Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis
- Conditions
- Juvenile Psoriatic ArthritisMedDRA version: 20.0Level: PTClassification code 10076674Term: Juvenile psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2020-005503-40-PL
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
1. =5 to <18 years of age, inclusive.
2. Diagnosis of jPsA by Vancouver inclusion criteria, with exclusion of ERA. Diagnosis made =3 months (ie. 90 days) prior to screening. Arthritis plus psoriasis, or arthritis plus =2 of the following: dactylitis, nail pits, family history of psioriasis 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 or hematology 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: 60
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; see definition in
Appendix 17 of the study protocol)
2. Taken any disallowed therapies as noted in Section 6.8, Concomitant
Therapy within the timeframe specified before the planned first dose of
study intervention.
3. If participants were non-responders to previously received IL-23
blockers including guselkumab, tildrakizumab (MK3222) and
risankizumab (BI-655066). Prior non-response to an anti-TNFa inhibitor,
an IL-17 inhibitor or a Janus kinase (JAK) inhibitor is not an exclusion.
Participants who previously discontinued ustekinumab for intolerance or
inadequate response may be enrolled into the guselkumab cohort.
Patients who previously discontinued guselkumab due to intolerance
may be enrolled into the ustekinumab cohort. Participants who
previously discontinued tildrakizumab or risankizumab due to
intolerance may be enrolled into either cohort.
4. Received an investigational intervention (including investigational
vaccines) or used an invasive investigational medical device within 4
weeks or 5 half-lives (whichever is longer) before the planned first dose
of either study intervention or is currently enrolled in another study
using an investigational intervention or procedure. 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, 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 prior to the first administration of either study intervention (Section 5.2, Exclusion criterion 14b 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 and guselkumab in jPsA<br>- Evaluate efficacy of ustekinumab and guselkumab in jPsA;Secondary Objective: - Evaluate PK of ustekinumab and guselkumab in jPsA<br>- Evaluate efficacy of ustekinumab and guselkumab in jPsA<br>- Evaluate safety of ustekinumab and guselkumab in jPsA<br>- Evaluate immunogenicity of ustekinumab and guselkumab in jPsA;Primary end point(s): Ustekinumab<br>1. Steady-state trough concentrations and population PK model-predicted AUCss over a 12-week dosing interval at Week 28 by baseline age groups.<br>2. ACR Pedi 30 response at Week 24.<br><br>Guselkumab<br>1. Steady-state trough concentrations and population PK model-predicted AUCss over a dosing interval (4 or 8 weeks) at Week 28 by baseline age groups.<br>2. ACR Pedi 30 response at Week 24.;Timepoint(s) of evaluation of this end point: Ustekinumab and Guselkumab<br>1: Week 28<br>2: Week 24
- Secondary Outcome Measures
Name Time Method