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An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Participants Greater Than or Equal to 6 to Less Than 12 Years of Age (CADMUS Jr)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02698475
Recruitment Status : Active, not recruiting
First Posted : March 3, 2016
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in pediatric participants aged greater than or equal to (>=) 6 through less than (<) 12 years with moderate to severe chronic plaque psoriasis

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Ustekinumab 0.75 mg/kg Drug: Ustekinumab 45 mg Drug: Ustekinumab 90 mg Phase 3

Detailed Description:
This is an open label (identity of study drug will be known to participant and study staff) and multicenter (when more than one hospital or medical school team work on a medical research study) study. The participant population will be comprised of boys and girls who have had a diagnosis of plaque psoriasis for at least 6 months prior to first study drug administration and who have moderate to severe disease defined by Psoriasis Area and Severity Index score (PASI) >=12, Physician's Global Assessment (PGA) >=3, and Body Surface Area (BSA) >=10 percent (%). The study consists of Screening Phase (up to 10 weeks before administration of the study drug), Treatment Period (Week 0 up to Week 52) and Safety follow up (Week 56). Participants will be primarily evaluated for efficacy, pharmacokinetics (PK) and safety. Following completion of the Week 52 visit, participants who have had a beneficial response from ustekinumab treatment as determined by the investigator, and who have not yet reached the age of 12 years or older in countries where marketing authorization for ustekinumab has been granted for the treatment of psoriasis in adolescent participants (12-17 years), and are willing to continue ustekinumab treatment, may enter the long-term extension period (from Week 56 through Week 264) of the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Subjects Greater Than or Equal to 6 to Less Than 12 Years of Age
Actual Study Start Date : May 13, 2016
Actual Primary Completion Date : December 21, 2017
Estimated Study Completion Date : July 13, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Ustekinumab

Arm Intervention/treatment
Experimental: Ustekinumab Group
Participants will receive 1 of the following dose levels depending on their weight: participants weighing less than (<) 60 kg will receive Ustekinumab 0.75 milligram per kilogram (mg/kg); participants weighing greater than or equal to (>=) 60 kg to less than or equal to (<=) 100 kg will receive ustekinumab 45 mg; participants weighing >100 kg will receive ustekinumab 90 mg, at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants who enter the long-term extension (LTE) period will continue receiving ustekinumab every 12 weeks (q12w) beginning at Week 56 up to Week 248.
Drug: Ustekinumab 0.75 mg/kg
Participants weighing less than (<) 60 kilograms will receive ustekinumab 0.75 milligram per kilogram (mg/kg) at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants for LTE period will continue to receive ustekinumab 0.75 mg/kg up to Week 248.

Drug: Ustekinumab 45 mg
Participants weighing greater than or equal to (>=) 60 kg to less than or equal to (<=) 100 kg will receive ustekinumab 45 mg at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants for LTE period will continue to receive ustekinumab 45 mg up to Week 248.

Drug: Ustekinumab 90 mg
Participants weighing >100 kg will receive ustekinumab 90 mg at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants for LTE period will continue to receive ustekinumab 90 mg up to Week 248.




Primary Outcome Measures :
  1. Percentage of Participants with a Physician's Global Assessment (PGA) of Cleared (0) or Minimal (1) at Week 12 [ Time Frame: Week 12 ]
    The PGA is used to determine the participant's psoriasis lesions overall at a given time point. Overall lesions will be graded for induration scale which ranges from 0=no evidence of plaque elevation to 5=severe plaque elevation , erythema scale which ranges from 0=no evidence of erythema, hyperpigmentation may be present to 5=dusky to deep red coloration, and scaling scale which ranges from 0=no evidence of scaling to 5=severe; very thick tenacious scale predominates. The sum of the 3 scales will be divided by 3 to obtain a final PGA score (total score = 0 to 5).


Secondary Outcome Measures :
  1. Serum Ustekinumab Concentrations [ Time Frame: Week 4, 12, 16, 28 40 and 52 ]
    Ustekinumab concentrations in serum will be measured.

