a study to investigate efficacy and safety of og-6219 bid in 3 dose levels compared with placebo in participants aged 18 to 49 with moderate to severe endometriosis-related pain

Conditions: Endometriosis

Summary: the purpose of this global phase 2 study is to determine the efficacy, safety, and tolerability of 3 dose levels of og-6219 in pre-menopausal women between 18 and 49 years of age (inclusive), who have moderate to severe endometriosis-related pain.

this is a global multicenter, phase 2a/b, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of 3 dose levels of og-6219, in pre-menopausal women 18 to 49 years of age (inclusive), who have been surgically diagnosed with endometriosis with moderate to severe endometriosis-related pain. this study includes treatment lasting approximately 16 weeks in total and is followed by a safety follow-up visit. pre-menopausal females aged 18 to 49 years old (inclusive), who have been surgically diagnosed with endometriosis will be screened and randomly assigned to study treatment. a minimum subset of 10 participants per treatment group (including placebo group) will be voluntarily enrolled for optional intensive pk sampling for the entire duration of the study.

Eligibility criteria:
inclusion criteria: * pre-menopausal females of age 18 to 49 years old (inclusive) at the time of signing informed consent (v1). * surgically (laparoscopy or laparotomy) diagnosed with endometriosis * moderate to severe endometriosis-related pelvic pain * regular menstrual cycles * is not expected to undergo a planned gynecological surgery or other surgical procedures for treatment of endometriosis during study participation. * normal breast exam at v1. in participants of ≥40 years mammography or contrast-enhanced breast mri performed within the last 12 months prior to screening (v1) without clinically significant abnormal findings. * agree not to participate in another interventional study while participating in the present study. * able and willing to adhere to study procedures, including * agree to use 2 forms of non-hormonal contraception throughout the study * must be willing and able to provide signed informed consent before any study-related activities * has demonstrated compliance with ≥75% of ediary entries * has a negative pregnancy test exclusion criteria: * surgical history of hysterectomy and/or bilateral oophorectomy * chronic pelvic and/or non-pelvic pain not caused by endometriosis that requires chronic analgesic or other chronic therapy * undiagnosed (unexplained), abnormal vaginal bleeding not associated with endometriosis within the past 6 months before screening. * presence of high-risk human papillomavirus (hpv). * has an active sexually transmitted infection (sti) (eg, gonorrhea, chlamydia, or trichomonas). * intends to become pregnant or breast feed during study participation or has a known or suspected pregnancy. * history of malignancy (except for basal cell or squamous cell skin cancer) before signing informed consent. * history of family history of hereditary abnormal hemoglobin or an enzyme deficiency that can result in methemoglobinemia. * has a medical condition associated with hemolytic anemia * known human immunodeficiency virus infection, and/or acute or active, recurrent/relapsing, or chronic infection (eg, hepatitis a, b, or c virus) * has a clinically significant abnormal ecg or qt interval prolongation * used any medication that is either a sensitive substrate, moderate, or strong inhibitor or inducer of cyp3a4 within 30 days or 10 half-lives (whichever is longer) prior to the planned first day of dosing.

Keywords: endometriosis related pain (erp) endometriosis pre-menopausal women