Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003361-37 | EudraCT Number | ||
| APD334-314 | Other Identifier | Alias Study Number |
Not provided
Not provided
Not provided
Per the results of the planned interim analysis, the study met futility criteria for efficacy so the trial was terminated. This decision was made for efficacy reasons only and is not due to any safety concerns.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etrasimod | Experimental | 2 mg, oral tablet, once daily |
|
| Placebo (Part 1 DB period only) | Placebo Comparator | Oral sham comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etrasimod | Drug | PART 1 Double Blind one 2 mg tablet once daily for up to 16 weeks PART 1 Open Label Extension one 2 mg tablet once daily for an additional 52 weeks PART 2 Open Label one 2 mg tablet once daily for up 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1, DB Period: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response at 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. | DB Period: Week 16 |
| Part 1, DB Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All Causality) | 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. | DB Period: From first dose of study drug up to 16 Weeks of treatment |
| Part 1, DB Period: Number of Participants With TEAEs (All Causality) Leading to Study Treatment Discontinuation | 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. | DB Period: From first dose of study drug up to 16 Weeks of treatment |
| Part 1, DB Period: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (All Causality) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. |
Not provided
Inclusion Criteria:
Participants must meet the following key inclusion criteria to be eligible for enrollment into the study:
1. Age 18-80 at screening (or minimum age of consent according to local regulations).
2 Chronic AD (also known as atopic eczema) that was diagnosed at least 1 year prior to Screening and meets Hanifin and Rajka criteria at screening).1 3. Moderate to severe AD:
IGA score ≥3 (on the 0 to 4 IGA scale, in which 3 = moderate and 4 = severe) at screening and baseline (Day 1)
BSA ≥10% of AD involvement at screening and baseline (Day 1)
Eczema Area and Severity Index (EASI) ≥16 at screening and baseline (Day 1) 4. A participant who has failed a prior systemic therapy for AD, ie, refractory, moderate-to-severe AD that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.
5. Willing to apply a topical emollient/moisturizer at least once daily for ≥1 week prior to baseline (Day 1) and willing to maintain consistent (ie, no change in type, frequency, or application) daily application over the course of the study.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions:
Presence of confounding factors:
Hypersensitivity to etrasimod or any of the excipients.
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First OC Dermatology Research Inc | Fountain Valley | California | 92708 | United States | ||
| Jared R. Younger, MD (Ophthalmologist) |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
A total of 58 participants with moderate-to-severe atopic dermatitis (AD) were enrolled in Part 1- DB period and out of them 51 continued into the Part 1- OLE period.
The study had 2 parts: Part 1 and Part 2. Part 2 was never initiated; hence no results are reported for it. All results are pertaining to Part 1 in the record. Part 1 of the study had 16-week double-blind (DB) treatment period and then 52-week part 1 open label extension (OLE) treatment period.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DB Etrasimod 2 mg Then OLE Etrasimod 2 mg | Participants were randomized to receive etrasimod 2 milligram (mg) orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator's judgement then continued to receive etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1: DB Period |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 17, 2023 | Apr 22, 2025 |
Not provided
Part 1: Approximately 60 participants with moderate-to-severe AD with a history of prior systemic treatment failure will be randomized (1:1 ratio) in a double blind (DB) manner to receive etrasimod 2 mg or placebo orally, once daily, for 16 weeks. Randomization will be stratified by disease severity as measured by IGA score (3 [moderate AD], 4 [severe AD]) at baseline.
After DB period, participants may be given the option to continue in an open label extension (OLE) phase whereby they will receive etrasimod 2 mg (tablet) for up to an additional 52 weeks.
Part 2: Approximately 340 additional participants will be enrolled to receive etrasimod 2 mg orally, once daily, for 52 weeks in an open-label manner.
Not provided
Not provided
PART 1 Double Blind portion (Day 1 through Week 16): all parties are blinded to treatment.
PART 1 Open Label Extension portion: All parties will be aware participant is taking etrasimod for up to an additional 52 weeks.
