US Clinical Trial
The Regulate-HS clinical trial is for adults living with hidradenitis suppurativa (HS), also known as acne inversa. The trial will test a new investigational cell therapy product, SBT777101, to determine if it can safely and effectively treat symptoms of HS in patients who have a history of inadequate response to previous therapies designed to treat HS.
SBT777101 is not approved by the FDA for the treatment of HS as the safety and efficacy have not yet been established.
You may be eligible to join the trial if you meet the following requirements:
18 to 70 years of age
Confirmed diagnosis of hidradenitis suppurativa (HS), also known as acne inversa
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Must have a history of inadequate response to previous medications or therapies designed to treat HS
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Must be willing to undergo skin biopsies
Cannot have a history of inflammatory or autoimmune disease, including but not limited to Crohn’s disease
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Must be willing to comply with all trial requirements
*Additional trial requirements will apply and be discussed with you by your trial team.
Trial participants can expect the following:
Participation in a clinical trial is voluntary. You can ask any questions you have and may leave the trial at any time, for any reason.
Visit the trial clinic map or clinicaltrials.gov to find a clinic near you.
Trial Clinic LocationsSBT777101 is a cell therapy, meaning it is made from the patient’s own immune cells called regulatory T cells. Blood cells are collected from the patient with hidradenitis suppurativa (HS) and then modified to have a special protein on their surface that targets a specific marker related to inflammatory diseases such as HS. After expanding and stimulating these modified cells, they are given back to the patient. Strict procedures are in place to ensure the product's identity and safety at every step, from cell collection to administration.
If you qualify to participate in the Regulate-HS trial, you will be placed in a dose-level cohort and will undergo a one-time intravenous (IV) administration of SBT777101 on Day 1 of the trial.
Investigational means the trial medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Investigational therapies such as SBT777101 can only be used in clinical trials like the Regulate-HS trial.
Hidradenitis suppurativa (HS), also known as acne inversa, is a chronic skin condition characterized by painful bumps and abscesses forming beneath the skin. It commonly occurs on areas of the body that experience friction, such as underarms, breasts, inner thighs, and the groin. In addition to causing pain, HS can result in permanent scarring and, if untreated, may lead to infections in severe cases. Women are three times more likely than men to develop HS, and individuals who are obese or smoke face a higher risk.
You can learn more about HS using the following resources:
American Academy of Dermatology
National Health Service
Here are some common questions and answers about trial participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the trial, including trial goals, how long the trial will last, benefits and risks, and the tests and procedures you will receive.
Trial participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a trial.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical research trial, contact a trial clinic near you.
Use the filters, map, and listing to find the trial clinic closest to you. Contact the trial clinic to learn more.