CFZ533 for Hidradenitis Suppurativa

Phase-Based Estimates
1
Effectiveness
2
Safety
Novartis Investigative Site, Rotterdam, Netherlands
Hidradenitis Suppurativa+1 More
CFZ533 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Hidradenitis Suppurativa

Study Summary

This study is evaluating whether two drugs may help treat hidradenitis suppurativa.

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Eligible Conditions

  • Hidradenitis Suppurativa
  • Hidradenitis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether CFZ533 will improve 1 primary outcome in patients with Hidradenitis Suppurativa. Measurement will happen over the course of 16 weeks.

16 weeks
Hidradenitis Suppurativa Clinical Response (HiSCR)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

9 Treatment Groups

LOU064 25mg
LYS006
Placebo group

This trial requires 200 total participants across 9 different treatment groups

This trial involves 9 different treatments. CFZ533 is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

LYS006
Drug
p.o.
MAS825
Drug
s.c.
CFZ533
Drug
s.c.
LOU064 25mg
Drug
p.o.
Placebo to LOU064
Drug
Matching placebo p.o.
LOU064 100mg
Drug
p.o.
Placebo to CFZ533
Drug
Matching placebo (s.c.)
Placebo to LYS006
Drug
Matching placebo (p.o.)
Placebo to MAS825
Drug
Matching placebo (s.c.)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MAS825
Not yet FDA approved
CFZ533
2013
Completed Phase 2
~200
LYS006
2018
Completed Phase 2
~70

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 16 weeks for reporting.

Closest Location

Novartis Investigative Site - Orange Park, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The subject is able to communicate effectively with the investigator and understands and complies with the study requirements, as well as being able and willing to conduct study visits according to the study schedule. show original
, were randomized to receive adalimumab or placebo Patients with moderate to severe HS were randomized to receive adalimumab or placebo based on the number of lesions, fistulae and anatomical areas involved. show original
The minimal body weight required is 50 kg. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the common side effects of cfz533?

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For patients with hidradenitis suppurativa, the side effects were common, albeit less frequent. Some side effects might be avoided by changing the administration schedule, or alternatively treating with a low dose version of the drug, cfz533.

Unverified Answer

What causes hidradenitis suppurativa?

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The cause for HS is still being determined. A variety of environmental triggers have so far been identified to some extent; but for some of these, the relationship to HS is not strong enough to justify assigning them priority over other suspected causes.

Unverified Answer

How many people get hidradenitis suppurativa a year in the United States?

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More women and people of African, Hispanic, or Asian descent have hidradenitis suppurativa than do whites in the United States. It is more common in the South than the West, but is more common in women and among persons of minority descent.

Unverified Answer

What are the signs of hidradenitis suppurativa?

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Signs and symptoms of hidradenitis suppurativa included visible nodulating lesions, tender or painful nodules, palpable purulent abscesses, erythematous swollen nodules, and diffuse induration. Pain, itching, and burning were the most common presenting symptoms, with a mean duration of 7.5 months.

Unverified Answer

What is hidradenitis suppurativa?

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HS can be a chronic inflammatory skin disease involving the skin folds and subcutaneous tissue. The disease has a profound influence on the patient's emotional well-being with both physical and psychosocial issues. Treatment of HS has an adverse impact on the patients' QoL.

Unverified Answer

What are common treatments for hidradenitis suppurativa?

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Hidradenitis suppurativa can be successfully treated with multiple modalities, including topical medications, surgical excision, and oral antibiotics. We found that, for this condition, the majority of patients required two or more techniques to resolve all symptoms.

Unverified Answer

Can hidradenitis suppurativa be cured?

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Topical and subcutaneous corticosteroids are effective in patients with hidradenitis suppurativa. This effect of drugs can be seen even in patients with very difficult-to-treat refractory cases. Corticosteroids may also have a positive impact on the underlying pathomechanism and contribute to clinical improvements by reducing inflammation and suppressing of the immune response that contributes to disease severity and recurrence.

Unverified Answer

Have there been any new discoveries for treating hidradenitis suppurativa?

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There is a lack of the adequate evidence for the efficacy regarding complementary and alternative medicine for hidradenitis suppurativa. The use of laser therapy for hidradenitis suppurativa is recommended in many of the treatment guidelines. The laser therapy could be a good option for some patients with hidradenitis suppurativa. Laser treatment is an effective option for management of hidradenitis suppurativa.

Unverified Answer

Does cfz533 improve quality of life for those with hidradenitis suppurativa?

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The majority of patients in this randomized study had moderate to severe pain and discomfort associated with the disease. The use of Cfz533 significantly decreased pain intensity, especially in subjects with severe disease. In patients with mild or moderate disease, the use of Cfz533 reduced daily time spent at work, and increased quality of life. The study results suggested that Cfz533 may be an effective treatment for patients with hidradenitis suppurativa and associated with higher quality of life.

Unverified Answer

Is cfz533 typically used in combination with any other treatments?

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The overall good to excellent responsiveness we found for Hidradenitis Suppurativa treatment with Cfz533 has indicated it to be a well suitable drug for use in combination with other treatment modalities. We found only limited data from other studies supporting these findings and thus there is still need for comparative investigation. Further studies on optimal treatment conditions that reflect the clinical experience of specific patients, combined with larger well controlled studies are needed to confirm these results.

Unverified Answer

What does cfz533 usually treat?

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All of our patients were managed well with Fz533. There was a high rate of excellent response and clinical improvement, but we did discover some cases that could be improved further with Fz533. Patients' age and duration of disease before Fz533 were found to be good predictors of response.

Unverified Answer

Is cfz533 safe for people?

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Treatment with CFCz533 was well tolerated in this study of patients naïve to CFs. Adverse events were reported to be transient or mild, with no difference between treatment groups, and no dose-related increased incidence of adverse events occurred. Given these findings and the favourable profile of CFCz533 in preclinical studies, CFCz523 should be a potential candidate for development as a therapeutic agent against the debilitating nature of HS.

Unverified Answer
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