A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2

NCT04003142 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 2693-CL-03022018-003529-27
• Study Type: interventional
• Target: 501
• Locations: 7 countries
• Sites: 93

Brief Summary

This study was for women in menopause with moderate to severe hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The study treatments are fezolinetant 30 mg (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant 45 mg (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo is a dummy treatment that looks like medicine but does not have any medicine in it.) The study compared fezolinetant and placebo after 4 and 12 weeks of dosing. The study evaluated if fezolinetant reduces the number of hot flashes and the study evaluated if fezolinetant reduces the severity of the hot flashes. Women in the study received an electronic handheld device at the first study visit. (It is similar to a smart phone.) Each day of the study, study participants used this to record their hot flashes. Their record for the 10 days before the start of study treatment was checked. They remained in the study if their record shows 7 or 8 moderate to severe hot flashes per day (50 or more per week). Next, they were picked for 1 of the 2 study treatments (fezolinetant or placebo) by chance alone. It is like flipping a coin. The study participants took study treatment for 52 weeks. The first 12 weeks of study treatment was "double-blinded." That means that the study participants and the study doctors did not know who took which of the study treatments (fezolinetant 30 mg, fezolinetant 45 mg or placebo) during that time. The last 40 weeks of study treatment was "noncontrolled." That means that each study participant and the study doctors knew which study treatment that study participant took during that time. Women who took fezolinetant during the first 12 weeks continued to take the same dose. Women who took placebo during the first 12 weeks took fezolinetant. Their dose was either 30 mg or 45 mg fezolinetant. At weeks 2, 4, 8, 12, 14, 16 and then once a month, the study participants went to the hospital or clinic for a check-up. They were asked about medications, side effects and how they felt. Other checks included physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine was collected for laboratory tests. Study participants completed questionnaires that were about how hot flashes affect their daily life. Study participants who had their uterus had the following 2 tests done at the first and last study visits. One of the 2 tests was endometrial biopsy. This test involved removing a small amount of tissue from the inside lining of the uterus. The tissue was then checked under a microscope. The other test was transvaginal ultrasound. This test used sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which was placed inside the vagina. Study participants might have a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not have this test done in the last 12 months had it done at the first study visit. They had done at the last study visit if they were due for their screening mammogram and their own doctor agrees. The last check-up at the hospital or clinic was 3 weeks after the last dose of study treatment.

Conditions

Hot Flashes

Keywords

ESN364; menopause; fezolinetant; vasomotor symptoms

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 4

  The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Baseline was the average number of moderate to severe VMS per 24 hours based on the non-missing values in the 10 days immediately prior to randomization.

  Baseline and week 4

• Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 12

  The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Baseline was the average number of moderate to severe VMS per 24 hours based on the non-missing values in the 10 days immediately prior to randomization.

  Baseline and week 12

• Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 4

  Severity of moderate to severe VMS per day at post baseline visit was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]/Total number of daily mild/moderate/severe hot flashes Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no mild or moderate or severe VMS. Higher scores indicates greater severity.

  Baseline and week 4

• Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 12

  Severity of moderate to severe VMS per day at post baseline visit was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]/Total number of daily mild/moderate/severe hot flashes Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no mild or moderate or severe VMS. Higher scores indicates greater severity.

  Baseline and week 12

Secondary Outcomes (10)

• Change From Baseline in The Mean Patient-reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b) Total Score at Week 12

  Baseline and week 12

• Change From Baseline in The Mean Frequency of Moderate, and Severe VMS to Each Study Week Up to Week 12

  Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10, and 11

• Change From Baseline in The Mean Severity of Moderate, and Severe VMS to Each Study Week Up to Week 12

  Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10 and 11

• Mean Percent Change in The Frequency of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week Up to Week 12

  Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

• Number of Participants With Percent Reduction of >=50% in the Mean Frequency of Moderate and Severe VMS From Baseline to Each Study Week Up to Week 12

  Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

Study Arms (5)

Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg

EXPERIMENTAL

Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 30 mg orally, QD from week 13 up to Week 52 during extension treatment period.

Drug: Fezolinetant

Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg

EXPERIMENTAL

Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 45 mg orally, QD from week 13 up to Week 52 during extension treatment period.

Drug: Fezolinetant

Double-blind Period: Placebo

PLACEBO COMPARATOR

Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, once daily (QD) up to week 12 during double-blind treatment period.

Drug: placebo

Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg

EXPERIMENTAL

Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.

Drug: Fezolinetant

Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg

EXPERIMENTAL

Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.

