What side effects are associated with this type of intervention?

Common treatments for Hidradenitis Suppurativa, particularly IL-17 inhibitors like Secukinumab, can have several side effects. These include an increased risk of infections, inflammatory bowel disease events, and injection site reactions. Other biologics used in HS, such as TNF inhibitors (e.g., infliximab), may cause similar side effects, including infections, infusion reactions, and potential development of antibodies against the drug. Non-biologic treatments like zinc gluconate can cause gastrointestinal upset and reduced copper absorption. Overall, while these treatments can be effective, they require careful monitoring for adverse effects.

What prior FDA approvals exist?

The FDA has approved adalimumab (Humira) for the treatment of moderate to severe Hidradenitis Suppurativa. Adalimumab is a TNF-alpha inhibitor and was the first biologic agent approved for HS. While Secukinumab, an IL-17A inhibitor, is being studied for HS, it has not yet received FDA approval for this indication. Other IL-17 inhibitors, such as ixekizumab and brodalumab, have shown efficacy in related inflammatory conditions like psoriasis but are not currently approved for HS.

What other types of research exist?

Promising novel alternatives to Secukinumab for Hidradenitis Suppurativa patients include Finasteride, which has been reported as an alternative treatment for women with HS, and other IL-23 inhibitors like Guselkumab and Tildrakizumab, which have shown efficacy in related inflammatory conditions. These treatments offer different mechanisms of action that may benefit HS patients.

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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

Must not have

Current severe progressive or uncontrolled disease which renders the subject unsuitable for the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 216 weeks: from randomization at the extension study (week 52) up to week 268. study day is defined with respect to the core studies.

Awards & highlights

Pivotal Trial

Summary

This trial aims to see if patients with moderate to severe hidradenitis suppurativa can maintain their response to secukinumab over time. Secukinumab helps reduce inflammation by blocking a specific protein. The study will also check the ongoing safety and tolerability of the medication. Secukinumab has shown effectiveness in treating moderate to severe hidradenitis suppurativa in previous 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.

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.

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

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I completed a 52-week study and received secukinumab during its second phase.

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I completed a 52-week study and received secukinumab during its second phase.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My condition is stable and not worsening rapidly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 216 weeks: from randomization at the extension study (week 52) up to week 268. study day is defined with respect to the core studies.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 216 weeks: from randomization at the extension study (week 52) up to week 268. study day is defined with respect to the core studies.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 216 weeks: from randomization at the extension study (week 52) up to week 268. study day is defined with respect to the core studies. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Reponders

