An Oral Option to Treat AD Could Be on the Horizon

We’re seeking adults ages 18–55 to join a research study testing the safety of an oral study drug that may help reduce the symptoms of atopic dermatitis, or AD (commonly called eczema).

Learn more about the study

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The BroADen Study at a Glance

We are enrolling up to 30 adults with moderate to severe eczema across the United States.

Eligible participants must:

  • Be 18–55 years of age
  • Have had moderate to severe AD (eczema) for at least one year
  • Have had a poor response to topical medications for AD (eczema)
  • Be willing and able to apply moisturizer at least twice daily during the clinical research study
  • Be willing and able to use a mobile device to answer questions daily during the clinical research study

Additional requirements will apply. The clinical research study team will discuss these with you.

About the BroADen Study

The purpose of this study is to evaluate if an investigational study drug is safe and how it works in adults with moderate to severe AD (eczema).

Most standard-of-care treatments for AD target the condition’s symptoms, such as inflammation and itchiness. These treatments may provide temporary relief, but AD symptoms will often return. There are also injection treatments available, but these may not be appropriate or preferred for some individuals.

The BroADen Study is being done to research a study drug called KT-621. Researchers believe that this investigational study drug may be a potential oral treatment option for AD. It works differently from standard treatments such as topical creams and injectables. Taken once daily as a tablet, KT-621 finds and breaks down a protein that can contribute to inflammation and other symptoms in patients with AD. The BroADen Study is being conducted to test if KT-621 is safe and how it affects the body in adults.

KT-621 is being used for research purposes only and is not yet approved for use to treat AD outside of clinical research.

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Study Schedule

Participation in the BroADen Study will last 11 weeks and includes 7 visits to the study site.

Screening – Up to 5 weeks – 1 visit

A study doctor will evaluate interested individuals to see if the study is a good match for them.

  • Individuals will first need to give their consent, or permission, to join the study by reading and signing the informed consent form.
  • A physical exam, laboratory sample collections, and questionnaires will be done.
  • Individuals will be shown how to use an electronic diary (eDiary) to keep track of when they take their study drug and record AD symptoms.

Treatment – 4 weeks – 5 visits

Participants will begin taking the study drug and attend regular study site visits. There is no placebo in this study, and all participants will receive the study drug.

  • Laboratory sample collections, questionnaires, and other assessments and procedures will be done, depending on the visit.

Follow-Up – 2 weeks – 1 visit

The study team will monitor participants’ health after they have stopped taking the study drug.

  • Laboratory sample collections, questionnaires, and other assessments will be done.

These tests, along with the study drug and the ongoing monitoring of participant health, will be provided at no cost. No insurance is needed to join this study. Support to cover study-related travel costs and stipends for certain procedures may be available.

Find a Participating Research Site

ClinicalTrials.gov

Active site locations

Future site locations

Participating Sites

About Atopic Dermatitis

Atopic dermatitis, or AD, is a common, chronic (long-term), inflammatory skin disease. It is the most common type of eczema, and may occur due to a combination of genetic, immune system, and environmental factors.1

Symptoms of AD may come and go (“flare up”), and commonly include:

  • Itchy skin
  • Skin redness and dryness, especially on the hands, feet, ankles, wrists, neck, upper chest, eyelids, and inside the bend of the elbows and knees
  • Small, raised bumps on the skin
  • Thickened, cracked, scaly skin

Since there is no cure for AD, standard treatments mainly focus on managing symptoms.

References

  1. nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/↵

What You Should Know About Clinical Research Studies

Clinical research studies look at an investigational study drug, medical device, or procedure to see if it is safe, how it affects the body, and if it works to treat a specific disease. Clinical research studies are conducted by doctors who are responsible for the study participants’ study-related care.

Clinical research studies must be reviewed by an institutional review board (IRB) or ethics committee (EC). An IRB/EC is an independent group that is responsible for helping to protect the rights and well-being of study participants. In addition, every study participant is monitored with study-related medical tests and exams before, during, and sometimes even after the study.

Participation in any clinical research study is completely voluntary, and you may choose to withdraw from the study at any time for any reason. If you would like to leave the study, you should discuss this with your study doctor, who will give you information about how to do this safely.

Throughout the study, the study team will perform tests and procedures to check on your health. These tests and procedures include vital sign measurements (such as blood pressure and temperature), physical exams, height and weight measurements, blood and urine sample collections for lab tests, heart tests such as electrocardiograms (ECGs), questionnaires on how you are feeling, and other assessments.

Participation in the BroADen Study will last 11 weeks. This includes a screening period, a treatment period, and a follow-up period.

Find a participating site