A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn*s Disease

Phase 2

Completed

• Conditions: Crohn's disease; 10017969

• Registration Number: NL-OMON49630
• Lead Sponsor: Arena Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1

Inclusion Criteria

1. Men or women 18 to 80 years of age,
2. Ability to provide written informed consent and to be compliant with the
schedule of protocol assessments
3. Diagnosed with CD * 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:
a.Oral corticosteroids (eg, prednisone or its equivalent, budesonide)
b.Immunosuppressants (eg, azathioprine [AZA], 6 mercaptopurine [6 MP], or
methotrexate [MTX])
c.Tumor necrosis factor alpha (TNF*) antagonists (eg, infliximab, adalimumab,
certolizumab pegol, or biosimilars)
d.Integrin receptor antagonist (eg, vedolizumab)
e.Interleukin 12/ 23 antagonist (eg, ustekinumab)
6.Females of childbearing potential must be nonpregnant
7.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, TNF* 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 Clostridium
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.
- Have a serious infection requiring IV antibiotics/medication(s) * 4 weeks
prior to randomization.
- Have primary or secondary immunodeficiency syndromes, opportunistic
infection, or infection with HIV, HBV, HCV or tuberculosis (active or latent):.
- Have a clinically relevant cardiovascular condition or receiving treatments
that may effect cardiovascular function
- Have active retinopathy or macular oedema.
- Have forced expiratory volume at 1 second or forced vital capacity < 70% of
predicted values at Screening.
- Lactating female who is breastfeeding.
- Any acute illnesses or medical conditions including cognitive impairment and
alcohol/drug abuse/dependence, or signs/symptoms suspicious for a serious
disease that, in the Investigator's opinion, could put the subject at increased
risk for safety event(s) or interfere with
protocol-specified procedures or adherence with study treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of subjects who achieve endoscopic response at Week 14</p><br>