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A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease (CULTIVATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04173273
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : May 18, 2023
Sponsor:
Collaborator:
Arena is a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Etrasimod Drug: Placebo Phase 3

Detailed Description:

This study includes 5 substudies:

Substudy A - Phase 2: A Phase 2, randomized, double-blind, substudy to assess the safety, tolerability, and efficacy of oral etrasimod therapy in participants with moderate to severe CD that supports the selection of an induction and maintenance dose(s) for Phase 3.

Substudy 1 - Phase 2: A Phase 2b randomized, double-blind, placebo-controlled, dose-ranging induction substudy to evaluate etrasimod as induction therapy and select an induction and maintenance dose(s) for continued evaluation in Phase 3.

Substudy 2 - Induction: A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as induction therapy.

Substudy 3 - Maintenance: A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as maintenance therapy. Participants from Substudy 1 and Substudy 2 will be enrolled in Substudy 3.

Substudy 4 - Long-Term Extension: A long-term extension substudy for participants who complete at least 52 weeks of treatment. Participants from Substudy 3 and Substudy A are planned to be enrolled in Substudy 4.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn's Disease
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : July 9, 2027
Estimated Study Completion Date : August 1, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: Etrasimod Dose A Drug: Etrasimod
Dose A taken by mouth, once daily.
Other Name: APD334
Experimental: Etrasimod Dose B Drug: Etrasimod
Dose B taken by mouth, once daily.
Other Name: APD334
Placebo Comparator: Placebo Drug: Placebo
Etrasimod matching placebo tablet taken by mouth, once daily.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Participants with Endoscopic Response [Substudy A] [ Time Frame: Weeks 14 and 52 ]
  2. Proportion of Participants With Endoscopic Response [Substudy 1] [ Time Frame: Week 14 ]
  3. Proportion of Participants With Endoscopic Response [Substudy 2] [ Time Frame: Week 14 ]
  4. Proportion of Participants With Clinical Remission Crohn's Disease Activity Index (CDAI) [Substudy 2] [ Time Frame: Week 14 ]
  5. Proportion of Participants With Clinical Remission CDAI [Substudy 3] [ Time Frame: Week 52 ]
  6. Proportion of Participants With Endoscopic Response [Substudy 3] [ Time Frame: Week 52 ]

Secondary Outcome Measures :
  1. Proportion of Participants With Clinical Remission CDAI [Substudy A] [ Time Frame: Up to Week 66 ]
  2. Change From Baseline in Simple Endoscopic Score in Crohn's Disease (SES-CD) Score [Substudy A] [ Time Frame: Baseline to Week 66 ]
  3. Change From Baseline in CDAI Score [Substudy A] [ Time Frame: Baseline to Week 66 ]
  4. Proportion of Participants With Clinical Remission CDAI [Substudy 1] [ Time Frame: Week 14 ]
  5. Proportion of Participants with Clinical Remission Patient Reported Outcome 2 (PRO2) [Substudy 1] [ Time Frame: Week 14 ]
  6. Proportion of Participants With Clinical Remission Patient Reported Outcome 2 (PRO2) [Substudy 2] [ Time Frame: Week 14 ]
  7. Proportion of Participants With Clinical Response CDAI [Substudy 2] [ Time Frame: Week 14 ]
  8. Proportion of Participants With Endoscopic Response and Clinical Remission CDAI [Substudy 2] [ Time Frame: Week 14 ]
  9. Proportion of Participants With Endoscopic Remission [Substudy 2] [ Time Frame: Week 14 ]
  10. Change from baseline in CD-PRO/SS [Substudy 2] [ Time Frame: Week 14 ]
  11. Proportion of Participants With Clinical Remission CDAI Among Participants In Clinical Remission CDAI at Substudy 3 Baseline [Substudy 3] [ Time Frame: Week 52 ]
  12. Proportion of Participants With Endoscopic Response Among Participants in Endoscopic Response at Substudy 3 Baseline [Substudy 3] [ Time Frame: Week 52 ]
  13. Proportion of Participants With Corticosteroid-Free Clinical Remission CDAI Among Participants Receiving Corticosteroids at Substudy 3 Baseline [Substudy 3] [ Time Frame: Week 52 ]
  14. Proportion of Participants With Endoscopic Remission [Substudy 3] [ Time Frame: Week 52 ]
  15. Proportion of Participants With Clinical Remission PRO2 [Substudy 3] [ Time Frame: Week 52 ]
  16. Proportion of Participants with Clinical Response or Endoscopic Response [Substudy 3] [ Time Frame: Week 52 ]
  17. Proportion of Participants With Clinical Remission CDAI by Visit up to the End Of Treatment [Substudy 4] [ Time Frame: Up to Week 208 ]
  18. Proportion of Participants With Clinical Remission PRO2 by Visit up to the End Of Treatment [Substudy 4] [ Time Frame: Up to Week 208 ]
  19. Number and Severity of Adverse Events [ Time Frame: Up to approximately 70 weeks for Substudy A,approximately 24 weeks for Substudy 1 and 2; 42 weeks for Substudy 3; and 212 weeks for Substudy 4 ]
    Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Eligibility criteria applicable to all substudies:

Inclusion Criteria:

  • Men or women 18 to 80 years of age,
  • Ability to provide written informed consent or assent and to be compliant with the schedule of protocol assessments
  • Diagnosed with Crohn's disease (CD) ≥ 3 months
  • Have moderately to severely active CD at Screening

  • Demonstrated inadequate response (ie, primary non-response), loss of response to, or intolerance to ≥ 1 of the following therapies for the treatment of CD:

    1. Oral corticosteroids (eg, prednisone or its equivalent, budesonide)
    2. Immunosuppressants (eg, azathioprine [AZA], 6 mercaptopurine [6-MP], or methotrexate [MTX])
    3. Tumor necrosis factor alpha (TNFα) antagonists (eg, infliximab, adalimumab, certolizumab pegol, or biosimilars)
    4. Integrin receptor antagonist (eg, vedolizumab)
    5. Interleukin -12/-23 antagonist (eg, ustekinumab)
  • Females of childbearing potential must be nonpregnant
  • Females of childbearing potential and males must use contraception

Exclusion Criteria:

  • History of inadequate response (ie, primary non-response) to agents from ≥ 2 classes of biologics marketed for the treatment of CD (ie, TNFα antagonists, interleukin 12/ 23 antagonist, and integrin receptor antagonist).
  • Have ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, toxic megacolon, or active infectious colitis or test positive for Clostridioides difficile toxin at Screening.
  • Have functional or post-operative short-bowel syndrome or any associated complications that may require surgery or interfere with efficacy assessments
  • Had surgical treatment for intra abdominal abscesses ≤ 8 weeks prior to randomization or surgical treatment for perianal abscesses ≤ 4 weeks prior to randomization.
  • Had intestinal resection ≤ 24 weeks prior to randomization or other intra abdominal surgeries ≤ 12 weeks prior to randomization.
  • Have an ileostomy or a colostomy.

Inclusion Criteria for Substudy 3:

- Participants who entered the Extended Induction Period of Substudy 1 and Substudy 2 must have completed the Extended Induction -Week 6 Visit

Inclusion Criteria for Substudy 4:

- Participant must have completed the Week 52 Visit of Substudy 3 or the Week 66 Visit of Substudy A

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173273


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Arena is a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04173273    
Obsolete Identifiers: NCT05033340
Other Study ID Numbers: APD334-202
C5041006 ( Other Identifier: Alias Study Number )
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: May 18, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Etrasimod
Crohn's disease
APD334
Inflammatory bowel disease
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases