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Immunomodulator

Investigational Treatments for Hidradenitis Suppurativa

Phase 2
Waitlist Available
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

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
simplified Hidradenitis Suppurativa Clinical Response (sHiSCR)

Side effects data

From 2017 Phase 1 & 2 trial • 59 Patients • NCT02217410
41%
Constipation
38%
Leukopenia
38%
Hypertension
32%
Wound complication
32%
Hypophosphataemia
32%
Insomnia
29%
BK virus infection
29%
Nausea
29%
Nasopharyngitis
29%
Cough
26%
Hyperkalaemia
24%
Diarrhoea
24%
Vomiting
24%
Urinary tract infection
21%
Oedema peripheral
18%
Cytomegalovirus infection
18%
Incision site pain
18%
Hypokalaemia
18%
Muscle spasms
18%
Headache
15%
Abdominal pain upper
15%
Fatigue
15%
Postoperative wound complication
15%
Back pain
15%
Polyuria
15%
Kidney transplant rejection
12%
Polyomavirus-associated nephropathy
12%
Tachycardia
12%
Bronchitis
12%
Decreased appetite
12%
Hyperglycaemia
12%
Hyperuricaemia
12%
Hypocalcaemia
12%
Myalgia
9%
Anaemia
9%
Leukocytosis
9%
Abdominal pain
9%
Chills
9%
Complications of transplanted kidney
9%
Delayed graft function
9%
Procedural pain
9%
Amylase increased
9%
Blood creatinine increased
9%
White blood cell count increased
9%
Diabetes mellitus
9%
Hyponatraemia
9%
Tremor
9%
Bladder spasm
9%
Oropharyngeal pain
9%
Hyperhidrosis
9%
Groin pain
6%
Alopecia
6%
Gastroenteritis
6%
Retroperitoneal haematoma
6%
Pyelonephritis
6%
Lymphopenia
6%
Arrhythmia
6%
Atrial fibrillation
6%
Impaired healing
6%
Herpes zoster
6%
Influenza
6%
Pneumonia
6%
Respiratory tract infection
6%
Upper respiratory tract infection
6%
Transplant dysfunction
6%
Gamma-glutamyltransferase increased
6%
Lipase increased
6%
Weight increased
6%
Hypercalcaemia
6%
Hyperlipidaemia
6%
Vitamin D deficiency
6%
Arthralgia
6%
Pain in extremity
6%
Dizziness
6%
Perinephric collection
6%
Proteinuria
6%
Dyspnoea
6%
Dermatitis
6%
Night sweats
6%
Haematoma
6%
Hot flush
6%
Hypotension
6%
Poor venous access
6%
Human polyomavirus infection
6%
Transplant rejection
3%
Inguinal hernia
3%
Nasal congestion
3%
Vertigo
3%
Hyperparathyroidism
3%
Sinusitis
3%
Skin infection
3%
Muscular weakness
3%
Mental status changes
3%
Soft tissue infection
3%
Ligament sprain
3%
Paraesthesia oral
3%
Decubitus ulcer
3%
Hepatitis C
3%
Joint injury
3%
Menorrhagia
3%
Migraine
3%
Increased appetite
3%
Dry eye
3%
Prostatomegaly
3%
Acute kidney injury
3%
Diarrhoea haemorrhagic
3%
Gastrointestinal inflammation
3%
Pneumocystis jirovecii pneumonia
3%
Renal cyst infection
3%
Transplant failure
3%
Dehydration
3%
Squamous cell carcinoma
3%
Renal tubular necrosis
3%
Pneumothorax
3%
Hypertensive crisis
3%
Iron deficiency anaemia
3%
Microcytic anaemia
3%
Nephrogenic anaemia
3%
Neutropenia
3%
Thrombocytosis
3%
Angina pectoris
3%
Bradycardia
3%
Extrasystoles
3%
Myocardial infarction
3%
Palpitations
3%
Sinus tachycardia
3%
Ear discomfort
3%
Chalazion
3%
Ocular hyperaemia
3%
Retinal vein occlusion
3%
Abdominal discomfort
3%
Abdominal pain lower
3%
Aphthous ulcer
3%
Colitis
3%
Duodenogastric reflux
3%
Dyspepsia
3%
Flatulence
3%
Gastritis
3%
Haemorrhoids
3%
Cyst
3%
Infusion site swelling
3%
Pyrexia
3%
Swelling
3%
Hepatitis
3%
Acute sinusitis
3%
Cytomegalovirus viraemia
3%
Diarrhoea infectious
3%
Folliculitis
3%
Gastroenteritis Escherichia coli
3%
Gastrointestinal infection
3%
Oral candidiasis
3%
Oral herpes
3%
Oral infection
3%
Pharyngitis streptococcal
3%
Pyuria
3%
Subcutaneous abscess
3%
Tracheobronchitis
3%
Viral infection
3%
Wound infection bacterial
3%
Animal bite
3%
Arterial injury
3%
Fall
3%
Graft complication
3%
Incision site complication
3%
Lip injury
3%
Post procedural complication
3%
Post procedural haemorrhage
3%
Wound dehiscence
3%
Wound haematoma
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Blood creatine phosphokinase increased
3%
Blood glucose increased
3%
Blood phosphorus increased
3%
Electrocardiogram T wave abnormal
3%
Heart rate irregular
3%
Polyomavirus test positive
3%
Weight decreased
3%
White blood cell count decreased
3%
Dyslipidaemia
3%
Fluid overload
3%
Hypercholesterolaemia
3%
Hypertriglyceridaemia
3%
Metabolic acidosis
3%
Bursitis
3%
Joint effusion
3%
Musculoskeletal discomfort
3%
Neck pain
3%
Osteochondrosis
3%
Pain in jaw
3%
Basal cell carcinoma
3%
Ataxia
3%
Polyneuropathy
3%
Anxiety
3%
Delirium
3%
Mood swings
3%
Dysuria
3%
Haematuria
3%
Leukocyturia
3%
Nocturia
3%
Tubulointerstitial nephritis
3%
Urethral pain
3%
Urinary incontinence
3%
Urinary tract disorder
3%
Erectile dysfunction
3%
Scrotal swelling
3%
Vulvovaginal pain
3%
Dyspnoea exertional
3%
Lung infiltration
3%
Pleural effusion
3%
Productive cough
3%
Respiratory distress
3%
Rhinorrhoea
3%
Lipohypertrophy
3%
Pruritus
3%
Skin lesion
3%
Urticaria
3%
Lymphocele
3%
Infection
3%
Laryngitis
3%
Bacteraemia
3%
Enterobacter bacteraemia
3%
Otitis media
3%
Mouth ulceration
3%
Magnesium deficiency
3%
Arthropod bite
3%
Cytomegalovirus test positive
3%
Haemoglobin decreased
3%
Flank pain
3%
Burning sensation
3%
Penile oedema
100%
80%
60%
40%
20%
0%
Study treatment Arm
CFZ533 + MMF (Part 2)
Total
CFZ533 + TAC + MMF (Part 1)
Tac + MMF (Part 2)

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 3
~790
CFZ533
2019
Completed Phase 2
~570
MAS825
2019
Completed Phase 3
~230

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,911 Previous Clinical Trials
4,250,429 Total Patients Enrolled
8 Trials studying Hidradenitis Suppurativa
2,933 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
~0 spots leftby Dec 2024
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