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A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain

Primary Purpose

Endometriosis

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

75 mg linzagolix tablet

200 mg linzagolix tablet

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

Placebo tablet to match 75 mg linzagolix tablet

Placebo tablet to match 200 mg linzagolix tablet

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 - 49 Years (Adult)FemaleDoes not accept healthy volunteers

Key Inclusion Criteria:

The subject must have:

Her most recent surgical and - if available - histological diagnosis of pelvic endometriosis up to 10 years before screening.
Moderate to severe endometriosis-associated pain during the screening period.
Regular menstrual cycles.
BMI ≥ 18 kg/m2 at the screening visit.

Key Exclusion Criteria:

The subject will be excluded if she:

Is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
Is less than 6 months postpartum or 3 months postabortion/ miscarriage at the time of entry into the screening period.
Has had a surgical history of any major abdominal surgery within 6 months or any interventional surgery for endometriosis performed within a period of 2 months before screening.
Did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis.
Has a history of, or known, osteoporosis or other metabolic bone disease.
Has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic or other chronic therapy which would interfere with the assessment of endometriosis-associated pain.

Sites / Locations

Birmingham OBGYN / ID # 740
Mesa Obstetricians and Gyneocologists / ID # 790
Precision Trials AZ, LLC / ID # 783
Quality of LIfe Medical & Research Center, LLC / ID # 813
Visions Clinical Research-Tucson / ID # 754
Lynn Institute of the Ozarks / ID # 826
Applied Research Center of Arkansas / ID # 735
Join Clinical Trials / ID # 778
Long Beach Clinical Trials, LLC / ID # 768
Matrix Clinical Research / ID # 751
Futura Research, Org / ID # 781
National Research Institute / ID # 805
Precision Research Institute / ID # 792
MD Strategies Research Centers / ID # 765
Downtown Women's Health Care / ID # 718
Center for Women's Health / ID # 761
Physicians Research Options, LLC / Red Rocks Ob/Gyn / ID # 732
Dr. David I. Lubetkin, LLC / ID # 703
Helix Biomedics Clincial Research, LLC / ID # 750
Accel Research Sites, DeLand Clinical Research Unit / ID # 713
Universal Axon Clinical Research / ID # 769
Clinical Neuroscience Solutions, Inc. / ID # 773
South Florida Clinical Research Institute / ID # 747
Global Health Research Center, Inc. / ID # 787
Coral Way Research / ID # 799
Suncoast Research Group, LLC / ID # 756
Biotech Pharmaceutical Group LLC / ID # 786
La Salud Research Clinic, Inc. / ID # 824
Suncoast Research Associates, LLC / ID # 760
LCC Medical Research Institute / ID # 814
Sensible Healthcare / ID # 749
A Premier Medical Research of Florida, LLC / ID # 752
Clinical Neuroscience Solutions, Inc. / ID # 731
Omega Research Orlando, LLC / ID # 785
Clinical Associates of Orlando, LLC / ID # 779
Synexus Clinical Research US, Inc. / ID # 725
Physician Care Clinical Research LLC / ID # 810
University of South Florida / ID # 738
GCP Clinical Research, LLC / ID # 825
Atlanta Women's Research Institute, Inc. / ID # 727
Sonara Clinical Research, LLC / ID # 720
Moore Health Wellness Research Institute, LLC / ID # 795
Providea Health Partners LLC / ID # 734
Cypress Medical Research Center, LLC / ID # 755
Horizon Research Group of Opelousas, LLC / ID # 757
Praetorian Pharmaceutical Research / ID # 739
Women Under Study, LLC / ID # 820
Johns Hopkins University, School Of Medicine / ID # 816
Pharmasite Research Inc / ID # 838
Continental Clinical Solutions, LLC / ID # 777
NECCR Fall River, LLC / Id # 712
Onyx Clinical Research / ID # 793
CMEP/CMU health / ID # 812
Valley OBGYN / ID # 704
Saginaw Valley Medical Research Group, LLC / ID # 743
Office of Edmond Pack, MD / Id # 818
Lawrence OB/GYN clinical Research, LLC / ID # 742
Albuquerque Clinical Trials, Inc. / ID # 707
Carolina Institute for Clinical Research / ID # 728
Unified Women's Clinical Research - Green Valley OBGYN / ID # 719
Eastern Carolina Women's Center / Id # 794
Unified Women's Clinical Research - Raleigh / Id # 714
Carolina Medical Trials, LLC / ID # 788
ClinOhio Research Services, LLC / ID # 722
Complete Healthcare for Women / ID # 801
Wright State Physicians / ID # 733
Hilltop OBGYN / ID # 711
Oregon Health & Science University / ID # 791
OB/GYN Associates of Erie / ID # 706
Penn State Health Milton S. Hershey Medical Center / ID # 804
The Clinical Trial Center / ID # 744
VitaLink Research - Upstate / ID # 789
Clinical Trials of South Carolina / ID # 741
VitaLink Research Spartanburg / ID # 753
Seasons at Bristol / ID # 705
WR-ClinSearch, LLC / ID # 821
University of Tennessee Medical Center / ID # 780
Clinical Neuroscience Solutions, Inc / ID # 772
Clinical Research Associates Inc / ID # 802
Women Partners in Health / ID # 836
Austin Area ObGyn PLLC / ID # 701
Christina Sebestyen MD, P.A. dba OBGYN North / ID # 764
Christus St. Elizabeth Gadolin Research, LLC / ID # 774
HCWC dba DiscoveryClinical Trials / ID # 771
UT Southwestern Medical Center / ID # 823
Signature Gyn Services / ID # 726
Georgetown OB/GYN / ID # 770
Ventavia Research Group, LLC / ID # 729
Vilo Research Group / ID # 709
UT Health Clinical Res Ctr / ID # 828
TMC Life Research, Inc. / ID # 809
MacArthur OB-Gyn Research / ID # 840
Medical Colleagues of Texas / ID # 819
FMC Science / ID # 730
Maximos OB/GYN / ID # 737
DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials / ID # 803
DCT-AACT, LLC dba Discovery Clinical Trials / ID # 815
Northeast Clinical Research of San Antonio, LLC / ID # 710
Physicians Research Options PRO / ID # 766
Physicians' Res Options - PG / ID # 833
Wasatch Clinical Research / ID # 746
Highland Clinical Research / ID # 708
Clinical Research Partners, LLC / ID # 715
Clinical Research Partners, LLC / ID # 775
Tidewater Clinical Research The Group for Women / ID # 716
Seattle Women's: Health, Research, Gynecology / ID # 702
Seattle Reproductive Medicine / ID # 811
CARe Clinic / ID # 872
McMaster University Medical Centre / ID # 870
Victory Reproductive Care / ID # 873
Ponce Medical SChool Foundation Inc./ CAIMED Center / ID # 891
Puerto Rico Medical Research Inc. / ID # 890

