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A Study to Evaluate the Safety and Efficacy of FYU-981 in Hyperuricemic Pediatric Patients with or without Gout (Phase III Study) (Extension Study)

A Phase III Study of FYU-981 in Hyperuricemic Pediatric Patients with or without Gout (Extension Study)

28

Hyperuricemic pediatric patients with or without gout, who completed the 30-week observation period of the preceding study FYU-981-018.

Informed consent: 28 [Body weight >= 40 kg] Number of subjects who received the study treatment: 18 Number of subjects who discontinued the study: 0 Number of subjects who completed the study: 18 [Body weight < 40 kg] Number of subjects who received the study treatment: 10 Number of subjects who discontinued the study: 0 Number of subjects who completed the study: 10

The safety of this study was analyzed by combination data obtained from the previous study (FYU-981-018, jRCT2031220036) for subjects enrolled in this study with data from this study. The incidence of adverse events was 100.0% (28/28 subjects) in the overall subjects, 100.0% (18/18 subjects) in subjects weighing >= 40 kg, and 100.0% (10/10 subjects) in subjects weighing < 40 kg. The incidence of adverse drug reactions was 14.3% (4/28 subjects) in the overall subjects, 16.7% (3/18 subjects) in subjects weighing >= 40 kg, and 10.0% (1/10 subjects) in subjects weighing < 40 kg. There were no deaths, serious adverse events, or adverse events leading to discontinuation or interruption of the investigational product.

The efficacy of this study was analyzed by combination data obtained from the previous study (FYU-981-018, jRCT2031220036) for subjects enrolled in this study with data from this study. [Primary Outcome] In the overall subjects (28 subjects), the Percentage (95% confidence interval) of subjects with serum uric acid of <= 6.0 mg/dL at the end of administration was 82.1% (63.1% to 93.9%), and the lower limit of the 95% confidence interval exceeded the threshold population of 30% as predefined. [Secondary Outcome] The mean (standard deviation) serum uric acid at baseline in the previous study was 9.39 (1.18) mg/dL, 5.02 (1.42) mg/dL after 30 weeks of administration (week 0 of administration in this study), and 5.13 (1.30) mg/dL at the end of administration. The reduction rate (standard deviation) from baseline was 46.00 (16.08) % at 30 weeks of administration and 45.03 (12.59) % at the end of administration. The change (standard deviation) from baseline was -4.38 (1.74) mg/dL at 30 weeks of administration and -4.26 (1.42) mg/dL at the end of administration.

In this study, FYU-981 was administered orally to hyperuricemic pediatric patients with or without gout, at a dosage and administration bordered by 40 kg body weight for repeated 54 weeks. As a result, it was confirmed that the serum uric acid lowering effect was maintained well over the long term, up to 54 weeks after administration, without any attenuation. No significant safety concern was identified.

Mar. 09, 2026

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2041220061

Fushimi Masahiko

FUJI YAKUHIN CO., LTD.

4-383, Sakuragi-cho, Omiya-ku, Saitama-shi, Saitama, Japan

clinical-trials@fujiyakuhin.co.jp

Development Department

FUJI YAKUHIN CO., LTD.

4-383, Sakuragi-cho, Omiya-ku, Saitama-shi, Saitama, Japan

+81-48-644-3403

clinical-trials@fujiyakuhin.co.jp

Complete

Nov. 01, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

-Hyperuricemic pediatric patients with or without gout, who completed the observation for 30 weeks of Study FYU-981-018 (jRCT2031220036).

-Kidney calculi or clinically significant urinary calculi
-Patients deemed inappropriate by the investigator to conduct this study
etc.

Both

Hyperuricemic pediatric patients with or without gout

FYU-981 is administered orally once daily with the maintenance doses of 0.5 to 4 mg/day.

Percentage of subjects with serum urate <=6.0 mg/dL at the end of administration

+81-52-832-1121

Oct. 20, 2022

none