그레이브스병(GD) 환자에서 바토클리맙의 안전성 및 효능을 평가하기 위한 연구

실험적: 바토클라맙

참가자는 12주 동안 바토클리맙 680mg(mg) 피하(SC) 매주(QW) 주사를 받은 후 12주 동안 340mg SC QW를 받게 됩니다.

의약품: IMVT-1401(바토클리맙)

바토클리맙은 완전 인간 항신생아 단편 결정화 수용체(FcRn) 단클론 항체입니다.

다른 이름들:

• IMVT-1401

Percentage of Participants Who Achieved Normalization of Free Triiodothyronine (FT3) and Free Thyroxine (FT4), or Have FT3 and/or FT4 Below the Lower Limit of Normal (LLN) at Week 24 Without Increase in ATD Dose Compared to Baseline

Antithyroid drug therapy was indicated as a first-line treatment for GD by effectively controlling hyperthyroidism. FT3 and FT4 were prespecified biomarkers of GD. Fasting blood samples were collected to assess the percentage of participants who achieved normalization of FT3 and FT4 or levels below the LLN without increase in ATD dose compared to baseline. The change in the ATD dose was compared only between baseline and Week 24 to determine if there was an increase. Percentages were estimated using the 2-sided Clopper-Pearson Exact method, with corresponding 95% confidence intervals. Participants who, at Week 24, without an increase in ATD dose compared with baseline, had achieved normalization of FT3 and FT4, or had FT3 and/or FT4 below the lower limit of normal (LLN), were considered responders. Participants with missing Week 24 assessments were considered nonresponders.

Percentage of Participants Who Achieved Normalization of FT3 and FT4 With ATD Dose ≤50% of the Baseline ATD Dose at Week 24

Antithyroid drug therapy was indicated as a first-line treatment for GD by effectively controlling hyperthyroidism. FT3 and FT4 were prespecified biomarkers of GD. Fasting blood samples were collected to assess the percentage of participants who achieved normalization of FT3 and FT4 with ATD dose ≤50% of the baseline ATD. The change in the ATD dose was compared only between baseline and Week 24 to determine if there was at least a 50% reduction. Percentages were estimated using the two-sided Clopper-Pearson exact method, with corresponding 95% confidence intervals.

Percentage of Participants Who Are Off ATD Treatment and Achieved Normalization of FT3 and FT4, or Had FT3 and/or FT4 Below the LLN at Week 24

Antithyroid drug therapy was indicated as a first-line treatment for GD by effectively controlling hyperthyroidism. FT3 and FT4 were prespecified biomarkers of GD. Fasting blood samples were collected to assess the percentage of participants who achieved normalization of FT3 and FT4 or levels below the LLN. Responders were defined as participants who were off ATD therapy at Week 24. Percentages were estimated using the two-sided Clopper-Pearson exact method, with corresponding 95% confidence intervals.