A Phase II/III Study of Efficacy and Safety of SHR7280 Tablets in Subjects With Menorrhagia With Uterine Fibroids

NCT05442827 | Recruiting Phase 2

• 1 other identifier: SHR7280-301
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II:To explore the optimal effective dose of SHR7280 tablets in subjects with menorrhagia with uterine fibroids as a phase III treatment dose. Phase III:To evaluate the efficacy of the selected dose of SHR7280 compared with placebo in reducing menstrual bleeding in subjects with menorrhagic uterine fibroids in phase II studies.

Conditions

Uterine Fibroids With Menorrhagia

Outcome Measures

Primary Outcomes (2)

• Phase one：Percentage of subjects with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline

  After treatment at week 12

• Phase two：Percentage of subjects with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline

  After treatment at week 24

Secondary Outcomes (26)

• Percentage of subjects with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline（Phase one）

  The treatment ended at week 4 and 8

• percentage of subjects without menstrual bleeding or spotting （Phase one）

  The treatment ended at week 4, 8 and 12

• Changes in hemoglobin concentration from baseline（Phase one）

  The treatment ended at week 4, 8 and 12

• Changes in uterine volume and maximum fibroid volume from baseline（Phase one）

  The treatment ended at week 8 and 12

• patient global impression of change scale evaluation，The minimum is 1, the maximum is 7, and higher scores mean worse results（Phase one）

  The treatment ended at week 12

Study Arms (3)

Treatment group A: SHR7280 tablets

EXPERIMENTAL

Drug: SHR7280 tablets

Treatment group B:SHR7280 tablets

EXPERIMENTAL

Drug: SHR7280 tablets

Treatment group C:Intervention: Drug: PlaceboSHR7280 tablets blank preparation

PLACEBO COMPARATOR

Drug: PlaceboSHR7280 tablets blank preparation

Interventions

SHR7280 tablets DRUG

SHR7280 tablets 300mg for 12 weeks

Treatment group A: SHR7280 tablets

PlaceboSHR7280 tablets blank preparation DRUG

Placebo group: SHR7280 tablets blank preparation for 12 weeks

Treatment group C:Intervention: Drug: PlaceboSHR7280 tablets blank preparation

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The informed consent has been signed and dated;
• Non-menopausal women between the ages of 18 and 49 (including 18 and 49);
• Single or multiple uterine fibroids were confirmed by ultrasound examination during screening, and the maximum diameter of at least one fibroid was ≥2 cm;
• Heavy menstrual bleeding measured by the alkaline hematin method during screening;
• months before screening, the subject's menstrual cycle is 21-38 days, and the period is no more than 14 days;
• The pregnancy test was negative on the day of screening visit and randomization;
• Human papillomavirus (HPV) testing should be added for subjects who have cervical cytology at the time of screening visit and whose TCT results are atypical squamous cells (ASC-US) of uncertain significance, or who test negative for high-risk HPV.

You may not qualify if:

• Excessive menstrual bleeding and anemia caused by other reasons;
• A history of depression or clinically significant depression;
• Have a history of drug abuse, drug dependence;
• History of smoking and alcohol abuse within 3 months prior to screening;
• A history of delivery, breastfeeding and miscarriage within 6 months prior to screening;
• Patients who received myomectomy within 3 months before screening, and patients who received uterine artery embolization, or high intensity focused ultrasound (HIFU) ablation within 6 months before screening;
• Patients who underwent endometrial resection within 1 year prior to screening;
• Patients with severe infection (one organ or whole body infection caused by pathogenic microorganism, and failure or death of the organ or multiple organs caused by infection), severe trauma (ISS ≥16 points) or major surgery (grade III/IV surgery in Surgical Classification Catalogue) within 6 months prior to screening;
• Previous clinical major systemic disease, endocrine or metabolic abnormalities;
• Having past or current thromboembolic disease or having a risk factor for thromboembolic disease (stage 2 only);
• Previous history of malignant tumors such as ovary, breast, uterus, liver, hypothalamus and pituitary gland;Known or suspected sex hormone-dependent malignancies;
• Any pre-existing disease or symptom (e.g., chronic intestinal disease, Crohn's disease, ulcerative colitis) that may affect systemic functioning of the body and may affect absorption, excessive accumulation, metabolism, or change the excretion pattern of the test drug;
• Persons with prior known serious mental illness or inability to understand the purpose, methods, etc. of the clinical trial, and who did not follow the study procedures;
• Live (attenuated) vaccine (other than influenza vaccine) received within 1 month prior to screening or planned during the trial;
• Other reasons that the investigator considered inappropriate for participation in the study.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Central Study Contacts

Zhenyi Zhu

CONTACT

0518-82342973; zhenyi.zhu@hengrui.com

Study Design

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

Model Details: Phase one：300mg/400mgSHR7280 tablets were compared with placebo Phase two：SHR7280 monotherapy group, SHR7280 reverse therapy group and placebo group were controlled

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: July 5, 2022
• Study Start: September 10, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

CN (1)