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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis, Atopic Dermatitis, Unspecified, Eczema, Eczema, Atopic

In brief

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).

Key facts

Study ID: NCT05732454
Run by: Pfizer
People needed: 58
Starts: 2023-01-18
Expected to finish: 2024-04-29
Last updated by the study team: 2025-05-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
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.
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.

You may not qualify if…

Participants are excluded from the study if any of the following criteria apply:
Medical Conditions:
Presence of confounding factors:
Skin conditions (eg, psoriasis, seborrheic dermatitis) that may interfere with evaluation of AD or assessment of treatment response as deemed by the investigator.
Current significant active infection or requiring a treatment for infection that may interfere with the assessment of AD.
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.

Where it is running

Jared R. Younger, MD (Ophthalmologist) — Fountain Valley, California, United States
Bryan D. Vo. MD (Pulmonologist) — Laguna Hills, California, United States
California Allergy and Asthma Medical Group — Los Angeles, California, United States
Dr. Carolyn M. Wong — Los Angeles, California, United States
Dr. Gerald Markovitz — Los Angeles, California, United States
Resolution Advanced Imaging Center — Santa Monica, California, United States
Ponce PFT & Medical services, INC [for pulmonology examination] — Aventura, Florida, United States
Advanced Eye Center: Rodrigo Belalcazar, MD — Hialeah, Florida, United States
Direct Helpers Research Center — Hialeah, Florida, United States
Gsi Clinical Research — Margate, Florida, United States
Randy Burks, MD, FACS — Margate, Florida, United States
D & H National Research Centers, Inc. — Miami, Florida, United States
Imaging - Advanced Health Imaging — Miami, Florida, United States
The Selem Center [Ophthalmologist JOSEPH SELEM] — Miami, Florida, United States
Miami Dermatology and Laser Research — Miami, Florida, United States
Ophthalmology - Dr. Edward Boshnick's Global Vision Rehabilitation Center — Miami, Florida, United States
Pulmonology - Miami Pulmonology Specialists — Miami, Florida, United States
Pelletier Jesse MD — North Miami Beach, Florida, United States
Santos Carlos R MD — North Miami Beach, Florida, United States
Tory Sullivan, Md Pa — North Miami Beach, Florida, United States
Gateway Radiology — Pinellas Park, Florida, United States
Hull & Hull Medical Specialists — Plantation, Florida, United States
GCP Research, Global Clinical professionals — St. Petersburg, Florida, United States
St. Anthonys Hospital — St. Petersburg, Florida, United States
First OC Dermatology Research Inc — Fountain Valley, California, United States

Full record on ClinicalTrials.gov

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