NL-OMON53596尚未招募3 期
A Phase 3 Multicenter, Open-label Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis - (PSUMMIT-Jr)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •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
- •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 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.
排除标准
- •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
研究者
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