Investigational Treatments for Hidradenitis Suppurativa

Not currently recruiting at 49 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new treatments for hidradenitis suppurativa, a skin condition that causes painful lumps and swelling. Researchers aim to determine if the treatments—CFZ533, LYS006, MAS825, LOU064 (Remibrutinib), and VAY736—are effective and safe for individuals with moderate to severe cases. Participants will be divided into groups to try these treatments, while some will receive a placebo (a harmless pill or injection with no active drug). Ideal candidates are those experiencing moderate to severe hidradenitis suppurativa, with noticeable lumps and sore areas on their skin. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LYS006 is generally safe for people, even at higher doses. Previous studies reported no serious side effects or harmful effects that required dose reduction.

Studies have confirmed that LOU064 is safe and well-tolerated. Most patients did not experience severe side effects, and the treatment was generally safe.

A different trial stopped the study of CFZ533, suggesting concerns, but specific safety details are not provided.

MAS825 has been found to be safe and well-tolerated, with most side effects being mild to moderate, indicating they were not serious and did not pose major health risks.

Overall, these treatments have demonstrated a good safety record in studies for other conditions, but individual reactions may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these investigational treatments for Hidradenitis Suppurativa because they offer novel approaches compared to current options like antibiotics, biologics, and surgical interventions. CFZ533, for instance, is unique because it targets a pathway in the immune system that is not typically addressed by standard treatments, potentially reducing inflammation in a new way. LYS006 is administered orally and works by inhibiting specific enzymes involved in inflammation, providing a convenient alternative to injectable treatments. MAS825 also offers a fresh mechanism by targeting cytokines involved in the inflammatory process. LOU064, available in different dosages, acts as an active comparator, potentially offering flexibility in treatment. These innovations could lead to more effective and convenient options for managing this challenging condition.

What evidence suggests that this trial's treatments could be effective for hidradenitis suppurativa?

Research has shown that several new treatments for hidradenitis suppurativa (HS) look promising. In this trial, participants may receive CFZ533, which significantly reduced symptoms in over 60% of patients in previous studies. Another treatment option is LOU064 (remibrutinib), which proved effective for nearly 73% of patients in different research. LYS006, also being tested, was found to be safe and well-tolerated, with about 60% of patients experiencing a noticeable decrease in symptoms in past studies. However, MAS825 was less effective in previous research, with only 34% of patients experiencing clear symptom relief. Overall, these treatments offer varying levels of potential effectiveness for managing moderate to severe HS. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

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

I weigh at least 50 kg.

Exclusion Criteria

Other protocol-defined inclusion/exclusion criteria may apply

Pregnant or lactating women

I am using reliable birth control methods.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10307738/

The Current Clinical Trial Landscape for Hidradenitis ... One of the secondary outcomes was HiSCR, and 63% of patients in group A and 61% of patients in group B achieved HiSCR at week 12. Possible ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03827798

NCT03827798 | Study of Efficacy and Safety of ... 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 ...

3. withpower.com withpower.com/trial/phase-3-hidradenitis-suppurativa-1-2019-8a2cc

Investigational Treatments for Hidradenitis Suppurativa 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0001731023003551

Narrative Review and Update on Biologic and Small ... In a placebo-controlled clinical trial, at week 12, a >50% decrease in disease activity score was used as the primary end-point, which was achieved by 78% of ...

5. clinicaltrial.be clinicaltrial.be/en/details/65365?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Study of Efficacy and Safety of Investigational Treatment... The main purpose of this study is to assess preliminary efficacy and safety of CFZ533, LYS006, MAS825 , LOU064 and VAY736 in patients with ...

6. ctv.veeva.com ctv.veeva.com/study/study-of-efficacy-and-safety-of-investigational-treatments-in-patients-with-moderate-to-severe-hidra

Study of Efficacy and Safety of Investigational Treatments in ... 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 ...

7. novartis.com novartis.com/news/novartis-announces-discontinuation-cirrus-1-study-cfz533-iscalimab-kidney-transplant-patients

Novartis announces discontinuation of CIRRUS-1 study of ... Novartis today announced that following an interim analysis of data from the CIRRUS-1 study, a decision has been taken to discontinue the trial.

8. trial.medpath.com trial.medpath.com/drug/54862d6eca7fcc59/iscalimab

Iscalimab | MedPath Iscalimab is under investigation in clinical trial NCT03905525 (Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of ...