Phase 3
N=44
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
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02698475 ↗Enrolled (actual)
44
Serious AEs
5.6%
Results posted
Aug 2020
Primary outcome: Primary: Percentage of Participants With Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 — 77.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ustekinumab 0.75 mg/kg (Drug); Ustekinumab 45 mg (Drug); Ustekinumab 90 mg (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 |
77.3 | — |
| SECONDARY Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 |
84.1 | — |
| SECONDARY Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Week 12 |
-6.3 | — |
| SECONDARY Percentage of Participants Who Achieved PASI 90 Response at Week 12 |
63.6 | — |
| SECONDARY 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 |
4.8; 33.3; 66.7; 26.8; 63.4; 85.4 | — |
| SECONDARY 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 |
2.4; 16.7; 26.2; 52.4; 17.1; 43.9 | — |
| SECONDARY Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52 |
52.9; 78.9; 89.7; 90.4; 90.4; 89.9 | — |
| SECONDARY 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 |
43.2; 61.4; 77.3; 93.2; 38.6; 63.6 | — |
| SECONDARY Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Weeks 4, 12, 28, and 52 |
-4.1; -6.3; -6.6; -6.4 | — |
| SECONDARY Percentage of Participants With a CDLQI Score of 0 or 1 at Week 12 in Participants With a Baseline CDLQI Score Greater Than (>) 1 |
61.5 | — |
| SECONDARY 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 |
37.8; 61.5; 62.2; 58.3 | — |
| SECONDARY Change From Baseline in CDLQI Component Scores at Week 12 |
-1.9; -1.7; -0.5; -0.8; -0.4; -0.9 | — |
| SECONDARY Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 |
64; 80; 100; 50; 70; 100 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT02698475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.