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July 29, 2020 Clinical Trials

Youth ages 12-18 years old may qualify for this new Chronic Plaque Psoriasis study.

Study focuses on how a drug called Risankizumab may help children with moderate to severe psoriasis. Psoriasis is a condition in which skin cells build up and form red, itchy, scaly patches. Risankizumab is approved for use in adults however, it has been not been approved for children in the United States and other countries, and we want to learn more about how it works. This is called a “research study.” This is the first study where the study drug will be tested in children.

If you decide to be in the research study, you will be asked to take part in this study for about 65 weeks and this may include 9 study visits and 1 follow-up phone call. You will receive a risankizumab injection every 12 weeks after the week 4 visit.

You will need your parent’s approval to participate in this study if you are younger than 18.

Call 817-795-7546 or email studies@acderm.com if you think you would like to participate in this study.


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July 29, 2020 Clinical Trials

New injection study for ages 12 years and older. Patient must have history with atopic dermatitis for at least 2 years. You would be asked to take part in a research study of an investigational drug called risankizumab, since you have moderate to severe atopic dermatitis. An investigational drug is one that has not been approved for AD in the United States by the U.S. Food and Drug Administration (FDA). The use of risankizumab is considered experimental.

Your time in this study could last up to 65 weeks, including:

    • Screening Period (to check whether you are suitable to take part in this study) of up to 35 days (5 weeks)
    • Treatment Period of 52 weeks
    • Follow-up Period of 20 weeks after your last dose of study drug when you will be contacted by your study site staff by phone to talk about your health.

During your participation, you will have approximately 11 study visits to the research center for Screening, Baseline/Week 0, Week 2, Week 4, Week 10, Week 16, Week 20, Week 24, Week 28, Week 40, and Week 52 visits or Premature Discontinuation (PD) visit if you exit the study before Week 52 visit. You may need to come in for additional (unscheduled) visits if necessary as determined by your study doctor.

If you decide to enter in this study and qualify, you will be selected by chance to receive either risankizumab or a placebo (which looks like risankizumab but contains no medicine). Neither you nor the study doctor or study staff will be able to pick which study group you are in. The investigational product (risankizumab) and the matching placebo are given as subcutaneous injections (which mean it will be injected under the skin). The placebo is not a drug and it is not expected to have any effects on your body, and it is not designed to treat any disease or illness. It looks like the study drug to ensure subjects and the study staff cannot guess what is actually being administered to you. This allows the study scientists to make the best judgment on whether the study drug is having effects that are greater than are expected by chance alone.

Call 817-795-7546 or email studies@acderm.com if you think you would like to participate in this study.


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June 2, 2020 Clinical Trials

Hidradenitis Suppurativa (injection)
– Adults 18 years and older may qualify for a new injection study.

To parcipate you must:

  • Have had signs and symptoms of hidradenitis suppurativa for at least 6 months
  • Have hidradenitis suppurativa bumps (or lesions) in or on at least 2 different areas of your body
  • Have previously taken antibiotics for the treatment of hidradenitis suppurativa

There are other criteria that you will need to meet before you can join the study. Your study doctor will discuss these with you to find out whether you can take part.

Once enrolled in the study, you will receive either the investigational study drug, bimekizumab, or placebo – a placebo looks similar to the study drug but contains no active medication. You will be randomly allocated (like drawing straws) to one of four groups; you will have a 1 in 7 chance of getting placebo for the first 16 weeks, and then, for the remaining 32 weeks you will receive the investigational study drug, for a total of 48 weeks of treatment. Neither you nor the study team will know if you are taking the study drug or placebo during the first part of the study. This ensures that the results from the tests are handled in the same way.

The study drugs will be given by a subcutaneous (under the skin) injection in your lower abdomen (stomach), thigh, or upper arm. Each injection will last less than 20 seconds. Your study doctor will ensure that, during the injection procedure, you are not able to see which study drug you are receiving. This is called ‘maintaining the blind’.
Participants are expected to be in the study for 53 weeks (up to 5 weeks screening plus 48 weeks of study treatment); during this period you will be required to visit the study center approximately 27 times.

Call 817-795-7546 or email studies@acderm.com if you think you would like to participate in this study.


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