Clinical Trials
With the discovery of many new treatments, we are now offering a variety of different clinical trials for individuals with hidradenitis suppurativa (HS). These clinical trials offer patients the opportunity to try the newest drugs that are being developed and to contribute to discovering and testing them; thus, changing the future of HS treatment.
Clinical trials differ from common medical care. Within a clinical trial, a small group of participants are subjected to a new drug. This new trial is then closely monitored by clinicians to study the effects of the new treatment on participants. Due to the commitment and length, entering a clinical trial is not for everybody. While it can be very exciting, patients should think about the implications including: multiple visits during the trial, schedule, anxiety about using a new treatment, and other potential factors that may hinder commitment.
Below is a list of the trials that the Clinic is currently conducting or participating in. Please understand that the details about qualifications to enter the trials are strict. If you think that you may be eligible to participate in one or more clinical research studies, please reach out to us directly at HSresearch@umassmed.edu.
Phase II Study evaluating botulinum toxin therapy in Hidradenitis Suppurativa
Now enrolling: Subjects are paid $300 for participation
Study PI: Dr. Sarah Whitley
In this study, the investigators will test the hypothesis that inhibiting neuropeptide activity with botulinum toxin reduces inflammation, relieves pain, and improves quality of life for HS patients.
- Inclusion criteria: Adults between ages 18 and 75, AN count ≥ 5 at baseline, draining tunnel count of <20 at baseline.
- Exclusion criteria: Age < 18 years or > 75 years, pregnant or breastfeeding, started a new biologic based therapy (e.g. anti-TNF, anti-IL-17A/F/R, anti-IL-12/23, or anti-IL-1) or oral JAK or TYK inhibitor within preceding 12 weeks, laser surgery, laser hair removal, or elective surgery to the treatment areas within 4 weeks prior to baseline visit.
Study involves 4 visits over a 6 month period. Patients receive 2 treatments with botulinum toxin (BotoxTM) injections, 3 months apart (free of charge). Skin biopsies are obtained before and after the 1st botulinum toxin treatment.
This is an investigator-initiated trial. Funding sources are: NIAMS/NIH, Hidradenitis Suppurativa Foundation (HSF), and AbbVie (providing BotoxTM).
Immune phenotyping in hidradenitis suppurativa
Now Enrolling: Subjects will be paid as follows: $100 for completion of all study procedures (punch biopsy, microneedles, blood, skin swab, and questionnaires); $50 for skin biopsy only.
Study PI: Dr. Sarah Whitley
- Inclusion criteria: Children 6 years of age and older.
Study involves a biopsy of HS-affected skin +/- a blood draw, skin swab, microneedle application, questionnaires.
Funding: NIAMS/NIH, Hidradenitis Suppurativa Foundation (HSF), National Eczema Association (NEA).
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of a novel JAK inhibitor in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy.
Enrollment Status: Coming soon - compensation is provided
Study PI: Dr. Sarah Whitley
- Inclusion Criteria: ≥ 12 years old, total AN count of ≥ 5 at Baseline, Draining fistula count of ≤ 20 at Baseline, At least 1 anatomic area of HS involvement characterized as Hurley Stage II, previous use of ≥ 1 TNF inhibitor for HS for at least 12 weeks and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate response or intolerance.
- Exclusion Criteria: pregnant or breastfeeding; treatment with immunomodulatory biologic therapy for any indication within the prior 8-16 weeks, active infection.
Sponsor: AbbVie
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