Phase 3
N=162
Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis
Chronic Severe Plaque-type Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02471144 ↗Enrolled (actual)
162
Serious AEs
11.6%
Results posted
Aug 2021
Primary outcome: Primary: Number and Percentage of Participants Achieving a 75% Improvement From Baseline in PASI Score at Week 12 — 32; 31; 6; 26 Participants — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Experimental : Secukinumab low dose (Biological); Experimental: Secukinumab high dose (Biological); Placebo Comparator: Secukinumab Placebo (Biological); Active Comparator: Etanercept (Biological)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Participants Achieving a 75% Improvement From Baseline in PASI Score at Week 12 |
32; 31; 6; 26 | <.0001 sig |
| PRIMARY Number and Percentage of Participants Who Showed Investigator's Global Assessment (IGA) Mod 2011 Response of 0 or 1 at Week 12 |
28; 24; 2; 14 | <.0001 sig |
| SECONDARY Number and Percentage of Participants Achieving a 90% Improvement From Baseline in PASI Score at Week 12 |
29; 27; 1; 12 | <.0001 sig |
| SECONDARY Number and Percentage of Participants Achieving a 50%, 100% Improvement From Baseline in PASI Score at Week 12 |
34; 34; 9; 34; 12; 11 | — |
| SECONDARY Number and Percentage of Participants Achieving a 50%, 75%, 90% or 100% Improvement From Baseline in PASI Score and IGA Mod 2011 Score of 0 or 1 up to Week 12 (Induction) |
6; 13; 0; 1; 26; 28 | — |
| SECONDARY Number and Percentage of Participants Achieving a 50%, 75%, 90% or 100% Improvement From Baseline in PASI Score and IGA Mod 2011 Score of 0 or 1 Up to Week 52 (Maintenance) |
32; 28; 5; 8; 19; 37 | — |
| SECONDARY Change From Baseline in Psoriasis Area & Severity Index (PASI) Score at Week 12 |
-22.27; -22.67; -7.94; -20.91 | — |
| SECONDARY Change From Baseline in Psoriasis Area & Severity Index (PASI) Scores at Week 52 |
-25.26; -25.75; -28.49; -24.69; -21.16 | — |
| SECONDARY Percentage of Participants in IGA Mod 2011 Score Categories at Week 12 |
12; 11; 0; 7; 14; 13 | — |
| SECONDARY Percentage of Participants in IGA Mod 2011 Score Categories at Week 52 |
16; 20; 10; 10; 9; 13 | — |
| SECONDARY Percentage Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) Score Up to Week 12 (Induction) |
-47.71; -50.71; 1.67; -35.13; -61.60; -66.97 | — |
| SECONDARY Percentage Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) Score Up to Week 52 (Maintenance) |
-73.7; -53.9; 40.3; -73.8; -55.0; -79.0 | — |
| SECONDARY Number and Percentage of Participants Achieving a Children's DLQI Score of 0 or 1 Over Time up to Week 12 (Induction) |
8; 11; 2; 9; 15; 19 | — |
| SECONDARY Number and Percentage of Participants Achieving a Children's DLQI Score of 0 or 1 Over Time up to Week 52 (Maintenance) |
19; 17; 8; 9; 17; 21 | — |
| SECONDARY Number and Percentage of Participants With Clinically Important Reduction in Disability as Evaluated by CHAQ Questionnaire Over Time at Week 12 |
2; 0; 0; 2 | — |
| SECONDARY Number and Percentage of Participants With Clinically Important Reduction in Disability as Evaluated by CHAQ Questionnaire Over Time at Week 52 |
2; 0; 1; 0; 2 | — |
Summary
This was a multicenter, randomized, double-blind, placebo- and active-controlled (etanercept in single blinded arm) study in pediatric subjects aged 6 years to less than 18 years with severe chronic plaque psoriasis. Approximately 160 subjects aged 6 years to <18 years were enrolled, of which at least 30 were 6 years to <12 years old. Subjects were enrolled at approximately 70 study sites worldwide.
Eligibility Criteria
Inclusion criteria
- Must be 6 to less than 18 years of age at the time of randomization
- Plaque-type psoriasis history for at least 3 months.
Severe plaque-type psoriasis meeting all of the following three criteria:
- PASI score of 20 or greater,
- Investigator's Global Assessment (IGA) score of 4
- Total body surface area (BSA) affected of 10% or greater.
- Patient being regarded by the investigator to be a candidate for systemic therapy because of:
- inadequate control of symptoms with topical treatment, or
- failure to respond to or tolerate previous systemic treatment and/or UV therapy
Exclusion criteria
- Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate) at randomization.
- Current drug-induced psoriasis.
- Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
- Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy
- History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
- History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
- Pregnant or nursing (lactating) women.
- Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02471144). 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.