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Monoclonal Antibodies
Treatment arm for Plaque Psoriasis
Phase 4
Waitlist Available
Research Sponsored by Narrows Institute for Biomedical Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights
Study Summary
This trial will use secukinumab to treat plaque psoriasis in 30 subjects. OCT will be used to monitor the resolution of psoriatic plaques and compare it to clinical improvements. This will help to understand how the drug works.
Eligible Conditions
- Plaque Psoriasis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Elucidate drug mechanism of action by monitoring morphologic changes in lesional vs. perilesional psoriatic plaques using optical coherence tomography (OCT).
Secondary outcome measures
Compare the onset/timing of subclinical improvement on OCT imaging to patients who achieve a 90% or 100% (PASI 90 and PASI 100) improvement from baseline in the PASI
Compare timing of subclinical improvement on OCT to the proportion of patients who achieve a reduction in PASI score by at least 75% (PASI 75) and/or score of 0 or 2-point improvement on the IGA (mod 2011) by week 12.
Side effects data
From 2019 Phase 4 trial • 102 Patients • NCT0305549419%
Nasopharyngitis
13%
Upper respiratory tract infection
7%
Cough
7%
Back pain
6%
Headache
4%
Aphthous ulcer
4%
Sinus congestion
4%
Gastroenteritis viral
4%
Diarrhoea
4%
Conjunctivitis
4%
Fatigue
4%
Pharyngitis streptococcal
4%
Fall
4%
Influenza
4%
Muscle strain
4%
Urinary tract infection
4%
Postoperative wound infection
4%
Anxiety
4%
Rhinorrhoea
2%
Sneezing
2%
Rash
2%
Actinic keratosis
2%
Palpitations
2%
Abdominal distension
2%
Cyst
2%
Dermatitis
2%
Pruritus
2%
Ear pain
2%
Anaemia
2%
Lacrimation increased
2%
Suicidal ideation
2%
Toothache
2%
Peripheral swelling
2%
Pyrexia
2%
Ear discomfort
2%
Influenza like illness
2%
Nausea
2%
Cellulitis
2%
Glossodynia
2%
Otitis media
2%
Cystitis
2%
Intertrigo
2%
Ligament sprain
2%
Tooth abscess
2%
Road traffic accident
2%
Hordeolum
2%
Post procedural contusion
2%
Pruritus generalised
2%
Otitis externa candida
2%
Dehydration
2%
Tonsillitis
2%
Sinusitis
2%
Ligament rupture
2%
Tinea pedis
2%
Blood pressure increased
2%
Decreased appetite
2%
Hypoglycaemia
2%
Seborrhoeic dermatitis
2%
Wound dehiscence
2%
Insomnia
2%
Muscle spasms
2%
Myalgia
2%
Productive cough
2%
Squamous cell carcinoma
2%
Oropharyngeal pain
2%
Irritability
2%
Nasal congestion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Secukinumab 300 mg
Placebo/Secukinumab 300 mg
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment armExperimental Treatment1 Intervention
Cosentyx (Secukinumab) 300 mg subcutaneous injection at weeks 0, 1, 2, 3 and 4 followed by every 4 weeks until 16 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Secukinumab
FDA approved
Find a Location
Who is running the clinical trial?
Narrows Institute for Biomedical ResearchLead Sponsor
4 Previous Clinical Trials
624 Total Patients Enrolled
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,721,005 Total Patients Enrolled
Frequently Asked Questions
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