A Study to Learn About the Study Medicine Etrasimod in Adults With Moderate to Severe Atopic Dermatitis (AD) Who Have Already Tried Treatments Taken by Mouth or by Injection
TerminatedPhase 2, PHASE3Results postedLast updated 8 May 2025
What this trial tests
Phase 2, PHASE3 trial testing etrasimod in Atopic Dermatitis in 58 participants. Terminated before completion.
Adults 18 to 80, any sex, with Atopic Dermatitis or Atopic Dermatitis, Unspecified. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Part 1, DB Period: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response at Week 16Primary· DB Period: Week 16
IGA measured AD severity, based on a 5-point scale (0-4); 0= AD is clear, 1= AD is almost clear, 2= mild AD, 3= moderate AD and 4= severe AD. IGA response was defined as participants achieving IGA 0 (clear) or 1 (almost clear) and a reduction of \>=2 points from baseline.
Group
Value
95% CI
DB Period: Etrasimod 2 mg
3.3
DB Period: Placebo
7.1
Part 1, DB Period: Percentage of Participants Who Achieved >=75% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-75) at Week 16Secondary· DB Period: Week 16
EASI-75 response was defined as a 75% reduction or greater in EASI score from Baseline to Week 16. EASI quantified severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\] and lichenification \[L\]) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score
Group
Value
95% CI
DB Period: Etrasimod 2 mg
23.3
DB Period: Placebo
14.3
Part 1, DB Period: Percent Change From Baseline in EASI Score at Week 16Secondary· DB Period: Baseline, Week 16
EASI quantified severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\] and lichenification \[L\]) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50
Group
Value
95% CI
DB Period: Etrasimod 2 mg
-53.87
± 9.007
DB Period: Placebo
-24.65
± 9.533
Part 1, DB Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All Causality)Primary· DB Period: From first dose of study drug up to 16 Weeks of treatment
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state.
Group
Value
95% CI
DB Period: Etrasimod 2 mg
16
DB Period: Placebo
8
Part 1, DB Period: Number of Participants With TEAEs (All Causality) Leading to Study Treatment DiscontinuationPrimary· DB Period: From first dose of study drug up to 16 Weeks of treatment
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state.
Group
Value
95% CI
DB Period: Etrasimod 2 mg
1
DB Period: Placebo
0
Part 1, DB Period: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (All Causality)Primary· DB Period: From first dose of study drug up to 16 Weeks of treatment
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of death); new or prolonged inpatient hospitalization; persistent or significant disability/incapacity;
Group
Value
95% CI
DB Period: Etrasimod 2 mg
0
DB Period: Placebo
0
Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality)Primary· DB Period: From first dose of study drug up to 16 Weeks of treatment
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. AESIs included here were cardiovascular events (i.e., bradycardia, Atrioventricular (AV) conduction delay, and hypertension); macular edema, pulmonary events (airflow obstruction or decreased gas exchange); infections (severe infections, opportunistic inf
Group
Value
95% CI
DB Period: Etrasimod 2 mg
2
DB Period: Placebo
1
Part 1, DB Period: Number of Participants With Laboratory Test AbnormalitiesPrimary· DB Period: From first dose of study drug up to 16 Weeks of treatment
Laboratory assessments included hematology, clinical chemistry, urinalysis, other parameters and reflex tests. Number of participants with abnormalities in any of laboratory parameters is reported.
Group
Value
95% CI
DB Period: Etrasimod 2 mg
22
DB Period: Placebo
13
Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV BlocksPrimary· DB Period: Pre-dose and 4 hours (hrs) post-dose on Day 1/Week 0; Pre-dose and 4 hrs post-dose on Day 113/Week 16
Standard 12-lead ECGs utilizing limb leads were used to measure PR interval, QT interval, QTc corrected using Fridericia's formula (QTcF), and QRS complex. Number of participants with non-zero ECG abnormalities and AV blocks are reported in this outcome measure.
