A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis (EDELWEISS)

June 27, 2022 updated by: ObsEva SA

A Randomized, Double-blind, Placebo-controlled, Phase 2b Dose-ranging Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis Associated Pain

The primary objective of this study is to assess the efficacy and safety of a range of oral doses of OBE2109 versus placebo, in reducing endometriosis associated pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is a prospective, dose-finding, randomized, parallel group, double-blind, placebo-controlled phase 2b study investigating the efficacy and safety of OBE2109 in the treatment of 330 women with moderate-to-severe endometriosis associated pain.

Subject will be randomized to one of 6 treatment groups in a 1:1:1:1:1:1 ratio (1 placebo group, 5 dose groups with different dosage/regimen).

Eligible subjects will be offered the opportunity to continue treatment with OBE2109 in an extension phase. Subjects who do not continue in the extension will enter the treatment-free follow-up phase of the study.

Study Type

Interventional

Enrollment (Actual)

328

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Katowice, Poland
        • Site reference ID 101
      • Katowice, Poland
        • Site reference ID 102
      • Lublin, Poland
        • Site reference ID 104
      • Lublin, Poland
        • Site reference ID 105
      • Szczecin, Poland
        • Site reference ID 103
  • Russian Federation
      • Moscow, Russian Federation
        • Site reference ID 201
      • Moscow, Russian Federation
        • Site reference ID 202
      • Moscow, Russian Federation
        • Site reference ID 203
      • Moscow, Russian Federation
        • Site reference ID 204
      • Saint Petersburg, Russian Federation
        • Site reference ID 205
  • Ukraine
      • Ivano-Frankivs'k, Ukraine
        • Site reference ID 305
      • Kyiv, Ukraine
        • Site reefrence ID 303
      • Kyiv, Ukraine
        • Site reference ID 301
      • Kyiv, Ukraine
        • Site reference ID 302
      • Kyiv, Ukraine
        • SIte reference ID 304
  • United States
    • Arizona
      • Chandler, Arizona, United States
        • Site reference ID 455
      • Scottsdale, Arizona, United States
        • Site reference ID 439
    • California
      • Arcadia, California, United States
        • Site reference ID 462
      • Chino, California, United States
        • Site reference ID 405
      • Huntington Park, California, United States
        • Site reference ID 463
      • Northridge, California, United States
        • Site refenrec ID 469
      • San Diego, California, United States
        • Site reference ID 431
      • Tustin, California, United States
        • Site reference ID 440
    • Colorado
      • Denver, Colorado, United States
        • Site reference ID 474
      • Lakewood, Colorado, United States
        • Site reference ID 450
      • Longmont, Colorado, United States
        • Site reference ID 425
    • District of Columbia
      • Washington, District of Columbia, United States
        • Site reference ID 410
    • Florida
      • Boca Raton, Florida, United States
        • Site reference ID 457
      • Clearwater, Florida, United States
        • Site reference ID 418
      • Gainesville, Florida, United States
        • Site reference ID 437
      • Jensen Beach, Florida, United States
        • Site reference ID 458
      • Miami, Florida, United States
        • Site reference ID 411
      • Miami, Florida, United States
        • Site reference ID 424
      • Miami, Florida, United States
        • Site reference ID 435
      • Miami Lakes, Florida, United States
        • Site reference ID 420
      • Miami Springs, Florida, United States
        • Site reference ID 441
      • New Port Richey, Florida, United States
        • Site reference ID 423
      • Tampa, Florida, United States
        • Site reference ID 426
      • Wellington, Florida, United States
        • Site reference ID 442
    • Georgia
      • Atlanta, Georgia, United States
        • Site reference ID 428
      • Atlanta, Georgia, United States
        • Site reference ID 459
    • Idaho
      • Nampa, Idaho, United States
        • Site reference ID 475
    • Illinois
      • Oak Brook, Illinois, United States
        • Site reference ID 465
    • Kansas
      • Shawnee Mission, Kansas, United States
        • Site reference ID 404
      • Wichita, Kansas, United States
        • Site reference ID 456
    • Louisiana
      • Marrero, Louisiana, United States
        • Site reference ID 454
      • Metairie, Louisiana, United States
        • Site reference ID 453
    • Maryland
      • Glen Burnie, Maryland, United States
        • Site reference ID 478
    • Massachusetts
      • Fall River, Massachusetts, United States
        • Site reference ID 445
      • Fall River, Massachusetts, United States
        • Site reference ID 471
    • Michigan
      • Ann Arbor, Michigan, United States
        • Site reference ID 430
      • Bay City, Michigan, United States
        • Site reference ID 409
      • Saginaw, Michigan, United States
        • Site reference ID 468
      • Saginaw, Michigan, United States
        • Site reference ID 473
      • Southfield, Michigan, United States
        • Site reference ID 427
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Site reference ID 421
    • New York
      • New York, New York, United States
        • Site reference ID 466
    • North Carolina
      • Greensboro, North Carolina, United States
        • Site reference ID 436
      • Morehead City, North Carolina, United States
        • Site reference ID 433
    • Ohio
      • Dayton, Ohio, United States
        • Site reference ID 443
      • Franklin, Ohio, United States
        • Site reference ID 472
      • Tiffin, Ohio, United States
        • Site reference ID 415
      • Westerville, Ohio, United States
        • Site reference ID 414
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States
        • Site reference ID 419
      • Jenkintown, Pennsylvania, United States
        • Site reference ID 449
    • South Carolina
      • Columbia, South Carolina, United States
        • Site reference ID 476
    • Tennessee
      • Bristol, Tennessee, United States
        • Site reference ID 408
      • Chattanooga, Tennessee, United States
        • Site reference ID 403
      • Nashville, Tennessee, United States
        • Site reference ID 429
    • Texas
      • Austin, Texas, United States
        • Site reference ID 452
      • Beaumont, Texas, United States
        • Site reference ID 461
      • Dallas, Texas, United States
        • Site reference ID 447
      • Dallas, Texas, United States
        • Site reference ID 460
      • Fort Worth, Texas, United States
        • Site reference ID 464
      • Houston, Texas, United States
        • Site reference ID 413
      • Houston, Texas, United States
        • Site reference ID 434
      • Houston, Texas, United States
        • Site reference ID 479
      • San Antonio, Texas, United States
        • Site reference ID 451
      • Schertz, Texas, United States
        • Site reference ID 402
      • Webster, Texas, United States
        • Site reference ID 432
    • Utah
      • Draper, Utah, United States
        • Site reference ID 422
    • Virginia
      • Centreville, Virginia, United States
        • Site reference ID 467
      • Norfolk, Virginia, United States
        • Site reference ID 407
      • Richmond, Virginia, United States
        • Site reference ID 412
      • Richmond, Virginia, United States
        • Site reference ID 417
    • Washington
      • Seattle, Washington, United States
        • Site reference ID 406

