Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6)

Endometriosis Clinical Trial

Official title:

A Double-blind Randomized Extension Study to Assess the Long-term Efficacy and Safety of Linzagolix in Subjects With Endometriosis-associated Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04335591
• Other study ID #: 19-OBE2109-006
• Status: Completed
• Phase: Phase 3
• Start date: March 5, 2020
• Est. completion date: December 15, 2022

Study information

• Verified date: March 2024
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: December 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• 75 mg linzagolix tablet
For oral administration once daily
• 200 mg linzagolix tablet
For oral administration once daily
• Placebo tablet to match 75 mg linzagolix tablet
For oral administration once daily
• Placebo tablet to match 200 mg linzagolix tablet
For oral administration once daily
• Add-back capsule (E2 1 mg / NETA 0.5 mg)
For oral administration once daily
• Placebo capsule to match Add-back capsule
For oral administration once daily

Locations

Country	Name	City	State
Austria	Salzburger Landeskliniken / ID # 105	Salzburg
Bulgaria	Multiprofile Hospital for Active Treatment Sliven/ ID # 131	Sliven
Bulgaria	MHAT Dr. Bratan Shukerov / ID #138	Smolyan
Bulgaria	Group Practice for Specialized Medical Assistance in GINART/ ID # 132	Sofia
Bulgaria	Medical Centre Excelsior /ID # 135	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment "Sofiamed"/ ID # 133	Sofia
Czechia	Gynekologicko - Porodnicka Ambulance/ ID # 162	Tábor
Czechia	Gynekologie MU Dr.Lubomir Mikulasek / ID # 160	Ujezd nad Lesy
France	Clinique Pasteur / ID # 206	Toulouse
Poland	Prywatna Klinika Ginekologiczno - Poloznicza/ ID # 404	Bialystok	Podlaskie
Poland	Clinical Medical Research sp. Z o. O/ ID # 406	Katowice
Poland	Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk/ ID # 411	Katowice
Poland	Niepubliczny Zaklad Opieki Zrowotnej GynCentrum/ ID # 407	Katowice
Poland	Centrum Medyczne Chodzki Lublin/ ID # 403	Lublin
Poland	Kotarski Jan Specjalistyczny Gabinet Ginekologiczno Polozniczy/ ID # 405	Lublin
Poland	VITA LONGA Sp. z o.o./ ID # 408	Lublin
Poland	Centrum Ginekologii Endokrynologii i Medycyny Rozrodu "Artemida"/ ID # 409	Olsztyn
Poland	Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu/ ID # 410	Przemysl
Poland	Lubelskie Centrum Diagnostyczne/ ID # 402	Swidnik	Lubelskie
Poland	Specjalistyczny Gabinet Lekarski Krzysztof Dynowski / ID # 401	Warsaw
Romania	Quantum Medical Center SRL/ ID # 353	Bucharest
Romania	Spitalul Clinic "Nicolae Malaxa"/ ID # 352	Bucharest
Romania	Centrul Medical EUROMED/ ID # 351	Bucuresti
Romania	Sp Cl de Obstetrica si Ginecologie "Prof. Dr. Panait Sirbu"/ ID # 354	Bucuresti
Romania	Gine Plus SRL Cluj- Napoca/ ID # 357	Cluj-Napoca
Romania	Centrul Medical GALENUS/ ID # 355	Târgu-Mures
Spain	Hospital Regional Universitario de Málaga/ ID # 303	Málaga
Spain	Hospital General Universitario Reina Sofia/ ID # 304	Murcia
Ukraine	City clinical maternity hospital ?1/ ID # 502	Chernivtsi
Ukraine	Ivano-Frankivsk regional perinatal center, Family planning center/ ID # 506	Ivano-Frankivs'k
Ukraine	Institute of Pediatrics Obstetrics and Gynecology/ ID # 508	Kyiv
Ukraine	Kyiv City Center of Reproductive and Perinatal Medicine/ ID # 509	Kyiv
Ukraine	Kyiv City Clinical Hospital #9/ ID # 501	Kyiv
Ukraine	Kyiv City Maternity Hospital #6/ ID # 504	Kyiv
Ukraine	Medical center of LLC "Medical Center "Verum"/ ID # 503	Kyiv
Ukraine	Ternopil' Communal City Hospital#2 / ID # 511	Ternopil
Ukraine	Vinnytsia City Clinical Hospital "Center of Mother and the Child "/ ID # 510	Vinnytsia
Ukraine	Maternity Hospital ? 3/ ID # 507	Zaporizhzhya
Ukraine	Zaporizhzhya Regional Clinical Hospital/ ID # 505	Zaporizhzhya
United States	Chattanooga Medical Research LLC/ ID# 602	Chattanooga	Tennessee
United States	Choice Research, LLC/ ID # 609	Dothan	Alabama
United States	Universal Axon - Homestead, LLC/ ID # 620	Homestead	Florida
United States	Tanner Clinic/ ID # 624	Layton	Utah
United States	Southern Clinical Research / ID # 611	Metairie	Louisiana
United States	Advanced Specialty Research/ ID # 610	Nampa	Idaho
United States	Women's & Family Care, LLC dba GTC Research/ ID # 608	Shawnee Mission	Kansas
United States	Stedman Clinical Trials/ ID # 612	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

United States,  Austria,  Bulgaria,  Czechia,  France,  Poland,  Romania,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysmenorrhea	Proportion of subjects with reduction of DYS (Month 3 MCT) and stable or decreased use of analgesics for EAP at Month 12	6-month extension study treatment period (from Month 6 to Month 12)
Primary	Non-menstrual Pelvic Pain	Proportion of subjects with reduction of NMPP (Month 3 MCT) and stable or decreased use of analgesics for EAP at Month 12	6-month extension study treatment period (from Month 6 to Month 12)