Trial intelligence / Profile preview

HMI-115 in moderate to severe endometriosis-associated pain

NCT05101317Phase 2

Key facts

Status: Completed
Start: Oct 2021
Primary completion: Sep 2024
Countries: 3
Sponsor: HopeMed
Modality: Monoclonal Antibodies

Drugs: HMI-115
Conditions: endometriosis

Overview

Phase 2, randomised, double-blind trial of HMI-115 in endometriosis (4 arms), sponsored by HopeMed. Primary endpoint: Dysmenorrhea at 12 weeks. Started Oct 2021; status: completed.

Design

4 arms

Study design: RandomizedDouble-blind

HMI-115 60mg
HMI-115 60mg subcutaneous injection every 2 weeks for 12 weeks
HMI-115 120mg
HMI-115 120mg subcutaneous injection every 2 weeks for 12 weeks
HMI-115 240mg
HMI-115 240mg subcutaneous injection every 2 weeks for 12 weeks
Placebo
Placebo subcutaneous injection every 2 weeks for 12 weeks

Who it enrols

Pre-menopausal women aged 18-49 with surgically confirmed endometriosis within 10 years, moderate to severe endometriosis-associated pain (CPSSS ≥6, DYS ≥2, NMPP ≥2), excluding those with other chronic pain conditions, significant gynecologic conditions, history of hysterectomy/bilateral oophorectomy, pituitary tumors, or osteoporosis

Endpoints

Primary

Dysmenorrhea12 weeks

Secondary

Dysmenorrhea24 weeks
Non-menstrual Pelvic Pain24 weeks
Dyspareunia24 weeks
Endometriosis Daily Impact Pain Scale24 weeks
Permitted Rescue Medication Use24 weeks
Menstrual Period Heaviness (Bleeding)24 weeks

Results

Primary endpoints met

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