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
- Registration Number
- NCT05560646
- Lead Sponsor
- Organon and Co
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 354
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A: OG-6219 Dose 1 OG-6219 Group A: OG-6219 Dose 1 BID Group D: Placebo Placebo Group D: Placebo BID Group B: OG-6219 Dose 2 OG-6219 Group B: OG-6219 Dose 2 BID Group C: OG-6219 Dose 3 OG-6219 Group C: OG-6219 Dose 3 BID
- Primary Outcome Measures
Name Time Method Safety and tolerability of OG-6219 First treatment cycle through completion of follow-up, an average of 20 weeks (each cycle is approximately 28 days). 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.
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). First treatment cycle to last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
- Secondary Outcome Measures
Name Time Method Change from first treatment cycle to last planned treatment cycle in the mean First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days). 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.
Change in Patient Global Impression of Severity (PGI-S) Score from V4 to Phone Contact 1, V6, and V7. Visit 4 through V7, an average of 12 weeks (each cycle is approximately 28 days). The PGI-S is a 4-point response scale, over a 7-day recall period, measuring the overall severity of pelvic pain as: 0=none, 1=Mild, 2=Moderate, 3=Severe.
Percentage of participants with any improvement on the Patient Global Impression of Change at second, third and last planned treatment cycle. Visit 4 through V7, an average of 12 weeks (each cycle is approximately 28 days). Change from first treatment cycle to last planned treatment cycle in the Endometriosis Health Profile-30 (EHP-30) Domain Scores. First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days The EHP-30 consists of 30 items measured on a scale from 0 = Never to 4 = Always where the lower number represents a better outcome.
Change from first treatment cycle to remaining treatment cycles in the mean number of tablets of rescue medication for endometriosis-related pain (ERP) and in the proportion of days participant has used rescue medication for ERP. First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days). ECG parameter changes at each of the four treatment cycle visits First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days). Mean change from V1 to V7 in serum hormone levels Screening through end of treatment, an average of 24 weeks Cmax, for both OG-6219 and FOR-1011. At 2 visits approximately 3 weeks apart beginning at second treatment cycle. Tmax for both OG-6219 and FOR-1011 At 2 visits approximately 3 weeks apart beginning at second treatment cycle AucTAU for both OG-6219 and FOR-1011 At 2 visits approximately 3 weeks apart beginning at second treatment cycle Change from first treatment cycle to last planned treatment cycle in the mean DYS score First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days). Mean change from first treatment cycle to second, third and fourth treatment cycles in the percentage of days with vaginal bleeding First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days). Plasma concentrations of OG-6219 and FOR-1011 at scheduled assessments using sparse PK sampling. Second treatment cycle through completion of last planned treatment cycle, an average of 12 weeks (each cycle is approximately 28 days). Change from first treatment cycle to last planned treatment cycle in the mean dyspareunia score. First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days). 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.
Proportion of participants with clinical parameters of significance from Visit 1 to Visit 5, Visit 6, Visit 7, and Visit 8. Screening through safety follow-up, an average of 28 weeks. Serum hormone levels at V7 comparing each treatment group At V7 approximately 24 weeks after patient consents to the study. Mean change from Visit 1 to Visit 7 in bone biomarker levels Screening through end of treatment, an average of 24 weeks. Serum hormone levels at V5 comparing each treatment group Visit 5
Trial Locations
- Locations (84)
Central Research Associates LLC dba Flourish Research
🇺🇸Birmingham, Alabama, United States
UAB Center for Women's Reproductive Health
🇺🇸Birmingham, Alabama, United States
Olympia Clinical Trials
🇺🇸Los Angeles, California, United States
Yale Fertility Center
🇺🇸Orange, Connecticut, United States
Physician Care Clinical Research, LLC
🇺🇸Sarasota, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
MediSense Inc
🇺🇸Atlanta, Georgia, United States
Paramount Research Solutions
🇺🇸College Park, Georgia, United States
Infinite Clinical Trials
🇺🇸Morrow, Georgia, United States
The Advanced Gynecologic Surgery Institute
🇺🇸Park Ridge, Illinois, United States
Scroll for more (74 remaining)Central Research Associates LLC dba Flourish Research🇺🇸Birmingham, Alabama, United States