Crohn's Disease
Conditions
Interventions
estrasimod Dose A, B or matching placebo taken by mouth, once daily.
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
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 (TNF a) 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 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
Exclusion criteria
Exclusion criteria: History of inadequate response (ie, primary non-response) to agents from => 2 classes of biologics marketed for the treatment of CD (ie, TNFa 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ] | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Denmark, Egypt, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Lebanon, Lithuania, Malaysia, Mexico, Poland, Romania, Serbia, Slovakia, South Africa, Spain, Switzerland, Ukraine, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed