Oral Etrasimod for Crohn's Disease

(CULTIVATE Trial)

Recruiting at1010 trial 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. ^{1 2 3 4 5}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

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.

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 Overview 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.

Participant Groups

Group I: Etrasimod Dose B Experimental Treatment 1 Intervention

Group II: Etrasimod Dose A Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Arena Pharmaceuticals

Lead Sponsor

Trials

29

Recruited

5,800+

Arena is a wholly owned subsidiary of Pfizer

Collaborator

Trials

7

Recruited

2,500+

Arena is a wholly owned subsidiary of Pfizer

Industry Sponsor

Trials

11

Recruited

2,600+

Findings from Research

The new controlled-release formulation of budesonide, Entocort CR-Astra, is designed specifically for treating Crohn's disease in the ileum and ascending colon, providing targeted therapy with rapid results similar to prednisolone.

Budesonide has a much lower systemic availability compared to prednisolone, which may lead to fewer systemic steroid side effects, making it a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled-release budesonide in Crohn's disease. [2019]

Corticosteroids are the most effective treatment for active Crohn's disease, achieving remission in 65-85% of patients, significantly outperforming other older drugs like high-dose sulphasalazine and 5-aminosalicylic acid.

For patients with steroid-refractory Crohn's disease, immunosuppressives like azathioprine and 6-mercaptopurine offer a 'steroid-sparing' effect and can help with fistula closure, although they are less effective than steroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current treatment modalities in active Crohn's disease. Biancone, L., Pallone, F.[2005]

In a study involving 180 patients with active moderate-severe Crohn's disease, laquinimod at a dose of 0.5 mg/day was found to be effective, achieving remission in 48.3% of patients compared to 15.9% in the placebo group.

Laquinimod was safe and well tolerated, with adverse events occurring at similar rates to placebo, indicating that it may be a promising treatment option for Crohn's disease, particularly at the lower dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II study of laquinimod in Crohn's disease. D'Haens, G., Sandborn, WJ., Colombel, JF., et al.[2021]

Budesonide is an effective treatment for mild to moderately active right-sided Crohn's disease, showing superiority over mesalamine and placebo, and comparable efficacy to prednisolone, while causing less adrenal suppression.

However, budesonide is not beneficial for left-sided colonic disease and is less effective for severe disease, making it best suited for intermittent use during acute flare-ups rather than continuous treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted delivery, safety, and efficacy of oral enteric-coated formulations of budesonide. Fedorak, RN., Bistritz, L.[2022]

In large clinical trials involving over 176 patients with active mild to moderate Crohn's disease, oral budesonide (9 mg/day) was significantly more effective than placebo and mesalazine in inducing remission, showing similar efficacy to prednisolone.

Budesonide was well tolerated, with adverse events occurring at rates similar to placebo and mesalazine, and significantly fewer glucocorticoid-related side effects compared to prednisolone, making it a safer option for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Budesonide (Entocort EC Capsules): a review of its therapeutic use in the management of active Crohn's disease in adults. McKeage, K., Goa, KL.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Controlled-release budesonide in Crohn's disease. [2019]

2. Italy pubmed.ncbi.nlm.nih.gov

Current treatment modalities in active Crohn's disease. [2005]

3. England pubmed.ncbi.nlm.nih.gov

A phase II study of laquinimod in Crohn's disease. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Targeted delivery, safety, and efficacy of oral enteric-coated formulations of budesonide. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Budesonide (Entocort EC Capsules): a review of its therapeutic use in the management of active Crohn's disease in adults. [2022]