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

Endometriosis Clinical Trial

— EDELWEISS 5  

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: Terminated

Administrative data

• NCT number: NCT04372121
• Other study ID #: 19-OBE2109-005
• Status: Terminated
• Phase: Phase 3
• Start date: March 23, 2020
• Est. completion date: February 16, 2021

Study information

• Verified date: December 2021
• 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-OBE2109-002 - 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: February 16, 2021
• Est. primary completion date: January 8, 2021
• 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

• agreed to continue to use only the analgesic rescue medication permitted by the protocol during the Treatment and Follow-up Periods

• agreed 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

• meets 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
• Add-back capsule (E2 1 mg / NETA 0.5 mg)
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
• Placebo capsule to match Add-back capsule
For oral administration once daily

Locations

Country	Name	City	State
Canada	CARe Clinic / ID # 872	Red Deer	Alberta
Puerto Rico	Puerto Rico Medical Res Inc. / ID # 890	Ponce
United States	Austin Area ObGyn PLLC / ID # 701	Austin	Texas
United States	OB/GYN North Austin / ID # 764	Austin	Texas
United States	Dr. David I. Lubetkin, LLC / ID # 703	Boca Raton	Florida
United States	ClinOhio Res Services, LLC / ID # 722	Columbus	Ohio
United States	Complete Healthcare for Women / ID # 801	Columbus	Ohio
United States	HCWC dba DiscoveryClinical Trials / ID # 771	Dallas	Texas
United States	Physicians Research Options / ID # 766	Draper	Utah
United States	Providea Health Partners LLC / ID # 734	Evergreen Park	Illinois
United States	Onyx Clinical Research / ID # 793	Flint	Michigan
United States	Signature Gyn Services / ID # 726	Fort Worth	Texas
United States	Hilltop OBGYN / ID # 711	Franklin	Ohio
United States	Adv Womens Health Institute / ID # 761	Greenwood Village	Colorado
United States	Medical Colleagues of Texas / ID # 819	Katy	Texas
United States	Red Rocks OB/GYN / ID # 732	Lakewood	Colorado
United States	Maximos OB/GYN	League City	Texas
United States	Applied Res Center of Ar / Id # 735	Little Rock	Arkansas
United States	Coral Way Research / ID # 799	Miami	Florida
United States	La Salud Research Clinic, Inc. / ID # 824	Miami	Florida
United States	Clinical Research Associates Inc / ID # 802	Nashville	Tennessee
United States	Futura Research, Inc. / ID # 781	Norwalk	California
United States	A Premier Medical Research of Florida, LLC / ID # 752	Orange City	Florida
United States	Clinical Associates of Orlando, LLC / ID # 779	Orlando	Florida
United States	Valley OBGYN / ID # 704	Saginaw	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysmenorrhea	Change at Month 12 from baseline in the mean daily assessment of dysmenorrhea measured on a 0-3 Verbal Rating Scale (VRS) using an electronic diary. The lower value represents a better outcome.	Baseline to Month 12
Primary	Non-menstrual pelvic pain	Change at Month 12 from baseline in the mean daily assessment of non-menstrual pelvic pain measured on a 0-3 Verbal Rating Scale (VRS) using an electronic diary. The lower value represents a better outcome.	Baseline to Month 12
Secondary	Dysmenorrhea	Change from baseline to Month 12 in dysmenorrhea measured on a 0-3 Verbal Rating Scale (VRS) using an electronic diary. The lower value represents a better outcome.	Baseline to Month 12
Secondary	Non-menstrual pelvic pain	Change from baseline to Month 12 in non-menstrual pelvic pain measured on a 0-3 Verbal Rating Scale (VRS) using an electronic diary. The lower value represents a better outcome.	Baseline to Month 12
Secondary	Dyschezia	Change from baseline to Month 12 in dyschezia measured on a 0-10 Numeric Rating Scale (NRS) using an electronic diary. The lower value represents a better outcome.	Baseline to Month 12
Secondary	Overall Pelvic Pain	Change from baseline to Month 12 in overall pelvic pain measured on a 0-10 Numeric Rating Scale (NRS) using an electronic diary. The lower value represents a better outcome.	Baseline to Month 12
Secondary	Interference of pain with the ability to perform daily activities	Change from baseline to Month 12 in the interference of pain with the ability to perform daily activities, measured using the pain dimension of the Endometriosis Health Profile-30 (EHP-30) using an electronic diary	Baseline to Month 12
Secondary	Dyspareunia	Change from baseline to Month 12 in dyspareunia measured on a 0-3 Verbal Rating Scale (VRS) using an electronic diary. The lower value represents a better outcome.	Baseline to Month 12
Secondary	No analgesic use for endometriosis associated pain	Proportion of subjects reporting no analgesic use for endometriosis associated pain, during the preceding 4-week period at each scheduled assessment	During the preceding 4-week period at each scheduled assessment
Secondary	No opiate use for endometriosis associated pain	Proportion of subjects reporting no opiate use for endometriosis associated pain, during the preceding 4-week period at each scheduled assessment	During the preceding 4-week period at each scheduled assessment