PART 2 Open Label All parties will be aware participant is taking etrasimod for 52 weeks.
|
| Placebo | Drug | PART 1 DOUBLE BLIND Placebo - one table daily for up to 16 weeks |
|
| DB Period: From first dose of study drug up to 16 Weeks of treatment |
| Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality) | 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. | DB Period: From first dose of study drug up to 16 Weeks of treatment |
| Part 1, DB Period: Number of Participants With Laboratory Test Abnormalities | Laboratory assessments included hematology, clinical chemistry, urinalysis, other parameters and reflex tests. Number of participants with abnormalities in any of laboratory parameters is reported. | DB Period: From first dose of study drug up to 16 Weeks of treatment |
| Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks | 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. | 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 |
| Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 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. | 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 |
| Part 1, OLE Period: Number of Participants With TEAEs (All Causality) | 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. | 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) |
| Part 1, OLE Period: Number of Participants With Treatment Emergent AEs (All Causality) Leading to Study Treatment Discontinuation | 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. | 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) |
| Part 1, OLE Period: Number of Participants With Treatment Emergent SAEs (All Causality) | 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. | 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) |
| Part 1, OLE Period: Number of Participants With Treatment Emergent AESIs (All Causality) | 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, AV conduction delay, and hypertension); macular edema, pulmonary events (airflow obstruction or decreased gas exchange); infections (severe infections, opportunistic infections [including PML], Herpes simplex and Herpes zoster); liver injury (liver transaminase elevation and/or bilirubin elevation); PRES and malignancies. | 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) |
| Part 1, OLE Period: Number of Participants With Laboratory Test Abnormalities | Laboratory assessments included hematology, clinical chemistry, urinalysis, other parameters and reflex tests. Number of participants with abnormalities in any of laboratory parameters is reported. | 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) |
| Part 1, OLE Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks | Standard 12-lead ECGs utilizing limb leads were used to measure PR interval, QT interval, QTcF, and QRS complex. Number of participants with non-zero ECG abnormalities and AV blocks are reported in this outcome measure. | OLE Period: Day 169/Week 24 |
| Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Vital signs evaluation included SBP, DBP, pulse rate. Number of participants with non-zero vital signs abnormalities are reported in this outcome measure. | OLE Period: Day 141/Week 20; Day 169/Week 24; Day 281/Week 40; Follow Up 1; Follow Up 2 |
| DB Period: Week 16 |
| Part 1, DB Period: Percent Change From Baseline in EASI Score at 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%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. | DB Period: Baseline, Week 16 |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Bryan D. Vo. MD (Pulmonologist) | Laguna Hills | California | 92653 | United States |
| California Allergy and Asthma Medical Group | Los Angeles | California | 90025 | United States |
| Dr. Carolyn M. Wong | Los Angeles | California | 90025 | United States |
| Dr. Gerald Markovitz | Los Angeles | California | 90025 | United States |
| Resolution Advanced Imaging Center | Santa Monica | California | 90404 | United States |
| Ponce PFT & Medical services, INC [for pulmonology examination] | Aventura | Florida | 33180 | United States |
| Advanced Eye Center: Rodrigo Belalcazar, MD | Hialeah | Florida | 33012 | United States |
| Direct Helpers Research Center | Hialeah | Florida | 33012 | United States |
| Gsi Clinical Research | Margate | Florida | 33063 | United States |
| Randy Burks, MD, FACS | Margate | Florida | 33063 | United States |
| D & H National Research Centers, Inc. | Miami | Florida | 33155 | United States |
| Imaging - Advanced Health Imaging | Miami | Florida | 33155 | United States |
| The Selem Center [Ophthalmologist JOSEPH SELEM] | Miami | Florida | 33165 | United States |
| Miami Dermatology and Laser Research | Miami | Florida | 33173 | United States |
| Ophthalmology - Dr. Edward Boshnick's Global Vision Rehabilitation Center | Miami | Florida | 33173 | United States |
| Pulmonology - Miami Pulmonology Specialists | Miami | Florida | 33173 | United States |
| Pelletier Jesse MD | North Miami Beach | Florida | 33162 | United States |
