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Monoclonal Antibodies
Secukinumab for Psoriasis
Phase 4
Waitlist Available
Led By Gil Yosipovitch, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
MRI Compatibility: No major contraindication for MRI (pacemaker, vascular stents, metallic ear tubes, and absence of metal implants or braces) as assessed by MRI technologist using site approved screening form.
Psoriasis patients (with/without psoriatic arthritis) with Psoriasis Area (BSA) more than 5%
Must not have
Diagnosis of a major psychiatric disorder such as schizophrenia, major depression or bipolar disorder that is active currently
Weight: 250 lb or more
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to week 4 (visit 3)
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will test whether a biologic drug can improve brain plasticity and perception of well-being for people with psoriasis.
Who is the study for?
This trial is for adults aged 18-65 with psoriasis covering more than 5% of their body. They must be MRI compatible, not pregnant, fluent in English, and have had a recent TB test. Excluded are those on certain medications or with chronic diseases, drug abuse history, severe obesity, or major psychiatric disorders.
What is being tested?
The study tests Secukinumab's effects on brain changes related to well-being perception and sensations like itch and pain in psoriasis patients. It aims to link these brain changes to the drug's impact on the IL-17 pathway.
What are the potential side effects?
While specific side effects aren't listed here, Secukinumab may cause reactions at injection sites, infections due to lowered immunity, allergic responses including anaphylaxis (severe allergy), as well as potential impacts on liver function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I don't have a pacemaker, stents, metal implants, or braces that would interfere with an MRI.
Select...
My psoriasis affects more than 5% of my body.
Select...
I am generally healthy with no history of major neurological, psychiatric, chronic pain, or skin conditions.
Select...
I am between 18 and 65 years old.
Select...
My psoriasis affects more than 5% of my body.
Select...
I am generally healthy with no history of major neurological, psychiatric, or chronic conditions.
Select...
I am between 18 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently diagnosed with an active major psychiatric disorder.
Select...
I weigh 250 pounds or more.
Select...
I am extremely overweight.
Select...
I use antihistamines for itch relief.
Select...
I am between 18 and 65 years old.
Select...
I have been treated with IL-17 targeting drugs before.
Select...
I have a chronic infectious disease or inflammatory bowel disease.
Select...
My thyroid condition is not under control.
Select...
I have an immune condition affecting IL-17.
Select...
I am currently taking opioid painkillers.
Select...
I am on biologic treatment and have not received any live vaccines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to week 4 (visit 3)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to week 4 (visit 3)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in brain activity
Change in gray matter density
Secondary study objectives
Change in PASI scores
Change in itch score as measured by the NRS
Change in pain score as measured by the NRS
+4 moreSide effects data
From 2019 Phase 4 trial • 102 Patients • NCT0305549419%
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%
Hypoglycaemia
2%
Nasal congestion
2%
Oropharyngeal pain
2%
Tinea pedis
2%
Tooth abscess
2%
Ligament sprain
2%
Irritability
2%
Sneezing
2%
Blood pressure increased
2%
Road traffic accident
2%
Pruritus
2%
Wound dehiscence
2%
Actinic keratosis
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
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Psoriasis GroupExperimental Treatment1 Intervention
Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12.
Group II: Healthy GroupActive Control1 Intervention
Healthy participants will not receive any intervention.
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?
University of MiamiLead Sponsor
955 Previous Clinical Trials
428,830 Total Patients Enrolled
NovartisIndustry Sponsor
1,639 Previous Clinical Trials
2,774,280 Total Patients Enrolled
8 Trials studying Psoriasis
4,018 Patients Enrolled for Psoriasis
Gil Yosipovitch, MDPrincipal Investigator - University of Miami
Larkin Community Hospital, Univ of Miami Hosp & Clinics-Sylvester Comp Cancer Center, University of Miami Hospital
Tel Aviv University (Medical School)
9 Previous Clinical Trials
229 Total Patients Enrolled
1 Trials studying Psoriasis
12 Patients Enrolled for Psoriasis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't started or changed doses of medications for mood, psychosis, or nerve pain in the last 3 months.I am currently diagnosed with an active major psychiatric disorder.I weigh 250 pounds or more.I don't have a pacemaker, stents, metal implants, or braces that would interfere with an MRI.I have had a TB test within the last 8 months or need one provided.My psoriasis affects more than 5% of my body.I am extremely overweight.I will take a pregnancy test to confirm I'm not pregnant.I am generally healthy with no history of major neurological, psychiatric, chronic pain, or skin conditions.You are allergic to biologic medications.I haven't used biologics in the last 8 weeks or Otezla in the last 4 weeks.I only use medication affecting the brain as needed.I am between 18 and 65 years old.My psoriasis affects more than 5% of my body.You are of child bearing potential.I use antihistamines for itch relief.I do not have any diseases that could interfere with the study or increase infection risk.I am generally healthy with no history of major neurological, psychiatric, or chronic conditions.I am between 18 and 65 years old.I cannot complete the required health assessments.I have been treated with IL-17 targeting drugs before.I have a chronic infectious disease or inflammatory bowel disease.My thyroid condition is not under control.I am between 18 and 65 years old.I have an immune condition affecting IL-17.Currently in prison.You have used illegal drugs or have been addicted to opiates in the past.I am currently taking opioid painkillers.I am on biologic treatment and have not received any live vaccines.You haven't had a tuberculosis test that came back negative in the last 12 months.
Research Study Groups:
This trial has the following groups:- Group 1: Psoriasis Group
- Group 2: Healthy Group
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Psoriasis Patient Testimony for trial: Trial Name: NCT04717466 — Phase 4