A treatment option for children with PsO grounded in experience in adults. Over 18+ years of clinical trial experience. COSENTYX (secukinumab) is approved to treat pediatric PsO in children as young as 6 years old.

For children with moderate to severe plaque psoriasis

Provide skin clearance with COSENTYX^®(secukinumab)²

Pivotal Trial PsO6 in pediatric patients with severe PsO

Randomized, double-blind, PBO- and active-controlled trial to demonstrate efficacy and assess safety and tolerability of COSENTYX vs PBO and etanercept (in a single-blinded arm) in subjects from 6 to <18 years of age with severe chronic PsO (defined by PASI score ≥20, an IGA modified 2011 score of 4, and involving ≥10% of the BSA) who were candidates for systemic therapy. Nonresponder imputation (NRI) is used to handle missing values.²

Start: Pivotal Trials in pediatric patients with severe plaque psoriasis.

Dosing of COSENTYX²: Patients <50 kg received 75 mg; patients ≥50 kg received 150 mg; administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4, followed by dosing every 4 weeks.

In exploratory analyses of Trial PsO6

Results observed for COSENTYX low-dose arm^†

PASI75 and PASI100 results in pediatric plaque psoriasis patients on COSENTYX (secukinumab).

In Trial PsO6, patients were randomized into two COSENTYX arms:

Low-dose arm: 75 mg for body weight (BW) <50 kg or 150 mg for ≥50 kg²
High-dose arm: 75 mg for BW <25 kg, 150 mg for BW ≥25 kg and <50 kg (2 times the recommended dose), or 300 mg for BW ≥50 kg (2 times the recommended dose)²

^†COSENTYX low-dose arm: patients weighing <50 kg received 75 mg doses. Data presented here do not account for 3 subjects from the COSENTYX high-dose arm weighing <25 kg who received COSENTYX 75 mg, based on the recommended dosing for pediatric patients <50 kg.⁵
^‡In this study, an IRT error led to additional dosing and higher dosing of some patients (LD: n=16; HD: n=20) at Weeks 13, 14, and 15, after the primary end point (Week 12) assessment. This value represents the population not affected by the dosing error.⁵

_{^{In an exploratory analysis in the open-label Trial PsO7 at Week 24}}
2 out of 3 patients achieved PASI 100⁶

66.7% achieved PASI 100 in the COSENTYX low-dose arm
(75 mg or 150 mg; n=42)

No clinical or statistical conclusions can be drawn.

Trial PsO7 in pediatric patients with moderate to severe PsO

Randomized, open-label trial to assess the efficacy, long-term safety and tolerability of COSENTYX compared to historical PBO in subjects from 6 to <18 years of age with moderate to severe chronic PsO (defined by a PASI score ≥12, IGA mod 2011 score of ≥3, and BSA involvement of ≥10% at randomization).⁶
Patients were randomized into two COSENTYX arms in the same manner as Trial PsO6.

Coprimary end point: low-dose arm (75 mg or 150 mg) at Week 12 (n=42): 93% of patients achieved PASI 75 and 79% achieved IGA 0/1; the estimated probability of a positive treatment effect for COSENTYX vs historical placebo was 100%.⁶

See efficacy data in adult patients >

*PBO-PASI 75 nonresponders at Week 12 were switched to either the COSENTYX low-dose or COSENTYX high-dose treatment group in the maintenance period according to the pre-assignment at their baseline randomization visit. PBO subjects who were PASI 75 responders at Week 12 had to terminate the study.⁴
^†In this study, an IRT error led to additional dosing and higher dosing of some patients (LD: n=16; HD: n=20) at Weeks 13, 14, and 15, after the primary end point (Week 12) assessment. The number of patients in the affected and not-affected patient groups have been deemed to be too low for any differences to be considered as clinically relevant.
^‡Data presented here do not account for 3 subjects from the COSENTYX high-dose arm weighing <25 kg who received COSENTYX 75 mg, based on the recommended dosing for pediatric patients <50 kg.
LD, loading dose; PASI, Psoriasis Area and Severity Index; PBO, placebo; pNRI, pure nonresponder imputation; q1w, once per week.

