Oral Etrasimod for Crohn's Disease
(CULTIVATE Trial)
Recruiting in Palo Alto (17 mi)
+1010 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Pfizer
Disqualifiers: Ulcerative colitis, Short-bowel syndrome, others
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How does the drug Etrasimod differ from other treatments for Crohn's disease?
Etrasimod is unique because it is an oral medication that works by modulating the immune system, specifically targeting certain receptors involved in inflammation, which may offer a different approach compared to traditional treatments like steroids or immunosuppressants that have broader effects on the immune system.12345
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
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.
I have been diagnosed with Crohn's disease for at least 3 months.
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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.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Induction
Participants receive etrasimod as induction therapy to evaluate efficacy and select doses for maintenance
24 weeks
Maintenance
Participants continue to receive etrasimod to evaluate long-term efficacy and safety
42 weeks
Long-Term Extension
Participants who complete at least 52 weeks of treatment may continue in a long-term extension to further assess safety and efficacy
212 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Etrasimod (Sphingosine 1-phosphate receptor modulator)
- Placebo (Other)
Trial OverviewThe 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.
Participant Groups
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.
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.
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.
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.