ISRCTN49107623进行中（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)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- 性别
- All
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 =12 weeks 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.
排除标准
- •1. Participants with enthesitis-related arthritis (ERA)
- •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 biologic treatment with an overlapping mechanism including guselkumab, ustekinumab, 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. Patients who previously discontinued ustekinumab for intolerance may be enrolled into the guselkumab cohort. Patients who previously discontinued guselkumab due to intolerance may be enrolled into the ustekinumab 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 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, 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 either study intervention (Section 5.1, Inclusion criterion 16.a of the study protocol).
研究者
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