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Immunomodulator

Investigational Treatments for Hidradenitis Suppurativa

Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with moderate to severe HS based on the number of lesions, fistulae and anatomical areas involved
Minimal body weight of 50 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study Summary

This trial is testing four different drugs to see if they are safe and effective for treating hidradenitis suppurativa, a chronic skin condition.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, skin irritation at injection sites, fatigue, gastrointestinal issues like nausea or diarrhea, headaches, and possible allergic reactions. Specific side effects will vary by drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have moderate to severe HS with many lesions or fistulae.
Select...
I weigh at least 50 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hidradenitis Suppurativa Clinical Response (HiSCR)

Side effects data

From 2017 Phase 1 & 2 trial • 59 Patients • NCT02217410
56%
Diarrhoea
50%
Nausea
44%
Wound complication
44%
Constipation
39%
Urinary tract infection
33%
Hypertension
33%
Procedural pain
33%
BK virus infection
33%
Oedema peripheral
33%
Tremor
28%
Hyperkalaemia
28%
Hypokalaemia
28%
Insomnia
28%
Fatigue
28%
Hypophosphataemia
22%
Vomiting
22%
Hyperglycaemia
22%
Nasopharyngitis
22%
Headache
22%
Anaemia
17%
Delayed graft function
17%
Transplant dysfunction
17%
Rash
17%
Hypotension
17%
Hypomagnesaemia
17%
Diabetes mellitus
17%
Dizziness
17%
Leukopenia
17%
Pyelonephritis
17%
Abdominal pain
17%
Dyspnoea
11%
Leukocytosis
11%
Catheter site pain
11%
Complications of transplanted kidney
11%
Cytomegalovirus infection
11%
Graft loss
11%
Hypercholesterolaemia
11%
Metabolic acidosis
11%
Haematuria
11%
Urinary incontinence
11%
Pruritus
11%
Pain in extremity
11%
Cough
11%
Incision site pain
11%
Renal tubular necrosis
11%
Alopecia
11%
Stomatitis
11%
Dysmenorrhoea
11%
Gingival swelling
11%
Haemorrhoids
11%
Neutropenia
11%
Flatulence
11%
Fungal skin infection
11%
Hypervolaemia
11%
Renal impairment
11%
Urosepsis
6%
Tongue discomfort
6%
Hyperuricaemia
6%
Dizziness postural
6%
Peroneal nerve palsy
6%
Decreased appetite
6%
Skin infection
6%
Incision site haemorrhage
6%
Hypercalcaemia
6%
Thrombocytopenia
6%
Acute kidney injury
6%
Hepatic function abnormal
6%
Drug hypersensitivity
6%
Pelvic venous thrombosis
6%
Iron deficiency anaemia
6%
Atrial fibrillation
6%
Arteriovenous fistula aneurysm
6%
Incisional hernia
6%
Gastrointestinal infection
6%
Impaired healing
6%
Polyomavirus-associated nephropathy
6%
Urinary tract infection viral
6%
Postoperative wound complication
6%
Amylase increased
6%
Hypocalcaemia
6%
Wound haematoma
6%
Asthenia
6%
Blood creatinine increased
6%
Graft complication
6%
Blood lactate dehydrogenase increased
6%
Urinary retention
6%
Paraesthesia
6%
Dysphagia
6%
Sleep apnoea syndrome
6%
Seroma
6%
Penile pain
6%
Proteinuria
6%
Rhinitis
6%
Latent tuberculosis
6%
Lung infection
6%
Mucocutaneous candidiasis
6%
Gamma-glutamyltransferase increased
6%
Vitamin D decreased
6%
Folate deficiency
6%
Weight increased
6%
Fluid overload
6%
Pityriasis
6%
Vitamin D deficiency
6%
Hypercreatinaemia
6%
Pancytopenia
6%
Gingival pain
6%
Pyrexia
6%
Kidney transplant rejection
6%
Hepatomegaly
6%
Epstein-Barr virus infection
6%
Lymphocele
6%
Incision site complication
6%
Deep vein thrombosis
6%
Hyperlipidaemia
6%
Back pain
6%
Muscle spasms
6%
Muscle twitching
6%
Hypoaesthesia
6%
Leukocyturia
6%
Restlessness
6%
Angina pectoris
6%
Basosquamous carcinoma
6%
Normocytic anaemia
6%
Tricuspid valve incompetence
6%
Peripheral swelling
6%
Conjunctivitis
6%
Gastroenteritis norovirus
6%
Gastroenteritis viral
6%
Bladder pain
6%
Perinephric oedema
6%
Urinary tract obstruction
6%
Benign prostatic hyperplasia
6%
Hydrocele
6%
Gastric polyps
6%
Tachycardia
6%
Tinea versicolour
6%
Blood creatine phosphokinase increased
6%
Encephalitis
6%
Polycythaemia
6%
Arrhythmia
6%
Hyperparathyroidism secondary
6%
Abdominal discomfort
6%
Abdominal pain lower
6%
Anal fissure
6%
Dyspepsia
6%
Gastritis haemorrhagic
6%
Gingival recession
6%
Odynophagia
6%
Oesophagitis
6%
Malaise
6%
Pyuria
6%
Tooth infection
6%
Hyponatraemia
6%
Chronic kidney disease
6%
Renal tubular acidosis
6%
Renal tubular injury
6%
Sterile pyuria
6%
Night sweats
6%
Ileus
6%
Infection
6%
Influenza
6%
Incarcerated incisional hernia
6%
Arteriovenous fistula site complication
6%
Post procedural swelling
6%
C-reactive protein increased
6%
Drug level decreased
6%
Hyperphosphataemia
6%
Groin pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tac + MMF (Part 2)
CFZ533 + TAC + MMF (Part 1)
CFZ533 + MMF (Part 2)
Total

