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Monoclonal Antibodies

Secukinumab for Hidradenitis Suppurativa

Phase 3
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
Subject must have completed the study treatment period (52 weeks) in the core studies (AIN457M2301 or AIN457M2302) and have been receiving secukinumab treatment during Treatment Period 2
subject must have completed the study treatment period (52 weeks) in the core studies (AIN457M2301 or AIN457M2302)and have been receiving secukinumab treatment during Treatment Period 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 52 - 268
Awards & highlights

Study Summary

This trial is to study the long-term safety, tolerability, and efficacy of secukinumab in people with hidradenitis suppurativa who completed one of two Phase III studies.

Who is the study for?
This trial is for people with moderate to severe hidradenitis suppurativa who have already completed a year of treatment in previous core studies. Participants must have been on secukinumab during the latter part of those studies and be able to give written consent. Those with protocol deviations, using prohibited treatments, or having severe diseases that pose safety risks cannot join.Check my eligibility
What is being tested?
The study tests the long-term effects of continuous versus interrupted doses of secukinumab over two years. It aims to see if stopping and restarting treatment affects how well patients maintain their response compared to taking it non-stop.See study design
What are the potential side effects?
Secukinumab may cause side effects such as infections, allergic reactions, inflammation in various parts of the body, headache, diarrhea, and upper respiratory tract infection. Long-term use will help understand the full range of potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I completed a 52-week study and received secukinumab during its second phase.
Select...
I completed a 52-week study and received secukinumab during its second phase.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 52 - 268
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 52 - 268 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to loss of response (LOR) in HiSCR reponders
Secondary outcome measures
Number of Participants with Treatment Emergent Adverse Events

Side effects data

From 2020 Phase 3 trial • 86 Patients • NCT03031782
31%
Nasopharyngitis
22%
Nausea
22%
Upper respiratory tract infection
20%
Diarrhoea
15%
Cough
14%
Arthralgia
14%
Headache
14%
Oropharyngeal pain
14%
Pyrexia
10%
Vomiting
10%
Pharyngitis
9%
Rhinitis
9%
Abdominal pain
8%
Tonsillitis
8%
Back pain
7%
Contusion
7%
Ligament sprain
7%
Pain in extremity
7%
Acne
6%
Aphthous ulcer
6%
Conjunctivitis
6%
Influenza
6%
Joint injury
6%
Abdominal pain upper
6%
Respiratory tract infection
5%
Dyspepsia
5%
Paronychia
5%
Neutropenia
5%
Impetigo
5%
Otitis media
5%
Arthropod bite
5%
Pruritus
5%
Psoriasis
5%
Rash
5%
Gastroenteritis
5%
Alanine aminotransferase increased
5%
Aspartate aminotransferase increased
3%
Vertigo
3%
Fatigue
3%
Ear pain
3%
Tracheitis
3%
Respiratory disorder
3%
Sinusitis
3%
Skin abrasion
3%
Musculoskeletal stiffness
3%
Eczema
3%
Skin papilloma
3%
Haematuria
3%
Alopecia
3%
Urticaria
3%
Oral herpes
3%
Radius fracture
3%
Injection site pain
3%
Gastrointestinal infection
3%
Pneumonia
3%
Transaminases increased
2%
Muscle contracture
2%
Ocular hyperaemia
2%
Leukopenia
2%
Iron deficiency anaemia
2%
Nonalcoholic fatty liver disease
2%
Constipation
2%
Uveitis
2%
Toothache
2%
Mouth ulceration
2%
Nail infection
2%
Injection site pruritus
2%
Bronchitis
2%
Viral upper respiratory tract infection
2%
Road traffic accident
2%
Fall
2%
Ligament rupture
2%
Tendonitis
2%
Neutrophil count decreased
2%
Decreased appetite
2%
Arthritis
2%
Myalgia
2%
Dermatitis contact
2%
Scrotal pain
2%
Dyspnoea
2%
Dermatitis
2%
Ingrowing nail
2%
Dry skin
2%
Urinary tract infection
2%
Viral infection
2%
Joint swelling
2%
Conjunctivitis allergic
2%
Peripheral swelling
2%
Folliculitis
2%
Respiratory tract infection viral
2%
Enthesopathy
2%
Dysmenorrhoea
2%
Asthma
2%
Rhinorrhoea
2%
Erythema
1%
Postoperative wound infection
1%
Cholesteatoma
1%
Food poisoning
1%
Juvenile psoriatic arthritis
1%
Acute sinusitis
1%
Anaemia
1%
Lymphopenia
1%
Ventricular extrasystoles
1%
Gilbert's syndrome
1%
Myopia
1%
Administration site reaction
1%
Non-cardiac chest pain
1%
Mite allergy
1%
Appendicitis
1%
Feeling hot
1%
Injection site reaction
1%
Lymph node pain
1%
Tendon injury
1%
Oral mucosal blistering
1%
Gastrointestinal viral infection
1%
Nail bed infection
1%
Blood uric acid increased
1%
Ear disorder
1%
Helminthic infection
1%
Splenomegaly
1%
Injection site erythema
1%
Sinus bradycardia
1%
Lower respiratory tract infection
1%
Tachycardia
1%
Abdominal injury
1%
Hydrocele
1%
Adenoidal hypertrophy
1%
Medical device pain
1%
Herpes zoster
1%
Hordeolum
1%
Pain
1%
Skin infection
1%
Tinea pedis
1%
Concussion
1%
Abdominal distension
1%
Salivary hypersecretion
1%
Injection related reaction
1%
Hypercholesterolaemia
1%
Hepatic enzyme increased
1%
Post-traumatic stress disorder
1%
Gingival injury
1%
Thermal burn
1%
Nerve compression
1%
Muscle strain
1%
Overdose
1%
Diffuse alopecia
1%
Lactose intolerance
1%
Otitis externa
1%
Pharyngotonsillitis
1%
Hand fracture
1%
Obesity
1%
Eosinophil count increased
1%
Joint stiffness
1%
Intentional self-injury
1%
Foot fracture
1%
Venomous sting
1%
Body temperature increased
1%
C-reactive protein increased
1%
Jaw disorder
1%
Muscle spasms
1%
Tremor
1%
Synovial cyst
1%
Anxiety
1%
Euphoric mood
1%
Platelet count increased
1%
Productive cough
1%
Intervertebral disc disorder
1%
Joint effusion
1%
Menstruation irregular
1%
Renal colic
1%
Blister
1%
Papilloma
1%
Haemoptysis
1%
Neck pain
1%
Distractibility
1%
Mental disorder
1%
Testicular pain
1%
Hyperhidrosis
1%
Skin erosion
1%
Visual field defect
1%
Depressed mood
1%
Proteinuria
1%
Dizziness
1%
Rhinitis allergic
1%
Osteochondrosis
1%
Epistaxis
1%
Sexual abuse
1%
Gynaecomastia
1%
Dyshidrotic eczema
1%
Cyanosis
1%
Acarodermatitis
1%
Seasonal allergy
1%
Adenoiditis
1%
Dysphagia
1%
Noninfective gingivitis
1%
Odynophagia
1%
Onychomycosis
1%
Pilonidal cyst
1%
Soft tissue infection
1%
Staphylococcal infection
1%
Vaginal infection
1%
Vulvovaginal mycotic infection
1%
Blood pressure systolic increased
1%
Blood triglycerides increased
1%
Liver function test increased
1%
Lymphocyte count decreased
1%
Pharyngeal erythema
1%
Skin plaque
1%
Hot flush
1%
Crohn's disease
1%
Eye haematoma
1%
Eye pain
1%
Functional gastrointestinal disorder
1%
Gastritis
1%
Gastrooesophageal reflux disease
1%
Lip disorder
1%
Malpositioned teeth
1%
Enterobiasis
1%
Oral viral infection
1%
Pulpitis dental
1%
Skin laceration
1%
Sunburn
1%
Blood alkaline phosphatase increased
1%
Blood calcium increased
1%
Blood creatinine increased
1%
Blood glucose increased
1%
Blood phosphorus increased
1%
Weight increased
1%
White blood cell count decreased
1%
White blood cells urine positive
1%
Groin pain
1%
Musculoskeletal chest pain
1%
Musculoskeletal pain
1%
Temporomandibular joint syndrome
1%
Epilepsy
1%
Varicocele
1%
Exfoliative rash
1%
Skin striae
100%
80%
60%
40%
20%
0%
Study treatment Arm
Total
Placebo in TP2
AIN457 in Entire Treatment Period

