A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis.

Phase 3

Withdrawn

• Conditions: psoriasis vulgaris - plaque psoriasis; 10040785

• Registration Number: NL-OMON35122
• Lead Sponsor: Janssen-Cilag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

- boys or girls * 12 and < 18 years of age
- have a diagnosis of plaque-type psoriasis with or without PsA for at least 6 monhts prior to first administration of study agent, with widespread lesions defined by PASI * 12, PGA * 3 and involved BSA * 10%.
- are candidates for phototherapy or systemic treatment of psoriasis or have psoriasis consdered by the investigator as poorly controlled with topical therapy after an adequeate dose and duration of therapy.
- no history of latent or active TB prior to screeniing, nor have signs or symptoms suggestive for active TB upon medical history and /or physical examination nor have been in close contact with a person with active TB.
- must not receive live virus or live bacterial vaccination at least 6 weeks prior to first administration of study agent, during the study, or within 15 weeks after the last administration of study agent, and no BCG vaccination within 12 months of screening, during the study or within 12 months after the last administration of study agent.
- subject or legally-acceptable representative must have signed an informed consent. Assent is required for minors.

Exclusion Criteria

- currently have non-plaque forms of psoriasis
- have a drug-induced psoriasis
- have used any therapeutic agent targeted at reducing IL-12 or IL-23, including but not limited to ustekinumab or briakinumab.
- have used topical medications/treatments that could affect psoriasis or PASI evaluation within 2 weeks of the first administration of study agent.
- have received phototherapy or systemic medications/treatments that could affect psoriasis or PASI evaluation within 4 weeks of the first administration of study agent.
- have received any systemic immunosuppressants within 4 weekes of the first administration of study agent
- have received any biologic agent within the previous 3 months or 5 times the t1/2 of the agent, whichever is longer.
- have used a topical investigational agent within 4 weeks or 5 times the t1/2 of the investigational agent before planned start of treatment or are currently enrolled in a study with a topical agent.
- have used a non-topical investigational drug within 3 monhts or 5 times the t1/2 of the investigational agent before the planned start of treatment or are currently enrolled in a study with a non-topical investigational agent.
- have a history of chroinic or recurrent infectious disease, have or have had a serious infection
- have a documented history of immune deficiency syndrome
- are currentlky receiving venom immunotherapy
- have been hospitalized in the past 1 year for asthma, ever required intubation for treatment of asthma, currently require oral corticosteroids for the treatment of asthma, or required more than one short-term course of oral corticosteroids for ashma within the previous year
- employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint in this study is the proportion of subjects who achieve a<br /><br>PGA score of cleared or minimal at Week 12. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The major secondary endpoints are as follows:<br /><br>1. The proportion of subjects who achieve a PASI 75 response at Week 12 will be<br /><br>compared between the ustekinumab LD group and the placebo group and between the<br /><br>ustekinumab HD group and the placebo group.<br /><br>2. The change from baseline in CDLQI at Week 12 will be compared between the<br /><br>ustekinumab LD group and the placebo group and between the ustekinumab HD group<br /><br>and the placebo group.<br /><br>3. The proportion of subjects who achieve a PASI 90 response at Week 12 will be<br /><br>compared between the ustekinumab LD group and the placebo group and between the<br /><br>ustekinumab HD group and the placebo group.</p><br>