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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 (ELENA)

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ClinicalTrials.gov Identifier: NCT05560646
Recruitment Status : Recruiting
First Posted : September 29, 2022
Last Update Posted : February 23, 2024
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
Organon and Co

Study Description
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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
Endometriosis Drug: OG-6219 Drug: Placebo 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 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of OG-6219 in 3 Dose Levels, in Women 18 to 49 Years of Age With Moderate to Severe Endometriosis-related Pain
Actual Study Start Date : October 25, 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A: OG-6219 Dose 1
Group A: OG-6219 Dose 1 BID
 Drug: OG-6219
OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles.
Experimental: Group B: OG-6219 Dose 2
Group B: OG-6219 Dose 2 BID
 Drug: OG-6219
OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles.
Experimental: Group C: OG-6219 Dose 3
Group C: OG-6219 Dose 3 BID
 Drug: OG-6219
OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles.
Placebo Comparator: Group D: Placebo
Group D: Placebo BID
 Drug: Placebo
Participants will receive (orally) OG-6219 Placebo tablets BID during treatment cycles.


Outcome Measures
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Primary Outcome Measures :
  1. 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). ]
  2. Safety and tolerability of OG-6219 [ Time Frame: 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.


Secondary Outcome Measures :
  1. 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). ]
  2. Change from first treatment cycle to last planned treatment cycle in the mean [ Time Frame: 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.

  3. Change from first treatment cycle to last planned treatment cycle in the mean dyspareunia score. [ Time Frame: 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.

  4. 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. [ Time Frame: First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days). ]
  5. Change in Patient Global Impression of Severity (PGI-S) Score from V4 to Phone Contact 1, V6, and V7. [ Time Frame: 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.

  6. Percentage of participants with any improvement on the Patient Global Impression of Change at second, third and last planned treatment cycle. [ Time Frame: Visit 4 through V7, an average of 12 weeks (each cycle is approximately 28 days). ]
  7. Change from first treatment cycle to last planned treatment cycle in the Endometriosis Health Profile-30 (EHP-30) Domain Scores. [ Time Frame: 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.

  8. Mean change from Visit 1 to Visit 7 in bone biomarker levels [ Time Frame: Screening through end of treatment, an average of 24 weeks. ]
  9. Proportion of participants with clinical parameters of significance from Visit 1 to Visit 5, Visit 6, Visit 7, and Visit 8. [ Time Frame: Screening through safety follow-up, an average of 28 weeks. ]
  10. Mean change from first treatment cycle to second, third and fourth treatment cycles in the percentage of days with vaginal bleeding [ Time Frame: First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days). ]
  11. ECG parameter changes at each of the four treatment cycle visits [ Time Frame: First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days). ]
  12. Mean change from V1 to V7 in serum hormone levels [ Time Frame: Screening through end of treatment, an average of 24 weeks ]
  13. Serum hormone levels at V5 comparing each treatment group [ Time Frame: Visit 5 ]
  14. Serum hormone levels at V7 comparing each treatment group [ Time Frame: At V7 approximately 24 weeks after patient consents to the study. ]
  15. Plasma concentrations of OG-6219 and FOR-1011 at scheduled assessments using sparse PK sampling. [ Time Frame: Second treatment cycle through completion of last planned treatment cycle, an average of 12 weeks (each cycle is approximately 28 days). ]
  16. Cmax, for both OG-6219 and FOR-1011. [ Time Frame: At 2 visits approximately 3 weeks apart beginning at second treatment cycle. ]
  17. Tmax for both OG-6219 and FOR-1011 [ Time Frame: At 2 visits approximately 3 weeks apart beginning at second treatment cycle ]
  18. AucTAU for both OG-6219 and FOR-1011 [ Time Frame: At 2 visits approximately 3 weeks apart beginning at second treatment cycle ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05560646


Contacts
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Contact: Toll Free Number 551-430-6000 OG-6219-P001@IQVIA.com

Locations
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Sponsors and Collaborators
Organon and Co
Iqvia Pty Ltd
More Information
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Additional Information:

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Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT05560646    
Other Study ID Numbers: OG-6219-P001
First Posted: September 29, 2022    Key Record Dates
Last Update Posted: February 23, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Organon and Co:
Endometriosis Related Pain (ERP)
Endometriosis
Pre-menopausal women
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases