← Back to Search

Monoclonal Antibodies

Secukinumab for Plaque Psoriasis (STEPin Trial)

Phase 4
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
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 104
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

STEPin Trial Summary

This trial is testing whether a new medication can prevent plaque psoriasis from getting worse or spreading.

Eligible Conditions
  • Plaque Psoriasis

STEPin Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You recently developed psoriasis within the past year and have not received any medications or light therapy for it yet.
Select...
You have had chronic plaque psoriasis for at least 5 years and haven't responded well to various treatments, including light therapy and medications. However, if you have previously taken IL-17A inhibitors, you may still be eligible for the trial.
Select...
You have had chronic plaque psoriasis for at least 5 years and have tried different treatments, including light therapy and medications, but they haven't worked well for you. However, if you have tried IL-17A inhibitors, you can still participate.

STEPin Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients who achieve Pain Assessment Severity Index (PASI) 90 at Week 52.
Secondary outcome measures
Proportion of all randomized patients who achieve PASI 90 at Week 104

Side effects data

From 2019 Phase 4 trial • 102 Patients • NCT03055494
19%
Nasopharyngitis
13%
Upper respiratory tract infection
7%
Cough
7%
Back pain
6%
Headache
4%
Aphthous ulcer
4%
Conjunctivitis
4%
Diarrhoea
4%
Pharyngitis streptococcal
4%
Urinary tract infection
4%
Fall
4%
Rhinorrhoea
4%
Fatigue
4%
Gastroenteritis viral
4%
Influenza
4%
Postoperative wound infection
4%
Muscle strain
4%
Anxiety
4%
Sinus congestion
2%
Cellulitis
2%
Abdominal distension
2%
Seborrhoeic dermatitis
2%
Palpitations
2%
Lacrimation increased
2%
Glossodynia
2%
Nausea
2%
Pyrexia
2%
Otitis media
2%
Tinea pedis
2%
Tonsillitis
2%
Tooth abscess
2%
Ligament sprain
2%
Wound dehiscence
2%
Decreased appetite
2%
Hypoglycaemia
2%
Insomnia
2%
Irritability
2%
Nasal congestion
2%
Oropharyngeal pain
2%
Productive cough
2%
Sneezing
2%
Dermatitis
2%
Intertrigo
2%
Pruritus
2%
Muscle spasms
2%
Myalgia
2%
Ear discomfort
2%
Ear pain
2%
Suicidal ideation
2%
Anaemia
2%
Toothache
2%
Cyst
2%
Influenza like illness
2%
Peripheral swelling
2%
Cystitis
2%
Hordeolum
2%
Otitis externa candida
2%
Sinusitis
2%
Ligament rupture
2%
Post procedural contusion
2%
Road traffic accident
2%
Dehydration
2%
Squamous cell carcinoma
2%
Actinic keratosis
2%
Pruritus generalised
2%
Rash
2%
Blood pressure increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Secukinumab 300 mg
Placebo/Secukinumab 300 mg

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

STEPin Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Arm C2: chronic plaque psoriasis to be treated with secukinumabExperimental Treatment1 Intervention
Eligible patients with chronic plaque psoriasis will receive 300 mg secukinumab by s.c. injection at baseline, Weeks 1, 2, 3 and 4 and then every 4 weeks until Week 100 inclusive (last dose administered at Week 100) (treatment duration = 104 weeks).
Group II: Arm C1: chronic plaque psoriasis to be treated with secukinumabExperimental Treatment1 Intervention
Eligible patients with chronic plaque psoriasis will receive 300 mg secukinumab by s.c. injection at baseline, Weeks 1, 2, 3 and 4 and then every 4 weeks until Week 48 inclusive (last dose administered at Week 48) (treatment duration = 52 weeks).
Group III: Arm A2: new-onset plaque psoriasis to be treated with secukinumabExperimental Treatment1 Intervention
Eligible patients with new-onset psoriasis will receive 300 mg secukinumab by s.c. injection at baseline, Weeks 1, 2, 3 and 4 and then every 4 weeks until Week 100 inclusive (last dose administered at Week 100) (treatment duration = 104 weeks).
Group IV: Arm A1 (A1a and A1b): new-onset plaque psoriasis to be treated with secukinumabExperimental Treatment1 Intervention
80 patients (68 in Arm A1a and 12 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 (treatment duration = 52 weeks).
Group V: Arm B1 (B1a and B1b): new-onset plaque psoriasis to be treated with nb-UVBActive Control3 Interventions
80 patients (68 in Arm B1a and 12 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 duration = 52 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Secukinumab
2015
Completed Phase 4
~22170

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,842 Previous Clinical Trials
4,192,778 Total Patients Enrolled

Media Library

Secukinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03020199 — Phase 4
Plaque Psoriasis Research Study Groups: Arm C1: chronic plaque psoriasis to be treated with secukinumab, Arm C2: chronic plaque psoriasis to be treated with secukinumab, Arm A2: new-onset plaque psoriasis to be treated with secukinumab, Arm A1 (A1a and A1b): new-onset plaque psoriasis to be treated with secukinumab, Arm B1 (B1a and B1b): new-onset plaque psoriasis to be treated with nb-UVB
Plaque Psoriasis Clinical Trial 2023: Secukinumab Highlights & Side Effects. Trial Name: NCT03020199 — Phase 4
Secukinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03020199 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment an unprecedented exploration of its type?

"Presently, 45 live trials for Secukinumab are occurring in 347 cities and 54 countries. The original study was funded by Mantecorp Industria Quimica e Farmaceutica Ltd., featuring 170 patients, which completed its Phase 3 approval back in 2010. Since then, 273 additional investigations have been finalized successfully."

Answered by AI

Is my participation an option in this trial?

"This trial is enrolling 196 individuals aged between 18 and 50 with psoriasis. Qualifying patients must have the capacity to comprehend and interact with researchers, adhere to all procedures of the study, present a valid informed consent document (either in person or through witness), suffer from either new-onset plaque psoriasis (within 12 months) without systemic treatment/phototherapy OR chronic plaque psoriasis that has been active for five years or more but is resistant to any form of therapy including biologicals (except IL-17A inhibitors). Other criteria include a PASI score ≥ 10%, BSA≥10% and I"

Answered by AI

Has the FDA sanctioned Secukinumab for public use?

"There is significant backing for the safety of secukinumab, so it was rated a 3 due to its phase 4 trial status which implies approval."

Answered by AI

Are there any preceding experiments involving Secukinumab?

"Currently, there are 45 active studies concerning Secukinumab with 18 of them being in the last phase. Although many locations for these clinical trials reside in Afula and Cluj, a total of 1107 medical sites have operations running on this drug."

Answered by AI

What is the upper limit of participants involved in this research project?

"Affirmative. Data hosted on clinicaltrials.gov attests that this experiential research, which was initially advertised on March 27th 2017, is actively seeking enrolment. Approximately 196 volunteers need to be recruited from 1 different medical centre."

Answered by AI

Does this program include people aged 55 and over?

"To be eligible for this trial, applicants must fall between the ages of 18 and 50. Alternatively, 40 trials are available to minors while 177 studies cater to elderly populations."

Answered by AI

Are there any vacancies available for individuals to participate in this clinical trial?

"This medical experiment is actively recruiting participants, as evidenced by the clinicaltrials.gov listing that was first posted on March 27th 2017 and last amended on July 20th 2022."

Answered by AI

What indications does Secukinumab generally address?

"Secukinumab is often prescribed to those suffering from nephrotic syndrome, yet it can also be utilised for the treatment of a variety of other conditions such as brain tumours, ophthalmia, sympathetic disorders and eye diseases."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Novartis Investigative Site: < 48 hours
Average response time
  • < 2 Days
~25 spots leftby Feb 2025