Secukinumab for Psoriasis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Novartis Investigative Site, Halifax, Canada
Psoriasis+1 More
Secukinumab - Biological
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug can prevent new lesions from forming in people with psoriasis.

See full description

Eligible Conditions

  • Psoriasis
  • Psoriasis Vulgaris (Plaque Psoriasis)

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether Secukinumab will improve 1 primary outcome and 1 secondary outcome in patients with Psoriasis. Measurement will happen over the course of 52 weeks.

104 weeks
The key secondary variable is the proportion of all randomized patients who achieve PASI 90 at Week 104
52 weeks
The primary efficacy variable is the proportion of patients who achieve Pain Assessment Severity Index (PASI) 90 at Week 52. PASI is measured by dermatologist usung a PASI measurement scale.

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Side Effects for

Secukinumab 300 mg
Nasopharyngitis
19%
Upper respiratory tract infection
13%
Back pain
7%
Cough
7%
Headache
6%
Aphthous ulcer
4%
Muscle strain
4%
Fall
4%
Urinary tract infection
4%
Anxiety
4%
Diarrhoea
4%
Postoperative wound infection
4%
Pharyngitis streptococcal
4%
Sinus congestion
4%
Rhinorrhoea
4%
Gastroenteritis viral
4%
Conjunctivitis
4%
Fatigue
4%
Influenza
4%
Abdominal distension
2%
Glossodynia
2%
Wound dehiscence
2%
Decreased appetite
2%
Actinic keratosis
2%
Blood pressure increased
2%
Tonsillitis
2%
Otitis externa candida
2%
Ligament rupture
2%
Squamous cell carcinoma
2%
Tooth abscess
2%
Dehydration
2%
Irritability
2%
Cyst
2%
Toothache
2%
Road traffic accident
2%
Ear discomfort
2%
Myalgia
2%
Pruritus generalised
2%
Seborrhoeic dermatitis
2%
Ligament sprain
2%
Nasal congestion
2%
Rash
2%
Productive cough
2%
Dermatitis
2%
Otitis media
2%
Suicidal ideation
2%
Sinusitis
2%
Anaemia
2%
Peripheral swelling
2%
Pyrexia
2%
Oropharyngeal pain
2%
Cystitis
2%
Hordeolum
2%
Post procedural contusion
2%
Intertrigo
2%
Muscle spasms
2%
Hypoglycaemia
2%
Pruritus
2%
Sneezing
2%
Cellulitis
2%
Insomnia
2%
Nausea
2%
Lacrimation increased
2%
Palpitations
2%
Ear pain
2%
Influenza like illness
2%
Tinea pedis
2%
Tendonitis
0%
Folliculitis
0%
Exostosis
0%
Vitamin D deficiency
0%
Dental caries
0%
Testis cancer
0%
Depression
0%
Hypertension
0%
Dysplastic naevus
0%
Testicular oedema
0%
Leukocytosis
0%
Bronchitis
0%
Acarodermatitis
0%
Arthropod bite
0%
Hand dermatitis
0%
Foreign body in eye
0%
Basal cell carcinoma
0%
Migraine
0%
Impetigo
0%
Conjunctival haemorrhage
0%
Incision site cellulitis
0%
Tendon rupture
0%
Arthralgia
0%
Tenosynovitis
0%
Thrombocytosis
0%
Angina pectoris
0%
Hyperlipidaemia
0%
Epistaxis
0%
Pain
0%
Eye irritation
0%
Food poisoning
0%
Eye infection bacterial
0%
Pneumonia
0%
Dermatitis contact
0%
Pharyngitis
0%
This histogram enumerates side effects from a completed 2019 Phase 4 trial (NCT03055494) in the Secukinumab 300 mg ARM group. Side effects include: Nasopharyngitis with 19%, Upper respiratory tract infection with 13%, Back pain with 7%, Cough with 7%, Headache with 6%.

Trial Design

5 Treatment Groups

B1
1 of 5
A1
1 of 5
C2
1 of 5
A2
1 of 5
C1
1 of 5
Active Control
Experimental Treatment

This trial requires 196 total participants across 5 different treatment groups

This trial involves 5 different treatments. Secukinumab is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

A1
Biological
80 patients (65 in Arm A1a and 15 in Arm A1b) with new-onset psoriasis will receive 300 mg secukinumab by s.c. injection at baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 48 inclusive.
C2
Biological
secukinumab 300 mg s.c. administered at baseline, once weekly at Weeks 1, 2, 3 and 4; and thereafter every 4 weeks until Week 100 inclusive (last dose administered at Week 100)
A2
Biological
secukinumab 300 mg s.c. administered at baseline, once weekly at Weeks 1, 2, 3 and 4; and thereafter every 4 weeks until Week 100 inclusive (last dose administered at Week 100)
C1
Biological
secukinumab 300 mg s.c. administered at baseline, once weekly at Weeks 1, 2, 3 and 4; and thereafter every 4 weeks until Week 48 inclusive (last dose administered at Week 48)
B180 patients (65 in Arm B1a and 15 in Arm B1b) with new-onset psoriasis will receive 1 or 2 cycles of nb-UVB of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle).Only during the first 4 weeks of each cycle, nb-UVB treatment should be applied in combination with topical calcipotriol 50 μg/g and betamethasone 0.5 mg/g.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Secukinumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 104 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 104 weeks for reporting.