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: HiSCR non-respondersExperimental Treatment1 Intervention
non-responder at Week 52 in core trial treatment; secukinumab 300mg every 2 weeks
Group II: secukinumab 2 HiSCR ResponderActive Control1 Intervention
HiSCR responder at Week 52 in core trial, secukinumab 300mg every 4 weeks
Group III: secukinumab 1 HiSCR ResponderActive Control1 Intervention
HiSCR responder at Week 52 in core trial, secukinumab 300mg every 2 weeks
Group IV: placebo 2 HiSCR ResponderPlacebo Group1 Intervention
HiSCR responder at Week 52 in core trial, placebo to secukinumab 300 mg every 4 weeks
Group V: placebo 1 HiSCR ResponderPlacebo Group1 Intervention
HiSCR responder at Week 52 in core trial, placebo to secukinumab 300mg every 2 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
secukinumab
2017
Completed Phase 3
~2910

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,196,647 Total Patients Enrolled
6 Trials studying Hidradenitis Suppurativa
2,001 Patients Enrolled for Hidradenitis Suppurativa

Media Library

Secukinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04179175 — Phase 3
Hidradenitis Suppurativa Research Study Groups: secukinumab 2 HiSCR Responder, secukinumab 1 HiSCR Responder, placebo 2 HiSCR Responder, HiSCR non-responders, placebo 1 HiSCR Responder
Hidradenitis Suppurativa Clinical Trial 2023: Secukinumab Highlights & Side Effects. Trial Name: NCT04179175 — Phase 3
Secukinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04179175 — Phase 3

Frequently Asked Questions

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

Are the findings of this clinical trial in line with what has been seen in other secukinumab 1 HiSCR Responder studies?

"28 clinical trials are underway for secukinumab 1 HiSCR Responder, with 13 of them being Phase 3 studies. Most of the secukinumab 1 HiSCR Responder trials are based in Brest and Buenos Aires, but there are a total of 1040 locations running trials for this medication."

Answered by AI

What are the risks associated with secukinumab 1 HiSCR Responder?

"Secukinumab 1 HiSCR Responder is in Phase 3 of clinical trials, which suggests that while there is some support for its efficacy, there is also extensive data testifying to its safety--earning it a 3 on our scale."

Answered by AI

What is secukinumab 1 HiSCR Responder most effective in treating?

"secukinumab 1 HiSCR Responder is most frequently prescribed to patients suffering from ankylosing spondylitis. However, it can also alleviate the pain and swelling of era, psoriatic arthritis, and severe plaque psoriasis."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa
2020. "Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04179175.
All > Hidradenitis Suppurativa
~138 spots leftby Apr 2025
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