Today, we will be looking into the latest research and clinical trials focused on hidradenitis suppurativa (HS) in adults.
The following list has been carefully curated by evaluating the ongoing Phase 3 trials for HS, specifically targeting adults in the United States. Please note that the dates provided are approximate and subject to change. This compilation primarily features studies that have released updates within the past 12 months.
This series aims to offer a glimpse into upcoming innovations in the field and how the outcomes of these studies could potentially influence clinical guidelines related to the topic.
Without further ado, let us explore the Hidradenitis Suppurativa Clinical Trials!
Quick View Table of Hidradenitis Suppurativa Clinical Trials
Hidradenitis Suppurativa Clinical Trials:
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD I)
- Sponsor: UCB Biopharma SRL
- The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)
- Interventions: DRUG: Bimekizumab, OTHER: Placebo
- Primary Outcomes Measures: Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16, HiSCR50 is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count, week 16.
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD II)
- Sponsor: UCB Biopharma SRL
- The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS).
- Interventions: DRUG: Bimekizumab, OTHER: Placebo
- Primary Outcomes Measures: Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16, HiSCR50 is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count, week 16.
Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
- Sponsor: MoonLake Immunotherapeutics AG
- This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.
- Interventions: DRUG: Sonelokimab, DRUG: Placebo
- Primary Outcomes Measures: Hidradenitis Suppurativa Clinical Response 75, Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), where HiSCR75 is defined as at least a 75% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count, week 16.
Hidradenitis Suppurativa Study of Izokibep
- Sponsor: ACELYRIN Inc.
- Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin 17A, to which it binds with high affinity. This study investigates izokibep in participants with active Hidradenitis Suppurativa (HS), including tumor necrosis factor-alpha inhibitor (TNFi) naïve participants, and those who had an inadequate response or intolerance to TNFi, or for whom TNFi is contraindicated.
- Interventions: DRUG: Placebo, DRUG: Izokibep
- Primary Outcomes Measures: Percentage of Participants Achieving HiSCR75, Week 12.
A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
- Sponsor: MoonLake Immunotherapeutics AG
- This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.
- Interventions: DRUG: Sonelokimab, DRUG: Placebo
- Primary Outcomes Measures: Hidradenitis Suppurativa Clinical Response 75, Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) where HiSCR75 is defined as at least a 75% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count,Week 16.
Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa
- Sponsor: Novartis Pharmaceuticals
- The purpose of this extension study is to evaluate maintenance of HiSCR response in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials CAIN457M2301 (NCT03713619) and CAIN457M2302 (NCT03713619).
- Interventions: DRUG: secukinumab, DRUG: secukinumab
- Primary Outcomes Measures: “Time to Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Reponders, Loss of response was defined as: * at least a 50% increase in abscess and/or nodules (AN) count compared to the average AN count from the 3 previous visits or at Week 52, whichever is lower and the increase was at least of 3 AN. * at least a 30% increase in AN compared to the average AN count from the 3 previous visits or Week 52, whichever is lower, with an increase of at least 2 AN and a further increase in the AN count of at least 2 AN at a re-assessment visit within 2-4 weeks, Up to 52 weeks: from randomization at the extension study (Week 52) up to Week 104 or loss of response. Study day is defined with respect to the core studies.”
Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)(SUNRISE)
- Sponsor: Novartis Pharmaceuticals
- The purpose of this study was to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study assessed the safety and tolerability of secukinumab.
- Interventions: DRUG: Sonelokimab, DRUG: Placebo
- Primary Outcomes Measures: “Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50), HiSCR50 at Week 16 is defined as at least a 50% decrease in Abscess and inflammatory Nodule (AN) count compared to baseline with no increase in the number of abscesses and/or in the number of draining fistulas from baseline to Week 16. The baseline is defined as the last assessment (including unscheduled visits) obtained before/on the day of the first administration of the study treatment, or on the randomization date if there had been no drug administration.
- This endpoint was analyzed by logistic regression., 16 weeks”
A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (STOP-HS1)
- Sponsor: Incyte Corporation
- The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo controlled period, followed by a 42-week extension period.
- Interventions: DRUG: Povorcitinib, DRUG: Placebo
- Primary Outcomes Measures: Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR), HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count, Week 12.
A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa (STOP-HS LTE)
- Sponsor: Incyte Corporation
- The purpose of this study is to evaluate long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa who completed the 54 weeks of study treatment within the originating parent Phase 3 studies (INCB 54707-301 \[NCT05620823\] or INCB 54707-302 \[NCT05620836\]).
- Interventions: DRUG: Povorcitinib
- Primary Outcomes Measures: Proportion of participants with Treatment-Emergent Adverse Events (TEAEs), TEAE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug, up to approximately 56 weeks.
AA Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS) (STOP-HS2)
- Sponsor: Incyte Corporation
- The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo-controlled period, followed by a 42-week extension period.
- Interventions: DRUG: Povorcitinib, DRUG: Placebo
- Primary Outcomes Measures: Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR), HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count, Week 12.
Potential Guideline That May Be Affected Includes:
- Hidradenitis Suppurativa – Topical, Intralesional, and Systemic Medical Management
- Hidradenitis Suppurativa Foundation
- Published: July 1, 2019
- Hidradenitis Suppurativa- Diagnosis, Evaluation and that Use of Complementary and Procedural Management
- Hidradenitis Suppurativa Foundation
- Published: July 1, 2019
This is it – a list of Phase 3 Clinical Trials for Hidradenitis Suppurativa as of July 2024. Stay tuned, for our next Guidelines+ Trials Rundown. Sign up for alerts and stay informed on the latest published guidelines and articles.