Fezolinetant for reducing hot flashes in menopausal Chinese women

A Phase 2, Randomized, Placebo-controlled, 12-week, Double-blind Study to Assess the Efficacy and Safety of Fezolinetant 45 mg in Chinese Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause

This study tests if a new medication called fezolinetant can help reduce hot flashes in Chinese women going through menopause.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 40 Years to 65 Years
• Sex: Female
• Sponsor: Astellas Pharma Inc (Industry-sponsored)
• Locations: 22 sites (Beijing, Beijing and 21 other locations)
• Trial ID: NCT06812754 on ClinicalTrials.gov

What this trial studies

This study aims to confirm the effectiveness of fezolinetant in reducing hot flashes in Chinese women experiencing menopause. Participants will be randomly assigned to receive either fezolinetant or a placebo for up to 12 weeks. The study will also assess the safety and tolerability of the treatment. Women will track their symptoms using an electronic device with an app throughout the study period.

Who should consider this trial

Good fit: Ideal candidates are Chinese women experiencing moderate to severe hot flashes and seeking relief from menopausal symptoms.

Not a fit: Patients who are not experiencing hot flashes or have contraindications to fezolinetant may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-hormonal option for managing hot flashes in menopausal women.

How similar studies have performed: Other studies have shown success with fezolinetant in treating hot flashes, indicating a promising approach for this population.

Eligibility criteria

Inclusion Criteria:

* Participant has a body mass index \>/= 16 kg/m2 and \</= 38 kg/m2 at screening visit.
* Participant must be seeking treatment or relief for vasomotor symptom(s) (VMS) associated with menopause and confirmed as menopausal per 1 of the following criteria at the screening visit:

  * Spontaneous amenorrhea for \>/= 12 consecutive months
  * Spontaneous amenorrhea for \>/= 6 months with biochemical criteria of menopause (follicle-stimulating hormone (FSH) \> 40 IU/L); or
  * Having had bilateral oophorectomy \>/= 6 weeks prior to the screening visit (with or without hysterectomy).
  * FSH \> 40 IU/L if participants received hysterectomy but still have an ovary/ovaries.
* Within the 10 days prior to randomization, participant must have a minimum average of 7 moderate to severe hot flash(es) (HFs) (VMS) per day (data must be available for at least 7 of the last 10 days prior to randomization).
* Participant is in good general health as determined on the basis of medical history and general physical examination, performed at the screening visit; hematology and biochemistry parameters, pulse rate and/or blood pressure, and electrocardiogram (ECG) within the reference range for the population studied, or showing no clinically relevant deviations.
* Participant has documentation of a normal/negative or no clinically significant findings mammogram (or breast ultrasound) (e.g., \< Breast Imaging-Reporting and Data System (BI-RADS) class 4; obtained at screening or within the prior 12 months of study enrollment). Appropriate documentation includes a written report or an electronic report indicating normal/negative or no clinically significant mammographic findings.
* Participant is willing to undergo a transvaginal ultrasound (TVU) to evaluate the uterus and ovaries at screening and week 12 (end of treatment (EOT)), and for participants who are withdrawn from the study prior to completion, a TVU at the early discontinuation (ED) visit. This is not required for participants who have had a partial (supracervical) or total hysterectomy.
* Participant has documentation of a normal or not clinically significant Pap test (or equivalent cervical cytology) within the previous 12 months of study enrollment or at screening. This is not required for participants who have had a total hysterectomy.
* Participant has a negative urine pregnancy test at screening; this is not required for participants who have had a total hysterectomy.
* Participant has a negative serology panel \[i.e., negative hepatitis B surface antigen (HBsAg) and negative hepatitis C virus antibody (HCVAb) screens\] at screening.
* Participant agrees not to participate in another interventional study while participating in the present study.

