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A phase 3, randomized, multicenter, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of AKP-022 administered for 24 weeks in patients with uterine fibroids (LUNA1)

A phase 3 clinical study to compare the efficacy and safety of AKP-022 with placebo in patients with uterine fibroids (LUNA1)

Tomita Shinpei

ASKA Pharmaceutical Co., Ltd.

2-5-1, Shibaura, Minato-ku, Tokyo, Japan

aska-clinical@aska-pharma.co.jp

Tomita Shinpei

ASKA Pharmaceutical Co., Ltd.

2-5-1, Shibaura, Minato-ku, Tokyo, Japan

+81-80-6645-9201

aska-clinical@aska-pharma.co.jp

Not Recruiting

Jan. 21, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Japanese premenopausal female patients who are aged 18 years or older
- Patients who had consecutive days of menstrual bleeding
- Patients with at least 1 measurable fibroid on transvaginal ultrasound, excluding calcified fibroids
- Patients with a diagnosis of menorrhagia
- Patients who are capable of using appropriate contraception during the study period

- Patients who have had a hysterectomy or bilateral oophorectomy
- Patients with pathologic findings other than uterine fibroid that could either cause or contribute to menorrhagia, or any other clinically significant gynecologic disorder
- Patients with a current history of thyroid dysfunction with irregular menstruation, or with a potential for irregular menstruation due to thyroid dysfunction
- Patients with undiagnosed abnormal vaginal bleeding
- Patients with marked metrorrhagia or anovulatory bleeding
- Patients with current or previous blood disorders (e.g., thalassemia, sickle cell anemia, folic-acid deficiency, and coagulopathy), excluding iron-deficiency anemia or latent iron-deficiency anemia
- Patients with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis
- Patients with current or previous osteoporosis, osteopenia, or other metabolic bone diseases

Female

Heavy menstrual bleeding associated with uterine fibroid

Oral administration of AKP-022, placebo or relugolix

Proportion of participants with a total PBAC score of < 10 from Week 18 to Week 24 of study treatment

+81-92-721-9900

Nov. 28, 2024

No

none