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Linzagolix 75 mg

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

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Dysmenorrhea

Change at Month 3 from baseline in the mean daily assessment of dysmenorrhea measured on a Verbal Rating Scale (VRS) using an electronic diary

Non-menstrual pelvic pain

Change at Month 3 from baseline in the mean daily assessment of non-menstrual pelvic pain measured on a Verbal Rating Scale (VRS) using an electronic diary

Secondary Outcome Measures

Dysmenorrhea

Change from baseline to Month 6 in dysmenorrhea measured on a Verbal Rating Scale (VRS) using an electronic diary

Non-menstrual pelvic pain

Change from baseline to Month 6 in non-menstrual pelvic pain measured on a Verbal Rating Scale (VRS) using an electronic diary

Dyschezia

Change from baseline to Month 6 in dyschezia measured on a Numeric Rating Scale (NRS) using an electronic diary

Overall Pelvic Pain

Change from baseline to Month 6 in overall pelvic pain measured on a Numeric Rating Scale (NRS) using an electronic diary

Interference of pain with the ability to perform daily activities

Change from baseline to Month 6 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 6 in dyspareunia measured on a Verbal Rating Scale (VRS) using an electronic diary

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 Month 6

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 Month 6

Percentage change from baseline to Month 6 in Bone Mineral Density (BMD)

Percentage change from baseline to Month 6 of the BMD measured by dual-energy X-ray absorptiometry (DXA) scan of Lumbar Spine

Change from baseline to Month 6 in Bone Mineral Density (BMD)

Change from baseline to Month 6 of the BMD measured by dual-energy X-ray absorptiometry (DXA) scan of Lumbar Spine Z-scores

Clinical laboratory assessments: total cholesterol

Change from baseline to Month 6 in clinical laboratory assessments: total cholesterol

Clinical laboratory assessments: LDL

Change from baseline to Month 6 in clinical laboratory assessments: LDL cholesterol

Clinical laboratory assessments: triglycerides

Change from baseline to Month 6 in clinical laboratory assessments: Triglycerides

Change from baseline to Month 6 in the endometrial thickness

Change from baseline to Month 6 in endometrial thickness measured by Transvaginal Ultrasound (TVUS)

Change From Baseline to Month 6 in ECG results

Change from baseline to Month 6 in ECG results (QTcF values)

Full Information

NCT ID

NCT03986944

First Posted

June 6, 2019

Last Updated

May 5, 2022

Sponsor

ObsEva SA

1. Study Identification

Unique Protocol Identification Number

NCT03986944

Brief Title

A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain

Official Title

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Assess the Efficacy and Safety of Linzagolix in Subjects With Moderate to Severe Endometriosis-associated Pain.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Terminated

Why Stopped

Study halted due to the significant enrollment challenges encountered since its beginning. Screening and enrollment have been impacted by the COVID pandemic and more importantly by changes in the diagnosis and treatment of women with endometriosis.

Study Start Date

May 23, 2019 (Actual)

Primary Completion Date

January 6, 2021 (Actual)

Study Completion Date

February 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ObsEva SA

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 study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP).

Detailed Description

This is a prospective, randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of linzagolix administered orally once daily at doses of 75 mg alone and 200 mg in combination with low dose ABT (E2 1 mg/NETA 0.5 mg) versus placebo in the management of moderate to severe EAP in 450 women. Eligible subjects who have completed the 6-month treatment period may enter a separate extension study for 6 additional months of active treatment (no placebo control). Subjects who do not continue in the extension study will enter a 6 month treatment-free follow-up phase.

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

85 (Actual)

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

75 mg linzagolix tablet

Intervention Description