Health Condition 1: K00-K95- Diseases of the digestive system
Conditions
Interventions
Intervention1: Eligible subjects will be randomized into one of two doses of etrasimod or matching placebo.: Sub Study SSA-Ph2
2 mg etrasimod Film Coated Tablet, Oral, once daily
2 mg +1 mg etrasimod
Sponsors
Arena Pharmaceuticals
IQVIA RDSIndia Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects 18 to 80 years of age, inclusive, at the time of consent 2. Ability to provide written informed consent and to be compliant with the schedules of protocol assessments 3. Diagnosed with Crohnâ??s Disease >= 3 months 4. Have moderately to severely active CD at Screening 5. Demonstrated inadequate response, loss of response to, or intolerance to >= 1 of the following therapies for the treatment of CD â?? Oral corticosteroids (eg, prednisone [or its equivalent] or budesonide) â?? Immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate) â?? Tumor necrosis factor alpha (TNFα) antagonists (eg, infliximab, adalimumab, certolizumab pegol, or biosimilars) â?? Integrin receptor antagonist (eg, vedolizumab) â?? Interleukin-12/-23 antagonist (eg, ustekinumab) 6. Females of childbearing potential must be nonpregnant 7. Females of childbearing potential and males must agree to use contraception Participants who entered the Extended Induction Period of SS1, SS2 must have completed the Extended Induction â?? Week 6 Visit (Inclusion for SS3) Participant must have completed the Week 52 Visit of SS3 or the Week 66 Visit of SSA (Inclusion for SS4)
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, TNFα antagonists, interleukin-12/-23 antagonist, and integrin receptor antagonist) 2. 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 3. Have functional or post-operative short-bowel syndrome or any associated complications that may require surgery or interfere with efficacy assessments 4. Had surgical treatment for intra-abdominal abscesses 5. Had intestinal resection 25 cm of colon remaining 6. Have an ileostomy or a colostomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SS1-P2b SS2-I SS3-MTimepoint: 1)Proportion of subjects with endoscopic response at Week 14 2)Proportion of subjects with endoscopic response at Week 14,Proportion of subjects with clinical remission CDAI at Week 14 3)Proportion of subjects with clinical remission CDAI at Week 52 Proportion of subjects with endoscopic response at Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| SS1-P2bTimepoint: Proportion of subjects with clinical remission CDAI at Week 14;SS2-ITimepoint: Proportion of subjects with clinical remission PRO2 at Week 14 Proportion of subjects with clinical response CDAI at Week 14 Proportion of subjects with endoscopic response and clinical remission CDAI at Week 14 Proportion of subjects with endoscopic remission at Week 14;SS3-MTimepoint: Proportion of subjects with clinical remission CDAI at Wk 52 among subjects in clinical remission CDAI at SS3-M baseline (defined as Wk14 or EI-Wk 6Visit). Proportion of subjects with endoscopic response at Wk52 among subjects in endoscopic response at SS3-M baseline. Proportion of subjects with corticosteroid-free clinical remission CDAI at Wk52 among subjects receiving corticosteroids at SS3-M baseline. Proportion of subjects with endoscopic remission at Wk52;SSA-P2Timepoint: Proportion of subjects with endoscopic response Proportion of subjects with clinical remission CDAI Change from baseline in SES-CD score Change from baseline in CDAI score | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, Nigeria, Norway, Other, Peru, Philippines, Poland, Portugal, Republic of Korea, Republic of Moldova, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactSuneela Thatte
IQVIA RDS India Private Limited
Outcome results
None listed