Is the drug Etrasimod a promising treatment for Crohn's Disease?The information provided does not mention Etrasimod, so we cannot determine if it is a promising treatment for Crohn's Disease based on this data.12359
What data supports the idea that Oral Etrasimod for Crohn's Disease is an effective drug?The available research does not provide specific data on the effectiveness of Oral Etrasimod for Crohn's Disease. Instead, it discusses other treatments like adalimumab and budesonide. Adalimumab is shown to help patients who did not respond to another drug, infliximab, and budesonide is effective for mild to moderate Crohn's Disease, especially in certain parts of the intestine. However, there is no direct information on Oral Etrasimod's effectiveness in the provided research.4561011
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you must stop taking your current medications. However, since the trial is for those who have not responded well to current therapies, you might need to stop or adjust them. Please consult with the trial coordinators for specific guidance.
Eligibility Criteria
Adults aged 18-80 with moderate to severe Crohn's Disease, who haven't responded well to or can't tolerate steroids, immunosuppressants, or biologics. They must be able to follow the study plan and use contraception if they can have children.Inclusion Criteria
I am between 18 and 80 years old.
Ability to provide written informed consent or assent and to be compliant with the schedule of protocol assessments
I have been diagnosed with Crohn's disease for at least 3 months.
My Crohn's disease is currently moderate to severe.
I have Crohn's disease and treatments like steroids, immunosuppressants, or biologics didn’t work for me.
Exclusion Criteria
You have a surgical opening in your abdomen to help eliminate waste.
I have short-bowel syndrome that might need surgery or affect treatment results.
Treatment Details
The trial is testing Etrasimod, an oral medication for Crohn's Disease. It compares Etrasimod against a placebo over several years to check its effectiveness and safety in those not helped by standard treatments.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Etrasimod Dose BExperimental Treatment1 Intervention
Group II: Etrasimod Dose AExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Find a clinic near you
Research locations nearbySelect from list below to view details:
The Surgical Hospital at SouthwoodsYoungstown, OH
San Antonio Military Medical Center, Department of PathologyFort Sam Houston, TX
3T Imaging of Morton Grove (Diagnostic Imaging)Morton Grove, IL
Johnston OpthalmologyOklahoma City, OK
More Trial Locations
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Who is running the clinical trial?
PfizerLead Sponsor
Arena PharmaceuticalsLead Sponsor
Arena is a wholly owned subsidiary of PfizerCollaborator
Arena is a wholly owned subsidiary of PfizerIndustry Sponsor
References
Controlled-release budesonide in Crohn's disease. [2019]Budesonide is a glucocorticoid with high local activity but much lower systemic availability than prednisolone. Topical formulations have long been licensed for use in asthma and rhinitis. Here we discuss a new orally active controlled-release preparation of budesonide (Entocort CR-Astra) formulated specifically for treating patients with Crohn's disease affecting the ileum and/or ascending colon. The manufacturer claims that the preparation "targets the ileum and ileocaecal area, achieving rapid results equivalent to prednisolone" with a "low level of systemic steroid side effects".
Current treatment modalities in active Crohn's disease. [2005]The aetiology of Crohn's disease is unknown and, therefore, no curative treatments are currently available. Crohn's disease treatment requires knowledge of several variables affecting patient's responsiveness including: characteristics of the disease and of the host, as well as the specific purposes of treatment and the characteristics of the effective drugs. Currently available drugs for active Crohn's disease include: a) old drugs (oral/topical salicylates, conventional steroids); b) old drugs with a new face (immunosuppressives, antibacterial drugs); c) new drugs (budesonide, anti-cytokines/cytokines, probiotics). Among the old drugs, corticosteroids (1 mg/kg) are the most effective, with a 65-85% induction of remission, when compared to high dose sulphasalazine (3-5 g/day) (12%) and 5-aminosalicylic acid (4 g/day) (25%). The following drugs represent current treatment modalities in steroid/refractory active Crohn's disease. Immunosuppressives, including azathioprine (2-2.5 mg/kg) and 6-mercaptopurine (1-1.5 mg/kg) are less effective than steroids (30-40% vs 65-85%), but in chronic active Crohn's disease they show a 76% "steroid-sparing" effect and 63% fistula closure. The reported efficacy of methotrexate (25 mg/kg) and cyclosporine A in fistulous Crohn's disease needs to be confirmed. Antibiotics, such as metronidazole and ciprofloxacin (1 g/day) are effective in perianal or colonic active Crohn's disease. Budesonide, a steroid with low systemic absorption, shows an efficacy comparable to prednisone in active small bowel Crohn's disease. Bowel rest and enteral feeding are effective in active Crohn's disease. To summarize, conventional steroids still represent the most effective drugs in active Crohn's disease. However, refractory disease, steroid-dependence, drug-side effects and/or complications may require two main alternative management strategies: a) surgical resection in localized or primary Crohn's disease; b) alternative drugs in extensive or recurrent Crohn's disease.
Budesonide (Entocort EC Capsules): a review of its therapeutic use in the management of active Crohn's disease in adults. [2022]Budesonide (Entocort EC Capsules) is an oral corticosteroid with a high degree of topical activity and low systemic bioavailability (approximately 11%). This action is achieved by a high affinity for the glucocorticoid receptor and an extensive first-pass hepatic metabolism. The budesonide capsule has been formulated to dissolve in a pH dependent manner, delivering most of the drug to the ileum and ascending colon, areas of the intestine most commonly affected by Crohn's disease. In large (n > or = 176), well designed clinical trials of 10 to 12 weeks' duration in patients with active, mild to moderate Crohn's disease, budesonide (9 mg/day) was significantly more effective in inducing remission than placebo or mesalazine (mesalamine) slow release, and demonstrated similar efficacy to recommended dosages of prednisolone. Results of health-related quality-of-life assessments support clinical data, showing a significantly greater improvement among patients treated with budesonide than with placebo or mesalazine slow release. Oral budesonide was well tolerated in clinical trials of up to 16 weeks' duration. In these studies, the incidence of adverse events associated with budesonide (9 mg/day) was similar to that seen with placebo and mesalazine slow release. The rate of glucocorticoid-related adverse effects observed with budesonide was significantly less than that reported with prednisolone.
Oral budesonide in the management of Crohn's disease. [2007]To review the pharmacology, pharmacokinetics, efficacy, and safety of oral budesonide (Entocort EC) in the treatment of mild to moderate Crohn's disease (CD).
Targeted delivery, safety, and efficacy of oral enteric-coated formulations of budesonide. [2022]Budesonide is a potent corticosteroid with a high first-pass metabolism rate. Two commercially available enteric-coated pH-dependent release formulations (Entocort EC and Budenofalk) deliver budesonide to the ileum and proximal colon, regions most commonly affected in Crohn's disease. The drug's effectiveness in this disease has been proven in multiple, placebo-controlled trials, where it has been shown to be superior to mesalamine and placebo, and equivalent to prednisolone for the control of mild to moderately active right-sided Crohn's disease. This beneficial therapeutic effect comes with less adrenal suppression and a small improvement in the clinical adverse effect profile, as compared to prednisolone. However, budesonide provides no benefit over conventional therapy for left-sided colonic disease, and it is less effective for treatment of more severe disease activity and more distal colonic disease. Continuous budesonide does not prolong remission and is, therefore, best used in an intermittent fashion to treat acute exacerbations.
Adalimumab maintenance therapy for Crohn's disease with intolerance or lost response to infliximab: an open-label study. [2015]Adalimumab is effective in inducing remission in patients with active Crohn's disease who had secondary failure to infliximab therapy.
Adalimumab safety in global clinical trials of patients with Crohn's disease. [2022]Adalimumab, a fully human anti-tumor necrosis factor (anti-TNF) monoclonal antibody, is approved for the treatment of Crohn's disease (CD) in adults. We evaluated the overall safety profile of adalimumab in global clinical trials in patients with CD. Patients who participated in these trials, which included randomized induction and maintenance trials, Phase IIIb trials, and open-label extension studies, had moderately to severely active CD and were evaluated for safety at regular intervals.
Efficacy and safety of adalimumab in the treatment of Crohn´s disease in children. [2019]to describe the efficacy and safety of adalimumab (ADA) in inducing clinical remission and reducing inflammation of intestinal mucosa in children with Crohn´s disease (CD).
A phase II study of laquinimod in Crohn's disease. [2021]Laquinimod is an oral therapeutic agent under investigation for the treatment of Crohn's disease (CD), Huntington's disease, lupus nephritis and multiple sclerosis. This dose escalation study evaluated the safety and efficacy of laquinimod as induction therapy in patients with active moderate-severe CD.
Clinical, biological, and endoscopic responses to adalimumab in antitumor necrosis factor-naive Crohn's disease: predictors of efficacy in clinical practice. [2015]Endoscopic healing and clinical remission are important parameters to evaluate therapeutic efficacy in Crohn's disease. The aim of this study was to investigate the clinical effectiveness of adalimumab in terms of clinical and endoscopic response and to identify predictors of efficacy in clinical practice.
Impact of the early use of immunomodulators or TNF antagonists on bowel damage and surgery in Crohn's disease. [2018]The impact of early treatment with immunomodulators (IM) and/or TNF antagonists on bowel damage in Crohn's disease (CD) patients is unknown.
Retrospective Analysis of Safety of Vedolizumab in Patients With Inflammatory Bowel Diseases. [2021]There are few real-world data on the safety of vedolizumab for treatment of Crohn's disease (CD) or ulcerative colitis (UC). We quantified rates and identified factors significantly associated with infectious and non-infectious adverse events in clinical practice.
Adverse events in IBD therapy: the 2018 update. [2019]Crohn's disease and ulcerative colitis affect an increasing number of patients, and utilization of immune suppressant and biologic therapies is also increasing. These agents are linked to adverse events ranging from mild nuisance symptoms to potentially life-threatening complications including infections and malignancies. Areas covered: This review provides an updated discussion on adverse events associated with immunomodulator, anti-TNF-α, anti-integrin, and anti-IL 12/IL-23 antibody therapies. In addition, we review the risk profile of the currently widely available infliximab biosimilar medication. Expert commentary: Providers should engage in risk-benefit discussion with information specific to each medication discussed, and consider individualized risk factors when selecting therapeutic agents. Drug monitoring and shared decision-making results in more personalized medical management of inflammatory bowel disease.
Effectiveness and safety of risankizumab induction therapy for 100 patients with Crohn's disease: A GETAID multicentre cohort study. [2023]Phase III trials have demonstrated the efficacy of risankizumab in moderate-to-severe Crohn's disease (CD), but no real-world data are currently available. We aimed to assess the short-term effectiveness and safety of risankizumab in patients with CD.