ELENA: 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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Pre-menopausal females aged 18 to 49 years old (inclusive), who have been surgically diagnosed with endometriosis will be screened to randomly assign 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: OG-6219 Dose 1 OG-6219 Dose 1 BID |
Drug: OG-6219
OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 during treatment cycles.
|
| Experimental: OG-6219 Dose 2 OG-6219 Dose 2 BID |
Drug: OG-6219
OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 during treatment cycles.
|
| Experimental: OG-6219 Dose 3 OG-6219 Dose 3 BID |
Drug: OG-6219
OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 during treatment cycles.
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Participants will receive (orally) OG-6219 Placebo tablets BID during treatment cycles.
|
Outcome Measures
Primary Outcome Measures
- Mean change from first treatment cycle to last planned treatment cycle of the daily OPP score. [First treatment cycle to last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).]
The OPP measures endometriosis-related pain using NRS with range 0(no pain) to 10(worst imaginable).
- 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, by abnormalities in clinical laboratory assessments, vital signs, and physical examination, and by proportion of participants who prematurely discontinued study treatment due to AEs/SAEs.
Secondary Outcome Measures
- Mean change from first treatment cycle to last planned treatment cycle of the daily 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 last planned treatment cycle of the daily NMPP 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 remaining treatment cycles in daily number of tablets of rescue medication for endometriosis-related pain. [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 remaining treatment cycles in the proportion of days participant has used rescue medication for endometriosis-related pain. [First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).]
- Mean change from Visit 1 to Visit 7 in serum hormone levels. [Screening through end of treatment, an average of 24 weeks.]
- Mean change at Visit 5 and Visit 7 in serum hormone levels. [Visit 5 through Visit 7, an average of 9 weeks.]
- Plasma concentrations of OG-6219 and FOR-1011 at scheduled assessments using sparse PK sampling during the treatment period. [First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).]
- Mean change from Visit 1 to Visit 7 in bone biomarker levels [Screening through end of treatment, an average of 24 weeks.]
- 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.]
- 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).]
- 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).]
- Change from first treatment cycle to last planned treatment cycle in the Mean 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).]
- Mean change in dyspareunia as measured by NRS from eDiary from first treatment cycle to last planned treatment cycle. [First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).]
- Change in PGI-S score from first treatment cycle to second, third and fourth treatment cycles. [First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).]
- Percent of participants with any improvement on the PGI-C from first treatment cycle to last planned treatment cycle. [First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days)]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Pre-menopausal females of age 18 to 49 years old (inclusive) at the time of signing Informed Consent (V1).
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Surgically (laparoscopy or laparotomy) diagnosed with endometriosis
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Moderate to severe endometriosis-related pelvic pain
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Regular menstrual cycles
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Is not expected to undergo a planned gynecological surgery or other surgical procedures for treatment of endometriosis during study participation.
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Normal breast exam at V1
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Agree not to participate in another interventional study while participating in the present study.
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Able and willing to adhere to study procedures, including
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agree to use 2 forms of non-hormonal contraception throughout the study
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Must be willing and able to provide signed informed consent before any study-related activities
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Has demonstrated compliance with ≥75% of eDiary entries
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Has a negative pregnancy test
Exclusion Criteria:
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Surgical history of hysterectomy and/or bilateral oophorectomy
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Chronic pelvic and/or non-pelvic pain not caused by endometriosis that requires chronic analgesic or other chronic therapy
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Undiagnosed (unexplained), abnormal vaginal bleeding not associated with endometriosis within the past 6 months before screening.
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Presence of high-risk human papillomavirus (HPV).
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Has an active sexually transmitted infection (STI) (eg, gonorrhea, chlamydia, or trichomonas).
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Intends to become pregnant or breast feed during study participation or has a known or suspected pregnancy.
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History of malignancy ≤5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
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History of family history of hereditary abnormal hemoglobin or an enzyme deficiency that can result in methemoglobinemia.
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Has a medical condition associated with hemolytic anemia
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Known human immunodeficiency virus infection, with active, recurrent, or chronic infection (eg, hepatitis A, B, or C virus)
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Has a clinically significant abnormal ECG or QT interval prolongation
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Paramount Research Solutions | College Park | Georgia | United States | 30349 |
| 2 | The Advanced Gynecologic Surgery Institute | Park Ridge | Illinois | United States | 60068 |
| 3 | Clinical Trials Management, LLC | Metairie | Louisiana | United States | 70006 |
| 4 | Omni Fertility and Laser Institute | Shreveport | Louisiana | United States | 71118 |
| 5 | Meridian Clinical Research, LLC | Norfolk | Nebraska | United States | 68701 |
| 6 | Unified Women's Clinical Research-Lyndhurst Clinical Research | Winston-Salem | North Carolina | United States | 27103 |
| 7 | Centricity Research Dublin | Dublin | Ohio | United States | 43016 |
| 8 | Clinical Research of Philadelphia, LLC | Philadelphia | Pennsylvania | United States | 19114 |
| 9 | Chattanooga Medical Research, LLC | Chattanooga | Tennessee | United States | 37404 |
| 10 | Clinical Trial Network LLC | Houston | Texas | United States | 77074 |
| 11 | Northeast Clinical Research of San Antonio | San Antonio | Texas | United States | 78233 |
| 12 | Wasatch Clinical Research | Salt Lake City | Utah | United States | 84107 |
| 13 | Tidewater Clinical Research | Virginia Beach | Virginia | United States | 23456 |
Sponsors and Collaborators
- Organon and Co
- Iqvia Pty Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OG-6219-P001