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

Phase 2

Recruiting

Conditions: 10017969
Crohn's disease

Registration Number: NL-OMON51883

Lead Sponsor: Arena Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 9

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. Have CD for >= 3 months prior to randomization, involving the ileum and/or
colon, at a minimum; diagnosis may be confirmed at any time in the past by
endoscopy and/or histopathology. The screening endoscopy and histopathology
reports may serve as source documents for subjects who do not have diagnostic
endoscopy reports in their medical chart
4. Have moderately to severely active CD at Screening, defined as:
* Crohn's Disease Activity Index (CDAI) score >= 220 and <= 450, AND
* Unweighted average worst daily abdominal pain (AP) score >= 2 unweighted
average daily loose/watery stool frequency (SF) score >= 4, AND
* Simple Endoscopic Score in Crohn's disease (SES-CD) of >= 6 or SES-CD >= 4 for
subjects with isolated ileal disease
5. Demonstrated inadequate 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] or budesonide)
* Immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate)
* Tumor necrosis factor alpha (TNFa) antagonists (eg, infliximab, adalimumab,
certolizumab pegol, or biosimilars)
* Integrin receptor antagonist (eg, vedolizumab)
* Interleukin-12/-23 antagonist (eg, ustekinumab)
6. Females of childbearing potential must be nonpregnant
7. Females must meet either a or b of the following criteria and males must
meet criterion c to qualify for the study:
a. A female who is not of childbearing potential must meet 1 of the following:
* Postmenopausal, defined as no menses for 12 months without an alternative
medical cause and confirmed by follicle-stimulating hormone (FSH) within
postmenopausal range according to local standards
* Permanent sterilization procedure, such as hysterectomy, bilateral
salpingectomy, or bilateral oophorectomy
b. A female who is of childbearing potential must agree to using a highly
effective contraception method during treatment and for 4 weeks following
treatment that can achieve a failure rate of less than 1% per year when used
consistently and correctly.
The following are considered highly effective birth control methods:
* Combined (estrogen and progestogen containing) hormonal contraception
associated with inhibition of ovulation, which may be oral, intravaginal, or
transdermal
* Progestogen-only hormonal contraception associated with inhibition of
ovulation, which may be oral, injected, or implanted
* Intrauterine device (IUD)
* Intrauterine hormone-releasing system (IUS)
* Bilateral tubal occlusion
* Vasectomized partner, provided that partner is the sole sexual partner of the
FOCBP trial participant and that the vasectomized partner has received medical
assessment of the surgical success
* Sexual abstinence (complete sexual abstinence defined as refraining from
heterosexual intercourse for the entire period of risk associated with study
drug). The reliability of sexual abstinence needs to be evaluated in relation
to the duration of the clinical study and the preferred and usual lifestyle of
the subject. Periodic abstinence (calendar, symptothermal, post-ovulation
methods) is not acceptable
c. A male must agree

Exclusion Criteria

Key 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 (ie, have > 3 small
bowel resections) 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. Subjects who have
undergone previous colonic resection or ileocolectomy must have > 25 cm of
colon remaining
- Have an ileostomy or a colostomy
- Have a serious infection requiring intravenous antibiotic(s)/medication(s) <=
4 weeks prior to randomization
- Have primary or secondary immunodeficiency syndromes, history of organ
transplant, history of an opportunistic infection, history of disseminated
herpes simplex or herpes zoster, have or test positive for HIV, HBV, or active
HCV
- Lactating female who is breastfeeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>SS1-P2b<br /><br>• Proportion of subjects with endoscopic response at Week 14<br /><br>SS2-I<br /><br>• Proportion of subjects with endoscopic response at Week 14<br /><br>• Proportion of subjects with clinical remission CDAI at Week 14<br /><br>SS3-M<br /><br>• Proportion of subjects with clinical remission CDAI at Week 52<br /><br>• Proportion of subjects with endoscopic response at Week 52</p><br>

Secondary Outcome Measures