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Key Inclusion Criteria:

  • The subject must have had her most recent surgical and - if available - histological, diagnosis of pelvic endometriosis up to 10 years before screening.
  • The subject has moderate to severe endometriosis-associated pain during the screening period.
  • The subject has regular menstrual cycles.
  • The subject has a BMI ≥ 18 kg/m2 at the screening visit.

Key Exclusion Criteria:

  • The subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
  • The subject had an interventional surgery for endometriosis performed within a period of 60 days before screening.
  • The subject did not respond to prior treatment with gonadotropin releasing hormone (GnRH) agonists or GnRH antagonists for endometriosis.
  • The subject has a history of, or known osteoporosis or other metabolic bone disease.
  • The subject has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic / therapy, or that would interfere with the assessment of endometriosis related pain.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OBE2109 50 mg
Drug: OBE2109
OBE2109 tablets for oral administration once daily
Experimental: OBE2109 75mg fixed dose (FD)
Drug: OBE2109
OBE2109 tablets for oral administration once daily
Experimental: OBE2109 75mg titrated dose (TD)
Drug: OBE2109
OBE2109 tablets for oral administration once daily
Experimental: OBE2109 100mg
Drug: OBE2109
OBE2109 tablets for oral administration once daily
Experimental: OBE2109 200 mg
Drug: OBE2109
OBE2109 tablets for oral administration once daily
Placebo Comparator: Placebo / OBE2109 100mg
Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.
Drug: OBE2109
OBE2109 tablets for oral administration once daily
Drug: Placebo
Placebo tablets for oral administration once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Overall Pelvic Pain Score (0-3 VRS)
Time Frame: From baseline to week 12

The primary efficacy endpoint of the study was a response at Week 12, with response defined as a reduction of 30% or greater from baseline in the mean overall pelvic pain score, defined as the mean of daily pain scores reported in electronic diary during the preceding 28 days (4-week period), assessed on a Verbal Rating Scale for pelvic pain of 0 (no pain) to 3 (severe pain). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period.

