Back to results

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

Primary Purpose

Endometriosis

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

75 mg linzagolix tablet

200 mg linzagolix tablet

Placebo tablet to match 75 mg linzagolix tablet

Placebo tablet to match 200 mg linzagolix tablet

Add-back capsule (E2 1 mg / NETA 0.5 mg)

Placebo capsule to match Add-back capsule

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Dysmenorrhea, Dyspareunia, Dyschezia, Non-menstrual pelvic pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Choice Research, LLC/ ID # 609
Universal Axon - Homestead, LLC/ ID # 620
Stedman Clinical Trials/ ID # 612
Advanced Specialty Research/ ID # 610
Women's & Family Care, LLC dba GTC Research/ ID # 608
Southern Clinical Research / ID # 611
Chattanooga Medical Research LLC/ ID# 602
Tanner Clinic/ ID # 624
Salzburger Landeskliniken / ID # 105
Multiprofile Hospital for Active Treatment Sliven/ ID # 131
MHAT Dr. Bratan Shukerov / ID #138
Medical Centre Excelsior /ID # 135
Group Practice for Specialized Medical Assistance in GINART/ ID # 132
University Multiprofile Hospital for Active Treatment "Sofiamed"/ ID # 133
Gynekologicko - Porodnicka Ambulance/ ID # 162
Gynekologie MU Dr.Lubomir Mikulasek / ID # 160
Clinique Pasteur / ID # 206
Lubelskie Centrum Diagnostyczne/ ID # 402
Prywatna Klinika Ginekologiczno - Położnicza/ ID # 404
Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk/ ID # 411
Clinical Medical Research sp. Z o. O/ ID # 406
Niepubliczny Zaklad Opieki Zrowotnej GynCentrum/ ID # 407
Kotarski Jan Specjalistyczny Gabinet Ginekologiczno Polozniczy/ ID # 405
Centrum Medyczne Chodźki Lublin/ ID # 403
VITA LONGA Sp. z o.o./ ID # 408
Centrum Ginekologii Endokrynologii i Medycyny Rozrodu "Artemida"/ ID # 409
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu/ ID # 410
Specjalistyczny Gabinet Lekarski Krzysztof Dynowski / ID # 401
Quantum Medical Center SRL/ ID # 353
Spitalul Clinic "Nicolae Malaxa"/ ID # 352
Centrul Medical EUROMED/ ID # 351
Sp Cl de Obstetrica si Ginecologie "Prof. Dr. Panait Sirbu"/ ID # 354
Gine Plus SRL Cluj- Napoca/ ID # 357
Centrul Medical GALENUS/ ID # 355
Hospital General Universitario Reina Sofia/ ID # 304
Hospital Regional Universitario de Málaga/ ID # 303
City clinical maternity hospital №1/ ID # 502
Ivano-Frankivsk regional perinatal center, Family planning center/ ID # 506
Kyiv City Maternity Hospital #6/ ID # 504
Medical center of LLC "Medical Center "Verum"/ ID # 503
Institute of Pediatrics Obstetrics and Gynecology/ ID # 508
Kyiv City Clinical Hospital #9/ ID # 501
Kyiv City Center of Reproductive and Perinatal Medicine/ ID # 509
Ternopil' Communal City Hospital#2 / ID # 511
Vinnytsia City Clinical Hospital "Center of Mother and the Child "/ ID # 510
Zaporizhzhya Regional Clinical Hospital/ ID # 505
Maternity Hospital № 3/ ID # 507

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Linzagolix 75 mg

Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg)

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

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

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.

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

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

Full Information

NCT ID

NCT04335591

First Posted

April 3, 2020

Last Updated

January 12, 2023

Sponsor

Kissei Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04335591

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 5, 2020 (Actual)

Primary Completion Date

April 7, 2022 (Actual)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kissei Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometriosis

Keywords

Dysmenorrhea, Dyspareunia, Dyschezia, Non-menstrual pelvic pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Linzagolix 75 mg

Arm Type

Experimental

Arm Title

Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

75 mg linzagolix tablet

Intervention Description