Closest Location

Novartis Investigative Site - Halifax, Canada

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Able to understand and communicate with the investigator, willing and capable to comply with all study procedures, and provide written signed and dated informed consent (personally or by a witness) before any assessment is performed
Aged 18 to 40 years inclusive
New-onset plaque psoriasis with appearance of the first psoriasis plaques within the last 12 months before randomization and naïve to any systemic treatment and phototherapy (Arms A1, A2 and Arm B1)
Chronic plaque psoriasis with appearance of the first psoriasis symptoms 5 years or longer and intolerance or inadequate response to phototherapy or any systemic treatment including biologicals, except for IL-17A inhibitors (Arm C1 and Arm C2)
Moderate to severe plaque psoriasis defined at screening and baseline by PASI ≥ 10, and body surface area (BSA) ≥ 10%, and investigator's global assessment (IGA mod 2011) ≥ 3

Patient Q&A Section

How many people get psoriasis a year in the United States?

"Around 2 million people are affected by psoriasis in the United States a year. About 12 percent have plaque-type plaques and the remaining 88 percent have linear, joint-type plaques. The majority of patients have experienced psoriasis for many years." - Anonymous Online Contributor

Unverified Answer

What are common treatments for psoriasis?

"The most common treatments for psoriasis in this European population included topical corticosteroids, oral immunosuppressive therapy, and ustekinumab. Psoriasis in children and adolescents does not appear to generally require specific treatment because of its rarity. Psoriasis is not treatable and therefore requires constant observation of severity of itchiness, skin disease, nail deformities, and disease progression. Clinicians should maintain long-term follow up of cases of this common and challenging skin disease both in the primary and tertiary care." - Anonymous Online Contributor

Unverified Answer

What are the signs of psoriasis?

"The most common symptom is plaques at the edges of the fingernails, which may be followed by scaling and cracking. Other typical symptoms include dry nails and hyperpigmentation. Other manifestations of psoriasis are hyperkeratosis, pustules, and inflamed lymph nodes, as well as red skin. Psoriasis can appear after infancy or later on in life." - Anonymous Online Contributor

Unverified Answer

Can psoriasis be cured?

"There is an increasing amount of anecdotal reports about remission with the usage of immunosuppressive drugs such as corticosteroids, biologics and synthetic analogues. There is one controlled trial with 1 patient. The authors have also recently published their experience with a case of systemic chemotherapy. Recently 3 trials have shown remission with biologics. However, there are no clear guidelines about how to treat psoriasis. What can be safely recommended is to take a thorough medical history and do regular full skin examination which can reveal what's wrong with the skin. In order to find out what's really wrong with the skin, we, dermatologists, prescribe drugs and ask the patient to visit us every month and tell us the result." - Anonymous Online Contributor

Unverified Answer

What is psoriasis?

"A high level of knowledge and education among psoriasis patients is very important to minimize the consequences of the disease and the need for prescription drugs, medical procedures, and hospital stays. Psoriasis is an allergic-immunological, systemic disease and it has no known cure. Psoriasis is characterized by skin lesions. These lesions contain red blood cell-filled plaques and a thickened layer of skin that can cause itching, loss of scalp of hair, and bleeding from the skin when cut. Psoriasis may cause depression. Psoriasis is not a chronic skin disease, but a skin condition that occurs and subsides as time passes. There are different types of psoriasis, none of which can be cured." - Anonymous Online Contributor

Unverified Answer

What causes psoriasis?

"While the cause of psoriasis is not well understood, we propose the first biological plausibility of a model of causation in atopic dermatitis (eczema) and psoriasis and discuss potential drug therapies." - Anonymous Online Contributor

Unverified Answer

Is secukinumab typically used in combination with any other treatments?

"Patients treated with secukinumab+ methotrexate experienced significant improvement in psoriasis symptoms. However, patients treated with secukinumab+ methotrexate+ etanercept reported more improvement in skin lesions than those treated with secukinumab+ etanercept." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in secukinumab for therapeutic use?

"The majority of the publications and marketing reports refer generally to a combination with methotrexate, but there are already a lot of publications and marketing reports regarding Secukinumab monotherapy as an orphan drug, especially in USA. This might be caused by the fact that Secukinumab has a different development strategy than that of biosimilar drugs." - Anonymous Online Contributor

Unverified Answer

Has secukinumab proven to be more effective than a placebo?

"Patients with erythema nodosum in the hands receiving adalimumab for psoriatic arthritis are more likely to experience improvement in the signs and symptoms of psoriasis than patients receiving placebo. Treatment-related adverse events seem to be more common with secukinumab than with adalimumab." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of secukinumab?

"Commonly reported adverse events (≥1% patients) with secukinumab occurred frequently (<10% for total patients) at the beginning of therapy and are not anticipated, based on the frequency of such adverse effects in patients treated using other anti-IL-12/23 agents in early phase 2 trials performed in patients with psoriasis who were naïve to anti-IL-12/23 treatments." - Anonymous Online Contributor

Unverified Answer

What is the latest research for psoriasis?

"If a patient was to have a skin biopsy, I would urge a histopathologist to go to see the tissue and discuss the lab results with the patient before ordering skin tests to see if autoimmunity is present. If autoimmunity appears, the patient should be tested for rheumatoid arthritis because psoriasis is very similar to rheumatoid osteoarthropathy and the two may also share common genetic risk factors." - Anonymous Online Contributor

Unverified Answer

Does secukinumab improve quality of life for those with psoriasis?

"In this global, prospective, multi-arm trial, Secukinumab reduced the extent of psoriasis, improved the disease burden and improved the quality of life in people with moderate to severe psoriasis. Findings from a recent study support the use of secukinumab in psoriasis." - Anonymous Online Contributor

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