Trial Design

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.)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VAY736
2014
Completed Phase 2
~290
CFZ533
2013
Completed Phase 2
~660
MAS825
2019
Completed Phase 3
~230

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,858 Previous Clinical Trials
4,197,598 Total Patients Enrolled
6 Trials studying Hidradenitis Suppurativa
2,459 Patients Enrolled for Hidradenitis Suppurativa

Media Library

CFZ533 (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT03827798 — Phase 2
Hidradenitis Suppurativa Research Study Groups: LYS006, VAY736, Placebo to MAS825, Placebo to VAY736, Placebo to LYS006, MAS825, LOU064 100mg, Placebo to LOU064, LOU064 25mg, CFZ533, Placebo to CFZ533
Hidradenitis Suppurativa Clinical Trial 2023: CFZ533 Highlights & Side Effects. Trial Name: NCT03827798 — Phase 2
CFZ533 (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03827798 — Phase 2

Frequently Asked Questions

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

How many medical settings are currently offering this research trial?

"The research project is currently enrolling patients in 7 places, including Indianapolis, Boston and Hershey. Participants should consider a medical site nearby to reduce travel requirements if they become involved."

Answered by AI

What deleterious effects has CFZ533 been known to cause in patients?

"The safety of CFZ533 has been partially supported, earning it a rating of 2. This is because no efficacy data exists for this Phase 2 trial."

Answered by AI

Could you provide me with information about the prior investigations involving CFZ533?

"In 2019, research on CFZ533 was initiated at the Novartis Investigative Site. Subsequently, 8 trials have been entirely completed and 2 more are currently recruiting participants in Indianapolis, Indiana."

Answered by AI

Who is qualified to enroll in this research trial?

"For this research trial, 200 people between the ages of 18 and 65 who have hidradenitis suppurativa will be admitted. In addition to these requirements, successful participants must demonstrate fluency with the investigator , observe all necessary study protocols and visits, display moderate-severe symptoms based on lesion count and area affected, as well as a body weight no less than 50 kgs."

Answered by AI

Are there current opportunities for enrollment in this investigation?

"Affirmative. As shown on clinicaltrials.gov, this experiment is actively searching for participants and was initially listed in February 2019 with the last update occuring November 2022. 200 people are needed to be recruited from 7 separate medical centres."

Answered by AI

How many participants has this clinical experiment recruited?

"Affirmative. Clinicaltrials.gov records divulge that this clinical trial is in the process of recruiting 200 participants from seven sites, first posted on February 27th 2019 and last edited on November 23rd 2022."

Answered by AI

Does the criterion for this clinical experiment include those below forty years of age?

"This research is seeking out volunteers aged 18 and older, though no older than 65."

Answered by AI

Is this trial the inaugural instance of its kind?

"Currently, there are two ongoing research projects exploring the effects of CFZ533. Across fifteen countries and 23 cities, these studies attempt to build on Novartis' earlier work in 2019 when 200 participants were enrolled for their Phase 2 trial. Since then, eight more assessments have been completed with promising results."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
South Carolina
How old are they?
18 - 65
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa
2019. "Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03827798.
All > Hidradenitis Suppurativa
~78 spots leftby Oct 2026
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