SAR444656 for Hidradenitis Suppurativa
(ZEN Trial)
Recruiting in Palo Alto (17 mi)
+38 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Sanofi
Must not be taking: Antibiotics, Antivirals, Antifungals, Antihelminthics
Disqualifiers: Active skin disease, Chronic infection, Malignancy, Cardiovascular events, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?This is a parallel, Phase 2, 3-arm study to evaluate the efficacy, safety, PK, and biological effects of SAR444656 compared with placebo in adult participants with moderate to severe HS aged ≥18 to 70 years.
Study details include:
* Screening period: up to 4 weeks (30 days)
* Treatment duration: up to 16 weeks
* Follow-up period: up to 4 weeks
* Total study duration: up to 24 weeks
* Number of visits: 14
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot have any active or chronic infections requiring systemic treatment within 30 days before starting the trial, and you must not have used prescription topical therapies for HS within 14 days before the trial begins.
What evidence supports the effectiveness of the drug SAR444656 for treating Hidradenitis Suppurativa?
While there is no direct evidence for SAR444656, similar treatments like IL-17 inhibitors and TNF-alpha inhibitors have shown effectiveness in treating Hidradenitis Suppurativa, with a significant number of patients responding positively to these therapies.
12345What makes the drug SAR444656 unique for treating hidradenitis suppurativa?
SAR444656 (also known as KT-474, KYM-001) is unique because it represents a novel approach to treating hidradenitis suppurativa, a condition with limited effective treatments. Unlike traditional therapies that often rely on antibiotics, which can lead to resistance, SAR444656 may offer a new mechanism of action, although specific details about its uniqueness compared to existing treatments are not provided in the available research.
36789Eligibility Criteria
Adults aged 18-70 with moderate to severe Hidradenitis Suppurativa (HS), having lesions in at least two areas and one area being Hurley Stage II or III. They must have had HS for over a year, not responded well to antibiotics for HS, have an active lesion count of 5 or more, fewer than 20 draining tunnels, and elevated CRP levels indicating inflammation.Inclusion Criteria
I have HS lesions in at least 2 different areas, with one area being moderate or severe.
I have tried an oral antibiotic for HS for 3 months without improvement.
I am willing and able to keep a diary for the study.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
up to 4 weeks
Treatment
Participants receive SAR444656 or placebo orally for efficacy, safety, PK, and biological effects evaluation
up to 16 weeks
14 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
up to 4 weeks
Participant Groups
The trial is testing SAR444656 against a placebo in adults with HS. Participants will be randomly assigned to receive either the drug or placebo during a treatment period of up to 16 weeks, followed by follow-up visits totaling up to 24 weeks duration.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: SAR444656 dose 2Experimental Treatment1 Intervention
Participants will receive SAR444656 dose 2 orally
Group II: SAR444656 dose 1Experimental Treatment1 Intervention
Participants will receive SAR444656 dose 1 orally
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive placebo orally
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Pittsburgh Medical Center-3601 5th Ave Site Number : 8400009Pittsburgh, PA
Tory Sullivan, MD, PA Site Number: 8400003North Miami Beach, FL
Dermatology Specialists Research - 3810 Springhurst Blvd Site Number : 8400012Clarksville, IN
Wayne Health-Dearborn Site Number : 8400004Dearborn, MI
More Trial Locations
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Who Is Running the Clinical Trial?
SanofiLead Sponsor
Kymera Therapeutics, Inc.Industry Sponsor
References
Hidradenitis suppurativa/acne inversa: a practical framework for treatment optimization - systematic review and recommendations from the HS ALLIANCE working group. [2020]Hidradenitis suppurativa (HS)/acne inversa is a debilitating chronic disease that remains poorly understood and difficult to manage. Clinical practice is variable, and there is a need for international, evidence-based and easily applicable consensus on HS management. We report here the findings of a systematic literature review, which were subsequently used as a basis for the development of international consensus recommendations for the management of patients with HS. A systematic literature review was performed for each of nine clinical questions in HS (defined by an expert steering committee), covering comorbidity assessment, therapy (medical, surgical and combinations) and response to treatment. Included articles underwent data extraction and were graded according to the Oxford Centre for Evidence-based Medicine criteria. Evidence-based recommendations were then drafted, refined and voted upon, using a modified Delphi process. Overall, 5310 articles were screened, 171 articles were analysed, and 65 were used to derive recommendations. These articles included six randomized controlled trials plus cohort studies and case series. The highest level of evidence concerned dosing recommendations for topical clindamycin in mild disease (with systemic tetracyclines for more frequent/widespread lesions) and biologic therapy (especially adalimumab) as second-line agents (following conventional therapy failure). Good-quality evidence was available for the hidradenitis suppurativa clinical response (HiSCR) as a dichotomous outcome measure in inflammatory areas under treatment. Lower-level evidence supported recommendations for topical triclosan and oral zinc in mild-to-moderate HS, systemic clindamycin and rifampicin in moderate HS and intravenous ertapenem in selected patients with more severe disease. Intralesional or systemic steroids may also be considered. Local surgical excision is suggested for mild-to-moderate HS, with wide excision for more extensive disease. Despite a paucity of good-quality data on management decisions in HS, this systematic review has enabled the development of robust and easily applicable clinical recommendations for international physicians based on graded evidence.