Exclusion Criteria:

* Participant has known substance abuse or alcohol addiction within 6 months of screening.
* Participant has a current malignancy, with exception of non-metastatic basal cell carcinoma of the skin.
* Participant has a history of malignancy with exceptions of at least 5 years post-treatment and without known recurrence.
* For participants with a uterus: Participant has an unacceptable result from the TVU assessment at screening, i.e., full length of endometrial cavity cannot be visualized or presence of a clinically significant finding.
* Participant has a history within the last 6 months of undiagnosed uterine bleeding.
* Participant has a medical condition or chronic disease (including history of neurological \[including cognitive\], hepatic, renal, cardiovascular, gastrointestinal, pulmonary \[e.g., moderate asthma\], endocrine, or gynecological disease) or malignancy that could confound interpretation of the study outcome.
* Participant has a history of suicide attempt or suicidal behavior within the last 12 months or has suicidal ideation within the last 12 months (a response of "yes" to question 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale \[C-SSRS\]), or who is at significant risk to commit suicide at screening \[visit 1\].
* Participant has previously been enrolled in a clinical trial with fezolinetant or other neurokinin (NK) receptor antagonists.
* Participant uses a prohibited therapy (strong and moderate cytochrome P450 1A2 \[CYP1A2\] inhibitors, hormone replacement therapy (HRT), hormonal contraceptive or any treatment for VMS \[prescription, over-the-counter, or herbal\]) or is not willing to wash-out and discontinue use of such drugs for the full duration of study conduct.
* Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
* Participant has uncontrolled hypertension, defined as systolic blood pressure \>/=140 mmHg or diastolic blood pressure as \>/= 90 mmHg based on an average of 2 to 3 readings within the screening period.

  * Participants with a medical history of hypertension who are well controlled may be enrolled
  * Participants who do not meet these criteria may be re-assessed after initiation or review of antihypertensive measures
* Participant has active liver disease, jaundice, elevated liver aminotransferases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST)), elevated total or direct bilirubin, elevated international normalized ratio (INR) or elevated alkaline phosphatase (ALP). Patients with mildly elevated ALT or AST up to 1.5 × upper limit of normal (ULN) can be enrolled if total and direct bilirubin are normal. Patients with mildly elevated ALP (up to 1.5 × ULN) can be enrolled if cholestatic liver disease is excluded and no cause other than fatty liver is diagnosed. Patients with Gilbert's syndrome with elevated total bilirubin (TBL) may be enrolled as long as hemolysis is ruled-out (i.e., direct bilirubin, hemoglobin and reticulocytes are normal).
* Participant has creatinine \> 1.5 × ULN; or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease formula \</=30 mL/min/1.73 m2 at screening.
* Participant has a positive result for human immunodeficiency virus (HIV) at screening.
* Participant has any condition which makes the participant unsuitable for study participation.
* Participant is unable or unwilling to complete the study procedures.
* Participant has a known or suspected hypersensitivity to fezolinetant or any components of the formulation used.

Where this trial is running

Beijing, Beijing and 21 other locations

• Beijing Hospital — Beijing, Beijing, China (Recruiting)
• Capital Medical University (CMU) - Beijing Shijitan Hospital — Beijing, Beijing, China (Recruiting)
• Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
• Guangzhou Medical University - The Third Affiliated Hospital — Guangzhou, Guangdong, China (Recruiting)
• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)
• Shenzhen Maternal & Child Health Hospital — Shenzhen, Guangdong, China (Recruiting)
• Guangxi Medical University (GXMU) - Liuzhou Renmin Hospital — Liuzhou, Guangxi, China (Recruiting)
• Liuzhou Worker's Hospital — Liuzhou, Guangxi, China (Recruiting)
• The second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
• Hunan Provincial Maternal and Child Health Care Hospital — Changsha, Hunan, China (Recruiting)
• Xiangya Hospital, Central South University — Zhuzhou, Hunan, China (Recruiting)
• Jiangxi Maternal and Child Health Hospital — Nan Chang, Jiang XI, China (Recruiting)
• Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)
• Southeast University, ZhongDa Hospital — Nanjing, Jiangsu, China (Recruiting)
• Jilin Province FAW General Hospital — Changchun, Jilin, China (Recruiting)
• Jinan Central Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China (Recruiting)
• Shandong Provincial Hospital — Jinan, Shandong, China (Recruiting)
• Shanxi Woman and Children Hospital — Taiyuan, Shanxi, China (Recruiting)
• The First hospital of Shanxi Medical University — Taiyuan, Shanxi, China (Recruiting)
• Chengdu Women's and Children's Central Hospital — Chengdu, Sichuan, China (Recruiting)
• The Second Hospital of Tianjin Medical University — Tianjin, Tianjin, China (Recruiting)
• Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Astellas Pharma Global Development, Inc.

Conditions Hot Flashes; ESN364; vasomotor symptoms; fezolinetant; VEOZAH™; menopause