Pre-dose/Day 1: AV conduction: First-degree AV Block
Group
Value
95% CI
DB Period: Etrasimod 2 mg
1
DB Period: Placebo
0
4 hrs post-dose/Day 1: QTCF (msec), single beat:>= 450 (male) or >= 470 (female)
Group
Value
95% CI
DB Period: Etrasimod 2 mg
1
DB Period: Placebo
0
4 hrs post-dose/Day 1: Change From Baseline (CFB) in QT: >30 msec increase
Group
Value
95% CI
DB Period: Etrasimod 2 mg
9
DB Period: Placebo
0
4 hrs post-dose/Day 1: AV conduction: First degree AV Block
Group
Value
95% CI
DB Period: Etrasimod 2 mg
3
DB Period: Placebo
0
Pre-dose/Week 16: CFB in QT: >30 msec increase
Group
Value
95% CI
DB Period: Etrasimod 2 mg
1
DB Period: Placebo
0
Pre-dose/Week 16: CFB in QT: >60 msec increase
Group
Value
95% CI
DB Period: Etrasimod 2 mg
1
DB Period: Placebo
0
Pre-dose/Week 16: CFB in QTcF: >30 msec increase
Group
Value
95% CI
DB Period: Etrasimod 2 mg
2
DB Period: Placebo
0
4 hrs post-dose/Week 16: CFB in QTcF: >30 msec increase
Group
Value
95% CI
DB Period: Etrasimod 2 mg
2
DB Period: Placebo
0
Part 1, DB Period: Number of Participants With Markedly Abnormal Vital SignPrimary· DB Period: Pre-dose and 1, 2, 3, 4 hours (hrs) post-dose on Day 1/Week 0; Day 29/Week 4; Day 57/Week 8; Day 85/Week 12; Pre-dose and 1, 2, 3, 4, 5 and 6 hrs post-dose on Day 113/Week 16
Vital signs evaluation included systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate. Number of participants with non-zero vital signs abnormalities are reported in this outcome measure.
Part 1, OLE Period: Number of Participants With TEAEs (All Causality)Primary· OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state.
Group
Value
95% CI
OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period)
9
OLE Period: Etrasimod 2 mg (Placebo in DB Period)
5
Part 1, OLE Period: Number of Participants With Treatment Emergent AEs (All Causality) Leading to Study Treatment DiscontinuationPrimary· OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state.
Group
Value
95% CI
OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period)
0
OLE Period: Etrasimod 2 mg (Placebo in DB Period)
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Part 1, DB Period: Day 1 to Week 16; Part 1, OLE Period: Week 20 to Week 68; Part 1, DB +OLE Period: Day 1 to Week 68.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
DB Period: Etrasimod 2 mg
Serious: 0/30 (0%)
Deaths: 0/30
DB Period: Placebo
Serious: 0/28 (0%)
Deaths: 0/28
OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period)
The purpose of this study is to learn about the safety and effects of the study medicine called etrasimod for the possible treatment of atopic dermatitis (AD), also called eczema, in adults who have already tried AD treatments taken by mouth or by injection that work all over the body. These adults can have moderate to severe AD.
This study is seeking participants who:
* have AD for at least 1 year
* have moderate-to-severe AD
* have tried treatments that work all over the body and saw no effects
* are willing to apply a moisturizer at least once daily during the study
This is a 2-part study that is only selecting about 60 participants for Part 1 as of now. In Part 1, half of the participants will receive etrasimod, a pill to be taken by mouth once daily. The other half will receive a placebo, a pill that looks like etrasimod but has no medicine also taken by mouth once daily. No one will know what treatment the participant is taking. The Sponsor will compare participant experiences of those taking etrasimod to those taking placebo for 16 weeks. This will help determine if the study medicine is safe and effective. After the first 16 weeks, some participants may continue the study knowing they are taking etrasimod for an additional 52 weeks.
Those participating for just the first 16-weeks, will need to visit the study clinic at least 6 times during the study (about every 4 weeks), and will have to come for 2 safety follow up visits at 2nd and 4th week after the last dose of study medicine. People who want to and can continue for an additional 52 weeks will need to visit the study clinic for at least 6 more visits making 12 total visits over 68 weeks followed by 2 safety follow up visits at the 2nd and 4th week after the last dose of study medicine.
In Part 2 of the study, around 340 more participants will be participating. Everyone will receive etrasimod pills once daily for 52 weeks. Participants will need to go to the study clinic at least 9 times after which they will have to go for 2 more safety follow up visits at the 2nd and 4th weeks after the last dose of study medicine.
At every study visit in Part 1 and Part 2, the focus will be on signs and symptoms of AD (like lesions, itch, and pain) as well as general health and overall side effects. Blood samples and vital signs will be taken at every visit. Due to the way the study medicine works, the in-study clinic visit will last at least 4 hours on Day 1 (Part 1 and Part 2) and Week 16 (Part 1).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07262983 — Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopi
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· recruiting
NCT07445919 — A Clinical Study to Evaluate SM17 for Atopic Dermatitis
· Phase 2
· recruiting
NCT07488065 — A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants
· Phase 1
· recruiting
NCT07467564 — The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatit
· recruiting
NCT07358156 — A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and E
· Phase 1
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 8 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05732454.