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Monoclonal Antibodies

Secukinumab Therapy for the Treatment of Moderate to Severe Plaque Psoriasis With Response Monitoring Using Optical Coherence Tomography (OCT).

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
Drug Has Already Been Approved
Pivotal Trial
All Individual Drugs Already Approved
No Placebo-Only Group

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 weeks
Treatment ~ Varies
Follow Up ~week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Elucidate drug mechanism of action by monitoring morphologic changes in lesional vs. perilesional psoriatic plaques using optical coherence tomography (OCT).
Secondary study objectives
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 • NCT03055494
19%
Nasopharyngitis
13%
Upper respiratory tract infection
7%
Back pain
7%
Cough
6%
Headache
4%
Urinary tract infection
4%
Anxiety
4%
Muscle strain
4%
Rhinorrhoea
4%
Postoperative wound infection
4%
Sinus congestion
4%
Conjunctivitis
4%
Pharyngitis streptococcal
4%
Gastroenteritis viral
4%
Diarrhoea
4%
Fatigue
4%
Aphthous ulcer
4%
Influenza
4%
Fall
2%
Productive cough
2%
Insomnia
2%
Oropharyngeal pain
2%
Hypoglycaemia
2%
Nasal congestion
2%
Tinea pedis
2%
Tooth abscess
2%
Ligament sprain
2%
Actinic keratosis
2%
Irritability
2%
Sneezing
2%
Blood pressure increased
2%
Road traffic accident
2%
Pruritus
2%
Wound dehiscence
2%
Pruritus generalised
2%
Dermatitis
2%
Dehydration
2%
Tonsillitis
2%
Ligament rupture
2%
Squamous cell carcinoma
2%
Decreased appetite
2%
Intertrigo
2%
Sinusitis
2%
Post procedural contusion
2%
Palpitations
2%
Glossodynia
2%
Cyst
2%
Cystitis
2%
Otitis externa candida
2%
Peripheral swelling
2%
Hordeolum
2%
Otitis media
2%
Ear pain
2%
Anaemia
2%
Cellulitis
2%
Suicidal ideation
2%
Lacrimation increased
2%
Muscle spasms
2%
Ear discomfort
2%
Pyrexia
2%
Abdominal distension
2%
Nausea
2%
Toothache
2%
Myalgia
2%
Influenza like illness
2%
Rash
2%
Seborrhoeic dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Secukinumab 300 mg
Placebo/Secukinumab 300 mg

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,638 Previous Clinical Trials
2,774,173 Total Patients Enrolled
~4 spots leftby Dec 2025
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