A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)

Study Overview
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Brief Summary
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This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.

Detailed Description
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This is a randomized (drug assigned by chance), double-blind (a medical research study in which neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, parallel (a medical research study comparing the response in two or more groups of participants receiving different treatments), multicenter of ustekinumab in adolescent participants with moderate to severe psoriasis. The total duration of study will be 60 weeks. The study will consists of 2 parts; a Screening period and a Treatment period. In treatment period participants will receive either ustekinumab half standard dosage, ustekinumab standard dosage or Placebo. Participants receiving ustekinumab half standard dosage and ustekinumab standard dosage at Week 0, will receive placebo at Week 12 and participants receiving placebo at Week 0 will be randomly assigned to either ustekinumab half standard dosage or ustekinumab standard dosage Weeks 12, 16, 28, and 40. Primarily efficacy will be evaluated by physician's global assessment (PGA) score of cleared or minimal disease. Participants' safety will be monitored throughout the study.

Official Title
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A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the of Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis (CADMUS)

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Ustekinumab - Half-Standard Dosage
* Drug: Ustekinumab - Standard Dosage
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (PsA) for at least 6 months Are candidates for phototherapy or systemic treatment of psoriasis Have screening laboratory test results within the study parameters Exclusion Criteria: Currently have nonplaque forms of psoriasis Have used any therapeutic agent targeted at reducing interleukin-12 (IL-12) or interleukin-23 (IL-23), including but not limited to ustekinumab and briakinumab Received conventional systemic therapies or phototherapy within the last 4 weeks Received biologic therapies within the last 3 months

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ustekinumab Half-standard Dosage<br>Participants will receive ustekinumab at half the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12. | Drug: Ustekinumab - Half-Standard Dosage<br>* Ustekinumab 0.375 mg/kg, 22.5 mg, or 45 mg based on body weight, administered subcutaneously (under the skin) at Weeks 0, 4, 16, 28, and 40.<br>Other: Placebo<br>* Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.<br>|
| Experimental: Ustekinumab Standard Dosage<br>Participants will receive ustekinumab at the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12. | Drug: Ustekinumab - Standard Dosage<br>* Ustekinumab 0.75 mg/kg, 45 mg, or 90 mg based on body weight administered subcutaneously at Weeks 0, 4, 16, 28, and 40.<br>Other: Placebo<br>* Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.<br>|
| Experimental: Placebo<br>Participants will receive matching placebo at Week 0 and 4, followed by ustekinumab at half-standard or standard dosage at Weeks 12, 16, 28, and 40. | Other: Placebo<br>* Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 or 1 at Week 12 in each treatment group. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. A PASI 75 response is defined as a equal to or greater than (=>) 75% improvement in PASI score from baseline. The table below shows the percentage of participants who achieved a PASI 75 response at Week 12 in each treatment group. | Week 12 | 
| Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups | The CDLQI is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a child's quality of life. The CDLQI, a 10-item questionnaire has 4 items response options and a recall period of 1 week. In addition to evaluating overall quality of life, the CDLQI can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, leisure, School or holidays, personal relationships, sleep, and treatment. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in quality of life. The table below shows the mean change in CDLQI score from baseline at Week 12 for each treatment group. | Baseline; Week 12 | 
| The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. The table below shows the percentage of participants who achieved a PASI 90 response defined as achieving a greater than or equal to (≥) 90% improvement in PASI score from baseline. | Week 12 | 
| The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12 | The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 and the percentage of participants who achieved a PGA score of 0, 1, or 2 at Week 12 in each treatment group. | Week 12 | 
| The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). The table below shows the percentage of participants in each treatment group who were PASI 50 responders at Week 12 defined as participants who achieved a greater than or equal to (>=) 50% improvement in PASI score from baseline as well as the percentage of participants with a PASI score of 0. | Week 12 | 
| The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12 | The PedsQL is a general health-related quality of life measure developed for use in children and adolescent populations. The Generic Core Scale contains 23 items and is comprised of 4 domains: physical, social, emotional, and school functioning. Each domain can be scored independently. Additionally, a Psychosocial Health and Physical Health Summary Score can be calculated as well as a total score. The measure distinguishes between healthy children and children with acute and chronic health conditions and disease severity within a chronic health condition. The measure is applicable for healthy school and community populations, as well as with pediatric populations with acute and chronic health conditions and has versions for both parent and teen report. Scores range from 0 to 100, and higher scores indicate better health related quality of life. | Week 12 | 
| The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1 |  | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ustekinumab, Injection, CNTO 1275, Stelara, Pediatric psoriasis, Adolescents