Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis
- Conditions
- Juvenile Psoriatic ArthritisTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]MedDRA version: 20.0Level: PTClassification code 10076674Term: Juvenile psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
- Registration Number
- EUCTR2020-005503-40-Outside-EU/EEA
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
1. =5 to <18 years of age, inclusive.
2. Diagnosis of jPsA by Vancouver inclusion criteria, with exclusion of ERA. Diagnosis made =3 months prior to screening. Arthritis plus psoriasis, or arthritis plus at least 2 of the following: dactylitis, nail pits, family history in a first or second-degree relative, psoriasis-like rash.
3. Active disease in =3 joints at screening and at Week 0 (defined as swelling OR loss of motion with pain and/or tenderness). Swelling alone meets the criteria for an active arthritic joint. In the absence of swelling, loss of motion with pain or tenderness or both pain and tenderness meet the criteria for an active arthritic joint.
4. Medically stable on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant’s source documents and initialed by the investigator.
5. Medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to not be clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator.
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Participants with enthesitis-related arthritis (ERA)
2. Taken any disallowed therapies as noted in Section 6.8, Concomitant Therapy of the study protocol before the planned first dose of study intervention.
3. If participants were nonresponders to previously received biologic treatment (excluding anti TNFas), including, but not limited to, guselkumab, secukinumab (AIN457), tildrakizumab (MK3222), ixekizumab (LY2439821), brodalumab (AMG827), risankizumab (BI-655066), or other investigative biologic treatments for PsA or psoriasis. Prior nonresponse to an anti-TNFa inhibitor or to a Janus kinase (JAK) inhibitor is not an exclusion.
4. Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 4 months before the planned first dose of study intervention or is currently enrolled in an investigational study. Receipt of an investigational vaccine for COVID-19 is not an automatic exclusion criterion; discuss with medical monitor.
5. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to screening. An exception is made for participants currently receiving treatment for latent TB with no evidence of active TB, or who have a history of latent TB and documentation of having completed appropriate treatment for latent TB within 3 years prior to the first administration of study agent (Section 5.1, Inclusion criterion 16.a of the study protocol).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - Evaluate PK of ustekinumab in jPsA<br>- Evaluate efficacy of ustekinumab in jPsA;Secondary Objective: - Evaluate PK of ustekinumab in jPsA<br>- Evaluate efficacy of ustekinumab in jPsA<br>- Evaluate safety of ustekinumab in jPsA<br>- Evaluate immunogenicity of ustekinumab in jPsA;Primary end point(s): 1. Observed steady-state trough concentrations and population PK model-predicted area under<br>the curve at steady-state over a 12-week dosing interval (AUCss) at Week 28.<br>2. Percentage of participants with jPsA achieving the JIA ACR 30 criteria at Week 24.;Timepoint(s) of evaluation of this end point: 1: Week 28<br>2: Week 24
- Secondary Outcome Measures
Name Time Method