Study ID: 23-358-05. For eczema (atopic dermatitis)
Summary
This study is to test the safety and effectiveness of a novel injectable medication for eczema (also known as atopic dermatitis).
The study drug has the potential to be much more effective
than topicals or creams at
treating moderate to severe eczema symptoms.
This medication is a biologic modifier .
Injected into the body, it targets the pathways of the immune system to cut off the signal that stimulates eczema symptoms.
We are seeking volunteers with moderate to severe eczema that hasn’t improved with standard treatment options (topicals, creams).
This study will assess the efficacy of the study drug to:
Reduce the skin irritation and
other problems that atopic
dermatitis causes.
Moderate the overreaction in
your body’s immune system that
results in atopic dermatitis
symptom
Improve peoples’
overall quality
of life
Volunteers are needed to improve the outlook for other eczema patients globally.
If you have moderate to severe eczema, and want to help us research innovative treatments by trying them with us, read on to the inclusion criteria.
There are other criteria that our clinical staff will discuss with you as well.
Inclusion Criteria
You are eligible* to participate in the study if:
You are aged 18–65
You have been diagnosed with moderate-to-
severe atopic dermatitis (also referred to as
eczema) for at least 6 months
You have not found relief despite the use of
standard treatments for atopic dermatitis
You are in generally good health besides your
atopic dermatitis diagnosis
* Additional criteria for eligibility apply
If study investigators determine you are eligible, your participation may help find a potential treatment option for you and others with atopic dermatitis
If you participate in the study, you will be asked to:**
Provide signed informed consent
Comply with all scheduled clinic
visits and study-related
procedures
Not take any study-prohibited
medications during the trial
period
** Additional responsibilities apply
Your participation in the study is entirely voluntary, and your information
will be confidential. If you change your mind, you can withdraw from the study at any
time, for any reason, and without any consequence
What to expect during the study
Beyond the initial screening period, the study lasts for about 36 weeks
consisting of 14 clinic visits to update on your health status, including:***
Routine laboratory
tests
Urinalysis
Physical Exam
Vital signs
Standard assessments for the severity of atopic dermatitis symptoms
The study lasts for about 40 weeks consisting of 15 clinic visits to update on your health status, including:
An initial Screening Period of up to 5 weeks with 1 clinic visit
You will undergo assessments to check if you fully qualify to participate in the study
A Treatment Period of 12 weeks with 7 clinic visits
At randomization and 6 additional visits, you will receive a dose of either ANB032 or an inactive placebo. Each dose consists of 2 injections under the skin
You or your doctor will not know if you received the active drug or the placebo until after the end of the study
A Follow-up Period of 24 weeks with 7 clinic visits
This includes follow-ups to ensure your well-being and measure your response to the doses you receive
***Additional assessments apply
Click here to read attached documentation. Eczema Trial FAQ Document
Contact us about joining the trial
To be eligible for this trial, applicants MUST have a skin condition. We DO NOT accept volunteers who do not have a skin disease.
Fill out this form, or call us to get in touch. Our phone number is # (289)-763-8666.
We will contact you in 1-2 business days regarding your application to participate in the trial.
Privacy Policy for SimcoDerm Clinical Trials
Your privacy is important to us, and we take the protection of your personal health information (PHI) seriously. This policy explains how we collect, use, and protect your information.
We collect information directly from you, including your name, contact details, health information, and treatment history.
We use your information to determine eligibility for clinical trials, manage appointments, and communicate with you about your participation in clinical trials.
Data Protection:
Your information is stored securely and is only accessible by authorized personnel. We use data encryption, conduct security audits, and implement strict access controls to ensure the protection of your personal information.
You have the right to access, amend, or request the deletion of your health records. To exercise these rights, send a request to our clinical trial support team.