Investigational Treatments for Hidradenitis Suppurativa

Recruiting at 47 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must not be taking: Investigational drugs

Disqualifiers: Pregnancy, Lactation, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

248 Participants Needed

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. ^{1 2 3 4 5}

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.

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

Group I: VAY736 Experimental Treatment 1 Intervention

s.c.

Group II: MAS825 Experimental Treatment 1 Intervention

s.c.

Group III: LYS006 Experimental Treatment 1 Intervention

p.o.

Group IV: CFZ533 Experimental Treatment 1 Intervention

s.c.

Group V: LOU064 100mg Active Control 1 Intervention

p.o.

Group VI: LOU064 25mg Active Control 1 Intervention

p.o.

Group VII: Placebo to MAS825 Placebo Group 1 Intervention

Matching placebo (s.c.)

Group VIII: Placebo to VAY736 Placebo Group 1 Intervention

Matching placebo (s.c.)

Group IX: Placebo to LYS006 Placebo Group 1 Intervention

Matching placebo (p.o.)

Group X: Placebo to LOU064 Placebo Group 1 Intervention

Matching placebo p.o.

Group XI: Placebo to CFZ533 Placebo Group 1 Intervention

Matching placebo (s.c.)

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

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

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.

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Hidradenitis suppurativa (HS) is a chronic inflammatory disease affecting 1-2% of the population, characterized by painful nodules and abscesses, primarily in areas like the armpits and groin, leading to significant tissue damage over time.

Currently, adalimumab is the only FDA-approved biologic for HS, showing a clinical response in about 50% of patients, while new treatments targeting IL-17 and JAK/STAT pathways are being explored in clinical trials, highlighting the urgent need for better diagnostic and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hidradenitis suppurativa: New insights into disease mechanisms and an evolving treatment landscape. Krueger, JG., Frew, J., Jemec, GBE., et al.[2023]

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]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

Alterations in innate immunity and epithelial cell differentiation are the molecular pillars of hidradenitis suppurativa. [2021]

3. Sweden pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Hidradenitis suppurativa: New insights into disease mechanisms and an evolving treatment landscape. [2023]

5. 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]