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

Organon and Co354 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

354

Conditions

Endometriosis

Interventions

OG-6219DRUG

OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles.

PlaceboDRUG

Participants will receive (orally) OG-6219 Placebo tablets BID during treatment cycles.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 Years

Medical Language ↔ Plain English

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.

Locations (86)

Outcomes

Primary Outcomes

Change from first treatment cycle to last planned treatment cycle in the mean OPP (endometriosis-related overall pelvic pain) score. The OPP measures endometriosis-related pain using NRS with range 0 (no pain) to 10 (worst imaginable).

Time frame: First treatment cycle to last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).

Safety and tolerability of OG-6219

Safety and tolerability of the treatment is assessed by proportion of participants who experienced any AEs/SAEs, abnormalities in clinical laboratory assessments, vital signs, and physical examination, and by proportion of participants who prematurely discontinued study treatment due to AEs/SAEs.

Time frame: First treatment cycle through completion of follow-up, an average of 20 weeks (each cycle is approximately 28 days).

Secondary Outcomes

Change from first treatment cycle to last planned treatment cycle in the mean DYS score

Time frame: First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).

Change from first treatment cycle to last planned treatment cycle in the mean

Non-menstrual pelvic pain (NMPP) scores. NMPP is a Numeric rating scale (NRS) that measures pain severity on a scale of 0 (no pain) to 10 (worst pain imaginable) where a lower value represents a better outcome.

Time frame: First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).

Change from first treatment cycle to last planned treatment cycle in the mean dyspareunia score.

Dyspareunia score is measured by the Endometriosis Pain Daily Diary on a numerical rating scale of 0-10 where 0=No Pain and 10=Worst Pain Imaginable. A lower value represents a better outcome.

Time frame: First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).

Data from ClinicalTrials.gov

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