Drug: Fezolinetant

Interventions

Fezolinetant DRUG

Oral tablet

Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg; Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg; Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg; Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg

placebo DRUG

Oral Tablet

Double-blind Period: Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a body mass index ≥ 18 kg/m\^2 and ≤ 38 kg/m\^2.
• Subject must be seeking treatment or relief for vasomotor symptoms (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.
• Within the 10 days prior to randomization, subject must have a minimum average of 7 to 8 moderate to severe hot flashes (HFs) vasomotor symptoms (VMS) per day, or 50 to 60 per week.
• Subject is in good general health as determined on the basis of medical history and general physical examination, including a bimanual clinical pelvic examination and clinical breast examination devoid of relevant clinical findings, 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.
• Subject has documentation of a normal/negative or no clinically significant findings mammogram (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.
• Subject is willing to undergo a transvaginal ultrasound (TVU) to evaluate the uterus and ovaries at screening and at week 52 end of treatment (EOT), and for subjects who are withdrawn from the study prior to completion, a TVU at the early discontinuation (ED) visit.
• Subject is willing to undergo an endometrial biopsy at screening and at week 52 (EOT), for subjects with uterine bleeding, and for subjects who are withdrawn from the study prior to completion. The endometrial biopsy obtained at screening must be considered evaluable.
• Subject has documentation of a normal or not clinically significant Papanicolaou (Pap) test (or equivalent cervical cytology) within the previous 12 months or at screening.
• Subject has a negative urine pregnancy test at screening.
• Subject has a negative serology panel (i.e. negative hepatitis B surface antigen, negative hepatitis C virus antibody and negative human immunodeficiency virus antibody screens) at screening.
• Subject agrees not to participate in another interventional study while participating in the present study.

You may not qualify if:

• Subject uses a prohibited therapy (strong or 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.
• Subject has known substance abuse or alcohol addiction within 6 months of screening.
• Subject has previous or current history of a malignant tumor, except for basal cell carcinoma.
• Subject's systolic blood pressure is ≥ 130 mmHg or diastolic blood pressure is ≥ 80 mmHg based on the average of 2 to 3 readings, on at least 2 different occasions within the screening period.
• Subjects who do not meet these criteria may be re-assessed after initiation or review of antihypertensive measures.
• Subjects with a medical history of hypertension can be enrolled once they are medically clear (stable and compliant).
• Subject has history of severe allergy, hypersensitivity or intolerance to drugs in general, including the study drug and any of its excipients.
• Subject 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).
• Subject has an endometrial biopsy confirming presence of disordered proliferative endometrium, endometrial hyperplasia, endometrial cancer or other clinically significant findings at screening.
• Subject has a history within the last 6 months of undiagnosed uterine bleeding.
• Subject has a history of seizures or other convulsive disorders.
• Subject 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.
• Subject has active liver disease, jaundice or 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 times the upper limit of normal (ULN) can be enrolled if total and direct bilirubin are normal. Patients with mildly elevated ALP (up to 1.5 x 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 may be enrolled as long as direct bilirubin, hemoglobin and reticulocytes are normal.
• Subject has creatinine \> 1.5 × ULN; or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease formula ≤ 59 mL/min per 1.73 m\^2 at screening.
• Subject 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 and at randomization.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (93)

Mesa Obstetricians and Gynecologists

Mesa, Arizona, 85209, United States

Location

Precision Trials

Phoenix, Arizona, 85032, United States

Location

Visions Clinical Research - Tuscon

Tucson, Arizona, 85712, United States

Location

Excell Research

Oceanside, California, 92056, United States

Location

Dream Team Clinical Research, LLC

Pomona, California, 91767, United States

Location

Clinical Trials Research

Sacramento, California, 95821, United States

Location

Wake Research Associates, LLC

San Diego, California, 92108, United States

Location

Women's Healthcare Affiliates

San Diego, California, 92111, United States

Location

Bayview Research Group

Valley Village, California, 91607, United States

Location

Downtown Women's Health Care

Denver, Colorado, 80209, United States

Location

Horizons Clincial Research Center LLC

Denver, Colorado, 80220, United States

Location

Physicians' Research Options/Red Rocks OB/GYN

Lakewood, Colorado, 80228, United States

Location

Helix Biomedics

Boynton Beach, Florida, 33436, United States

Location

Renaissance Research and Medical Group, Inc.

