Etrasimod for Crohn's Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Crohn's DiseaseEtrasimod - Drug
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug for Crohn's disease in adults who haven't had success with other treatments. The study will last about 5 and a half years, and will assess the drug's efficacy, safety, and tolerability.

Eligible Conditions
  • Crohn's Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 17 Secondary · Reporting Duration: Up to approximately 24 weeks for Substudy 1 and 2; 42 weeks for Substudy 3; and 212 weeks for Substudy 4

Baseline to Week 66
Change From Baseline in CDAI Score [Substudy A]
Change From Baseline in Simple Endoscopic Score in Crohn's Disease (SES-CD) Score [Substudy A]
Up to Week 208
Proportion of Participants With Clinical Remission CDAI by Visit up to the End Of Treatment [Substudy 4]
Proportion of Participants With Clinical Remission PRO2 by Visit up to the End Of Treatment [Substudy 4]
Up to Week 66
Proportion of Participants With Clinical Remission CDAI [Substudy A]
Week 212
Number and Severity of Adverse Events
Week 70
Number and Severity of Adverse Events [Substudy A]
Week 14
Proportion of Participants With Clinical Remission CDAI [Substudy 1]
Proportion of Participants With Clinical Remission Crohn's Disease Activity Index (CDAI) [Substudy 2]
Proportion of Participants With Clinical Remission Patient Reported Outcome 2 (PRO2) [Substudy 2]
Proportion of Participants With Clinical Response CDAI [Substudy 2]
Proportion of Participants With Endoscopic Remission [Substudy 2]
Proportion of Participants With Endoscopic Response [Substudy 1]
Proportion of Participants With Endoscopic Response [Substudy 2]
Proportion of Participants With Endoscopic Response and Clinical Remission CDAI [Substudy 2]
Week 52
Proportion of Participants With Clinical Remission CDAI Among Participants In Clinical Remission CDAI at Substudy 3 Baseline [Substudy 3]
Proportion of Participants With Clinical Remission CDAI [Substudy 3]
Proportion of Participants With Clinical Remission PRO2 [Substudy 3]
Proportion of Participants With Corticosteroid-Free Clinical Remission CDAI Among Participants Receiving Corticosteroids at Substudy 3 Baseline [Substudy 3]
Proportion of Participants With Endoscopic Remission [Substudy 3]
Proportion of Participants With Endoscopic Response Among Participants in Endoscopic Response at Substudy 3 Baseline [Substudy 3]
Proportion of Participants With Endoscopic Response [Substudy 3]
Weeks 14 and 66
Proportion of Participants With Endoscopic Response [Substudy A]

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Etrasimod 2 mg
8%Headache
8%Anaemia
7%COVID-19
6%Colitis ulcerative
5%Dizziness
5%Pyrexia
4%Arthralgia
4%Abdominal pain
3%Nausea
3%Hypertension
3%Alanine aminotransferase increased
2%Rash
2%Respiratory tract infection viral
2%Diarrhoea
2%Muscle spasms
2%Urinary tract infection
2%Vomiting
2%Fatigue
2%Hypercholesterolaemia
2%Flatulence
2%Blood creatine phosphokinase increased
2%Back pain
2%Asthenia
2%Haemorrhoids
2%Gamma-glutamyltransferase increased
1%Osteoarthritis
1%Chest discomfort
1%COVID-19 pneumonia
1%Pruritus
1%Bronchitis
1%Weight decreased
1%Pharyngitis
1%Abdominal pain lower
1%Anal pruritus
1%Aphthous ulcer
1%Large intestine polyp
1%Blood cholesterol increased
1%Dyspnoea
1%Upper respiratory tract infection
1%Hordeolum
1%Serum ferritin decreased
1%Dehydration
1%Erythema
1%Oral herpes
1%Dyspepsia
1%Constipation
1%Migraine
1%Oedema peripheral
1%Peripheral swelling
1%Hyperglycaemia
1%Iron deficiency
1%Varicose vein
1%Candida infection
1%Vitamin D deficiency
1%Nasopharyngitis
1%Lymphocyte count decreased
1%Weight increased
1%Cataract
1%Proctalgia
1%Transaminases increased
1%Blood alkaline phosphatase increased
1%Neck pain
1%Iron deficiency anaemia
1%Thrombocytosis
1%Vaccination site pain
1%Dyspnoea exertional
1%Rhinorrhoea
1%Tachycardia
1%Insomnia
1%Bradycardia
1%Cystitis
1%Aspartate aminotransferase increased
1%Blood triglycerides increased
1%Hepatic enzyme increased
1%Psoriasis
1%Papilloedema
1%Rhinitis allergic
1%Hepatic steatosis
1%Cough
1%Eczema
1%Myopia
1%Abdominal distension
1%Night sweats
1%SARS-CoV-2 test positive
1%Pain in extremity
1%Hyperthyroidism
1%Anal abscess
1%Herpes zoster
1%Pustule
1%Stomatitis
1%Gastritis
1%Head discomfort
1%Tendonitis
1%Pain
1%Acne
1%Vision blurred
1%Anxiety
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT03945188) in the Etrasimod 2 mg ARM group. Side effects include: Headache with 8%, Anaemia with 8%, COVID-19 with 7%, Colitis ulcerative with 6%, Dizziness with 5%.

Trial Design

3 Treatment Groups

Etrasimod Dose A
1 of 3
Etrasimod Dose B
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

1265 Total Participants · 3 Treatment Groups

Primary Treatment: Etrasimod · Has Placebo Group · Phase 2

Etrasimod Dose A
Drug
Experimental Group · 1 Intervention: Etrasimod · Intervention Types: Drug
Etrasimod Dose B
Drug
Experimental Group · 1 Intervention: Etrasimod · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etrasimod
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 24 weeks for substudy 1 and 2; 42 weeks for substudy 3; and 212 weeks for substudy 4

Who is running the clinical trial?

PfizerIndustry Sponsor
4,309 Previous Clinical Trials
7,110,270 Total Patients Enrolled
Arena PharmaceuticalsLead Sponsor
28 Previous Clinical Trials
4,794 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,280 Previous Clinical Trials
4,819,601 Total Patients Enrolled
Arena CT.gov AdministratorStudy DirectorArena Pharmaceuticals
21 Previous Clinical Trials
3,800 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a male or female aged between 18 and 80 years.
You are able to provide written informed consent or assent and to be compliant with the schedule of protocol assessments.
You have been diagnosed with Crohn's disease (CD) for at least 3 months.
You have integrin receptor antagonist (eg, vedolizumab) in your blood.
You are a female of childbearing potential who is not pregnant.\n

Who else is applying?

What state do they live in?
North Carolina100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%