The relevant time points are Baseline and Week 12.
From baseline to week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 in the Mean Overall Pelvic Pain Score (0-10 NRS)
Time Frame: From baseline to week 12

This endpoint corresponds to the change from baseline to Week 12 in the mean overall pelvic pain score, defined as the mean of daily pain scores reported in electronic diary during the preceding 28 days (4-week period), assessed on a Numerical Rating Scale (NRS) for pelvic pain of 0 (no pelvic pain) to 10 (worst pelvic pain imaginable). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period.

The relevant time points are Baseline and Week 12.
From baseline to week 12
Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Pelvic Pain Scores (0-3 VRS) for Days With Uterine Bleeding
Time Frame: From baseline to week 12

This endpoint corresponds to a response at Week 12, with response defined as a reduction of 30% or greater from baseline in the mean pelvic pain score for days with uterine bleeding/spotting, defined as the mean of daily pain scores on days with uterine bleeding/spotting recorded in electronic diary during the preceding 28 days (4-week period), assessed on a Verbal Rating Scale for pelvic pain of 0 (no pain) to 3 (severe pain). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period.

The relevant time points are Baseline and Week 12.
From baseline to week 12
Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Pelvic Pain Scores (0-3 VRS) for Days With no Uterine Bleeding
Time Frame: From baseline to week 12

This endpoint corresponds to a response at Week 12, with response defined as a reduction of 30% or greater from baseline in the mean pelvic pain score for days with no uterine bleeding, defined as the mean of daily pain scores on days with no uterine bleeding recorded in electronic diary during the preceding 28 days (4-week period) on a Verbal Rating Scale for pelvic pain of 0 (no pain) to 3 (severe pain). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period.

The relevant time points are Baseline and Week 12.
From baseline to week 12
Change From Baseline to Week 12 in the Mean Dyspareunia Score (0-3 VRS)
Time Frame: From baseline to week 12

This endpoint corresponds to the change from baseline to Week 12 in the mean dyspareunia score, defined as the mean of daily dyspareunia scores recorded in electronic diary during the preceding 28 days (4-week period), assessed on a 0-3 Verbal Rating Scale (VRS) for dyspareunia, with 0 representing "No discomfort during sexual intercourse" and 3 representing "I avoided sexual intercourse because of pain". The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period.

The dyspareunia questionnaire also included an option "not applicable: I was not sexually active for reasons other than my endometriosis or did not have sexual intercourse"; for scoring, answering "not applicable" was considered like a missing value.

The relevant time points are Baseline and Week 12.
From baseline to week 12
Change From Baseline to Week 12 in the Mean Dyschezia Score (0-10 NRS)
Time Frame: From baseline to week 12

This endpoint corresponds to the change from baseline to week 12 in the mean dyschezia score, defined as the mean of weekly dyschezia scores reported in electronic diary during the preceding 28 days (4-week period), assessed on a 0-10 Numerical Rating Scale for dyschezia, with 0 representing no pain and 10 representing the worst pain imaginable. The baseline mean score was calculated as the mean of weekly scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period.

The relevant time points are Baseline and Week 12.
From baseline to week 12
Percentage of Subjects With Any Analgesics Use at Week 12
Time Frame: Up to week 12
This endpoint corresponds to the percentage of subjects at week 12 who recorded at least one pain medication intake in electronic diary during the preceding 28 days (4-week period).
Up to week 12
Change From Baseline to Week 12 in the Mean Score of Endometriosis Health Profile-30 (EHP-30) Pain Domain
Time Frame: From baseline to week 12

This endpoint corresponds to the change from baseline to Week 12 in the mean score of pain dimension of the EHP-30. The EHP-30 questionnaire was answered on electronic diary after activation by site staff during subject's monthly visits at site.

The EHP-30 pain dimension consists of 11 items each addressing the effect of pain on various activities in the past 4 weeks and each assessed on a 5-point scale (0=Never through to 4=Always). Scaled score was equalled to total of raw score of each item in scale divided by the maximum possible raw score of all the items in the dimension, multiplied by 100, resulting in a score on a scale from 0 (best possible health status) to 100 (worst possible health status).

The relevant time points are Baseline and Week 12.
From baseline to week 12
Percentage of Subjects With Improvement in the Patient Global Impression of Change (PGIC) Score at Week 12
Time Frame: Up to week 12

The PGIC questionnaire consists of one question rated on a seven point scale (1="Very Much Improved" to 7="Very Much Worse"), with which the subject had to qualify her overall status since the start of the study. The PGIC was answered on electronic diary after activation by site staff during Week 12 visit at site.

This endpoint corresponds to the percentage of subjects with an "improvement" in the PGIC score, which includes all subjects who answered "Very much improved" or "Much improved" or "Minimally improved" at Week 12.
Up to week 12
Percentage of Subjects With an Endometriosis Severity Score of "Severe" at Week 12
Time Frame: Up to week 12
Subject was asked monthly on electronic diary to assess their impression of endometriosis severity, considering the preceding 4-weeks, with following possible answers: no symptoms, very mild, mild, moderate, severe. This question was programmed to raise automatically every 4 weeks on the subject electronic diary. Result reported here is the percentage of subjects who answered "severe" at week 12.
Up to week 12
Change From Baseline to Week 12 in the Difficulty in Doing Daily Activities Mean Score
Time Frame: From baseline to week 12

This endpoint corresponds to the change from baseline to Week 12 in the mean of daily scores for "difficulty in doing daily activities", assessed via electronic diary during the preceding 28 days (4-week period), on a Numerical Rating Scale (NRS) of 0 (no difficulty doing daily activities) to 10 (unable to do daily activities). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period.

The relevant time points are Baseline and Week 12.
From baseline to week 12
Percentage Change From Baseline to Week 24 in Bone Mineral Density (BMD)
Time Frame: From baseline up to week 24
Change from baseline to Week 24 in BMD assessed by dual-energy X-ray absorptiometry (DXA) scan of LUMBAR SPINE.
From baseline up to week 24
Number of Non Benign Endometrial Biopsies at Week 24
Time Frame: Week 24

Any pathological changes in the endometrium at week 24 were assessed from endometrial biopsies. The number of non benign biopsies at Week 24 is presented per treatment arm.

Note: an isolated case of hyperplasia (without atypia) was observed at week 12 in the 200 mg group in a subject whose screening biopsy results were normal. A follow-up biopsy at week 24 revealed no abnormalities.
Week 24
Change From Baseline to Week 24 in Endometrial Thickness Measured by Transvaginal Ultrasound (TVUS)
Time Frame: From baseline up to week 24
The endometrium thickness was measured by TVUS at screening and at Week 24 visit by the gynaecologist and result was recorded in mm. This endpoint reports the changes from baseline to Week 24 in the endometrial thickness.
From baseline up to week 24
Percentage Change From Baseline to Week 24 in the Clinical Laboratory Assessments: LDL
Time Frame: From baseline up to week 24
This endpoint reports the change from baseline up to Week 24 in the clinical laboratory assessments: LDL cholesterol.
From baseline up to week 24
Percentage Change From Baseline to Week 24 in Clinical Laboratory Assessments: HDL
Time Frame: From Baseline up to week 24
This endpoint reports the change from baseline to week 24 in clinical laboratory assessments: HDL cholesterol.
From Baseline up to week 24
Percentage Change From Baseline to Week 24 in Clinical Laboratory Assessments: Triglycerides
Time Frame: From baseline up to week 24
This endpoint reports the change from baseline to week 24 in clinical laboratory assessments: triglycerides.
From baseline up to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ObsEva SA

Investigators

  • Study Director: ObsEva SA, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimate)

May 19, 2016

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

June 27, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-OBE2109-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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