Endometriosis Clinical Trial
— ELENAOfficial 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
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.
Status | Recruiting |
Enrollment | 380 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques Universitaires de Bruxelles Hopital Erasme | Bruxelles | |
Belgium | Cliniques Universitaires Saint-Luc | Bruxelles | |
Belgium | AZ Jan Palfijn Gent | Gent | |
Belgium | Universitair Ziekenhuis Ghent | Gent | |
Belgium | Jessa Ziekenhuis Hospital | Hasselt | |
Belgium | CHU de Tivoli | La Louvière | |
Belgium | UZ Leuven | Leuven | |
Bulgaria | MHAT - Blagoevgrad, EOOD | Blagoevgrad | |
Bulgaria | Medical Center Repromed EOOD | Pleven | |
Bulgaria | UMHAT "Sv. Georgi", EAD | Plovdiv | |
Bulgaria | DCC " Ascendent" EAD | Sofia | |
Bulgaria | DCC "Alexandrovska", EOOD | Sofia | |
Bulgaria | Group practice for specialized medical care in the field of obstetrics and gynecology - Gin Art OOD | Sofia | |
Bulgaria | Medical Center Hera EOOD | Sofia | |
Bulgaria | MHAT for women's health - Nadezhda, OOD | Sofia | |
Bulgaria | Second SHATGO Sheynovo | Sofia | |
Bulgaria | SHATOD - Sofia District, EOOD | Sofia | |
Bulgaria | MHAT NiaMed OOD | Stara Zagora | |
Bulgaria | Acibadem City Clinic MC Varna EOOD | Varna | |
Czechia | Fakultni nemocnice Brno | Brno | |
Czechia | Fertimed s.r.o. | Olomouc | |
Czechia | Fakultni nemocnice Kralovske Vinohrady | Praha 10 | |
Czechia | Femina Sana s.r.o. | Praha 3 | |
Czechia | Ustav pro peci o matku a dite | Praha 4 | |
France | Hôpital Beaujon | Clichy cedex | Hauts De Seine |
France | Hôpital Cochin | Paris | |
France | Hopital Tenon | Paris | |
France | Hopital Saint Joseph Paris | Paris Cedex 14 | Paris |
France | Hospital of Hautepierre | Strasbourg | |
Germany | Charité - Campus Benjamin Franklin | Berlin | |
Germany | Universitaetsklinikum Carl Gustav Carus TU Dresden | Dresden | |
Germany | Universitaetsklinikum Duesseldorf AoeR | Duesseldorf | Nordrhein Westfalen |
Germany | Universitätsklinikum des Saarlandes | Homburg | |
Germany | Universitaetsklinikum Muenster | Muenster | |
Germany | LMU-Campus Innenstadt | Munich | |
Hungary | Aranyklinika Budapest | Budapest | |
Hungary | Clinexpert Kft. | Budapest | |
Hungary | Semmelweis Egyetem | Budapest | |
Hungary | Debreceni Egyetem | Debrecen | |
Hungary | Szent Anna Maganrendelo | Debrecen | |
Hungary | Somogy Varmegyei Kaposi Mor Oktato Korhaz | Kaposvár | |
Hungary | Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz | Nyíregyháza | |
Hungary | Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont | Szeged | |
Italy | Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS | Bologna | |
Italy | Università di Cagliari-Presidio Policlinico Monserrato | Monserrato | |
Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Roma |
Italy | Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico | Seriate | Milano |
Italy | University of Siena Policlinico | Siena | |
Italy | Centro Ricerche Cliniche di Verona s.r.l. | Verona | |
Latvia | Dr. Vasaraudze's Private Clinic | Riga | |
Latvia | Latvian Maritime Medical Centre | Riga | |
Latvia | Vitols & Vitols, Ltd. | Riga | |
Poland | Klinika Leczenia Nieplodnosci, Ginekologii i Poloznictwa Bocian | Bialystok | |
Poland | NZOZ Artemida - Centrum Ginekologii, Endokrynologii i Medycyny Rozrodu | Bialystok | |
Poland | Specjalistyczna Poradnia Ginekologiczna Janusz Tomaszewski Spólka Komandytowa | Bialystok | |
Poland | MICS Centrum Medyczne Bydgoszcz | Bydgoszcz | |
Poland | Clinical Medical Research Sp. z o.o. | Katowice | |
Poland | Klinika Leczenia Nieplodnosci, Ginekologii i Poloznictwa Bocian | Katowice | |
Poland | NZOZ Medem | Katowice | |
Poland | Centra Medyczne Medyceusz | Lódz | |
Poland | Centrum Medyczne Chodzki HLK | Lublin | |
Poland | KO-MED Centra Kliniczne Lublin II | Lublin | |
Poland | Specjalistyczny Gabinet Ginekologiczno-Polozniczy | Lublin | |
Poland | ETYKA Osrodek Badan Klinicznych | Olsztyn | |
Poland | Etg Siedlce | Siedlce | |
Poland | Centrum Medyczne Pratia Poznan | Skórzewo | |
Poland | Klinika Leczenia Nieplodnosci, Ginekologii i Poloznictwa Bocian | Szczecin | |
Poland | MICS Centrum Medyczne Torun | Torun | |
Poland | PRATIA S.A. MTZ Clinical Research Powered by Pratia | Warszawa | |
Poland | Specjalistyczna Praktyka Lekar | Warszawa | |
Poland | WIM Panstwowy Instytut Badawczy Centralny Szpital Kliniczny MON | Warszawa | |
Poland | Przychodnia Wielospecjalistyczna Sk-Medica Spólka Z O.O. | Wroclaw | Dolnoslask |
United States | Bosque Women's Care | Albuquerque | New Mexico |
United States | MediSense Inc | Atlanta | Georgia |
United States | Augusta University Medical Center | Augusta | Georgia |
United States | John Hopkins University | Baltimore | Maryland |
United States | Central Research Associates LLC dba Flourish Research | Birmingham | Alabama |
United States | UAB Center for Women's Reproductive Health | Birmingham | Alabama |
United States | Medical University of South Carolina (MUSC) | Charleston | South Carolina |
United States | Chattanooga Medical Research, LLC | Chattanooga | Tennessee |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Paramount Research Solutions | College Park | Georgia |
United States | Centricity Research Dublin | Dublin | Ohio |
United States | Cedar Health Research, LLC | Euless | Texas |
United States | Penn State Health Women's Health Clinic | Hershey | Pennsylvania |
United States | Clinical Trial Network LLC | Houston | Texas |
United States | The Women's Hospital of Texas | Houston | Texas |
United States | TMC Life Research, Inc. | Houston | Texas |
United States | Olympia Clinical Trials | Los Angeles | California |
United States | Clinical Trials Management, LLC | Metairie | Louisiana |
United States | Infinite Clinical Trials | Morrow | Georgia |
United States | Ochsner Health Center - Baptist McFarland Medical Plaza | New Orleans | Louisiana |
United States | Tidewater Clinical Research | Norfolk | Virginia |
United States | Velocity Clinical Research, Norfolk | Norfolk | Nebraska |
United States | Yale Fertility Center | Orange | Connecticut |
United States | The Advanced Gynecologic Surgery Institute | Park Ridge | Illinois |
United States | Clinical Research of Philadelphia, LLC | Philadelphia | Pennsylvania |
United States | Penn Medicine - Penn Fertility Care | Philadelphia | Pennsylvania |
United States | Sundance Clinical Research | Saint Louis | Missouri |
United States | Wasatch Clinical Research | Salt Lake City | Utah |
United States | Northeast Clinical Research of San Antonio | San Antonio | Texas |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Physician Care Clinical Research, LLC | Sarasota | Florida |
United States | Seattle Women's: Health, Research, Gynecology | Seattle | Washington |
United States | Omni Fertility and Laser Institute | Shreveport | Louisiana |
United States | Palmetto Clinical Research | Summerville | South Carolina |
United States | University of South Florida | Tampa | Florida |
United States | MedStar Washington Hospital Center | Washington | District of Columbia |
United States | Unified Women's Clinical Research-Lyndhurst Clinical Research | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Organon and Co | Iqvia Pty Ltd |
United States, Belgium, Bulgaria, Czechia, France, Germany, Hungary, Italy, Latvia, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | ||
Primary | 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. | First treatment cycle through completion of follow-up, an average of 20 weeks (each cycle is approximately 28 days). | |
Secondary | 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). | ||
Secondary | 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. | First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days). | |
Secondary | 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. | First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days). | |
Secondary | 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). | ||
Secondary | Change in Patient Global Impression of Severity (PGI-S) Score from V4 to Phone Contact 1, V6, and V7. | 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. | Visit 4 through V7, an average of 12 weeks (each cycle is approximately 28 days). | |
Secondary | 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). | ||
Secondary | Change from first treatment cycle to last planned treatment cycle in the Endometriosis Health Profile-30 (EHP-30) Domain Scores. | 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. | First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days | |
Secondary | Mean change from Visit 1 to Visit 7 in bone biomarker levels | Screening through end of treatment, an average of 24 weeks. | ||
Secondary | 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. | ||
Secondary | 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). | ||
Secondary | 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). | ||
Secondary | Mean change from V1 to V7 in serum hormone levels | Screening through end of treatment, an average of 24 weeks | ||
Secondary | Serum hormone levels at V5 comparing each treatment group | Visit 5 | ||
Secondary | Serum hormone levels at V7 comparing each treatment group | At V7 approximately 24 weeks after patient consents to the study. | ||
Secondary | 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). | ||
Secondary | Cmax, for both OG-6219 and FOR-1011. | At 2 visits approximately 3 weeks apart beginning at second treatment cycle. | ||
Secondary | Tmax for both OG-6219 and FOR-1011 | At 2 visits approximately 3 weeks apart beginning at second treatment cycle | ||
Secondary | AucTAU for both OG-6219 and FOR-1011 | At 2 visits approximately 3 weeks apart beginning at second treatment cycle |
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