ISCALIMAB-KAHALY-SUPPLEMENTAL

A supplemental dataset from an open-label, multicenter phase II proof-of-concept study evaluating the efficacy and safety of iscalimab in 15 hyperthyroid patients with Graves' disease. The data includes measurements of thyroid-related hormones, autoantibodies, plasma soluble CD40, free CD40 on B cells, soluble CXCL13, pharmacokinetics, and safety assessments collected over a 12-week intervention period. The study was authored by George J. Kahaly and is associated with an open-access publication.

Use Cases

• Analyzing the correlation between CD40 engagement and clinical response based on thyroid hormone normalization data.
• Modeling the pharmacokinetic profile of iscalimab based on the administered dose and measurement schedule.
• Investigating biomarker dynamics, such as the reduction in thyrotropin receptor autoantibodies (TSH-R-Ab) and CXCL13 levels.
• Assessing the safety profile of a non-depleting anti-CD40 monoclonal antibody based on reported adverse events.

Strengths

• Data originates from a structured, multicenter phase II clinical trial with a defined protocol.
• Includes specific quantitative results, such as a 66% mean reduction in TSH-R-Ab levels and CXCL13 concentration changes from 94.1 pg/mL to 68.5 pg/mL.
• Reports detailed patient-level outcomes, including clinical response in 7 of 15 patients and safety data for 12 patients.

Limitations

• Row count is unknown, which may limit suitability assessment.
• Column-level documentation is absent; field semantics must be inferred after download.
• Last update date is unknown; freshness unverified.

Provenance

Source

George J. Kahaly (author), associated with a paper on paperswithcode.

Collection Method

Data collected during an open-label clinical trial where patients received five intravenous doses of iscalimab over 12 weeks.

Geography

Multicenter study; specific locations unknown.