Phase 2 Study of SJX-653 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms

NCT04278872 | Terminated Phase 2 Results

• 1 other identifier: SJX-653-006
• Study Type: interventional
• Target: 13
• Locations: 4 countries
• Sites: 22

Brief Summary

This study evaluates the efficacy, safety, tolerability, and pharmacokinetics of once daily SJX-653 in postmenopausal women with moderate to severe VMS.

Conditions

Hot Flashes

Outcome Measures

Primary Outcomes (1)

• Mean Change in Average Daily Frequency of Moderate to Severe Vasomotor Symptoms (VMS) From Baseline to Week 4

  Moderate to severe vasomotor symptoms collected daily by e-diary

  Baseline to Week 4

Secondary Outcomes (2)

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

  Baseline to Week 4

• Mean Change and Percent Change of Parameters of VMS Frequency and Severity by Study Week

  Baseline up to Week 6

Other Outcomes (2)

• Change From Baseline in Insomnia Severity Index (ISI)

  Baseline up to Week 4

• Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS)

  Baseline up to Week 4

Study Arms (2)

SJX-653

EXPERIMENTAL

Participants will receive SJX-653

Drug: SJX-653

Placebo

PLACEBO COMPARATOR

Participants will receive placebo

Drug: Placebo

Interventions

SJX-653 DRUG

administered orally once daily

SJX-653

Placebo DRUG

administered orally once daily

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:

• Signed a consent form before Screening procedures begin.
• Be a postmenopausal female, 40 to 65 years of age (inclusive) at the Screening Visit, defined as:
• Spontaneous amenorrhea for at least 12 months, OR
• months of spontaneous amenorrhea with serum FSH levels \>40 milli-International unit (mIU/mL), OR
• weeks past a postsurgical bilateral oophorectomy with or without hysterectomy.
• All postmenopausal woman (PMW) must have a serum follicle stimulating hormone (FSH) \>40 mIU/mL at Screening.
• Have an average of at least 7 moderate to severe VMS per day at Baseline. The following definitions for severity are used:
• Mild: Sensation of heat without sweating/damping; if at night, do not wake up but later notice damp sheets or clothing.
• Moderate: Sensation of heat with sweating/dampness, but able to continue activity; if at night, wake up because hot and/or sweating, but no action is necessary other than rearranging the bed sheets.
• Severe: Sensation of heat with sweating causing disruption of current activity; if at night, wake up hot and sweating and need to take action (eg, removing layer of clothes, open the window, or get out of bed).
• Have a body mass index between 18 and 35 kg/m2, inclusive.
• For subjects 50-65 years old, have documentation (written or electronic report) of a satisfactory mammogram result at Screening within applicable intervals stated in local breast cancer screening guidelines. Subjects 40-49 years old require a mammogram within the same intervals.
• Have documentation (written or electronic report) of a normal Pap smear (or equivalent cervical cytology) ) in combination with Human Papilloma virus (HPV) testing, or a Pap smear of no clinical significance in the opinion of the Investigator, at Screening within applicable intervals stated in local cervical cancer prevention guidelines.
• Have an endometrial thickness ≤4 mm by transvaginal ultrasound at Screening.
• Be willing to undergo an endometrial biopsy if they have unexplained bleeding during the study or endometrial thickness \>4 mm at the EOT visit. An endometrial biopsy is not required for subjects who have had a partial (supracervical) or full hysterectomy.

You may not qualify if:

• Have clinically significant history or evidence of poorly controlled cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator or have any medical condition that requires chronic medication and that in the Investigator's opinion, would make subjects unsuitable for participation in the study.
• Have manifest or suspected active COVID-19 infection. Have tested positive for presence of SARS-CoV-2 based on a RT-PCR or other validated test; or have clinical symptoms suggestive of COVID-19 infection; or have to comply with quarantine requirements per local Public Health directive.
• Have a history of diagnosis of major depressive disorder in the 3 years prior to Screening, or are on any antidepressant, anxiolytic or antipsychotic treatment. Selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) treatment for mild depression and/or mild anxiety is allowed provided medication is stable and well-tolerated in the 3 months prior to the Screening Visit and does not change during study participation.
• Have a history of suicide ideation or attempt in the past 3 years.
• Have a history of a sleep disorder other than insomnia due to VMS (eg, narcolepsy, sleep apnea, restless leg syndrome).
• Have clinical or biochemical evidence of active hepatitis or other significant hepatic or biliary disease (eg, chronic hepatitis, cirrhosis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, nonalcoholic steatohepatitis, nonalcoholic fatty liver disease, or hereditary liver disease).
• Have any abnormal liver function tests at Screening or an estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2 (CKD-EPI 2009 calculation; Levey et al 2009).
• Have tested positive for human immunodeficiency virus, hepatitis B, C or E at Screening.
• Have any gastrointestinal, liver, kidney or other disorder that would significantly interfere with the absorption, distribution, metabolism, or excretion (ADME) of drugs in the opinion of the Investigator.
• Have a history of alcohol abuse or a history of substance abuse.
• Smoking \>10 cigarettes per day.
• Regularly working night shifts.
• Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, based on the median of a total of 4 to 6 readings, from 2 to 3 readings taken on 2 different occasions.
• Have clinically significant abnormal ECG or QT interval prolongation (corrected for heart rate using Fridericia formula \[QTcF\] prolongation \>470 ms) at Screening.
• Have a history of endometrial hyperplasia or uterine/endometrial cancer.

Sponsors & Collaborators

• Sojournix, Inc.: lead

Study Sites (22)

Sojournix Site #202

Brussels, Belgium

Location

Sojournix Site #204

Genk, Belgium

Location

Sojournix Site #201

Ghent, Belgium

Location

Sojournix Site #308

Berlin, Germany

Location

Sojournix Site #309

Berlin, Germany

Location

Sojournix Site #304

Bernburg, Germany

Location

Sojournix Site #301

Hamburg, Germany

Location

Sojournix Site #306

Hamburg, Germany

Location

Sojournix Site #305

Marburg, Germany

Location

Sojournix Site #401

Bialystok, Poland

Location

Sojournix Site #402

Katowice, Poland

Location

Sojournix Site #406

Lodz, Poland

Location

Sojournix Site #403

Lublin, Poland

Location

Sojournix Site #404

Lublin, Poland

Location

Sojournix Site #405

Lublin, Poland

Location

Sojournix Site #108

Blackpool, United Kingdom

Location

Sojournix Site #111

Cannock, United Kingdom

Location

Sojournix Site #104

Glasgow, United Kingdom

Location

Sojournix Site #112

Leeds, United Kingdom

Location

Sojournix Site #110

Liverpool, United Kingdom

Location

Sojournix Site #105

London, United Kingdom

Location

Sojournix Site #107

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

SJX-653

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Head of Regulatory Affairs
• Organization: Sojournix, Inc.

clinicaltrials@sojournixpharma.com

6174758469

Study Officials

• Medical Director

  Sojournix, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: November 9, 2020
• Primary Completion: February 12, 2021
• Study Completion: April 7, 2021
• Last Updated: January 11, 2022
• Results First Posted: January 11, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7); DE (6); BE (3); PL (6)