Clinical trial NCT05560646: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Endometriosis Related Pain (ERP)
Endometriosis
Pre-menopausal women
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2022-09-29
Enrollment: 354
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: 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).
timeFrame: First treatment cycle to last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
measure: Safety and tolerability of OG-6219
timeFrame: First treatment cycle through completion of follow-up, an average of 20 weeks (each cycle is approximately 28 days).
Secondary outcomes:
measure: Change from first treatment cycle to last planned treatment cycle in the mean DYS score
timeFrame: First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
measure: Change from first treatment cycle to last planned treatment cycle in the mean
timeFrame: First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
measure: Change from first treatment cycle to last planned treatment cycle in the mean dyspareunia score.
timeFrame: First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
measure: 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.
timeFrame: First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
measure: Change in Patient Global Impression of Severity (PGI-S) Score from V4 to Phone Contact 1, V6, and V7.
timeFrame: Visit 4 through V7, an average of 12 weeks (each cycle is approximately 28 days).
measure: Percentage of participants with any improvement on the Patient Global Impression of Change at second, third and last planned treatment cycle.
timeFrame: Visit 4 through V7, an average of 12 weeks (each cycle is approximately 28 days).
measure: Change from first treatment cycle to last planned treatment cycle in the Endometriosis Health Profile-30 (EHP-30) Domain Scores.
timeFrame: First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days
measure: Mean change from Visit 1 to Visit 7 in bone biomarker levels
timeFrame: Screening through end of treatment, an average of 24 weeks.
measure: Proportion of participants with clinical parameters of significance from Visit 1 to Visit 5, Visit 6, Visit 7, and Visit 8.
timeFrame: Screening through safety follow-up, an average of 28 weeks.
measure: Mean change from first treatment cycle to second, third and fourth treatment cycles in the percentage of days with vaginal bleeding
timeFrame: First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
measure: ECG parameter changes at each of the four treatment cycle visits
timeFrame: First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
measure: Mean change from V1 to V7 in serum hormone levels
timeFrame: Screening through end of treatment, an average of 24 weeks
measure: Serum hormone levels at V5 comparing each treatment group
timeFrame: Visit 5
measure: Serum hormone levels at V7 comparing each treatment group
timeFrame: At V7 approximately 24 weeks after patient consents to the study.
measure: Plasma concentrations of OG-6219 and FOR-1011 at scheduled assessments using sparse PK sampling.
timeFrame: Second treatment cycle through completion of last planned treatment cycle, an average of 12 weeks (each cycle is approximately 28 days).
measure: Cmax, for both OG-6219 and FOR-1011.
timeFrame: At 2 visits approximately 3 weeks apart beginning at second treatment cycle.
measure: Tmax for both OG-6219 and FOR-1011
timeFrame: At 2 visits approximately 3 weeks apart beginning at second treatment cycle
measure: AucTAU for both OG-6219 and FOR-1011
timeFrame: At 2 visits approximately 3 weeks apart beginning at second treatment cycle
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates LLC dba Flourish Research
state: Alabama
city: Birmingham
country: United States
facility: UAB Center for Women's Reproductive Health
state: Alabama
city: Los Angeles
country: United States
facility: Olympia Clinical Trials
state: California
city: Orange
country: United States
facility: Yale Fertility Center
state: Connecticut
city: Sarasota
country: United States
facility: Physician Care Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: MediSense Inc
state: Georgia
city: College Park
country: United States
facility: Paramount Research Solutions
state: Georgia
city: Morrow
country: United States
facility: Infinite Clinical Trials
state: Georgia
city: Park Ridge
country: United States
facility: The Advanced Gynecologic Surgery Institute
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Health Center - Baptist McFarland Medical Plaza
state: Louisiana
city: Shreveport
country: United States
facility: Omni Fertility and Laser Institute
state: Louisiana
city: Baltimore
country: United States
facility: John Hopkins University
state: Maryland
city: Albuquerque
country: United States
facility: Bosque Women's Care
state: New Mexico
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Dublin
country: United States
facility: Centricity Research Dublin
state: Ohio
city: Hershey
country: United States
facility: Penn State Health Women's Health Clinic
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research, LLC
state: Tennessee
city: Euless
country: United States
facility: Cedar Health Research, LLC
state: Texas
city: Houston
country: United States
facility: The Women's Hospital of Texas
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network LLC
state: Texas
city: San Antonio
country: United States
facility: Northeast Clinical Research of San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Norfolk
country: United States
facility: Tidewater Clinical Research
state: Virginia
city: Seattle
country: United States
facility: Seattle Women's: Health, Research, Gynecology
state: Washington
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Gent
country: Belgium
facility: AZ Jan Palfijn Gent
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Ghent
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis Hospital
city: La Louvière
country: Belgium
facility: CHU de Tivoli
city: Pleven
country: Bulgaria
facility: Medical Center Repromed EOOD
city: Plovdiv
country: Bulgaria
facility: UMHAT "Sv. Georgi", EAD
city: Sofia
country: Bulgaria
facility: DCC " Ascendent" EAD
city: Sofia
country: Bulgaria
facility: SHATOD - Sofia District, EOOD
city: Sofia
country: Bulgaria
facility: MHAT for women's health - Nadezhda, OOD
city: Sofia
country: Bulgaria
facility: DCC "Alexandrovska", EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD
city: Sofia
country: Bulgaria
facility: Group practice for specialized medical care in the field of obstetrics and gynecology - Gin Art OOD
city: Stara Zagora
country: Bulgaria
facility: MHAT NiaMed OOD
city: Varna
country: Bulgaria
facility: Acibadem City Clinic MC Varna EOOD
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Olomouc
country: Czechia
facility: Fertimed s.r.o.
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 3
country: Czechia
facility: Femina Sana s.r.o.
city: Praha 4
country: Czechia
facility: Ustav pro peci o matku a dite
city: Paris Cedex 14
country: France
facility: Hopital Saint Joseph Paris
state: Paris
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hopital Tenon
city: Strasbourg
country: France
facility: Hospital of Hautepierre
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf AoeR
state: Nordrhein Westfalen
city: Berlin
country: Germany
facility: Charité - Campus Benjamin Franklin
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Budapest
country: Hungary
facility: Clinexpert Kft.
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Debrecen
country: Hungary
facility: Szent Anna Maganrendelo
city: Kaposvár
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
city: Seriate
country: Italy
facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
state: Milano
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: Roma
city: Monserrato
country: Italy
facility: Università di Cagliari-Presidio Policlinico Monserrato
city: Siena
country: Italy
facility: University of Siena Policlinico
city: Verona
country: Italy
facility: Centro Ricerche Cliniche di Verona s.r.l.
city: Riga
country: Latvia
facility: Latvian Maritime Medical Centre
city: Riga
country: Latvia
facility: Vitols & Vitols, Ltd.
city: Riga
country: Latvia
facility: Dr. Vasaraudze's Private Clinic
city: Wroclaw
country: Poland
facility: Przychodnia Wielospecjalistyczna Sk-Medica Spółka Z O.O.
state: Dolnoslask
city: Bialystok
country: Poland
facility: Specjalistyczna Poradnia Ginekologiczna Janusz Tomaszewski Spółka Komandytowa
city: Bialystok
country: Poland
facility: Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
city: Katowice
country: Poland
facility: Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
city: Katowice
country: Poland
facility: Clinical Medical Research Sp. z o.o.
city: Katowice
country: Poland
facility: NZOZ Medem
city: Lublin
country: Poland
facility: Specjalistyczny Gabinet Ginekologiczno-Położniczy
city: Lublin
country: Poland
facility: Centrum Medyczne Chodzki HLK
city: Lublin
country: Poland
facility: KO-MED Centra Kliniczne Lublin II
city: Olsztyn
country: Poland
facility: ETYKA Osrodek Badan Klinicznych
city: Siedlce
country: Poland
facility: Etg Siedlce
city: Szczecin
country: Poland
facility: Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
city: Torun
country: Poland
facility: MICS Centrum Medyczne Torun
city: Warszawa
country: Poland
facility: Specjalistyczna Praktyka Lekar
city: Warszawa
country: Poland
facility: PRATIA S.A. MTZ Clinical Research Powered by Pratia
city: Warszawa
country: Poland
facility: WIM Panstwowy Instytut Badawczy Centralny Szpital Kliniczny MON
city: Łódź
country: Poland
facility: Centra Medyczne Medyceusz
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Danderyd Sjukhus
Study officials:
affiliation: Organon and Co
name: Clinical Lead Late-Stage Clinical Development
role: STUDY_DIRECTOR
References: