Etrasimod for Ulcerative Colitis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Ulcerative ColitisEtrasimod - Drug
Eligibility
16 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial will assess the safety and efficacy of etrasimod in people with moderate-to-severe UC who have previously received treatment in a double-blind study.

Eligible Conditions
  • Ulcerative Colitis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Up to approximately 5 years

Week 260
Proportion of Participants Achieving Improvement in Extraintestinal Manifestations (EIMs) in Participants With EIMs at Baseline
Eye Manifestations
Week 260
Change From Baseline in Partial Mayo Score
Week 104
Change From Baseline in the Total Mayo Score
Up to Week 260
Percentage of Participants With Histologic Remission at Each Visit With Endoscopy Assessed by the Geboes, Robarts, and Nancy Histopathology Scores
Time to Loss of Response Assessed by Mayo Component Sub-scores
Year 5
Number and Severity of Safety Measures
Week 260
Endoscopy (procedure)
Week 260
Longitudinal change from both Open-Label Extension and Parent Study in Mayo Component Sub-scores
Proportion of Participants Achieving Non-invasive Response Assessed by Mayo Component Sub-scores
Proportion of Participants Achieving Symptomatic Response Assessed by Mayo Component Sub-scores
Week 260
Proportion of Participants Remaining in Clinical Remission Assessed by Mayo Component Sub-scores
Week 260
Proportion of Participants With Remission and Response Using Total Mayo Clinic Score
Week 104
Percentage of Participants With Histologic Improvement Assessed by the Geboes, Robarts, and Nancy Histopathology Scores
Percentage of Participants With Histologic Remission Assessed by the Geboes, Robarts, and Nancy Histopathology Scores
Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores
Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry
Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores
Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores
Week 260
Proportion of Participants Achieving Symptomatic Remission Assessed by Mayo Component Sub-scores

Trial Safety

Safety Progress

3 of 3
This is further along than 85% 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%Alanine aminotransferase increased
3%Nausea
3%Hypertension
2%Muscle spasms
2%Rash
2%Urinary tract infection
2%Diarrhoea
2%Vomiting
2%Gamma-glutamyltransferase increased
2%Fatigue
2%Hypercholesterolaemia
2%Flatulence
2%Blood creatine phosphokinase increased
2%Back pain
2%Asthenia
2%Respiratory tract infection viral
2%Haemorrhoids
1%Bronchitis
1%Anal pruritus
1%Neck pain
1%Osteoarthritis
1%Chest discomfort
1%Vaccination site pain
1%Pruritus
1%Herpes zoster
1%Anal abscess
1%Upper respiratory tract infection
1%Hordeolum
1%Dyspepsia
1%Transaminases increased
1%Serum ferritin decreased
1%Migraine
1%Dehydration
1%Rhinorrhoea
1%Varicose vein
1%Erythema
1%Candida infection
1%Oral herpes
1%Constipation
1%Stomatitis
1%Blood alkaline phosphatase increased
1%Tendonitis
1%Peripheral swelling
1%Vitamin D deficiency
1%Vision blurred
1%Dyspnoea
1%Tachycardia
1%Thrombocytosis
1%Nasopharyngitis
1%Lymphocyte count decreased
1%Blood cholesterol increased
1%Weight increased
1%Cataract
1%Iron deficiency anaemia
1%Bradycardia
1%Cystitis
1%Pustule
1%Proctalgia
1%Aspartate aminotransferase increased
1%Blood triglycerides increased
1%Hepatic enzyme increased
1%Head discomfort
1%Oedema peripheral
1%Hyperglycaemia
1%Iron deficiency
1%Acne
1%Psoriasis
1%Papilloedema
1%Rhinitis allergic
1%Dyspnoea exertional
1%Anxiety
1%Gastritis
1%Aphthous ulcer
1%Pain
1%Hepatic steatosis
1%Cough
1%Weight decreased
1%COVID-19 pneumonia
1%Eczema
1%Myopia
1%Pharyngitis
1%Abdominal distension
1%Abdominal pain lower
1%Large intestine polyp
1%Insomnia
1%Night sweats
1%SARS-CoV-2 test positive
1%Pain in extremity
1%Hyperthyroidism
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

1 Treatment Group

Etrasimod 2 mg
1 of 1

Experimental Treatment

912 Total Participants · 1 Treatment Group

Primary Treatment: Etrasimod · No Placebo Group · Phase 3

Etrasimod 2 mg
Drug
Experimental Group · 1 Intervention: Etrasimod · 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 5 years

Who is running the clinical trial?

PfizerIndustry Sponsor
4,304 Previous Clinical Trials
7,093,867 Total Patients Enrolled
31 Trials studying Ulcerative Colitis
425,076 Patients Enrolled for Ulcerative Colitis
Arena PharmaceuticalsLead Sponsor
28 Previous Clinical Trials
5,147 Total Patients Enrolled
8 Trials studying Ulcerative Colitis
1,460 Patients Enrolled for Ulcerative Colitis
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,277 Previous Clinical Trials
4,803,758 Total Patients Enrolled
25 Trials studying Ulcerative Colitis
10,856 Patients Enrolled for Ulcerative Colitis
Arena CT.gov AdministratorStudy DirectorArena Pharmaceuticals
21 Previous Clinical Trials
4,153 Total Patients Enrolled
8 Trials studying Ulcerative Colitis
1,460 Patients Enrolled for Ulcerative Colitis

Eligibility Criteria

Age 16 - 80 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Participants who were enrolled in either of the two studies mentioned earlier must have finished the Week 12 visit and been assessed to have UC that either got better, stayed the same, or got worse from when it was first measured, or they must have finished the Week 52 visit.
People who were previously enrolled in the study called APD334-302 must have finished their visit at Week 12.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Texas Digestive Disease Consultants - San Marcos100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%