  2. Percentage of Participants who Achieve a Greater Than or Equal to (>=75) Percent (%) Improvement in Psoriasis Area and Severity Index Score (PASI) From Baseline at Week 12 [ Time Frame: Week 12 ]
    The Psoriasis Area and Severity Index or 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. The severity of disease is calculated as follows. In the PASI system, the body is divided into 4 regions: the head (h), trunk (t), upper extremities (u), and lower extremities (l), which account for 10%, 30%, 20% and 40% of the total Body Surface Area (BSA), respectively. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The scoring system for the signs of the disease (erythema, induration, and scaling) are: 0 = none, 1 = slight, 2 = moderate, 3 = severe, and 4 = very severe.

  3. Change in Children's Dermatology Life Quality Index (CDLQI) From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ]
    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 item 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.

  4. Percentage of Participants who Achieve a >=90% Improvement in PASI From Baseline at Week 12 [ Time Frame: Week 12 ]
    The Psoriasis Area and Severity Index or 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. The severity of disease is calculated as follows. In the PASI system, the body is divided into 4 regions: the head (h), trunk (t), upper extremities (u), and lower extremities (l), which account for 10%, 30%, 20% and 40% of the total BSA, respectively. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The scoring system for the signs of the disease (erythema, induration, and scaling) are: 0 = none, 1 = slight, 2 = moderate, 3 = severe, and 4 = very severe.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants who have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (PsA) for at least 6 months prior to first administration of study drug, with widespread lesions defined by Psoriasis Area and Severity Index score (PASI) greater than or equal to (>=) 12, Physician's Global Assessment (PGA) >=3, and involved body surface area (BSA) >=10 percent (%)
  • Participants who are candidates for phototherapy or systemic treatment of psoriasis (either naive or history of previous treatment) or have psoriasis considered by the investigator as poorly controlled with topical therapy after an adequate dose and duration of therapy
  • Participants who are considered eligible according to the protocol defined tuberculosis (TB) screening criteria
  • Participants must have positive protective antibody titers to varicella and measles prior to the first administration of study drug. In the absence of positive protective antibody titers, the participant must have documentation of age-appropriate vaccination for varicella and/or measles (that includes both doses of each vaccine) or verification of past varicella and/or measles infection documented by a health care provider
  • Participants must agree not to receive a live virus or live bacterial vaccination at least 2 weeks (or longer as indicated in the package insert of the relevant vaccine) prior to the first administration of study drug, during the study, or within 15 weeks after the last administration of study drug
  • Participants must agree not to receive a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening, during the study, or within 12 months after the last administration of study drug

Exclusion Criteria:

  • Participants who currently have nonplaque forms of psoriasis (example, erythrodermic, guttate, or pustular)
  • Have received any systemic immunosuppressants (example methotrexate [MTX], azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of the first administration of study drug
  • Have received any biologic agent (example ENBREL, HUMIRA) within the previous 3 months or 5 times the t1/2 of the agent, whichever is longer
  • Have a history of chronic or recurrent infectious disease
  • Have a history of latent or active granulomatous infection
  • Have any known malignancy or have a history of malignancy
  • Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698475


Locations
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United States, California
San Diego, California, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, Texas
Arlington, Texas, United States
Dallas, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
Belgium
Brussels, Belgium
Gent, Belgium
Liege, Belgium
Canada, Alberta
Calgary, Alberta, Canada
Canada, Newfoundland and Labrador
St. John's, Newfoundland and Labrador, Canada
Germany
Berlin, Germany
Bonn, Germany
Dresden, Germany
Frankfurt, Germany
Hungary
Budapest, Hungary
Debrecen, Hungary
Kaposvar, Hungary
Kecskemet, Hungary
Szeged, Hungary
Korea, Republic of
Bundang, Korea, Republic of
Incheon, Korea, Republic of
Seoul, Korea, Republic of
Netherlands
Nijmegen, Netherlands
Poland
Lodz, Poland
Warszawa, Poland
Wroclaw, Poland
Taiwan
Kaohsiung, Taiwan
Taipei, Taiwan
Taoyuan, Taiwan
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02698475    
Other Study ID Numbers: CR108129
CNTO1275PSO3013 ( Other Identifier: Janssen Research & Development, LLC )
2016-000121-40 ( EudraCT Number )
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Research & Development, LLC:
Psoriasis
Ustekinumab
STELARA
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ustekinumab
Dermatologic Agents