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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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 104
Awards & highlights

Summary

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

Eligible Conditions
  • Plaque Psoriasis

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%
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

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
2,874 Previous Clinical Trials
4,199,795 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 A1 (A1a and A1b): new-onset plaque psoriasis to be treated with secukinumab, Arm A2: new-onset plaque psoriasis to be treated with secukinumab, Arm B1 (B1a and B1b): new-onset plaque psoriasis to be treated with nb-UVB, Arm C2: chronic plaque psoriasis to be treated with secukinumab
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
~24 spots leftby Jul 2025
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