Trial · NCT05732454
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
NCT05732454, Phase 2, Phase 3, Terminated, Pfizer; results first posted 2025-05-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT05732454. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05732454
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT05732454
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 58 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Atopic Dermatitis, Atopic Dermatitis, Unspecified, Eczema, Eczema, Atopic
- Interventions
- etrasimod, Placebo
- First posted
- 2023-02-17
- Last updated
- 2025-05-08
- Other registries' IDs
- eudract:2022-003361-37
- Results first posted
- 2025-05-08
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1, DB Period: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response at Week 16 | 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. |
| Primary | Part 1, DB Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All Causality) | 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. |
| Primary | Part 1, DB Period: Number of Participants With TEAEs (All Causality) Leading to Study Treatment Discontinuation | 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. |
| Primary | Part 1, DB Period: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (All Causality) | 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; congenital anomaly/birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medical events judged by investigator. |
| Primary | Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality) | 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 infections \[including progressive multifocal leukoencephalopathy (PML)\], Herpes simplex and Herpes zoster); liver injury (liver transaminase elevation and bilirubin elevation); posterior reversible encephalopathy syndrome (PRES) and malignancies. |
| Primary | Part 1, DB Period: Number of Participants With Laboratory Test Abnormalities | 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. |
| Primary | Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks | 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. |
| Primary | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 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. |
| Primary | Part 1, OLE Period: Number of Participants With TEAEs (All Causality) | 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. |
| Primary | Part 1, OLE Period: Number of Participants With Treatment Emergent AEs (All Causality) Leading to Study Treatment Discontinuation | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1, DB Period: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response at Week 16 | DB Period: Week 16 | FAS included all participants who were randomized to the study irrespective of whether they received any dose of study intervention (i.e., etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized. Number of participants in FAS with baseline IGA\>=2 was included in this analysis. | Percentage of Participants | NUMBER |
| SECONDARY | 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 16 | DB Period: Week 16 | FAS included all participants who were randomized to the study irrespective of whether they received any dose of study intervention (i.e., etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Part 1, DB Period: Percent Change From Baseline in EASI Score at Week 16 | DB Period: Baseline, Week 16 | FAS included all participants who were randomized to the study irrespective of whether they received any dose of study intervention (i.e., etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized. | Percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Part 1, DB Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All Causality) | DB Period: From first dose of study drug up to 16 Weeks of treatment | DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1, DB Period: Number of Participants With TEAEs (All Causality) Leading to Study Treatment Discontinuation | DB Period: From first dose of study drug up to 16 Weeks of treatment | DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1, DB Period: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (All Causality) | DB Period: From first dose of study drug up to 16 Weeks of treatment | DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality) | DB Period: From first dose of study drug up to 16 Weeks of treatment | DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1, DB Period: Number of Participants With Laboratory Test Abnormalities | DB Period: From first dose of study drug up to 16 Weeks of treatment | DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks | 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 | DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period. Here, Number Analyzed= number of participants evaluable for specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 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 | DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period. Here, Number Analyzed= number of participants evaluable for specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group192
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1, DB Period: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response at Week 16 | DB Period: Etrasimod 2 mg | 3.3 | 3.28 to ? | Percentage of Participants | |
| Part 1, DB Period: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response at Week 16 | DB Period: Placebo | 7.1 | 4.87 to ? | Percentage of Participants | |
| 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 16 | DB Period: Etrasimod 2 mg | 23.3 | 7.72 to ? | Percentage of Participants | |
| 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 16 | DB Period: Placebo | 14.3 | 6.61 to ? | Percentage of Participants | |
