Learn more about a Pfizer clinical trial for adults with moderate to severe Atopic Dermatitis.
Managing Atopic Dermatitis (AD), or eczema, can be challenging. Topical treatments are not always effective, and other medications may cause unwanted side effects or become less effective over time. That is why we are researching another potential option.
This clinical trial will help us learn how an investigational medicine is processed by the body over time, and if it is safe and effective for adults with moderate to severe AD.
Who may participate
Joining a clinical trial is an important decision. Thank you for considering participation as an option that may be right for you.
This study is enrolling adults who:
- Are 18 to 70 years old
- Weigh more than 50 kg / 110 lbs.
- Were diagnosed with AD at least 1 year ago
- Currently have moderate to severe AD, and approved treatments have not been effective or appropriate
There are other requirements for taking part in this clinical trial. The study team will explain these to you if you’d like to learn more.
Condition
Moderate to severe Atopic Dermatitis (AD)
Age
18-70 years
Sex
Male or Female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If this study is a good fit for you and you agree to take part, you will be assigned by chance (like pulling a number out of a hat) to receive the study medicine or placebo. Out of every 7 participants, 6 will receive the study medicine, and 1 will receive the placebo. The placebo looks like the study medicine but does not contain any active ingredients.
You will receive once-weekly doses of the study medicine or placebo for 8 weeks. Doses will be given as an injection (shot) under the skin in your abdomen, thigh, or arm.
Throughout the study, you will make daily entries in an electronic diary (eDiary) app or device to rate the severity of any itching you are experiencing.
There is no cost to participate. You will also be reimbursed for some study-related expenses.
Length of study treatment
8 weeks
Length of study
About 4 months
Number of study visits
At least 11 visits
Your participation matters
Participation by people of all backgrounds is critical to advancing treatment options for AD. The greater the representation among clinical trial participants, the more we can learn about the study medicine and how it works for different people. Including people from all backgrounds will help us develop a potential treatment that is more likely to be effective for everyone.
Frequently asked questions
You may or may not directly benefit from participating in this clinical trial. However, you may receive an investigational medicine that could improve your AD. Additionally, your health will be closely monitored by the study team, and you will be contributing to research that could help other people with AD in the future.
The study treatment may cause serious symptoms or side effects, including an allergic reaction. Study-related injections, blood draws, and biopsies may cause discomfort, bruising, bleeding, and in rare cases, infection. There may be other risks that are unknown at this time. The study team will provide more information about the potential benefits and risks of taking part.
While all clinical trials come with some risks, participant safety is always the top priority. Clinical trials are reviewed by committees responsible for protecting the rights and safety of all participants. These committees continue to regularly review the trial’s progress to ensure there are no unnecessary or excessive risks to participants.
At the beginning of the clinical trial, the study doctor will ask about your medical history and complete a physical exam. They will also draw blood samples, complete an electrocardiogram (ECG), take photos of your AD, and ask you to provide a urine sample. The study team will give you more information about all tests and procedures during your first study visit.
You will use an electronic diary (eDiary) every day to rate the severity of any itching you are experiencing throughout the clinical trial. The study team will provide more information about the eDiary during your first study visit.
The study doctor will review your medications during your first study visit and let you know if any medication changes are required for participation. You should not use any new or medicated topical therapies (e.g., lotions, ointments, etc.) during the clinical trial. The study doctor will prescribe approved therapies for AD as needed.
Participation is your choice. You can choose to leave the clinical trial at any time, for any reason.
