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

NCT ID: NCT02698475

Last Updated: 2021-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2020-10-31

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

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.

Conditions

Psoriasis

Keywords

Psoriasis; Ustekinumab; STELARA

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ustekinumab 0.75 mg/kg

Intervention Type: DRUG

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.

Ustekinumab 45 mg

Intervention Type: DRUG

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.

Ustekinumab 90 mg

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

San Diego, California, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

St Louis, Missouri, United States

Arlington, Texas, United States

Dallas, Texas, United States

Norfolk, Virginia, United States

Brussels, , Belgium

Ghent, , Belgium

Liège, , Belgium

Calgary, Alberta, Canada

St. John's, Newfoundland and Labrador, Canada

Berlin, , Germany

Bonn, , Germany

Dresden, , Germany

Frankfurt, , Germany

Budapest, , Hungary

Debrecen, , Hungary

Kaposvár, , Hungary

Kecskemét, , Hungary

Szeged, , Hungary

Nijmegen, , Netherlands

Lodz, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Bundang, , South Korea

Incheon, , South Korea

Seoul, , South Korea

Kaohsiung City, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Countries

France; United States; Belgium; Canada; Germany; Hungary; Netherlands; Poland; South Korea; Taiwan

References

Leu JH, Shiff NJ, Clark M, Bensley K, Lomax KG, Berezny K, Nelson RM, Zhou H, Xu Z. Intravenous Golimumab in Patients with Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis and Subcutaneous Ustekinumab in Patients with Juvenile Psoriatic Arthritis: Extrapolation of Data from Studies in Adults and Adjacent Pediatric Populations. Paediatr Drugs. 2022 Nov;24(6):699-714. doi: 10.1007/s40272-022-00533-y. Epub 2022 Sep 28.

Reference Type: DERIVED

PMID: 36171515 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CNTO1275PSO3013

Identifier Type: OTHER

Identifier Source: secondary_id

2016-000121-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108129

Identifier Type: -

Identifier Source: org_study_id