| Santos Carlos R MD | North Miami Beach | Florida | 33162 | United States |
| Tory Sullivan, Md Pa | North Miami Beach | Florida | 33162 | United States |
| Gateway Radiology | Pinellas Park | Florida | 33781 | United States |
| Hull & Hull Medical Specialists | Plantation | Florida | 33324 | United States |
| GCP Research, Global Clinical professionals | St. Petersburg | Florida | 33705 | United States |
| St. Anthonys Hospital | St. Petersburg | Florida | 33705 | United States |
| USF Health | Tampa | Florida | 33612 | United States |
| Lung and Sleep Disorder Center | Lathrup Village | Michigan | 48076 | United States |
| Revival Research Institute, LLC | Troy | Michigan | 48084 | United States |
| Somerset Opthalmology PC | Troy | Michigan | 48084 | United States |
| Eye Institute | Tulsa | Oklahoma | 74136 | United States |
| Pulmonary and Sleep Center of Oklahoma | Tulsa | Oklahoma | 74136 | United States |
| Vital Prospects Clinical Research Institute, PC | Tulsa | Oklahoma | 74136 | United States |
| Monument Health Rapid City Hospital | Rapid City | South Dakota | 57701 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| In Vision Optical and Eyecare | Rapid City | South Dakota | 57702 | United States |
| Eye Care Associates of Arlington | Arlington | Texas | 76010 | United States |
| Arlington Research Center | Arlington | Texas | 76011 | United States |
| Texas Pulmonary | Arlington | Texas | 76012 | United States |
| Alpesh D. Desai, DO PLLC | Houston | Texas | 77008 | United States |
| Becky Fredrickson, MD [Optometrist/Ophthalmologist] | Houston | Texas | 77008 | United States |
| Rupesh Vakil, MD [Pulmonologist] | Houston | Texas | 77008 | United States |
| Acclaim Dermatology | Sugar Land | Texas | 77479 | United States |
| Horizon Eye Care and Optical | Sugar Land | Texas | 77479 | United States |
| Sweetwater Pulmonary Associates | Sugar Land | Texas | 77479 | United States |
| Rejuvenation Dermatology | Edmonton | Alberta | T5J 3S9 | Canada |
| CaRe Clinic | Red Deer | Alberta | T4P 1K4 | Canada |
| Visique | Québec | Quebec | G2J 0C4 | Canada |
| Biron | Québec | G1W 2K9 | Canada |
| Alpha Recherche Clinique | Québec | G2J 0C4 | Canada |
| Poliklinika VEKTOR Pardubice | Pardubice | 53002 | Czechia |
| Pratia Pardubice a.s. | Pardubice | 53002 | Czechia |
| Fakultní nemocnice v Motole | Prague | 150 06 | Czechia |
| Flosmed | Poznan | Greater Poland Voivodeship | 60-192 | Poland |
| Niepubliczny Zakład Opieki Zdrowotnej Zespół Poradni Specjalistycznych "Termedica" | Poznan | Greater Poland Voivodeship | 60-681 | Poland |
| Medoculis | Poznan | Greater Poland Voivodeship | 61-551 | Poland |
| Centrum Medyczne ,,All - Med'' Badania Kliniczne | Krakow | Lesser Poland Voivodeship | 30-033 | Poland |
| Centrum Medyczne Dietla 19 | Krakow | Lesser Poland Voivodeship | 31-070 | Poland |
| Artemed Centrum Medyczne | Wroclaw | Lower Silesian Voivodeship | 50-450 | Poland |
| Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska | Wroclaw | Lower Silesian Voivodeship | 50-566 | Poland |
| Specjalistyczna Praktyka Lekarska Joanna Kalinowska | Wroclaw | Lower Silesian Voivodeship | 51-605 | Poland |
| Indywidualna Specjalistyczna Praktyka Lekarska Michał Silber | Wroclaw | Lower Silesian Voivodeship | 53-124 | Poland |
| DERMEDIC Iwona Zdybska | Lublin | Lublin Voivodeship | 20-607 | Poland |
| Eyemed | Lublin | Lublin Voivodeship | 20-631 | Poland |
| AUGON Gabinet Okulistyczny | Bialystok | Podlaskie Voivodeship | 15-427 | Poland |
| Nzoz Specjalistyczny Ośrodek Dermatologiczny "Dermal" | Bialystok | Podlaskie Voivodeship | 15-453 | Poland |
| Gabinet Alergologiczny IR-med dr n. med. Izabela Roszko-Kirpsza | Bialystok | Podlaskie Voivodeship | 15-872 | Poland |
| Centrum Medyczne Angelius Provita | Katowice | Silesian Voivodeship | 40-611 | Poland |
| Centrum Zdrowia Ochaliczówka | Katowice | Silesian Voivodeship | 40-750 | Poland |
| Medicus | Szczecin | West Pomeranian Voivodeship | 70-233 | Poland |
| Twoja Przychodnia SCM | Szczecin | West Pomeranian Voivodeship | 71-500 | Poland |
| Gabinety Lekarskie Rivermed | Poznan | 61-441 | Poland |
| Centrum Medyczne Szpital Świętej Rodziny | Lodz | Łódź Voivodeship | 90-302 | Poland |
| Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak | Lodz | Łódź Voivodeship | 90-436 | Poland |
| Ekovivus | Lodz | Łódź Voivodeship | 91-833 | Poland |
| DB Placebo Then OLE Etrasimod 2 mg |
Participants were randomized to receive placebo matched to etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator's judgement then received etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part 1: OLE Period |
|
|
The full analysis set (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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DB Etrasimod 2 mg Then OLE Etrasimod 2 mg | Participants were randomized to receive etrasimod 2 milligram (mg) orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator's judgement then continued to receive etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1. |