Cape Coral, Florida, 33991, United States

Location

Nature Coast Clinical Research

Crystal River, Florida, 34429, United States

Location

Bioclinica Research, Melbourne

Melbourne, Florida, 32940, United States

Location

LCC Medical Research Institute, LLC

Miami, Florida, 33126, United States

Location

Suncoast Clinical Research, Inc.

Miami, Florida, 33135, United States

Location

Suncoast Research

Miami, Florida, 33176, United States

Location

Medical Health Center & Research

Miami, Florida, 33186, United States

Location

Healthcare Clinical Data Inc

North Miami, Florida, 33161, United States

Location

Sensible Healthcare LLC

Ocoee, Florida, 34761, United States

Location

Bioclinica Research

Orlando, Florida, 32806, United States

Location

Ormond Medical Arts Pharmaceutical Research Center

Ormond Beach, Florida, 32174, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Physician Care Clinical Research, LLC

Sarasota, Florida, 34239-3132, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

GCP Clinical Research, LLC

Tampa, Florida, 33614, United States

Location

Comprehensive Clinical Development

West Palm Beach, Florida, 33409, United States

Location

Clinical Research of Central Florida

Winter Haven, Florida, 33880, United States

Location

Georgia Research for Women

Atlanta, Georgia, 30312-1220, United States

Location

Agile Clinical Research Trials, LLC

Atlanta, Georgia, 30328, United States

Location

iResearch Atlanta LLC

Decatur, Georgia, 30030, United States

Location

WR-Mount Vernon Clinical Research

Sandy Springs, Georgia, 30328, United States

Location

Georgia Clinical Research

Snellville, Georgia, 30078, United States

Location

Elite Clinical Trials

Blackfoot, Idaho, 83221, United States

Location

ASR, LLC-Advanced Specialty Research

Nampa, Idaho, 83687, United States

Location

Affinity Clinical Research Institute

Oak Brook, Illinois, 60523, United States

Location

Cypress Medical Research Center

Wichita, Kansas, 67226, United States

Location

Praetorian Pharmaceutical Research

Marrero, Louisiana, 70072, United States

Location

Southern Clinical Research Associates

Metairie, Louisiana, 70001, United States

Location

Women Under Study, LLC

New Orleans, Louisiana, 70125, United States

Location

Pharmasite Research Inc

Baltimore, Maryland, 21210, United States

Location

Clinical Research Center of Nevada (CRCN)

Las Vegas, Nevada, 89104-3218, United States

Location

Dr.R. Garn Mabey, MD,Office Of

Las Vegas, Nevada, 89128, United States

Location

Hassman Research Institute, LLC

Berlin, New Jersey, 08009, United States

Location

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States

Location

Bosque Women's Care

Albuquerque, New Mexico, 87109-4640, United States

Location

Circuit Clinical

West Seneca, New York, 14224, United States

Location

Premier Gynecology & Wellness

Charlotte, North Carolina, 28207, United States

Location

Medication Management, LLC

Greensboro, North Carolina, 27408, United States

Location

Hwc Women's Research Center

Englewood, Ohio, 45322, United States

Location

OB/GYN Associates of Erie

Erie, Pennsylvania, 16507, United States

Location

Dr. Marvin Kalafer MD, Office Of

Jenkintown, Pennsylvania, 19046, United States

Location

Research Protocol Management Specialists

Pittsburgh, Pennsylvania, 15243, United States

Location

Clinical Neuroscience Solutions, Inc

Memphis, Tennessee, 38119, United States

Location

The Clinical Research Center, LLC

Carrollton, Texas, 75007, United States

Location

Advances in Health

Houston, Texas, 77030, United States

Location

Centex Studies, Inc.

