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

Endometriosis Clinical Trial

— ELENA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05560646
• Other study ID #: OG-6219-P001
• Status: Recruiting
• Phase: Phase 2
• Start date: October 25, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Organon and Co
• Contact: Toll Free Number
• Phone: 551-430-6000
• Email: OG-6219-P001[@]IQVIA.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• OG-6219
OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles.
• Placebo
Participants will receive (orally) OG-6219 Placebo tablets BID during treatment cycles.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Organon and Co	Iqvia Pty Ltd

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Czechia,  France,  Germany,  Hungary,  Italy,  Latvia,  Poland, 

Outcome

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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