SAR444656 for Hidradenitis Suppurativa

(ZEN Trial)

Recruiting at 45 trial locations

Overseen By Trial Transparency email recommended (Toll free number for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must not be taking: Antibiotics, Antivirals, Antifungals, Antihelminthics

Disqualifiers: Active skin disease, Chronic infection, Malignancy, Cardiovascular events, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

Duration: up to 16 weeks

156 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

What 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. ^{3 6 7 8 9}

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

Eligibility 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.

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

Treatment Details

Interventions

• SAR444656

Trial Overview 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.

Participant Groups

Group I: SAR444656 dose 2 Experimental Treatment 1 Intervention

Participants will receive SAR444656 dose 2 orally

Group II: SAR444656 dose 1 Experimental Treatment 1 Intervention

Participants will receive SAR444656 dose 1 orally

Group III: Placebo Placebo Group 1 Intervention

Participants will receive placebo orally

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Kymera Therapeutics, Inc.

Industry Sponsor

Trials

8

Recruited

850+

Findings from Research

A systematic review of 5310 articles led to the analysis of 171 studies, resulting in evidence-based recommendations for managing hidradenitis suppurativa (HS), emphasizing the use of topical clindamycin for mild cases and biologic therapy like adalimumab for more severe cases after conventional treatments fail.

The review established that local surgical excision is recommended for mild-to-moderate HS, while more extensive disease may require wide excision, highlighting the need for tailored treatment approaches based on disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hidradenitis suppurativa/acne inversa: a practical framework for treatment optimization - systematic review and recommendations from the HS ALLIANCE working group. Zouboulis, CC., Bechara, FG., Dickinson-Blok, JL., et al.[2020]

IL-17 inhibitors, particularly secukinumab and brodalumab, show promising efficacy in treating hidradenitis suppurativa (HS), with response rates of 57.1% and 100% respectively among 128 patients studied.

These treatments can be effective for patients who do not respond to other therapies, highlighting the need for standardized outcome measures to improve future research and clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Outcomes of IL-17 Inhibitors in Hidradenitis Suppurativa: A Systematic Review. Kashetsky, N., Mufti, A., Alabdulrazzaq, S., et al.[2022]

Adalimumab administered weekly is effective for treating hidradenitis suppurativa (HS), showing a significant reduction in Dermatology Life Quality Index (DLQI) scores compared to placebo, with a difference of 2.8 points.

Infliximab also shows moderate-quality evidence of benefit for HS, but evidence for other treatments is less robust or lacking, making it difficult to draw further conclusions about their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for Hidradenitis Suppurativa: Updated Summary of an Original Cochrane Review. Ingram, JR.[2018]

Hidradenitis suppurativa (HS) is a challenging condition to treat, but recent guidelines recommend a combination of medical and surgical therapies, reflecting a growing understanding of the disease's complexity.

A systematic review of 365 papers identified 79 relevant studies, highlighting promising treatments such as infliximab, adalimumab, and ustekinumab, indicating a significant need for continued development of effective therapies for HS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New treatment strategies for hidradenitis suppurativa. Andersen, R., Jemec, GB.[2018]

A systematic review of 34 publications involving 105 patients with hidradenitis suppurativa (HS) found that TNF-alpha inhibitors, particularly infliximab, led to positive treatment outcomes in 90% of cases, indicating their potential efficacy in managing this challenging skin condition.

While side effects were reported in 8 out of 105 patients, they were similar to those seen in other studies with TNF-alpha inhibitors, suggesting a manageable safety profile; however, the need for more standardized reporting and randomized controlled trials is emphasized to better understand long-term effects and optimal treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of hidradenitis suppurativa with tumour necrosis factor-alpha inhibitors. Haslund, P., Lee, RA., Jemec, GB.[2018]

In a retrospective study of 6 patients with severe hidradenitis suppurativa, infliximab monotherapy led to significant improvements in symptoms, including reduced exudation and fewer lesions over a 6-month follow-up period.

The treatment was generally well tolerated, with only one mild infusion reaction reported, indicating a favorable safety profile for infliximab in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infliximab for the treatment of hidradenitis suppurativa. Fernández-Vozmediano, JM., Armario-Hita, JC.[2015]

The Fourth Annual Symposium on Hidradenitis Suppurativa brought together global experts to discuss recent advancements in understanding and treating hidradenitis suppurativa (HS), covering topics like clinical trials, pain management, and surgical options.

A special preconference workshop focused on innovative laser treatments for HS, highlighting the importance of advanced techniques like laser hair reduction and sinus tract deroofing in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proceeding report of the Fourth Symposium on Hidradenitis Suppurativa Advances 2019. Narla, S., Price, KN., Sachdeva, M., et al.[2021]

Hidradenitis suppurativa (HS) is a challenging skin condition marked by painful nodules and pus-filled lesions, primarily affecting areas like the armpits and groin, and current treatments are often inadequate.

The inaugural Symposium on Hidradenitis Suppurativa Advances highlighted the need for better understanding and research into HS, summarizing key areas such as its epidemiology, treatment options, and the importance of identifying gaps in knowledge to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Major gaps in understanding and treatment of hidradenitis suppurativa. Hoffman, LK., Ghias, MH., Garg, A., et al.[2017]

A novel lotion containing triethyl-citrate, ethyl-linoleate, and g-peptide-10 was tested on 30 patients with mild to moderate hidradenitis suppurativa (HS) for eight weeks, showing significant improvement in both the Sartorius score and lesion counts.

The lotion was found to be effective and well-tolerated, with no reported side effects, making it a promising alternative to traditional antibiotic treatments that can lead to resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Skroza, N., Mambrin, A., Tolino, E., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Hidradenitis suppurativa/acne inversa: a practical framework for treatment optimization - systematic review and recommendations from the HS ALLIANCE working group. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment Outcomes of IL-17 Inhibitors in Hidradenitis Suppurativa: A Systematic Review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Interventions for Hidradenitis Suppurativa: Updated Summary of an Original Cochrane Review. [2018]

4. Spain pubmed.ncbi.nlm.nih.gov

New treatment strategies for hidradenitis suppurativa. [2018]

5. Sweden pubmed.ncbi.nlm.nih.gov

Treatment of hidradenitis suppurativa with tumour necrosis factor-alpha inhibitors. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Infliximab for the treatment of hidradenitis suppurativa. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Proceeding report of the Fourth Symposium on Hidradenitis Suppurativa Advances 2019. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Major gaps in understanding and treatment of hidradenitis suppurativa. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

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]