| Part 1, DB Period: Percent Change From Baseline in EASI Score at Week 16 | DB Period: Etrasimod 2 mg | -53.87 | Standard Error 9.007 | Percent change | |
| Part 1, DB Period: Percent Change From Baseline in EASI Score at Week 16 | DB Period: Placebo | -24.65 | Standard Error 9.533 | Percent change | |
| Part 1, DB Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All Causality) | DB Period: Etrasimod 2 mg | 16 | Participants | ||
| Part 1, DB Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All Causality) | DB Period: Placebo | 8 | Participants | ||
| Part 1, DB Period: Number of Participants With TEAEs (All Causality) Leading to Study Treatment Discontinuation | DB Period: Etrasimod 2 mg | 1 | Participants | ||
| Part 1, DB Period: Number of Participants With TEAEs (All Causality) Leading to Study Treatment Discontinuation | DB Period: Placebo | 0 | Participants |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1: DB Period | STARTED | DB Etrasimod 2 mg Then OLE Etrasimod 2 mg | 30 | |
| Part 1: DB Period | STARTED | DB Placebo Then OLE Etrasimod 2 mg | 28 | |
| Part 1: DB Period | COMPLETED | DB Etrasimod 2 mg Then OLE Etrasimod 2 mg | 27 | |
| Part 1: DB Period | COMPLETED | DB Placebo Then OLE Etrasimod 2 mg | 25 | |
| Part 1: DB Period | NOT COMPLETED | DB Etrasimod 2 mg Then OLE Etrasimod 2 mg | 3 | |
| Part 1: DB Period | NOT COMPLETED | DB Placebo Then OLE Etrasimod 2 mg | 3 | |
| Part 1: OLE Period | STARTED | DB Etrasimod 2 mg Then OLE Etrasimod 2 mg | 27 | |
| Part 1: OLE Period | STARTED | DB Placebo Then OLE Etrasimod 2 mg | 24 | |
| Part 1: OLE Period | COMPLETED | DB Etrasimod 2 mg Then OLE Etrasimod 2 mg | 0 | |
| Part 1: OLE Period | COMPLETED | DB Placebo Then OLE Etrasimod 2 mg | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | DB Period: Etrasimod 2 mg | 2 | 30 | 2 |
| other | COVID-19 | Infections and infestations | DB Period: Placebo | 0 | 28 | 0 |
| other | COVID-19 | Infections and infestations | OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) | 0 | 30 | 0 |
| other | COVID-19 | Infections and infestations | OLE Period: Etrasimod 2 mg (Placebo in DB Period) | 0 | 28 | 0 |
| other | COVID-19 | Infections and infestations | DB Etrasimod 2 mg Then OLE Etrasimod 2 mg | 2 | 30 | 2 |
| other | COVID-19 | Infections and infestations | DB Placebo Then OLE Etrasimod 2 mg | 0 | 28 | 0 |
| other | Nasopharyngitis | Infections and infestations | DB Period: Etrasimod 2 mg | 2 | 30 | 2 |
| other | Nasopharyngitis | Infections and infestations | DB Period: Placebo | 1 | 28 | 1 |
| other | Nasopharyngitis | Infections and infestations | OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) | 0 | 30 | 0 |
| other | Nasopharyngitis | Infections and infestations | OLE Period: Etrasimod 2 mg (Placebo in DB Period) | 0 | 28 | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DB Period: Etrasimod 2 mg | 0 | 30 |
| Total, all-cause mortality | DB Period: Placebo | 0 | 28 |
| Total, all-cause mortality | OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) | 0 | 30 |
| Total, all-cause mortality | OLE Period: Etrasimod 2 mg (Placebo in DB Period) | 0 | 28 |
| Total, all-cause mortality | DB Etrasimod 2 mg Then OLE Etrasimod 2 mg | 0 | 30 |
| Total, all-cause mortality | DB Placebo Then OLE Etrasimod 2 mg | 0 | 28 |
| Total, other adverse events | DB Period: Etrasimod 2 mg | 6 | 30 |
| Total, other adverse events | DB Period: Placebo | 4 | 28 |
| Total, other adverse events | OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) | 4 | 30 |
| Total, other adverse events | OLE Period: Etrasimod 2 mg (Placebo in DB Period) | 1 | 28 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| DB Period: Etrasimod 2 mg vs DB Period: Placebo: Part 1, DB Period: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (All Causality) | Trial comparisons |
OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) vs OLE Period: Etrasimod 2 mg (Placebo in DB Period): Part 1, OLE Period: Number of Participants With Treatment Emergent AEs (All Causality) Leading to Study Treatment Discontinuation | Trial comparisons |
| DB Period: Etrasimod 2 mg vs DB Period: Placebo: Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality) | Trial comparisons |
| DB Period: Etrasimod 2 mg vs DB Period: Placebo: Part 1, DB Period: Number of Participants With Laboratory Test Abnormalities | Trial comparisons |
| OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) vs OLE Period: Etrasimod 2 mg (Placebo in DB Period): Part 1, OLE Period: Number of Participants With Treatment Emergent SAEs (All Causality) | Trial comparisons |
| DB Period: Etrasimod 2 mg vs DB Period: Placebo: Part 1, DB Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All Causality) | Trial comparisons |
| OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) vs OLE Period: Etrasimod 2 mg (Placebo in DB Period): Part 1, OLE Period: Number of Participants With Treatment Emergent AESIs (All Causality) | Trial comparisons |
| OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) vs OLE Period: Etrasimod 2 mg (Placebo in DB Period): Part 1, OLE Period: Number of Participants With TEAEs (All Causality) | Trial comparisons |
| OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) vs OLE Period: Etrasimod 2 mg (Placebo in DB Period): Part 1, OLE Period: Number of Participants With Laboratory Test Abnormalities | Trial comparisons |
| DB Period: Etrasimod 2 mg vs DB Period: Placebo: Part 1, DB Period: Number of Participants With TEAEs (All Causality) Leading to Study Treatment Discontinuation | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05732454
GET https://conductscience.org/api/trials/v1/NCT05732454/results?page=2