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)
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| ClinicalTrials.gov Identifier: NCT04173273 |
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Recruitment Status :
Recruiting
First Posted : November 21, 2019
Last Update Posted : April 13, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Crohn's Disease | Drug: Etrasimod Drug: Placebo | Phase 2 Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1265 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 : | February 12, 2020 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2029 |
| 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. |
- Number and Severity of Adverse Events [Substudy A] [ Time Frame: Up to approximately 70 weeks ]Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
- Proportion of Participants With Endoscopic Response [Substudy 1] [ Time Frame: Week 14 ]
- Proportion of Participants With Endoscopic Response [Substudy 2] [ Time Frame: Week 14 ]
- Proportion of Participants With Clinical Remission Crohn's Disease Activity Index (CDAI) [Substudy 2] [ Time Frame: Week 14 ]
- Proportion of Participants With Clinical Remission CDAI [Substudy 3] [ Time Frame: Week 52 ]
- Proportion of Participants With Endoscopic Response [Substudy 3] [ Time Frame: Week 52 ]
- Proportion of Participants With Endoscopic Response [Substudy A] [ Time Frame: Weeks 14 and 66 ]
- Proportion of Participants With Clinical Remission CDAI [Substudy A] [ Time Frame: Up to Week 66 ]
- Change From Baseline in Simple Endoscopic Score in Crohn's Disease (SES-CD) Score [Substudy A] [ Time Frame: Baseline to Week 66 ]
- Change From Baseline in CDAI Score [Substudy A] [ Time Frame: Baseline to Week 66 ]
- Proportion of Participants With Clinical Remission CDAI [Substudy 1] [ Time Frame: Week 14 ]
- Proportion of Participants With Clinical Remission Patient Reported Outcome 2 (PRO2) [Substudy 2] [ Time Frame: Week 14 ]
- Proportion of Participants With Clinical Response CDAI [Substudy 2] [ Time Frame: Week 14 ]
- Proportion of Participants With Endoscopic Response and Clinical Remission CDAI [Substudy 2] [ Time Frame: Week 14 ]
- Proportion of Participants With Endoscopic Remission [Substudy 2] [ Time Frame: Week 14 ]
- Proportion of Participants With Clinical Remission CDAI Among Participants In Clinical Remission CDAI at Substudy 3 Baseline [Substudy 3] [ Time Frame: Week 52 ]
- Proportion of Participants With Endoscopic Response Among Participants in Endoscopic Response at Substudy 3 Baseline [Substudy 3] [ Time Frame: Week 52 ]
- Proportion of Participants With Corticosteroid-Free Clinical Remission CDAI Among Participants Receiving Corticosteroids at Substudy 3 Baseline [Substudy 3] [ Time Frame: Week 52 ]
- Proportion of Participants With Endoscopic Remission [Substudy 3] [ Time Frame: Week 52 ]
- Proportion of Participants With Clinical Remission PRO2 [Substudy 3] [ Time Frame: Week 52 ]
- Proportion of Participants With Clinical Remission CDAI by Visit up to the End Of Treatment [Substudy 4] [ Time Frame: Up to Week 208 ]
- Proportion of Participants With Clinical Remission PRO2 by Visit up to the End Of Treatment [Substudy 4] [ Time Frame: Up to Week 208 ]
- Number and Severity of Adverse Events [ Time Frame: Up to 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.
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.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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Demonstrated inadequate response (ie, primary non-response), loss of response to, or intolerance to ≥ 1 of the following therapies for the treatment of CD:
- Oral corticosteroids (eg, prednisone or its equivalent, budesonide)
- Immunosuppressants (eg, azathioprine [AZA], 6 mercaptopurine [6-MP], or methotrexate [MTX])
- Tumor necrosis factor alpha (TNFα) antagonists (eg, infliximab, adalimumab, certolizumab pegol, or biosimilars)
- Integrin receptor antagonist (eg, vedolizumab)
- 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
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
| Contact: Arena CT.gov Administrator | +1 855-218-9153 | ct.gov@arenapharm.com |
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| Study Director: | Arena CT.gov Administrator | Arena Pharmaceuticals |
| Responsible Party: | Arena Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT04173273 |
| Other Study ID Numbers: |
APD334-202 2019-002895-14 ( EudraCT Number ) |
| First Posted: | November 21, 2019 Key Record Dates |
| Last Update Posted: | April 13, 2021 |
| Last Verified: | April 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Etrasimod Crohn's disease APD334 Inflammatory bowel disease |
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Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |