Ended Therapeutic exploratory (Phase II) Endometriosis related pain

A study to investigate efficacy and safety of OG-6219 twice a day in 3 dose levels compared with Placebo in participants aged 18 to 49 with moderate to severe endometriosis-related pain

EU CTIS ID: 2022-501310-57-00

What this study is testing

-To evaluate the efficacy of 3 dose levels of OG-6219 (Group A,B,C) versus Placebo (Group D) in reducing Overall Pelvic Pain (endometriosis related) (OPP) during Treatment Cycle 3 (TRC3), as measured by a Numeric Rating Scale (NRS) in the eDiary. -To evaluate the safety and tolerability of OG-6219

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

Pre-menopausal females of age 18 to 49 years old (inclusive) at the time of signing Informed Consent (V1).
At Visit 4: Has moderate to severe ERP, determined by the NRS (0 to 10 anchored, with 0 [no pain] and 10 [extremely severe pain]), at V4 (before Randomization), based on the eDiary entries from the participant’s last menstrual cycle (BC), as follows: a) An OPP (DYS and NMPP) score of ≥4, OR b) For DYS at least 2 days with ≥4 and NMPP score of ≥4 on at least 7 days (not necessarily consecutive), OR c) For DYS at least 2 days with ≥4 and NMPP score of ≥7 on at least 3 days (not necessarily consecutive).
At Visit 4: Has demonstrated compliance with ≥75% of eDiary entries (ie, pelvic pain score, vaginal bleeding, rescue medication intake) during both the screening cycle (SC) and the BC.
At Visit 4: Is ≥80% compliant with the Placebo tablets over the BC (Placebo Run-in), as determined by tablet accountability at the site.
At Visit 4: Has taken only the study provided rescue medication, at a dose not exceeding the maximum dose determined by the Investigator, for control of ERP during the BC as evidenced in the eDiary.
Have a negative pregnancy test as outlined in the Schedule of activity of the protocol

You likely can't join if

Has a surgical history of hysterectomy and/or bilateral oophorectomy.
Has a history or family history of a hereditary abnormal hemoglobin or an enzyme deficiency that can result in methemoglobinemia (with an alteration in skin; color, pale, gray, or blue), or after receiving certain common drugs (ie, benzocaine, lidocaine, sulfonamides).
Has a medical condition associated with hemolytic anemia such as sickle cell anemia, thalassemia, glucose-6-phosphate dehydrogenase deficiency, thrombotic thrombocytopenic purpura among other conditions previously diagnosed and confirmed.
Has an allergy/sensitivity/intolerance to rescue medication provided by Sponsor or any contraindication to its use and in the setting of coronary artery bypass grafting surgery, or has experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other Nonsteroidal anti-inflammatory drug (NSAIDs)
Has a history or current evidence of any unstable medical condition (including cardiovascular, bone, musculoskeletal, thyroid, diabetes), or other circumstance that in the opinion of the Investigator might confound the results of the study, affect participant’s safety or well-being, or interfere with the participant’s participation for the full duration of the study
Has a known human immunodeficiency virus infection, and/or an acute or active, recurrent/relapsing or chronic infection (eg, hepatitis A, B, or C virus)

See the full eligibility criteria

Who can join

Pre-menopausal females of age 18 to 49 years old (inclusive) at the time of signing Informed Consent (V1).
At Visit 4: Has moderate to severe ERP, determined by the NRS (0 to 10 anchored, with 0 [no pain] and 10 [extremely severe pain]), at V4 (before Randomization), based on the eDiary entries from the participant’s last menstrual cycle (BC), as follows: a) An OPP (DYS and NMPP) score of ≥4, OR b) For DYS at least 2 days with ≥4 and NMPP score of ≥4 on at least 7 days (not necessarily consecutive), OR c) For DYS at least 2 days with ≥4 and NMPP score of ≥7 on at least 3 days (not necessarily consecutive).
At Visit 4: Has demonstrated compliance with ≥75% of eDiary entries (ie, pelvic pain score, vaginal bleeding, rescue medication intake) during both the screening cycle (SC) and the BC.
At Visit 4: Is ≥80% compliant with the Placebo tablets over the BC (Placebo Run-in), as determined by tablet accountability at the site.
At Visit 4: Has taken only the study provided rescue medication, at a dose not exceeding the maximum dose determined by the Investigator, for control of ERP during the BC as evidenced in the eDiary.
Have a negative pregnancy test as outlined in the Schedule of activity of the protocol
Surgically (laparoscopy or laparotomy) diagnosed with endometriosis within the last 4 months to 10 years prior to Screening Visit (V1), as documented by medical records
Has moderate to severe endometriosis-related pelvic pain in recent menstrual cycle(s) using a cutoff score of ≥4 in a numeric rating scale (NRS) and likely meets eligibility criterion # 10 at Randomization Visit (V4)
Has had spontaneous (ie, without hormonal therapy), regular, menstrual cycle with a cycle length between 21 to 32 days (inclusive) for the past 1 month before V1
Is not expected to undergo a planned gynecological surgery or other surgical procedures for treatment of endometriosis during study participation.
Has a normal breast examination at V1. In participants of ≥40 years mammography or contrast-enhanced breast magnetic resonance imaging (MRI) performed within the last 12 months prior to Screening (V1) without clinically significant abnormal findings.
Agrees not to participate in another interventional study while participating in the present study.
Is able and willing (in the opinion of the Investigator) to adhere to all required study procedures, including: a) Study visits schedule, b) Agree to switch from their usual analgesic to ONLY the rescue medication provided by the study and agree to discontinue their hormone treatment for ERP as outlined in Table 2 of the protocol. c) Agree to timely and duly complete eDiary entries, d) To cooperate and comply with the protocol requirements, including, Transvaginal ultrasound (TVUS), ECG, PK, and pharmacodynamic (PD) assessment among others. e) Agree to use 2 forms of non-hormonal contraception throughout the study (from V1 thorough V8). f) Not planning to relocate during the study (such that the participant would not be able to continue participation at the study site).
Must be willing and able to provide signed informed consent before any study-related activities.

What rules you out

Has a surgical history of hysterectomy and/or bilateral oophorectomy.
Has a history or family history of a hereditary abnormal hemoglobin or an enzyme deficiency that can result in methemoglobinemia (with an alteration in skin; color, pale, gray, or blue), or after receiving certain common drugs (ie, benzocaine, lidocaine, sulfonamides).
Has a medical condition associated with hemolytic anemia such as sickle cell anemia, thalassemia, glucose-6-phosphate dehydrogenase deficiency, thrombotic thrombocytopenic purpura among other conditions previously diagnosed and confirmed.
Has an allergy/sensitivity/intolerance to rescue medication provided by Sponsor or any contraindication to its use and in the setting of coronary artery bypass grafting surgery, or has experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other Nonsteroidal anti-inflammatory drug (NSAIDs)
Has a history or current evidence of any unstable medical condition (including cardiovascular, bone, musculoskeletal, thyroid, diabetes), or other circumstance that in the opinion of the Investigator might confound the results of the study, affect participant’s safety or well-being, or interfere with the participant’s participation for the full duration of the study
Has a known human immunodeficiency virus infection, and/or an acute or active, recurrent/relapsing or chronic infection (eg, hepatitis A, B, or C virus)
Has a gastrointestinal, liver, kidney, or other disorder that would significantly interfere with the absorption, distribution, metabolism, or excretion of drugs in the opinion of the Investigator
Has a clinically significant abnormal ECG or QT interval prolongation at Screening Visit (V1) or Randomization Visit (V4). Any participant with the following conditions must be excluded: a) A marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval >450 milliseconds) b) A history of additional risk factors for Torsade de Pointes (eg, heart failure, hypokalemia, family history of Long QT Syndrome) c) Use of concomitant medications that prolong the QT/QTc interval (such as but not limited to: ibutilide, quinidine, imipramine, erythromycin, and droperidol).
Plans to schedule elective surgery during the study execution or had surgery in the past 4 months before screening that continues to require pain management.
Suspected active Coronavirus Disease 2019 (COVID-19) infection a) Have tested positive for severe acute respiratory syndrome–related coronavirus 2 (SARS-CoV-2) based on a validated test per local guidelines at Screening and Baseline b) Have to comply with quarantine requirements per local Public Health directive
Has been vaccinated with live or live-attenuated virus vaccine within 30 days prior to Screening
Has chronic pelvic and/or non-pelvic pain NOT CAUSED by endometriosis that requires chronic analgesic or other chronic therapy (including, but not limited to, pain caused by interstitial cystitis, bladder pain syndrome, irritable bowel syndrome, hysteroscopic sterilization, adenomyosis [as confirmed by previous MRI], vaginismus, chronic pelvic infection, fibromyalgia, chronic headaches, chronic back pain). Participants using or who will be using frequent opioid analgesics, cannabis, or non-opioids analgesics for chronic pain or recurring pain other than that due to ERP should also be excluded.
Has an uncontrolled hypertension as diagnosed by participant’s treating physician.
Has any of the following abnormal laboratory values at Screening a)Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gamma glutamyl transpeptidase >2 × upper limit of normal (ULN) Alkaline Phosphatase >1.5 × ULN, provided cholestatic or other liver disease is excluded b) Total bilirubin (TBL) >1.0 × ULN (participants with Gilbert’s syndrome can be enrolled if other liver function tests are within stated limits)c) Impaired renal function as indicated by estimated glomerular filtration rate <30 mL/min/1.73 m2 (CKD-EPI 2009 calculation) d)Hemoglobin <10 gm/dL, white blood cell count <2500 mm3, neutrophil count <1500 mm3, platelet count <100 × 103/mm3.
Based on the known metabolism of OG-6219 there are no effects of alcohol, caffeine, or tobacco associated with study treatment. However, during the study participants are asked to refrain from: a) Excessive tobacco use and smoking (including cannabis-derived and cannabis-related compounds based on Investigator’s discretion). Note: Short term use (ie, ≤ 3 days per cycle) of cannabis-derived and cannabis-related compounds are permitted. b) Active use of illicit drugs and/or alcohol abuse/dependance, as determined by the Investigator.
Has a prior or current history of drug or alcohol abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders 5 (DSM5).
Has undergone blood transfusion within 2 weeks of V1. In addition, has lost ≥1 unit of blood (approximately 300 mL) within 8 weeks before the first dose of OG-6219.
Use of treatments that might interfere with the conduct of the study or interpretation of the results
Used any medication listed in the protocol 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. Participants must not consume other substances known to be potent inhibitors or inducers of CYP P450s such as grapefruit or Seville oranges containing products in 2 weeks before the planned first dose of study treatment administration.
Current or a history of psychiatric disorder in the 3 years prior to Screening that would, in the opinion of the Investigator, affect the ability to participate in the study or would impair interpretation of data. Participants with current major depression, posttraumatic stress disorder, bipolar disorder, schizophrenia, or other psychotic disorders are excluded. Participant has a history of suicidal ideation or attempt within 3 years of Screening (V1).
Has been a participant in an investigational drug or device study within 30 days prior to the Screening Visit.
A study site employee or relative of a study site employee.
Has a clinically significant gynecologic condition identified in the screening (including, but not limited to, endometriomas larger than 4 cm, complex ovarian cysts larger than 3 cm, simple ovarian cysts larger than 5 cm, single fibroid larger than 4 cm, symptomatic submucosal fibroid of any size, polyp >2 cm, hyperplasia, or endometrial cancer or any clinically significant endometrial pathology).
Participant is pregnant, breast feeding, or planning a pregnancy within the next 7 months.
Participants has received any treatment listed in the table of Prohibited Medication and Other Substances more recently than the “Last Allowable Use”, as indicated in the table, or must continue to receive any treatment listed in that table during the study.
Has a history of ERP that was not responsive at all (refractory) to treatment with CHCs, GnRH agonists and antagonists, progestins, or aromatase inhibitors alone or in combination. The participant that required >2 weeks of continuous use of narcotics for treatment of ERP within 6 months of V1 should also be excluded.
Had undiagnosed (unexplained), abnormal, vaginal bleeding not associated with the baseline condition (endometriosis) within the past 6 months before screening.
Has an active sexually transmitted infection (STI) (eg, gonorrhea, chlamydia, or trichomonas) is exclusionary
Has no documented normal Papanicolaou (PAP) test within the timeline of current standard of care guidelines or has a significantly abnormal PAP test at Screening (V1) (low grade squamous intraepithelial lesion, high grade squamous intraepithelial lesion, atypical glandular cells [any type], squamous cell carcinoma, or adenocarcinoma [in situ or invasive]). The presence of high-risk human papillomavirus (HPV), regardless of PAP result, is exclusionary (e.g. atypical squamous cells)
Intends to become pregnant during study participation or has a known or suspected pregnancy or has a positive β hCG or urine pregnancy test at any time before randomization.
Has a history of malignancy (except basal cell or squamous cell skin cancer) before signing informed consent. Note: Any history of hormonal sensitive malignancy (e.g., breast or ovarian cancers) excludes the participant

The study team makes the final eligibility decision.

Where it's taking place

United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.