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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

PHASE3RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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: 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.

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

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

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2020-01-06

Primary completion: 2025-07-16

Study completion finish: 2029-08-08

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT04173273

Intervention or treatment

DRUG: Etrasimod

DRUG: Placebo

Conditions

• Crohn's Disease

Condition: Crohn's Disease
DRUG: Etrasimod and other drugs
Heidelberg, Victoria, Australia and more
Sponsor: Pfizer

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Austin Hospital

Research sites nearby

Select from list below to view details:

Austin Hospital
Heidelberg, Victoria, Australia
Macquarie Respiratory Services
Macquarie University, New South Wales, Australia
Macquarie University Hospital Clinical Trials
Macquarie University, New South Wales, Australia
Macquarie University Hospital Pharmacy
Macquarie University, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Etrasimod Dose A Not Specified	DRUG: Etrasimod Dose A taken by mouth, once daily.
EXPERIMENTAL: Etrasimod Dose B Not Specified	DRUG: Etrasimod Dose B taken by mouth, once daily.
PLACEBO_COMPARATOR: Placebo Not Specified	DRUG: Placebo Etrasimod matching placebo tablet taken by mouth, once daily.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Proportion of Participants with Endoscopic Response [Substudy A]	Not Specified	Weeks 14 and 52
Proportion of Participants With Endoscopic Response [Substudy 1]	Not Specified	Week 14
Proportion of Participants With Endoscopic Response [Substudy 2]	Not Specified	Week 14
Proportion of Participants With Clinical Remission Crohn's Disease Activity Index (CDAI) [Substudy 2]	Not Specified	Week 14
Proportion of Participants With Clinical Remission CDAI [Substudy 3]	Not Specified	Week 52
Proportion of Participants With Endoscopic Response [Substudy 3]	Not Specified	Week 52

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Proportion of Participants With Clinical Remission CDAI [Substudy A]	Not Specified	Up to Week 66
Change From Baseline in Simple Endoscopic Score in Crohn's Disease (SES-CD) Score [Substudy A]	Not Specified	Baseline to Week 66
Change From Baseline in CDAI Score [Substudy A]	Not Specified	Baseline to Week 66
Proportion of Participants With Clinical Remission CDAI [Substudy 1]	Not Specified	Week 14
Proportion of Participants with Clinical Remission Patient Reported Outcome 2 (PRO2) [Substudy 1]	Not Specified	Week 14
Proportion of Participants With Clinical Remission Patient Reported Outcome 2 (PRO2) [Substudy 2]	Not Specified	Week 14
Proportion of Participants With Clinical Response CDAI [Substudy 2]	Not Specified	Week 14
Proportion of Participants With Endoscopic Response and Clinical Remission CDAI [Substudy 2]	Not Specified	Week 14
Proportion of Participants With Endoscopic Remission [Substudy 2]	Not Specified	Week 14
Change from baseline in CD-PRO/SS [Substudy 2]	Not Specified	Week 14
Proportion of Participants With Clinical Remission CDAI Among Participants In Clinical Remission CDAI at Substudy 3 Baseline [Substudy 3]	Not Specified	Week 52
Proportion of Participants With Endoscopic Response Among Participants in Endoscopic Response at Substudy 3 Baseline [Substudy 3]	Not Specified	Week 52
Proportion of Participants With Corticosteroid-Free Clinical Remission CDAI Among Participants Receiving Corticosteroids at Substudy 3 Baseline [Substudy 3]	Not Specified	Week 52
Proportion of Participants With Endoscopic Remission [Substudy 3]	Not Specified	Week 52
Proportion of Participants With Clinical Remission PRO2 [Substudy 3]	Not Specified	Week 52
Proportion of Participants with Clinical Response or Endoscopic Response [Substudy 3]	Not Specified	Week 52
Proportion of Participants With Clinical Remission CDAI by Visit up to the End Of Treatment [Substudy 4]	Not Specified	Up to Week 208
Proportion of Participants With Clinical Remission PRO2 by Visit up to the End Of Treatment [Substudy 4]	Not Specified	Up to Week 208
Number and Severity of Adverse Events	Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.	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

Frequently Asked Questions

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References

Clinical Trials Gov: A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease