Clinical trial NCT04335591: Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6)
Official title: A Double-blind Randomized Extension Study to Assess the Long-term Efficacy and Safety of Linzagolix in Subjects With Endometriosis-associated Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometriosis
Keywords: Dysmenorrhea
Dyspareunia
Dyschezia
Non-menstrual pelvic pain
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-06
Enrollment: 356
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this extension study is to assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment in total) in women who have already completed 6 months of linzagolix treatment at a dose of 75 mg alone or of 200 mg in combination with ABT (E2 1 mg / NETA 0.5 mg), in the management of moderate to severe endometriosis-associated pain (EAP) in women with surgically confirmed endometriosis.

Detailed description: This is a prospective, randomized, double-blind study. Subjects who have completed the 6-month Treatment Period in 18-OBE2109-003 - Edelweiss 3 study (herein referred to as main study) will be invited to enter the present extension study. Month 6 visit of the main study is a decision point for Subjects to either end treatment and enter a post-treatment follow up (part of the main study), or to opt for a 6-month treatment extension.

All subjects will receive once daily either linzagolix 75 mg alone (with ABT placebo) or 200 mg combined with ABT for 6 months. Subjects who received placebo during the main study will be randomized to either linzagolix 75 mg alone (with ABT placebo) or linzagolix 200 mg with ABT. Subjects who received active treatment during the main study will continue with the same treatment. Double-dummy design will be used in order to maintain the blinding of the study.

After end of treatment in the extension study (6-month treatment period: from Month 6 to Month 12), subjects will enter a post-treatment Follow-Up Period of 6 months with no investigational medicinal product (IMP) or - for subjects willing to continue treatment - a second extension study will be proposed.

Eligibility criteria: Inclusion Criteria:

The subject must have:

* completed the 6-month treatment in the main study.
* agree to continue to use only the analgesic rescue medication permitted by the protocol during the Treatment and Follow-up Periods.
* To continue to comply with the requirements of the study protocol for the duration of the extension study.

Exclusion Criteria:

The subject will be excluded if she:

* Is pregnant or breast feeding or is planning a pregnancy within the duration of the of the study (including the Follow-up Period).
* likely to require treatment during the study with any of the restricted medications
* has any other clinically significant gynecologic condition identified during the main study on transvaginal ultrasound (TVUS), on endometrial biopsy or at the manual breast examination, which might interfere with the study efficacy and safety objectives.
* met any of the main study discontinuation criteria

Primary outcomes:
measure: Dysmenorrhea
timeFrame: 6-month extension study treatment period (from Month 6 to Month 12)
measure: Non-menstrual Pelvic Pain
timeFrame: 6-month extension study treatment period (from Month 6 to Month 12)
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Choice Research, LLC/ ID # 609
state: Alabama
city: Homestead
country: United States
facility: Universal Axon - Homestead, LLC/ ID # 620
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials/ ID # 612
state: Florida
city: Nampa
country: United States
facility: Advanced Specialty Research/ ID # 610
state: Idaho
city: Shawnee Mission
country: United States
facility: Women's & Family Care, LLC dba GTC Research/ ID # 608
state: Kansas
city: Metairie
country: United States
facility: Southern Clinical Research / ID # 611
state: Louisiana
city: Chattanooga
country: United States
facility: Chattanooga Medical Research LLC/ ID# 602
state: Tennessee
city: Layton
country: United States
facility: Tanner Clinic/ ID # 624
state: Utah
city: Salzburg
country: Austria
facility: Salzburger Landeskliniken / ID # 105
city: Sliven
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Sliven/ ID # 131
city: Smolyan
country: Bulgaria
facility: MHAT Dr. Bratan Shukerov / ID #138
city: Sofia
country: Bulgaria
facility: Medical Centre Excelsior /ID # 135
city: Sofia
country: Bulgaria
facility: Group Practice for Specialized Medical Assistance in GINART/ ID # 132
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sofiamed"/ ID # 133
city: Tábor
country: Czechia
facility: Gynekologicko - Porodnicka Ambulance/ ID # 162
city: Ujezd nad Lesy
country: Czechia
facility: Gynekologie MU Dr.Lubomir Mikulasek / ID # 160
city: Toulouse
country: France
facility: Clinique Pasteur / ID # 206
city: Świdnik
country: Poland
facility: Lubelskie Centrum Diagnostyczne/ ID # 402
state: Lubelskie
city: Białystok
country: Poland
facility: Prywatna Klinika Ginekologiczno - Położnicza/ ID # 404
state: Podlaskie
city: Katowice
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk/ ID # 411
city: Katowice
country: Poland
facility: Clinical Medical Research sp. Z o. O/ ID # 406
city: Katowice
country: Poland
facility: Niepubliczny Zaklad Opieki Zrowotnej GynCentrum/ ID # 407
city: Lublin
country: Poland
facility: Kotarski Jan Specjalistyczny Gabinet Ginekologiczno Polozniczy/ ID # 405
city: Lublin
country: Poland
facility: Centrum Medyczne Chodźki Lublin/ ID # 403
city: Lublin
country: Poland
facility: VITA LONGA Sp. z o.o./ ID # 408
city: Olsztyn
country: Poland
facility: Centrum Ginekologii Endokrynologii i Medycyny Rozrodu "Artemida"/ ID # 409
city: Przemyśl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu/ ID # 410
city: Warsaw
country: Poland
facility: Specjalistyczny Gabinet Lekarski Krzysztof Dynowski / ID # 401
city: Bucharest
country: Romania
facility: Quantum Medical Center SRL/ ID # 353
city: Bucharest
country: Romania
facility: Spitalul Clinic "Nicolae Malaxa"/ ID # 352
city: Bucuresti
country: Romania
facility: Centrul Medical EUROMED/ ID # 351
city: Bucuresti
country: Romania
facility: Sp Cl de Obstetrica si Ginecologie "Prof. Dr. Panait Sirbu"/ ID # 354
city: Cluj-Napoca
country: Romania
facility: Gine Plus SRL Cluj- Napoca/ ID # 357
city: Târgu-Mureş
country: Romania
facility: Centrul Medical GALENUS/ ID # 355
city: Murcia
country: Spain
facility: Hospital General Universitario Reina Sofia/ ID # 304
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga/ ID # 303
city: Chernivtsi
country: Ukraine
facility: City clinical maternity hospital №1/ ID # 502
city: Ivano-Frankivs'k
country: Ukraine
facility: Ivano-Frankivsk regional perinatal center, Family planning center/ ID # 506
city: Kyiv
country: Ukraine
facility: Kyiv City Maternity Hospital #6/ ID # 504
city: Kyiv
country: Ukraine
facility: Medical center of LLC "Medical Center "Verum"/ ID # 503
city: Kyiv
country: Ukraine
facility: Institute of Pediatrics Obstetrics and Gynecology/ ID # 508
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #9/ ID # 501
city: Kyiv
country: Ukraine
facility: Kyiv City Center of Reproductive and Perinatal Medicine/ ID # 509
city: Ternopil
country: Ukraine
facility: Ternopil' Communal City Hospital#2 / ID # 511
city: Vinnytsia
country: Ukraine
facility: Vinnytsia City Clinical Hospital "Center of Mother and the Child "/ ID # 510
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhya Regional Clinical Hospital/ ID # 505
city: Zaporizhzhya
country: Ukraine
facility: Maternity Hospital № 3/ ID # 507
Study officials:
affiliation: ObsEva SA
name: Lecomte
role: STUDY_DIRECTOR
References: