As part of our ongoing clinical trials tracking process, TrialSite News staff analyzes Hidradenitis Suppurativa (HS) studies worldwide. We are utilizing U.S. National Library of Medicine sponsored ClinicalTrials.gov as a primary resource to locate and identify existing studies worldwide. We also depend on other news and commercial sponsors, as well as scientific publications. Should readers seek more specific trial information, contact us and our Research Services can tap into more granular data sources. For purposes of this review, we cover all phases and only including studies that are active. There are 16 clinical trials in this survey, including 8 academic medical centers sponsored and 8 commercially sponsored. In our survey we will highlight sponsor, focus, and phase.
According to the National Institutes of Health, HS is an inflammatory, chronic skin disease characterized by recurrent, painful, boil-like lumps (nodules) under the skin. HS affects the areas around skin folds (e.g., armpits, groin, and breasts) and where apocrine glands (a form of sweat gland) and hair follicles are found. It is not contagious. It typically manifests as a single pocket of pus (abscess) or hard, sebaceous lumps (lumps composed of sebum, or oil, which is excreted by the sebaceous glands associated with hair follicles). It may progress to painful, deep-seated, inflamed clusters of lesions with chronic seepage involving significant scarring. In most cases, the cause of HS is unknown. It is likely that it results from a combination of genetic and environmental factors. Some cases of HS have been associated with specific genes, including NCSTN, PSEN1, and PSENEN.
According to a recent study, the HS prevalence in the United States population sample was .10%, or 99 per 100,000 persons. It is an uncommon but not rare disease that in the United States that disproportionately affects female patients, young patients, and African American and biracial patients. Targeted immune modulating drugs appear to be at the forefront of therapy for Hidradenitis Suppurativa. Currently there are no registries to support data sharing and clinical efficacy comparison. Research reports that there was a seven fold increase in diagnosis from 2002-2007 to 208-2010.
Summary HS Clinical Trials
First, we cover the “Non-Applicable” phases in the ClinicalTrials.gov website. Wayne State University was planning to complete a study in Spring of 2018 focusing on patients with bilateral hidradenitis in the axilla, groin and /or inframammary to be treated on one side with Alexandrite hair removal laser. The other side was to serve as the control. There are no results yet. The principal investigator is Steve D. Daveluy. We note that in a recent article, it is reported that some studies and case reports suggest the alexandrite laser helps some HS patients. In another phase titled “Non Applicable” University Hospital of North Norway sponsors a trial emphasizing a randomized double blind placebo controlled pilot study/proof of concept-study to see if intradermal injection with Botulinum toxin B is an effective treatment of Hidradenitis suppurativa. Collaborators for this study include The Royal Norwegian Ministry of Health and Hidrosis Clinic of Stockholm Sweden. Relevant studies pointed that Botulinum toxin B could be applicable to HS. The lead investigator is Øystein Grimstad, MD PhD. The University Hospital of North Norway study is supposed to wrap up in September 2018, so TrialSite News will monitor for results.
Montefiore Medical Center in New York and investigative lead Dr. Steven Cohen are sponsoring an HS trial to establish the safety of radiotherapy in the treatment of advanced hidradenitis suppurativa. Patients will receive radiotherapy treatment over one week and then they will be followed for the next three months. The study is planned to be completed in December 2018.
On the topic of use of radiation therapy on HS, a Mayo Clinic led study concluded that this approach held promise for severe HS cases. In Denmark, Zealand University Hospital seeks to study the use of Intense Pulsed Light Therapy in patients with HS. Previous Scandinavian researchers concluded that this approach may be a useful treatment for HS patients. The principal investigator for the Danish study is Peter Riis, MD .
A Phase I study led by Boston-based Tufts Medical Center will monitor the safety and feasibility of secukinumab in HS patients, as well as information about the effect size will be determined to inform a future larger randomized control trial with an active comparator. Principal investigator Dr. David Rosmarin will follow up on existing Danish secukinumab research where patients showed rapid and distinct symptom relief, improved quality of life, and objective reduction in disease activity over a 6 month treatment.
In a Phase I and II combined study, Dr. Elena Gonzalez Brant of the University of Pittsburgh noted that current HS therapies have long-term risks including antibiotic resistance and the investigators aim to find new safe and effective therapies for HS. Hydroxychloroquine is a medication that has been used safely in other diseases for many years. The investigators believe that hydroxychloroquine has the potential to improve HS through multiple mechanisms. Patients enrolled in this study will be treated with hydroxychloroquine for 6 months. The investigators also aim to look at the blood of patients with HS to look for inflammatory molecules that we could possibly target for the treatment of HS. Blood samples will be taken at baseline and following 6 months of treatment.
Other Phase II studies include a collaboration between German-based InflaRx GmbH and global contract research organization Quintiles. The lead investigator, Othmar Zenker, CMO seeks to determine whether IFX-1 is safe and effective in the treatment of moderate to severe hidradenitis suppurativa. IFX-1 was developed by Beijing Mabworks Biotech and InflaRx—the latter which floated an IPO and raised $100 million last year.
XBiotech Inc is currently sponsoring a Phase II study of bermekimab, a proprietary treatment in development, for patients with moderate to severe HS. XBiotech floated an IPO for a few years ago and trades under the stock symbol XBIT . They are working with dermatology research site Tennessee Clinical Research Center for the Phase II study. Principal investigator is Dr. Michael Gold.
Biotech Incyte Corporation is sponsoring two trials to evaluate the safety of their drug INCB054707 over an 8-week treatment period in men and women with moderate to severe hidradenitis suppurativa. Incyte Study Director is Kathleen Butler. The planned completion date for the investigative drug INCB054707 is 2020.
Belgium-based UCB is sponsoring a Phase II study to test the efficacy, safety and pharmacokinetics of Bimekizumab in patients with moderate to severe HS. TrialSite News has reported on Bimekizumab before in our Psoriasis clinical trial survey. See recent news about the UCB investigational drug. The UCB study team sought to recruit 157 patients and were planning to complete by the end of 2018. The study is being carried out in the United States, Europe, and Russia in over 35 research sites.
Janssen (J&J) presently is sponsoring a Phase II study to evaluate the efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS). Guselkumab is sold under the trade name Tremfya, a monoclonal antibody currently used to treat plaque psoriasis.
Global biopharmaceutical company AbbVie currently sponsors two HS trials centering on the use of Adalimumab—a Phase III in Japan and a Phase IV where the objective of this study is to assess the safety and efficacy of adalimumab prior to surgery in subjects with moderate to severe (HS) who are surgical candidates.
To summarize, a TrialSite News global survey of clinical trials firstly demonstrates that commercial sponsors are not focusing heavily on HS. Given the growing occurrences of the debilitating disease we expected far more clinical studies. The table below summarizes study, phase, treatment, and expected study completion date. TrialSite News readers struggling with Hidradenitis Suppurativa can contact us for more information. Our Research Services can direct you to more information and even introductions to investigators.
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