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

Sponsor

ObsEva SA (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04335591

Collaborator

(none)

288

Enrollment

Locations

Arms

29.9

Anticipated Duration (Months)

6.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: 75 mg linzagolix tablet Drug: 200 mg linzagolix tablet Drug: Placebo tablet to match 75 mg linzagolix tablet Drug: Placebo tablet to match 200 mg linzagolix tablet Drug: Add-back capsule (E2 1 mg / NETA 0.5 mg) Drug: Placebo capsule to match Add-back capsule	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

288 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 5, 2020

Actual Primary Completion Date :

Apr 7, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Linzagolix 75 mg	Drug: 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
Experimental: Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg)	Drug: 200 mg linzagolix tablet For oral administration once daily Drug: Placebo tablet to match 75 mg linzagolix tablet For oral administration once daily Drug: Add-back capsule (E2 1 mg / NETA 0.5 mg) For oral administration once daily

Arm

Intervention/Treatment

Experimental: Linzagolix 75 mg

Drug: 75 mg linzagolix tablet