Secondary study objectives

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

Rhinitis

Abdominal pain

Tonsillitis

Back pain

Ligament sprain

Contusion

Pain in extremity

Acne

Joint injury

Aphthous ulcer

Conjunctivitis

Influenza

Abdominal pain upper

Respiratory tract infection

Paronychia

Neutropenia

Dyspepsia

Impetigo

Otitis media

Arthropod bite

Pruritus

Psoriasis

Rash

Gastroenteritis

Alanine aminotransferase increased

Aspartate aminotransferase increased

Vertigo

Ear pain

Fatigue

Sinusitis

Tracheitis

Skin abrasion

Musculoskeletal stiffness

Skin papilloma

Haematuria

Respiratory disorder

Alopecia

Eczema

Urticaria

Oral herpes

Radius fracture

Injection site pain

Gastrointestinal infection

Pneumonia

Transaminases increased

Ligament rupture

Injection site pruritus

Iron deficiency anaemia

Leukopenia

Ocular hyperaemia

Uveitis

Constipation

Mouth ulceration

Toothache

Nonalcoholic fatty liver disease

Bronchitis

Nail infection

Viral upper respiratory tract infection

Fall

Road traffic accident

Neutrophil count decreased

Decreased appetite

Arthritis

Muscle contracture

Myalgia

Tendonitis

Scrotal pain

Dyspnoea

Dermatitis

Dermatitis contact

Dry skin

Ingrowing nail

Urinary tract infection

Viral infection

Joint swelling

Conjunctivitis allergic

Peripheral swelling

Folliculitis

Respiratory tract infection viral

Enthesopathy

Dysmenorrhoea

Asthma

Rhinorrhoea

Erythema

Pharyngotonsillitis

Neck pain

Injection site reaction

Muscle strain

Adenoiditis

Gingival injury

Osteochondrosis

Venomous sting

Ear disorder

Postoperative wound infection

Food poisoning

Acute sinusitis

Appendicitis

Abdominal injury

Juvenile psoriatic arthritis

Cholesteatoma

Adenoidal hypertrophy

Anaemia

Lymph node pain

Lymphopenia

Splenomegaly

Sinus bradycardia

Tachycardia

Ventricular extrasystoles

Gilbert's syndrome

Hydrocele

Myopia

Abdominal distension

Oral mucosal blistering

Salivary hypersecretion

Administration site reaction

Feeling hot

Injection site erythema

Medical device pain

Non-cardiac chest pain

Pain

Mite allergy

Gastrointestinal viral infection

Helminthic infection

Herpes zoster

Hordeolum

Lower respiratory tract infection

Nail bed infection

Otitis externa

Skin infection

Tinea pedis

Concussion

Foot fracture

Hand fracture

Injection related reaction

Overdose

Tendon injury

Thermal burn

Blood uric acid increased

Body temperature increased

C-reactive protein increased

Eosinophil count increased

Hepatic enzyme increased

Platelet count increased

Hypercholesterolaemia

Lactose intolerance

Obesity

Intervertebral disc disorder

Jaw disorder

Joint effusion

Joint stiffness

Muscle spasms

Synovial cyst

Papilloma

Dizziness

Nerve compression

Tremor

Visual field defect

Anxiety

Depressed mood

Distractibility

Euphoric mood

Intentional self-injury

Mental disorder

Post-traumatic stress disorder

Proteinuria

Renal colic

Gynaecomastia

Menstruation irregular

Testicular pain

Epistaxis

Haemoptysis

Productive cough

Rhinitis allergic

Blister

Diffuse alopecia

Dyshidrotic eczema

Hyperhidrosis

Skin erosion

Sexual abuse

Cyanosis

Acarodermatitis

Seasonal allergy

Dysphagia

Noninfective gingivitis

Odynophagia

Onychomycosis

Pilonidal cyst

Soft tissue infection

Staphylococcal infection

Vaginal infection

Vulvovaginal mycotic infection

Blood pressure systolic increased

Blood triglycerides increased

Liver function test increased

Lymphocyte count decreased

Pharyngeal erythema

Skin plaque

Hot flush

Crohn's disease

Eye haematoma

Eye pain

Functional gastrointestinal disorder

Gastritis

Gastrooesophageal reflux disease

Lip disorder

Malpositioned teeth

Enterobiasis

Oral viral infection

Pulpitis dental

Skin laceration

Sunburn

Blood alkaline phosphatase increased

Blood calcium increased

Blood creatinine increased

Blood glucose increased

Blood phosphorus increased

Weight increased

White blood cell count decreased

White blood cells urine positive

Groin pain

Musculoskeletal chest pain

Musculoskeletal pain

Temporomandibular joint syndrome

Epilepsy

Varicocele

Exfoliative rash

Skin striae

100%

80%

60%

40%

20%

Study treatment Arm

Total

Placebo in TP2

AIN457 in Entire Treatment Period

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~3610

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Hidradenitis Suppurativa (HS) often target the immune system to reduce inflammation and prevent flare-ups. Secukinumab, an IL-17A inhibitor, works by blocking the activity of interleukin-17A, a cytokine involved in inflammatory responses, thereby reducing the chronic inflammation characteristic of HS. Other treatments, such as TNF inhibitors, also modulate the immune response by targeting tumor necrosis factor-alpha, another key player in inflammation. Additionally, antibiotics and hormonal therapies can help manage bacterial infections and hormonal imbalances that may exacerbate HS. Understanding these mechanisms is crucial for HS patients as it highlights the importance of controlling inflammation and immune dysregulation to manage their symptoms effectively.