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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04335591
Enrollment
356
Registered
2020-04-06
Start date
2020-03-05
Completion date
2022-12-15
Last updated
2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

Dysmenorrhea, Dyspareunia, Dyschezia, Non-menstrual pelvic pain

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.

Interventions

DRUG75 mg linzagolix tablet

For oral administration once daily

DRUG200 mg linzagolix tablet

For oral administration once daily

DRUGPlacebo tablet to match 75 mg linzagolix tablet

For oral administration once daily

DRUGPlacebo tablet to match 200 mg linzagolix tablet

For oral administration once daily

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

For oral administration once daily

DRUGPlacebo capsule to match Add-back capsule

For oral administration once daily

Sponsors

Kissei Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dysmenorrhea6-month extension study treatment period (from Month 6 to Month 12)Proportion of subjects with reduction of DYS (Month 3 MCT) and stable or decreased use of analgesics for EAP at Month 12
Non-menstrual Pelvic Pain6-month extension study treatment period (from Month 6 to Month 12)Proportion of subjects with reduction of NMPP (Month 3 MCT) and stable or decreased use of analgesics for EAP at Month 12

Countries

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

Participant flow

Recruitment details

Overall, 356 subjects entered the extension study and were treated. With the exception of 3 subjects who met a discontinuation criterion at Month 6, all other subjects who entered the extension study were included in the TEAS. The PP EAS consisted of 336 subjects. All 356 subjects who entered the extension study were included in the ESAF.

Pre-assignment details

Subjects who received placebo in the main study were randomized in a 1:1 ratio to either linzagolix (=LGX) 75 mg alone (with Add-back (=ABT) placebo) or LGX 200 mg with ABT, as per the main study randomization schedule. Subjects who received active treatment continued with the same treatment (LGX 75 mg alone or LGX 200 mg with ABT).

Participants by arm

ArmCount
LGX 75 mg
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally. * 1 x Linzagolix 75 mg tab. * 1 x Linzagolix 200 mg placebo tab. * 1 x ABT placebo cap. \[Extension study: 6 months\] Same treatment as the main study
119
LGX 200 mg+ABT
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally. * 1 x Linzagolix 200 mg tab. * 1 x Linzagolix 75 mg placebo tab. * 1 x ABT cap. (E2 1 mg / NETA 0.5 mg) \[Extension study: 6 months\] Same treatment as the main study
122
Placebo/LGX 75 mg
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally. * 1 x Linzagolix 75 mg placebo tab. * 1 x Linzagolix 200 mg placebo tab. * 1 x ABT placebo cap. \[Extension study: 6months\] Same treatment as LGX 75 mg group in the extension study
58
Placebo/LGX 200 mg+ABT
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally. * 1 x Linzagolix 75 mg placebo tab. * 1 x Linzagolix 200 mg placebo tab. * 1 x ABT placebo cap \[Extension study: 6 months\] Same treatment as LGX 200 mg+ABT group in the extension study
57
Total356

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyAdverse Event5232
Overall StudyProtocol Violation1000
Overall StudySubject planning pregnancy0100
Overall StudyUkrainian Russian war conflict4520
Overall StudyWithdrawal by Subject8445

Baseline characteristics

CharacteristicLGX 200 mg+ABTPlacebo/LGX 75 mgLGX 75 mgPlacebo/LGX 200 mg+ABTTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
122 Participants58 Participants119 Participants57 Participants356 Participants
Age, Continuous34.8 Years
STANDARD_DEVIATION 6.9
34.3 Years
STANDARD_DEVIATION 6.6
35.1 Years
STANDARD_DEVIATION 6.3
35.0 Years
STANDARD_DEVIATION 7.7
34.8 Years
STANDARD_DEVIATION 6.8
Age, Customized35.0 Years34.5 Years35.0 Years36.0 Years35.0 Years
BMI23.81 kg/m2
STANDARD_DEVIATION 4.58
23.39 kg/m2
STANDARD_DEVIATION 4.01
24.79 kg/m2
STANDARD_DEVIATION 5.54
24.77 kg/m2
STANDARD_DEVIATION 5.06
24.22 kg/m2
STANDARD_DEVIATION 4.93
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants1 Participants2 Participants0 Participants8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
117 Participants57 Participants117 Participants57 Participants348 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants1 Participants1 Participants3 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
120 Participants58 Participants117 Participants56 Participants351 Participants
Region of Enrollment
Austria
0 participants1 participants0 participants0 participants1 participants
Region of Enrollment
Bulgaria
3 participants0 participants2 participants1 participants6 participants
Region of Enrollment
Czechia
3 participants0 participants1 participants0 participants4 participants
Region of Enrollment
Poland
51 participants21 participants46 participants27 participants145 participants
Region of Enrollment
Romania
7 participants4 participants6 participants3 participants20 participants
Region of Enrollment
Spain
0 participants0 participants1 participants0 participants1 participants
Region of Enrollment
Ukraine
50 participants30 participants59 participants24 participants163 participants
Region of Enrollment
United States
8 participants2 participants4 participants2 participants16 participants
Sex: Female, Male
Female
122 Participants58 Participants119 Participants57 Participants356 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants
Weight65.210 kg
STANDARD_DEVIATION 13.497
64.004 kg
STANDARD_DEVIATION 11.103
68.475 kg
STANDARD_DEVIATION 15.115
68.029 kg
STANDARD_DEVIATION 13.826
66.560 kg
STANDARD_DEVIATION 13.83

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 1190 / 1220 / 580 / 57
other
Total, other adverse events
26 / 11919 / 12215 / 5813 / 57
serious
Total, serious adverse events
3 / 1190 / 1220 / 581 / 57

Outcome results

Primary

Dysmenorrhea

Proportion of subjects with reduction of DYS (Month 3 MCT) and stable or decreased use of analgesics for EAP at Month 12

Time frame: 6-month extension study treatment period (from Month 6 to Month 12)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
LGX 75 mgDysmenorrhea62 Participants
LGX 200 mg+ABTDysmenorrhea101 Participants
Placebo/LGX 75 mgDysmenorrhea32 Participants
Placebo/LGX 200 mg+ABTDysmenorrhea43 Participants
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

Time frame: 6-month extension study treatment period (from Month 6 to Month 12)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
LGX 75 mgNon-menstrual Pelvic Pain66 Participants
LGX 200 mg+ABTNon-menstrual Pelvic Pain75 Participants
Placebo/LGX 75 mgNon-menstrual Pelvic Pain34 Participants
Placebo/LGX 200 mg+ABTNon-menstrual Pelvic Pain27 Participants

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026