A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease

• Register: EUCTR
• Last refreshed on: 8 August 2022
• Main ID: EUCTR2019-002895-14-ES
• Date of registration: 15/05/2020
• Prospective Registration: No
• Primary sponsor: Arena Pharmaceuticals Inc.
• Public title: A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease
• Scientific title: 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
• Date of first enrolment: 14/05/2020
• Target sample size: 225
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-002895-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Latvia, Lebanon, Lithuania, Mexico, Moldova, Republic of, Netherlands, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Tracy Angelly
• Affiliation: Arena Pharmaceuticals, Inc.

• Name: Tracy Angelly
• Affiliation: Arena Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

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 (TNFa) 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Crohn's Disease
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: Etrasimod
Product Code: APD334
Pharmaceutical Form: Tablet
INN or Proposed INN: etrasimod L-arginine
CAS Number: 1206123-97-8
Current Sponsor code: APD334 L-arginine
Other descriptive name: AR401959 L-arginine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Etrasimod
Product Code: APD334
Pharmaceutical Form: Tablet
INN or Proposed INN: etrasimod L-arginine
CAS Number: 1206123-97-8
Current Sponsor code: APD334 L-arginine
Other descriptive name: AR401959 L-arginine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: •To evaluate the long-term safety, tolerability, and efficacy of etrasimod in subjects with moderately to severely active Crohn’s disease (CD).

Main Objective: •To evaluate the dose-response relationship of 2 doses of etrasimod versus placebo as induction therapy in subjects with moderately to severely active Crohn’s disease (CD).
To select an oral etrasimod dose, based on efficacy and safety, for continued development.

Primary end point(s): Proportion of subjects who achieve endoscopic response at Week 14

Timepoint(s) of evaluation of this end point: Week 14

Secondary Outcome(s)

Secondary end point(s): • Proportion of subjects who achieve clinical remission APSF at Week 14
• Proportion of subjects who achieve CDAI < 150 by visit up to Week 14
• Proportion of subjects who achieve clinical response CDAI by visit up to Week 14
• Proportion of subjects who achieve clinical response APSF by visit up to Week 14
• Proportion of subjects who achieve clinical response CDAI-70 by visit up to Week 14
• Proportion of subjects who achieve clinical response APSF-30 by visit up to Week 14
• Change from baseline in CDAI score by visit up to Week 14
• Change from baseline in SES-CD at Week 14
• Proportion of subjects with clinical response by PRO2 at Week 14
• Proportion of subjects with endoscopic response and clinical remission by PRO2 at Week 14
• Change and percentage change from baseline in absolute lymphocyte count by visit up to Week 14
• Change and percentage change from baseline in FCP concentration at Weeks 2, 4, 6, 10, and 14
• Change and percentage change from baseline in CRP concentration at Weeks 2, 4, 6, 10, and 14
• Proportion of subjects who achieve endoscopic remission at Week 14
Extension Period:
endpoints for the induction period will be assessed at scheduled visits up to Week 66.

Timepoint(s) of evaluation of this end point: by visit up to week 66

Secondary ID(s)

2019-002895-14-LT

APD334-202

Source(s) of Monetary Support

Arena Pharmaceuticals Inc.

Ethics review

Status: Approved
Approval date: 25/03/2020
Contact:

Results

• Results available: Yes
• Date Posted: 31/10/2021
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-002895-14/results