Please see PsO6 and PsO7 study design details

STUDY DESIGNS

PsO6^1,2
Trial PsO6 is a 52-Week (total 236 weeks) randomized multicenter, double-blind, placebo- and active-controlled phase 3 study in pediatric patients with severe chronic plaque PsO.¹

Patients were aged 6 to <18 years¹
Severe psoriasis was defined as: PASI score of ≥20, and; IGA score of 4, and; total BSA affected of ≥10%, and; patient being regarded by the investigator to be a candidate for systemic therapy¹
Coprimary end points were the proportion of patients who achieved a reduction in PASI score of ≥75% (PASI 75) from baseline to Week 12 and the proportion of patients who achieved an IGA mod 2011 score of 0 "clear" or 1 "almost clear" with at least a 2 point improvement from baseline to Week 12^1,2
The key secondary end point was the proportion of patients who achieved PASI 90 from baseline to Week 12. Other outcomes evaluated included PASI 100 response rates from baseline to Week 12 and through Week 52^1,2

PsO7³
Trial PsO7 is a 208-week randomized, open label, multicenter study in pediatric patients with moderate to severe chronic plaque PsO.³

Patients were aged 6 to <18 years³
Moderate to severe psoriasis was defined as: PASI score of ≥12 or greater, and; IGA score of ≥3, and; total BSA affected of 10% or greater, and; patient being regarded by the investigator to be a candidate for systemic therapy³
Coprimary end points were the proportion of patients who achieved a reduction in PASI score of ≥75% (PASI 75) from baseline to Week 12 and the proportion of patients who achieved an IGA mod 2011 score of 0 "clear" or 1 "almost clear" at Week 12³
The key secondary end point was achievement of PASI 90 response rate at Week 12. Other evaluated outcomes included PASI 100 response rates over time through Week 24³

BSA, body surface area; IGA, Investigator's Global Assessment; PASI, Psoriasis Area and Severity Index; PsO, plaque psoriasis.

References

1. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
2. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947 and supplement.
3. Data on file. CAIN457A2311 Clinical Study Report. Week 24 Analysis. Novartis Pharmaceuticals Corp; September 2019.

Definitions and references

Definitions

AS, ankylosing spondylitis; BSA, body surface area; ERA, enthesitis-related arthritis; IGA, Investigator's Global Assessment modified 2011; LD, loading dose; nr-axSpA, non-radiographic axial spondyloarthritis; PASI, Psoriasis Area and Severity Index; PBO, placebo; pNRI, pure nonresponder imputation; PsA, psoriatic arthritis; PsO, plaque psoriasis; q1w, once per week; RR, response rate.

References

1. Data on file. AIN457A2102 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2008.
2. Cosentyx. Prescribing Information. Novartis Pharmaceuticals Corp.
3. Cosentyx FDA approval history. Drugs.com. Accessed October 14, 2025. https://www.drugs.com/history/cosentyx.html
4. Data on file. CAIN457A2310 Clinical Study Report. Week 52 Analysis. Novartis Pharmaceuticals Corp; September 2019.
5. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947 and supplement.
6. Data on file. CAIN457A2311 Clinical Study Report. Week 24 Analysis. Novartis Pharmaceuticals Corp; September 2019.

Provide skin clearance with COSENTYX^®(secukinumab)²

Pivotal Trial PsO6 in pediatric patients with severe PsO

Results observed for COSENTYX low-dose arm^†

In Trial PsO6, patients were randomized into two COSENTYX arms:

_{^{In an exploratory analysis in the open-label Trial PsO7 at Week 24}}
2 out of 3 patients achieved PASI 100⁶

Trial PsO7 in pediatric patients with moderate to severe PsO

Please see PsO6 and PsO7 study design details

STUDY DESIGNS

Definitions and references

Important Safety Information

Indications

Provide skin clearance with COSENTYX® (secukinumab)2

Pivotal Trial PsO6 in pediatric patients with severe PsO

Results observed for COSENTYX low-dose arm†

In Trial PsO6, patients were randomized into two COSENTYX arms:

In an exploratory analysis in the open-label Trial PsO7 at Week 242 out of 3 patients achieved PASI 1006

Trial PsO7 in pediatric patients with moderate to severe PsO

Please see PsO6 and PsO7 study design details

Definitions and references

Provide skin clearance with COSENTYX^®(secukinumab)²

Results observed for COSENTYX low-dose arm^†

_{^{In an exploratory analysis in the open-label Trial PsO7 at Week 24}}
2 out of 3 patients achieved PASI 100⁶