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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02698475
• Date of registration: 29/02/2016
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: 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
• Scientific 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
• Date of first enrolment: June 2016
• Target sample size: 44
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02698475
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, France, Germany, Hungary, Korea, Republic of, Netherlands, Poland, Taiwan, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: 11 Years
Gender: All

Health Condition(s) or Problem(s) studied

Psoriasis

Intervention(s)

Drug: Ustekinumab 45 mg

Drug: Ustekinumab 90 mg

Drug: Ustekinumab 0.75 mg/kg

Primary Outcome(s)

Percentage of Participants With Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 [Time Frame: Weeks 4, 8, 12, 16, 28, 40, and 52]

Change From Baseline in CDLQI Component Scores at Week 12 [Time Frame: Baseline and Week 12]

Percentage of Participants With a CDLQI Score of 0 or 1 at Weeks 4, 12, 28 and 52 in Participants With a Baseline CDLQI Score > 1 [Time Frame: Weeks 4, 12, 28, and 52]

Percentage of Participants With a CDLQI Score of 0 or 1 at Week 12 in Participants With a Baseline CDLQI Score Greater Than (>) 1 [Time Frame: Week 12]

Percentage of Participants Who Achieved PASI 90 Response at Week 12 [Time Frame: Week 12]

Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 [Time Frame: Weeks 4, 8, 12, 16, 28, 40, and 52]

Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Weeks 4, 12, 28, and 52 [Time Frame: Baseline and Weeks 4, 12, 28, 52]

Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 [Time Frame: Week 12]

Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52 [Time Frame: Baseline and Weeks 4, 8, 12, 16, 28, 40, 52]

Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Week 12 [Time Frame: Baseline and Week 12]

Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 [Time Frame: Week 12]

Secondary ID(s)

CNTO1275PSO3013

2016-000121-40

CR108129

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02698475