| BG001 | DB Placebo Then OLE Etrasimod 2 mg | Participants were randomized to receive placebo matched to etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator's judgement then received etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1, DB Period: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response at 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. | 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. | Posted | Number | Percentage of Participants | DB Period: Week 16 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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 was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. | 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. | Posted | Number | Percentage of Participants | DB Period: Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 1, DB Period: Percent Change From Baseline in EASI Score at 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%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. | 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. | Posted | Least Squares Mean | Standard Error | Percent change | DB Period: Baseline, Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1, DB Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All Causality) | 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. | DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period. | Posted | Count of Participants | Participants | DB Period: From first dose of study drug up to 16 Weeks of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1, DB Period: Number of Participants With TEAEs (All Causality) Leading to Study Treatment Discontinuation | 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. | DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period. | Posted | Count of Participants | Participants | DB Period: From first dose of study drug up to 16 Weeks of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1, DB Period: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (All Causality) | 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. | DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period. | Posted | Count of Participants | Participants | DB Period: From first dose of study drug up to 16 Weeks of treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality) | 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. | DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period. | Posted | Count of Participants | Participants | DB Period: From first dose of study drug up to 16 Weeks of treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1, DB Period: Number of Participants With Laboratory Test Abnormalities | Laboratory assessments included hematology, clinical chemistry, urinalysis, other parameters and reflex tests. Number of participants with abnormalities in any of laboratory parameters is reported. | 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. | Posted | Count of Participants | Participants | DB Period: From first dose of study drug up to 16 Weeks of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks | 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. | 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. | Posted | Count of Participants | Participants | 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 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign | 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. | 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. | Posted | Count of Participants | Participants | 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 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1, OLE Period: Number of Participants With TEAEs (All Causality) | 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. | Safety analysis set included all participants who received at least 1 dose of study intervention (i.e., Etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized. | Posted | Count of Participants | Participants | 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) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1, OLE Period: Number of Participants With Treatment Emergent AEs (All Causality) Leading to Study Treatment Discontinuation | 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. | Safety analysis set included all participants who received at least 1 dose of study intervention (i.e., Etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized. | Posted | Count of Participants | Participants | 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) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1, OLE Period: Number of Participants With Treatment Emergent SAEs (All Causality) | 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. | Safety analysis set included all participants who received at least 1 dose of study intervention (i.e., Etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized. | Posted | Count of Participants | Participants | 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) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1, OLE