A Phase 2 interventional study of Botulinum Toxin A (Allergan, Inc, Irvine CA) and Placebo in Hidradenitis Suppurativa (HS), sponsored by University of Massachusetts, Worcester. Not yet recruiting at 1 site in United States. Open to participants aged 13 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by University of Massachusetts, Worcester · Phase 2, Interventional, and Treatment
Among 161 studies in Hidradenitis Suppurativa with a site in United States — 38 open to participants now, 55 under way, 12 of them phase 3. Hidradenitis Suppurativa · United States.
Among the 161 studies in Hidradenitis Suppurativa with a site in United States, this one is the 73rd largest by planned enrollment of the 139 interventional ones that give a count, is one of 17 that started in 2026, is one of 61 in phase 2, reaches primary completion later than 45 of the 54 other live ones, and was the 154th registered.
285 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.
Browse Hidradenitis Suppurativa studies →38 of the 161 studies in Hidradenitis Suppurativa with a site in United States are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in United States
Ages 18+
Novartis Pharmaceuticals · Sites in United States
Ages 18–65
Corvus Pharmaceuticals, Inc. · Sites in United States
Ages 18+
Harrison Dermatology · Sites in United States
Ages 12+
Beth Israel Deaconess Medical Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 61 Hidradenitis Suppurativa studies recruiting now, 33 (54%) set no upper age limit and 17 (28%) stop at 75 or younger; 13 take children under 18; 12 take healthy volunteers.
This study: 13 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
161 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 65 · Phase 3 27 · Phase 4 5
First in 2005; this study’s year is marked. 17 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 45 across 200 interventional studies indexed under Hidradenitis Suppurativa.
Median enrollment 45 across the 139 interventional studies, 300 across the 22 observational. Of the 95 that completed or were terminated, 52 (55%) have results posted.
This tab as a report to print or save as PDF → With an account.
87 of 161 have an industry lead sponsor. The 10 most frequent:
University of Massachusetts, Worcester is the lead sponsor of 291 studies on the registry; 51 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
University of Massachusetts, Worcester has 2 studies filed under Hidradenitis Suppurativa — fewer than ten, so there is no comparison to draw.
21 of the studies in Hidradenitis Suppurativa with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06468228Phase 3AbbVieA Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa | 2026-12 |
| NCT06921850Phase 3UCB Biopharma SRLA Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa | 2026-12-21 |
| NCT06212999Phase 3Incyte CorporationA Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa | 2026-12-26 |
| NCT06799000Phase 3Novartis PharmaceuticalsA Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1) | 2027-05-17 |
| NCT06840392Phase 3Novartis PharmaceuticalsA Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa | 2027-06-03 |
Add all 21 to your calendar (.ics) → With an account.
Among the 161 studies in Hidradenitis Suppurativa with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will build on data from mice and humans implicating TRPV1 nociceptors in the pathogenesis of the type-17 chronic inflammatory skin disease hidradenitis suppurativa (HS). In this study, the investigators will extend data from a 12-week pilot study to rigorously test the hypothesis that botulinum toxin (BoNT) therapy reduces disease severity and relieves HS pain symptoms..
This study will recruit 40 HS patients with an abscess and inflammatory nodule (AN) count ≥5 at a single body site (ex. bilateral axillae, medial thighs). Participants will be randomized 1:1 to receive placebo or 50U of BoNT per 100cm2 of skin (100U total) administered twice over a 6-month study period. Randomization will be stratified by disease stage (Hurley stage \<III, III). At baseline and weeks 4, 12, and 24 disease activity and pain symptom burden will be measured using percent change from baseline in abscess and inflammatory nodule (AN) count and draining tunnel (dT) count as primary outcomes and achievement of ≥ 30% reduction from baseline in the Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS)-30 as a secondary outcome. The investigators will conduct high-frequency ultrasound measurement of HS tunnel area at baseline and weeks 4,12, and 24 to determine if BoNT therapy can reduce tunnel size. The study team will also collect punch biopsies of lesional skin from HS patients before, and 4 weeks after BoNT treatment then perform flow cytometric, transcriptomic, and microscopic analysis of skin to determine if and how nonselective inhibition of neuropeptide release diminishes HS inflammation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be randomized 1:1 to receive placebo (saline) or botulinum toxin injections.
Drug: Placebo
Participants will be randomized 1:1 to receive placebo (saline) or botulinum toxin injections.
Drug: Botulinum Toxin A (Allergan, Inc, Irvine CA)
50U per axilla in 10 injections of 0.1mL
10 injections of 0.1mL of normal saline vehicle per laterality
Also known as: saline
percent change from baseline in abscess and inflammatory nodule (AN) count and draining tunnel (dT) count
All subjects will receive 2 treatments with onabotulinum toxin A OR placebo (saline) 3 months apart, over a 6-month study period. At baseline and at week 12 each patient will receive 50 units of Botox per 100cm2 of skin, injected intradermally in 10 injections of 0.1mL spaced 1 cm apart to one HS-affected body site (ex. bilateral axillae, inguinal, medial thighs, inframammary chest) for a total of 100U per treatment.