Treatment Outcomes of IL-17 Inhibitors in Hidradenitis Suppurativa: A Systematic Review. [2022]The IL-17 pathway is a potential therapeutic target shown to be implicated in hidradenitis suppurativa (HS), however, it remains unclear whether evidence from mechanistic studies may translate into clinical practice. This systematic review summarizes available treatment outcomes of IL-17 inhibitors in patients with HS. Embase, MEDLINE, PubMed, and clinicaltrials.gov were comprehensively searched on February 26, 2021 to include 16 original studies representing 128 patients with HS (mean age: 36.5 years; age range: 21-47 years; male: 50.0%). Treatment outcomes were reported for the following biologics: secukinumab (n = 105), brodalumab (n = 22), and ixekizumab (n = 1). Patients were classified as responders or non-responders according to achievement of a positive response/improvement based on criteria established for each included study. For secukinumab 57.1% (n = 60/105) of patients were responders in a mean response period of 16.2 weeks and 42.9% (n = 45/105) were non-responders; for brodalumab, 100.0% (n = 22/22) of patients were responders within 4.4 weeks; and the one patient treated with ixekizumab was a responder within 10 weeks. In conclusion, IL-17 inhibitors may serve as an effective therapeutic target in approximately two-thirds of patients with HS and can be considered in those who are refractory to other treatment modalities. We also stress the importance of consistent outcome measures to enhance evidence synthesis, decrease reporting bias, provide potential for future meta-analysis, and ultimately improve clinical outcomes for patients with HS.
Interventions for Hidradenitis Suppurativa: Updated Summary of an Original Cochrane Review. [2018]Which treatments have been shown to be effective in randomized clinical trials (RCTs) for hidradenitis suppurativa (HS) in adults?
New treatment strategies for hidradenitis suppurativa. [2018]Hidradenitis suppurativa (HS) is difficult to treat. Official guidelines have only recently been developed, and suggest that patients should be provided with both adjuvant, medical and surgical therapy. The guidelines are the result of resurgent interest in this disease, in which etiology and pathogenesis are only partially understood at present. Recent research has, however, identified possible targets for specific intervention using biologicals. In addition, classical clinically driven developments of new treatments continue to evolve, leading to several interesting new therapies for HS patients. In this article recent trends in medical treatments are described following a systematic review. Searches were conducted in MEDLINE(R), the Cochrane Library and Web of Science(TM) where specific treatments were combined with the search term 'hidradenitis suppurativa' and references from 2010 to March 2016 were included. A total of 365 papers were identified, 79 of which were retained for analysis following exclusions. The following treatments are discussed in detail: infliximab, adalimumab, ustekinumab, anakinra, alitretinoin, metformin and vitamin D. HS is a disease with a considerable morbidity and a great unmet need for treatment. A continued need for development of new treatments therefore exists for this otherwise often devastating disease.
