Phase 3
N=84
Study to Assess the Long-term Safety, Tolerability, Efficacy of Secukinumab in Pediatric Patients of Age 6 to <18 Years, With Moderate to Severe Plaque Psoriasis
Moderate to Severe Chronic Plaque-type Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT03668613 ↗Enrolled (actual)
84
Serious AEs
7.1%
Results posted
Jul 2021
Primary outcome: Primary: Number and Percentage of Participants With PASI 75 Response — 39; 39 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- secukinumab low dose (Drug); secukinumab high dose (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Participants With PASI 75 Response |
39; 39 | — |
| PRIMARY Number and Percentage of Participants With IGA Mod 2011 0 or 1 Response |
33; 35 | — |
| SECONDARY Number and Percentage of Participants With PASI 90 Response |
29; 32 | — |
| SECONDARY Secukinumab Concentration in Serum |
0.00; 0.00; 74.2; 135; 34.8; 69.6 | — |
| SECONDARY Summary Table of Adverse Events |
33; 35; 0; 0; 4; 2 | — |
Summary
This was an open-label, parallel-group, two-arm, multicenter study in pediatric subjects aged 6 years to less than 18 years, at randomization, with moderate to severe chronic plaque psoriasis. 84 subjects (most with moderate severity) were enrolled. Subjects were stratified by weight and disease severity.
Eligibility Criteria
Inclusion Criteria
- Written informed assent and parental permission (age as per local law) obtained at screening before any assessment is performed.
- Must be 6 to less than 18 years of age at the time of randomization
- Moderate to Severe plaque psoriasis, defined as a PASI score ≥ 12, and IGA mod 2011 score of ≥ 3, and BSA involvement of ≥10%, at randomization.
- Subject being regarded by the investigator to be a candidate for systemic therapy.
Exclusion Criteria
- Forms of psoriasis other than chronic plaque-type active at randomization
- Drug-induced psoriasis
- Ongoing use of prohibited treatments
- Female subjects of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing and for 16 weeks after stopping study treatment
- Pregnant or nursing (lactating) females
- Subjects with total WBC count <2, 500/μL, or platelets <100,000/μL or neutrophils <1,500/μL or hemoglobin <8.5 g/dL at screening
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor
Data sourced from ClinicalTrials.gov (NCT03668613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.