Time frame: baseline and weeks 4, 12, and 24
Microscopy Analyses of Skin Lesions
The study team will perform punch biopsies of lesions and non-lesional skin and perform direct immunohistochemistry and immunofluoresce microscopy analysis
Time frame: baseline and day 7
Ultrasound monitoring of skin lesions
Ultra-high frequency ultrasound (UHFU): This non- invasive imaging technique will be used to quantify HS tunnel area and cutaneous blood flow rate in treatment areas using an established protocol as detailed in Oranges T Skin Res Technology 2020).
Time frame: baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA)
Response is defined as at least a 2-point reduction in HS-IGA score relative to baseline.
Time frame: baseline and weeks 1, 12 ,24
Central sensitization Index (CSI)
measures centrally processed pain signals. The participant scores each answer on a scale of 0 (never) to 4 (always). A score of more than 40 indicates the presence of central sensitization.
Time frame: baseline and weeks 1, 12, 24
Numeric Rating Scale -30
The numeric rating scale (NRS) is a pain scale that asks a patient to rate their pain on a scale of 0 to 10 where a higher score indicates a higher pain level. It's a common tool used in healthcare to assess pain severity.
Time frame: baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Clinical Response (HiSCR)-50
defined as a 50% reduction in inflammatory lesion count (abscesses + inflammatory nodules) with no increase in abscesses or draining fistulas when compared with baseline.
Time frame: baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Physician Global Assessment (HS-PGA)
The six-point Hidradenitis Suppurativa Physician Global Assessment (PGA) ranges from clear to very severe where a higher score indicates more severe disease. It is used in clinical trials to measure clinical improvement in inflammatory nodules,abscesses and draining fistulae
Time frame: baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Quality of Life (HiSQOL)
A 17-item questionnaire designed to measure quality of life for people with HS. Scores range from 0-68 where higher scores indicate a worse impact on quality of life.
Time frame: baseline and weeks 1, 12, 24
Dermatology Quality of Life Index
Assesses the degree of pain, the number of flares, and the impact on daily life . Dermatology disease agnostic, not specific for HS
Time frame: baseline and weeks 1, 12, 24
International Hidradenitis Suppurativa Severity Score (IHS-4)
The International Hidradenitis Suppurativa Severity Score (IHS4) is a validated tool that measures the severity of hidradenitis suppurativa (HS). The IHS4 score is calculated by adding the number of nodules, abscesses, and draining tunnels, each multiplied by a weight A score of 3 or less indicates mild HS, 4-10 indicates moderate HS, and 11 or higher indicates severe HS. The IHS4 is used to assess the severity of HS and to measure inflammatory lesions, such as draining tunnels.
Time frame: baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Area and Severity Index Revised
The HASI-R method assesses HS severity in a manner that incorporates signs of inflammation and body surface area involved. Scores range from 0-720 where a higher score indicates worse disease.
Time frame: baseline and weeks 1, 12, 24
Numeric Rating Scale - Itch
rates itch score as 1-10, 10 indicating most severe itch. similar to NRS pain instrument
Time frame: baseline and weeks 1, 12, 24
PainDETECT
an assessment tool for neuropathic pain. Scores range from -1 to 38. A score of 19 or higher indicates neuropathic pain is likely.
Time frame: baseline and weeks 1, 12, 24
Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 (General Anxiety Disorder-7) measures severity of anxiety over a 2 week period. Answers are scored from 0 to 3 ("not at all" = 0, "several days" = 1, "more than half the days" = 2, and "nearly every day"=3). A score of 10 or higher is considered positive for anxiety.
Time frame: baseline
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 (Patient Health Questionnaire-9) objectifies and assesses degree of depression severity via questionnaire. Nine questions indicate how often the symptom occurred over a 2-week period. A score of 10 or higher is considered clinically significant.
Time frame: baseline and weeks 1, 12, 24
Plan to share: Yes — Research team will share data and samples from this study with other investigators who are interested in skin diseases, but in that case no patient identifying information will be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: starting at time of publication of results, ending 7 years following study endpoint
Access criteria: Proposals should be directed to sarah.whitley@umassmed.edu.To gain access to data, requesters will have to sign a data access agreement.
Start is estimated for Oct 2026; primary completion for Sep 2028, 23 months later.
Of 54 phase 2 interventional studies under Hidradenitis Suppurativa, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 24. This study's planned 23 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Botulinum toxin type A
University of Massachusetts, Worcester →