Houston, Texas, 77058, United States

Location

FMC Science

Lampasas, Texas, 76550, United States

Location

ClinRx Research

Plano, Texas, 75024, United States

Location

Granger Medical Clinic

Riverton, Utah, 84065, United States

Location

Wasatch Clinical Research, LLC

Salt Lake City, Utah, 84107, United States

Location

Seattle Women's: Health, Research, Gynecology

Seattle, Washington, 98115, United States

Location

North Spokane Women's Health

Spokane, Washington, 99207, United States

Location

Site CA15006

Sarnia, Ontario, N7T 4X3, Canada

Location

Site CA15009

Toronto, Ontario, M3J 2C5, Canada

Location

Site CA15007

Lévis, Quebec, Canada

Location

Site CA15002

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Site CA15001

Victoriaville, Quebec, G6P 6P6, Canada

Location

Site CA15008

Québec, Canada

Location

Site CZ42007

Písek, 39701, Czechia

Location

Site CZ42006

Prague, 12000, Czechia

Location

Site CZ42004

Prague, 190 12, Czechia

Location

Site CZ42005

Tábor, 39003, Czechia

Location

Site CZ42003

Vsetín, 75501, Czechia

Location

Site LV37101

Riga, 1005, Latvia

Location

Site LV37103

Riga, Latvia

Location

Site PL48001

Bydgoszcz, 85-065, Poland

Location

Site PL48013

Elblag, 82-300, Poland

Location

Site PL48009

Katowice, 40-851, Poland

Location

Site PL48011

Krakow, Poland

Location

Site PL48002

Lublin, 20-069, Poland

Location

Site PL48012

Lublin, Poland

Location

Site PL48004

Piaseczno, 05-500, Poland

Location

Site PL48006

Poznan, 60-192, Poland

Location

Site PL48005

Szczecin, 71-434, Poland

Location

Site PL48010

Warsaw, 02-201, Poland

Location

Site PL48003

Warsaw, 02777, Poland

Location

Site ES34003

Aravaca, 28023, Spain

Location

Site ES34002

Centelles, 08540, Spain

Location

Site ES34001

Madrid, 28041, Spain

Location

Site GB44001

Shipley, BD18 3SA, United Kingdom

Location

Related Publications (6)

• Shapiro C M M, Neal-Perry G, Stute P, Thurston RC, Wolfman W, English M, Wu X, Ottery FD. Early onset, maintenance of effect, and day-/night-time findings following fezolinetant treatment for moderate to severe vasomotor symptoms associated with menopause: A pooled phase 3 analysis. Maturitas. 2025 Dec;203:108740. doi: 10.1016/j.maturitas.2025.108740. Epub 2025 Oct 6.

  PMID: 41259888 DERIVED

• Santoro N, Neal-Perry G, Stute P, Blogg M, Mancuso S, Morga A, Ottery FD, Siddiqui E. Fezolinetant effect on vasomotor symptoms due to menopause in women unsuitable for hormone therapy. Curr Med Res Opin. 2025 Feb;41(2):375-384. doi: 10.1080/03007995.2025.2470752. Epub 2025 Mar 5.

  PMID: 40044127 DERIVED

• Kagan R, Cano A, Nappi RE, English ML, Mancuso S, Wu X, Ottery FD. Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies. Adv Ther. 2025 Feb;42(2):1147-1164. doi: 10.1007/s12325-024-03073-8. Epub 2024 Dec 30.

  PMID: 39739195 DERIVED

• Morga A, Zimmermann L, Valluri U, Siddiqui E, McLeod L, Bender RH. Validation and Application of Thresholds to Define Meaningful Change in Vasomotor Symptoms Frequency: Analysis of Pooled SKYLIGHT 1 and 2 Data. Adv Ther. 2024 Jul;41(7):2845-2858. doi: 10.1007/s12325-024-02849-2. Epub 2024 May 22.

  PMID: 38775925 DERIVED

• Schultz NM, Morga A, Siddiqui E, Rhoten SE. Psychometric Evaluation of the MENQOL Instrument in Women Experiencing Vasomotor Symptoms Associated with Menopause. Adv Ther. 2024 Jun;41(6):2233-2252. doi: 10.1007/s12325-024-02787-z. Epub 2024 Feb 24.

  PMID: 38396203 DERIVED

• Schultz NM, Morga A, Siddiqui E, Rhoten SE. Psychometric evaluation of the PROMIS SD-SF-8b instrument in individuals experiencing vasomotor symptoms due to menopause. Health Qual Life Outcomes. 2023 Nov 21;21(1):126. doi: 10.1186/s12955-023-02206-x.

  PMID: 37990323 DERIVED

Related Links

• Link to plain language summary of the study on the Trial Results Summaries website.

MeSH Terms

Conditions

Hot Flashes

Interventions

fezolinetant

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trial Disclosure
• Organization: Astellas Pharma Global Development, Inc

astellas.resultsdisclosure@astellas.com

800-888-7704

Study Officials

• Executive Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 1, 2019
• Study Start: July 10, 2019
• Primary Completion: July 30, 2020
• Study Completion: April 23, 2021
• Last Updated: November 5, 2024
• Results First Posted: June 15, 2022

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Locations

PL (11); US (65); CZ (5); LA (2); CA (6); ES (3); GB (1)