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DSIP

Emideltide, DSIP nonapeptide, Delta sleep-inducing peptide

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Studies 458
Trials 82
Active Not Recruiting PHASE3 INTERVENTIONAL NCT06640517

Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Netakimab in Children With Moderate to Severe Plaque Psoriasis

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The aim of the study is to evaluate the efficacy and safety of netakimab compared with placebo in a pediatric population of subjects over 6 years of age with moderate to severe plaque psoriasis. The study will have randomized, double-blind, placebo-controlled study with open-arm comparison.

Detailed Description

Following screening, subjects will be randomized to receive either netakimab, placebo or adalimumab in a 2:1:2 ratio and enter the main study period. During the main study period, subjects will receive therapy with netakimab/placebo (double-blind arms) or adalimumab (open-label arm), which will be administered subcutaneously until week 12. At Week 12, after completion of all scheduled procedures subjects in groups netakimab/placebo will continue to receive open-label netakimab for up to week 58, subjects in group adalimumab will switch to open-label adalimumab after 8-week "washout" period. At Week 58, after completion of all scheduled procedures subjects with sPGA ≤1 will be re-randomised to recieve either netakimab or placebo in double-blind maner. The subjects with \>1 will continue to recieve open-label netakimab.

Interventions

Name: Netakimab
Type: DRUG
Description: netakimab will be administered subcutaneously with induction once a week for the first three weeks, then once every 4 weeks
Name: Placebo
Type: DRUG
Description: placebo will be administered subcutaneously at a scheme masking netakimab treatment
Name: Adalimumab
Type: DRUG
Description: adalimumab will be administered subcutaneously at weeks 1, 2, and then once every 2 weeks

Primary Outcomes

Measure: Proportion of subjects achieving PASI75
TimeFrame: Week 12
Description: PASI combines assessments of the extent of body surface involvement in 4 regions (head \& neck(h), trunk(t), arms(u), legs(l)) \& severity of scaling (S), redness (R), \& plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total body surface area (BSA) affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = \>0% to \<10%, 2 = 10% to \<30%, 3 = 30% to \<50%, 4 = 50% to \<70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
Measure: Proportion of subjects achieving sPGA0/1
TimeFrame: Week 12
Description: Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.

Trial Information

NCT ID

NCT06640517

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Biocad

Last Updated

December 15, 2025