NCT04372121

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Kissei Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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-OBE2109-002 - Edelweiss 2 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.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	75 mg linzagolix tablet	For oral administration once daily
DRUG	200 mg linzagolix tablet	For oral administration once daily
DRUG	Add-back capsule (E2 1 mg / NETA 0.5 mg)	For oral administration once daily
DRUG	Placebo tablet to match 75 mg linzagolix tablet	For oral administration once daily
DRUG	Placebo tablet to match 200 mg linzagolix tablet	For oral administration once daily
DRUG	Placebo capsule to match Add-back capsule	For oral administration once daily

Timeline

• Start date: 2020-03-23
• Primary completion: 2021-01-08
• Completion: 2021-02-16
• First posted: 2020-05-01
• Last updated: 2025-04-02
• Results posted: 2025-03-19

Locations

25 sites across 3 countries: United States, Canada, Puerto Rico

Regulatory

• FDA-regulated drug study