248 Participants Needed

Investigational Treatments for Hidradenitis Suppurativa

Recruiting at 47 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Novartis Pharmaceuticals
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What evidence supports the effectiveness of the drugs CFZ533, LOU064, Remibrutinib, LOU-064, LOU064-NXA, NVP-LOU064-NXA, LYS006, MAS825 for treating hidradenitis suppurativa?

Research suggests that drugs targeting the IL-17 pathway, like secukinumab and brodalumab, have shown effectiveness in treating hidradenitis suppurativa, with a significant number of patients responding positively. This indicates that treatments affecting similar pathways may also be promising for this condition.12345

What is the purpose of this trial?

The main purpose of this study is to assess preliminary efficacy and safety of CFZ533, LYS006, MAS825 , LOU064 and VAY736 in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533, LYS006, MAS825, LOU064 and VAY736 have an adequate clinical profile for further clinical development.

Eligibility Criteria

This trial is for individuals over 50 kg with moderate to severe Hidradenitis Suppurativa. Participants must be able to follow the study's procedures and visit schedule. Pregnant or breastfeeding women, or those who can become pregnant and are not using effective contraception, cannot join.

Inclusion Criteria

I have moderate to severe HS with many lesions or fistulae.
I weigh at least 50 kg.
Able to communicate well with the investigator and understand and comply with the requirements of the study, and the ability and willingness to conduct study visits as per the study schedule

Exclusion Criteria

Other protocol-defined inclusion/exclusion criteria may apply
Pregnant or lactating women
I am using reliable birth control methods.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive investigational drugs or placebo for 16 weeks to assess efficacy and safety

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • CFZ533
  • LOU064
  • LYS006
  • MAS825
Trial Overview The trial is testing the effectiveness and safety of several potential treatments: CFZ533, LYS006, MAS825, LOU064 (in two doses), and VAY736 against placebos. The goal is to see if these drugs should be developed further for treating Hidradenitis Suppurativa.
Participant Groups
11Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: VAY736Experimental Treatment1 Intervention
s.c.
Group II: MAS825Experimental Treatment1 Intervention
s.c.
Group III: LYS006Experimental Treatment1 Intervention
p.o.
Group IV: CFZ533Experimental Treatment1 Intervention
s.c.
Group V: LOU064 100mgActive Control1 Intervention
p.o.
Group VI: LOU064 25mgActive Control1 Intervention
p.o.
Group VII: Placebo to MAS825Placebo Group1 Intervention
Matching placebo (s.c.)
Group VIII: Placebo to VAY736Placebo Group1 Intervention
Matching placebo (s.c.)
Group IX: Placebo to LYS006Placebo Group1 Intervention
Matching placebo (p.o.)
Group X: Placebo to LOU064Placebo Group1 Intervention
Matching placebo p.o.
Group XI: Placebo to CFZ533Placebo Group1 Intervention
Matching placebo (s.c.)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Findings from Research

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.
Treatment Outcomes of IL-17 Inhibitors in Hidradenitis Suppurativa: A Systematic Review.Kashetsky, N., Mufti, A., Alabdulrazzaq, S., et al.[2022]
A study using whole transcriptome profiling identified key regulatory pathways involved in hidradenitis suppurativa (HS), including glucocorticoid receptor and IL17A signaling, which may drive the disease's mechanisms.
Sixteen specific genes were found to characterize HS at a molecular level, and proteins associated with immune response were strongly expressed in affected skin areas, suggesting that HS involves significant immune-related processes affecting skin health.
Alterations in innate immunity and epithelial cell differentiation are the molecular pillars of hidradenitis suppurativa.Zouboulis, CC., Nogueira da Costa, A., Makrantonaki, E., et al.[2021]
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.
Treatment of hidradenitis suppurativa with tumour necrosis factor-alpha inhibitors.Haslund, P., Lee, RA., Jemec, GB.[2018]

References

Treatment Outcomes of IL-17 Inhibitors in Hidradenitis Suppurativa: A Systematic Review. [2022]
Alterations in innate immunity and epithelial cell differentiation are the molecular pillars of hidradenitis suppurativa. [2021]
Treatment of hidradenitis suppurativa with tumour necrosis factor-alpha inhibitors. [2018]
Hidradenitis suppurativa: New insights into disease mechanisms and an evolving treatment landscape. [2023]
Hidradenitis suppurativa/acne inversa: a practical framework for treatment optimization - systematic review and recommendations from the HS ALLIANCE working group. [2020]
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