Period: Number of Participants With Treatment Emergent AESIs (All Causality) | 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, AV conduction delay, and hypertension); macular edema, pulmonary events (airflow obstruction or decreased gas exchange); infections (severe infections, opportunistic infections [including PML], Herpes simplex and Herpes zoster); liver injury (liver transaminase elevation and/or bilirubin elevation); PRES and malignancies. | Safety analysis set included all participants who received at least 1 dose of study intervention (i.e., Etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized. | Posted | Count of Participants | Participants | 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) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1, OLE Period: Number of Participants With Laboratory Test Abnormalities | Laboratory assessments included hematology, clinical chemistry, urinalysis, other parameters and reflex tests. Number of participants with abnormalities in any of laboratory parameters is reported. | Safety analysis set included all participants who received at least 1 dose of study intervention (i.e., Etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | 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) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1, OLE Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks | Standard 12-lead ECGs utilizing limb leads were used to measure PR interval, QT interval, QTcF, and QRS complex. Number of participants with non-zero ECG abnormalities and AV blocks are reported in this outcome measure. | Safety analysis set included all participants who received at least 1 dose of study intervention (i.e., Etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for the specified outcome measure. | Posted | Count of Participants | Participants | OLE Period: Day 169/Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign | Vital signs evaluation included SBP, DBP, pulse rate. Number of participants with non-zero vital signs abnormalities are reported in this outcome measure. | Safety analysis set included all participants who received at least 1 dose of study intervention (i.e., Etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized. "Number Analyzed"=participants evaluable for specified timepoints. | Posted | Count of Participants | Participants | OLE Period: Day 141/Week 20; Day 169/Week 24; Day 281/Week 40; Follow Up 1; Follow Up 2 |
|
|
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
The same all-causality treatment-emergent event may appear as both SAE & non-SAE.However, what is presented are distinct events.An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious & non-serious event during study. Safety analysis set was evaluated.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DB Period: Etrasimod 2 mg | Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1. | 0 | 30 | 0 | 30 | 6 | 30 |
| EG001 | DB Period: Placebo | Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1. | 0 | 28 | 0 | 28 | 4 | 28 |
| EG002 | OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) | Participants who received etrasimod 2 mg in DB period, received etrasimod 2 mg orally once daily in OLE period for maximum of another 52 weeks. | 0 | 30 | 1 | 30 | 4 | 30 |
| EG003 | OLE Period: Etrasimod 2 mg (Placebo in DB Period) | Participants who received placebo matched to etrasimod in DB period, received etrasimod 2 mg orally once daily in OLE period for maximum of another 52 weeks. | 0 | 28 | 0 | 28 | 1 | 28 |
| EG004 | DB Etrasimod 2 mg Then OLE Etrasimod 2 mg | Participants were randomized to receive etrasimod 2 milligram (mg) orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator's judgement then continued to receive etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1. | 0 | 30 | 1 | 30 | 9 | 30 |
| EG005 | DB Placebo Then OLE Etrasimod 2 mg | Participants were randomized to receive placebo matched to etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1. Eligible participants per investigator's judgement then received etrasimod 2 mg orally once daily for maximum of another 52 weeks in OLE period of Part 1. | 0 | 28 | 0 | 28 | 5 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Clinical Trials.gov Call Center | Pfizer Inc. | 18007181021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 28, 2023 | Apr 22, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000656249 | etrasimod |
Not provided
Not provided
Not provided
| Adverse Event |
|
| Lack of Efficacy |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| DB Period: Placebo |
Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants who received placebo matched to etrasimod in DB period and then received etrasimod 2 mg orally once daily in OLE period for maximum of another 52 weeks. |
|
|
Participants who received placebo matched to etrasimod in DB period and then received etrasimod 2 mg orally once daily in OLE period for maximum of another 52 weeks.
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|