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
Study Details
Study Description
Brief Summary
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:
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have AD for at least 1 year
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have moderate-to-severe AD
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have tried treatments that work all over the body and saw no effects
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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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: etrasimod 2 mg, oral tablet, once daily |
Drug: etrasimod
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
Other Names:
|
| Placebo Comparator: Placebo (Part 1 DB period only) Oral sham comparator |
Drug: Placebo
PART 1 DOUBLE BLIND Placebo - one table daily for up to 16 weeks
|
Outcome Measures
Primary Outcome Measures
- Part 1 DB: Proportion of participants achieving IGA of clear (0) or almost clear (1) (on a 5-point scale) and a reduction of ≥ 2 points from baseline [at Week 16]
To evaluate the efficacy of etrasimod, 2 mg, QD versus placebo
- Part 1 OLE and Part 2: Incidence and severity of treatment-emergent adverse events (AEs), AEs leading to study treatment discontinuation, serious AEs, and AEs of special interest. [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in Hemoglobin (g/dL) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in RBC (x10^6/uL) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in Platelets, WBC, and WBC with Diff (x10^3/uL) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in TBNK panel (abs/uL) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in Hematocrit, WBC with Diff, TBNK with Diff (%) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in Total bilirubin, Urea Nitrogen, Creatinine (mg/dL) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in AP, ALT (SGPT), AST (SGOT) (U/L) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in Total Protein and Albumin-BCG (g/dL) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in Serum Sodium, Serum Potassium (mmol/L) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in urinalysis (pos/neg local dipstick) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (BP) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (pulse rate) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (temperature) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (respiratory rate) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (QT interval) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (QTc interval) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (heart rate) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (PR interval) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (QRS complex) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in Hemoglobin (g/dL) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in RBC (x10^6/uL) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in Platelets, WBC, and WBC with diff (x10^3/uL) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in TBNK Panel (abs/uL) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in Hematocrit, WBC with diff, TBNK with diff (%) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in Total bilirubin, Urea Nitrogen, Creatinine (mg/dL) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in AP, ALT (SGPT), AST (SGOT) (U/L) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in Total Protein and Albumin-BCG (g/dL) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in Serum Sodium, Serum Potassium (mmol/L) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in urinalysis (pos/neg local dipstick) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in vital sign values (BP) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in vital sign values (pulse rate) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in vital sign values (temperature) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in vital sign values (respiratory rate) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in ECG values (QT interval) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in ECG values (QTc interval) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in ECG values (heart rate) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in ECG values (PR interval) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
- Part 1 OLE and Part 2: Change from Baseline in ECG values (QRS complex) [Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2]
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Secondary Outcome Measures
- Part 1 DB: Proportion of participants achieving a EASI-75 [at Week 16]
To evaluate the efficacy of etrasimod, 2 mg, QD based on additional measures
- Part 1 DB: Percent change from baseline in EASI [at Week 16]
To evaluate the efficacy of etrasimod, 2 mg, QD based on additional measures
Eligibility Criteria
Criteria
Inclusion Criteria:
Participants must meet the following key inclusion criteria to be eligible for enrollment into the study:
- 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:
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IGA score ≥3 (on the 0 to 4 IGA scale, in which 3 = moderate and 4 = severe) at screening and baseline (Day 1)
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BSA ≥10% of AD involvement at screening and baseline (Day 1)
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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.
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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:
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Skin conditions (eg, psoriasis, seborrheic dermatitis) that may interfere with evaluation of AD or assessment of treatment response as deemed by the investigator.
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Current significant active infection or requiring a treatment for infection that may interfere with the assessment of AD.
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Hypersensitivity to etrasimod or any of the excipients.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First OC Dermatology Research Inc | Fountain Valley | California | United States | 92708 |
| 2 | Jared R. Younger, MD (Ophthalmologist) | Fountain Valley | California | United States | 92708 |
| 3 | California Allergy and Asthma Medical Group | Los Angeles | California | United States | 90025 |
| 4 | Dr. Carolyn M. Wong | Los Angeles | California | United States | 90025 |
| 5 | Dr. Gerald Markovitz | Los Angeles | California | United States | 90025 |
| 6 | Direct Helpers Research Center | Hialeah | Florida | United States | 33012 |
| 7 | D & H National Research Centers, Inc | Miami | Florida | United States | 33155 |
| 8 | The Selem Center [Ophthalmologist JOSEPH SELEM] | Miami | Florida | United States | 33165 |
| 9 | Gateway Radiology | Pinellas Park | Florida | United States | 33781 |
| 10 | GCP, Global Clinical Professionals | Saint Petersburg | Florida | United States | 33705 |
| 11 | Pulmonology Lung and sleep care inc Dr. Vinubhai C. Pansuriya, MD | Saint Petersburg | Florida | United States | 33713 |
| 12 | Akumin Imaging | Tampa | Florida | United States | 33603 |
| 13 | Clinical Research Trials of Florida | Tampa | Florida | United States | 33607 |
| 14 | Tampa Eye Clinic | Tampa | Florida | United States | 33607 |
| 15 | Lung and Sleep Disorder Center | Lathrup Village | Michigan | United States | 48076 |
| 16 | Revival Research Institute, LLC | Troy | Michigan | United States | 48084 |
| 17 | Somerset Opthalmology PC | Troy | Michigan | United States | 48084 |
| 18 | Health Concepts | Rapid City | South Dakota | United States | 57702 |
| 19 | Eye Care Associates of Arlington | Arlington | Texas | United States | 76010 |
| 20 | Arlington Research Center | Arlington | Texas | United States | 76011 |
| 21 | Envision Imaging | Arlington | Texas | United States | 76012 |
| 22 | Texas Pulmonary | Arlington | Texas | United States | 76012 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C5041005
- 2022-003361-37
- APD334-314