Treatment of hidradenitis suppurativa with tumour necrosis factor-alpha inhibitors. [2018]Hidradenitis suppurativa (HS) is a common inflammatory skin disease. Medical treatment is often disappointing and in severe disease surgery remains the therapy of choice. Extensive surgery may be effective but also mutilating. Patients experience a significant reduction in quality of life and the need for new treatment modalities are urgent. In recent years patients with HS have been treated off-label with tumour necrosis factor-alpha (TNF-alpha) inhibitors with a varying degrees of effect. We performed a systematic review of papers retrieved from two databases (PubMed and Web of Science) using the follow-ing keywords: hidradenitis suppurativa, acne inversa, infliximab, etanercept, and adalimumab. A total of 34 publications were retrieved, describing treatment of 105 patients. Most cases report treatment with infliximab (52/105). A positive treatment outcome was reported in 90/105 cases, with only 7/105 non-responders and 8/105 patients experiencing side-effects. The side-effects were comparable to those seen in other TNF-alpha inhibitor studies. In the majority of cases the treatment was effective when given as a suppressive therapy, but 15/105 cases were described with long-term remission (>or= 3 months) after the end of therapy. In most publications follow-up was, however, insufficient to allow a systematic exploration of this. TNF-alpha inhibitors seem to be effective in the treatment of HS. However, several questions remain to be answered through specific studies. This review has also identified a need for more standardized reporting of the outcomes as well as randomized controlled trials in this disease.
Infliximab for the treatment of hidradenitis suppurativa. [2015]Hidradenitis suppurativa is a chronic inflammatory disease characterized by significant morbidity. Current medical therapies are usually only minimally effective.
Proceeding report of the Fourth Symposium on Hidradenitis Suppurativa Advances 2019. [2021]The Fourth Annual Symposium on Hidradenitis Suppurativa (SHSA) took place on November 1-3, 2019, at the Westin Book Cadillac Hotel in Detroit, Michigan. This symposium was a joint meeting of the US Hidradenitis Suppurativa Foundation and the Canadian Hidradenitis Suppurativa Foundation. This cross-disciplinary meeting with experts from around the world was an opportunity to discuss the most recent advances in the study of hidradenitis suppurativa (HS) pathogenesis, clinical trials, classification, scoring systems, complementary/alternative medical treatments, diet, pain management, surgical and laser treatment, and ultrasonographic assessment. A special preconference workshop was held on the use of neodymium-doped yttrium-aluminum-garnet laser hair reduction, sinus tract deroofing, and carbon dioxide laser excision with ultrasonographic mapping and tumescent anesthesia for the treatment of HS. The focused workshops on establishing an HS clinic, setting up an HS support group, the Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository, and wound care were held during the meeting. A special program called HS Ambassadors was established for patients who may have questions about the conference presentations, and in addition, a meet and greet for patients and HS Ambassadors was arranged. To facilitate networking between those early in their careers and clinical and research experts, a mentoring reception was held.
Major gaps in understanding and treatment of hidradenitis suppurativa. [2017]Hidradenitis suppurativa (HS) is a complex dermatological disease characterized by recurrent painful nodules and suppuration in areas such as the axilla and groin. The disease is poorly understood and treatment is not satisfactory. In October 2016, the Canadian and United States Hidradenitis Suppurativa Foundations organized the inaugural Symposium on Hidradenitis Suppurativa Advances (SHSA) in Toronto, Canada. This meeting brought together experts from Canada, the United States, and Europe to discuss the latest advances in HS. After this important event, we considered that it would be helpful to outline current HS knowledge and to identify important gaps in treatment and research in order to move forward more efficiently. This paper briefly summarizes current knowledge in key areas including epidemiology, clinical presentation and morphological classification, natural history and prognosis, genotype-phenotype correlations, clinico-pathological correlation, pathogenesis, optimal treatment and outcome measures. General and initial suggestions for addressing these gaps are presented.
Efficacy and tolerability of a lotion containing triethyl citrate, ethyl linoleate, and GT peptide-10 in the adjuvant treatment of hidradenitis suppurativa: Real-life data. [2019]Hidradenitis suppurativa (HS) is a chronic disorder of terminal follicular epithelium in the apocrine gland-bearing areas. The long term therapy is based mainly on topical and/or systemic antibiotic use that could result in antibiotic resistance. The aim of our study was to present the real-life experience based on the efficacy and tolerability of a novel lotion containing triethyl-citrate, ethyl-linoleate, and g-peptide-10 in the treatment of mild to moderate HS that has already shown effectiveness in acne treatment. This was an open-label study on 30 patients of both sexes affected by HS. Patients were divided into two groups: 15 with Hurley I and 15 with Hurley II-III. The subjects were treated with the topical lotion, three-times-daily for eight weeks, with control at 4 (T1 ) and eight weeks (T2 ). Any other concomitant treatment (both topical and/or systemic) was avoided during study period. Improvement was observed in both Sartorius score grading system and inflammatory and noninflammatory lesion counts. The novel lotion has proved to be effective and well-tolerated topical agent alone or in association with other topical and/or systemic tratments in HS, without side effects.