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

NCT ID: NCT02778399

Last Updated: 2022-07-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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OBE2109 50 mg

Group Type EXPERIMENTAL

OBE2109

Intervention Type DRUG

OBE2109 tablets for oral administration once daily

OBE2109 75mg fixed dose (FD)

Group Type EXPERIMENTAL

OBE2109

Intervention Type DRUG

OBE2109 tablets for oral administration once daily

OBE2109 75mg titrated dose (TD)

Group Type EXPERIMENTAL

OBE2109

Intervention Type DRUG

OBE2109 tablets for oral administration once daily

OBE2109 100mg

Group Type EXPERIMENTAL

OBE2109

Intervention Type DRUG

OBE2109 tablets for oral administration once daily

OBE2109 200 mg

Group Type EXPERIMENTAL

OBE2109

Intervention Type DRUG

OBE2109 tablets for oral administration once daily

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets for oral administration once daily

OBE2109

Intervention Type DRUG

OBE2109 tablets for oral administration once daily

Interventions

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Placebo

Placebo tablets for oral administration once daily

Intervention Type DRUG

OBE2109

OBE2109 tablets for oral administration once daily

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ObsEva SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ObsEva SA

Role: STUDY_DIRECTOR

Geneva

Locations

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Site reference ID 455

Chandler, Arizona, United States

Site Status

Site reference ID 439

Scottsdale, Arizona, United States

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Site reference ID 462

Arcadia, California, United States

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Site reference ID 405

Chino, California, United States

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Site reference ID 463

Huntington Park, California, United States

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Site refenrec ID 469

Northridge, California, United States

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Site reference ID 431

San Diego, California, United States

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Site reference ID 440

Tustin, California, United States

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Site reference ID 474

Denver, Colorado, United States

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Site reference ID 450

Lakewood, Colorado, United States

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Site reference ID 425

Longmont, Colorado, United States

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Site reference ID 410

Washington D.C., District of Columbia, United States

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Site reference ID 457

Boca Raton, Florida, United States

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Site reference ID 418

Clearwater, Florida, United States

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Site reference ID 437

Gainesville, Florida, United States

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Site reference ID 458

Jensen Beach, Florida, United States

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Site reference ID 411

Miami, Florida, United States

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Site reference ID 424

Miami, Florida, United States

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Site reference ID 435

Miami, Florida, United States

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Miami Lakes, Florida, United States

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Miami Springs, Florida, United States

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New Port Richey, Florida, United States

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Tampa, Florida, United States

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Wellington, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Nampa, Idaho, United States

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Oak Brook, Illinois, United States

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Shawnee Mission, Kansas, United States

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Wichita, Kansas, United States

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Marrero, Louisiana, United States

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Metairie, Louisiana, United States

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Site reference ID 478

Glen Burnie, Maryland, United States

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Site reference ID 445

Fall River, Massachusetts, United States

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Fall River, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Bay City, Michigan, United States

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Saginaw, Michigan, United States

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Saginaw, Michigan, United States

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Southfield, Michigan, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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Site reference ID 436

Greensboro, North Carolina, United States

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Morehead City, North Carolina, United States

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Site reference ID 443

Dayton, Ohio, United States

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Franklin, Ohio, United States

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Tiffin, Ohio, United States

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Westerville, Ohio, United States

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Bryn Mawr, Pennsylvania, United States

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Jenkintown, Pennsylvania, United States

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Columbia, South Carolina, United States

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Site reference ID 408

Bristol, Tennessee, United States

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Chattanooga, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Beaumont, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Site reference ID 413

Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Site reference ID 451

San Antonio, Texas, United States

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Site reference ID 402

Schertz, Texas, United States

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Site reference ID 432

Webster, Texas, United States

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Site reference ID 422

Draper, Utah, United States

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Site reference ID 467

Centreville, Virginia, United States

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Site reference ID 407

Norfolk, Virginia, United States

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Site reference ID 412

Richmond, Virginia, United States

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Site reference ID 417

Richmond, Virginia, United States

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Site reference ID 406

Seattle, Washington, United States

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Site reference ID 101

Katowice, , Poland

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Katowice, , Poland

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Lublin, , Poland

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Lublin, , Poland

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Szczecin, , Poland

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Site reference ID 201

Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Site reference ID 305

Ivano-Frankivsk, , Ukraine

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Site reefrence ID 303

Kyiv, , Ukraine

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Site reference ID 301

Kyiv, , Ukraine

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Site reference ID 302

Kyiv, , Ukraine

Site Status

SIte reference ID 304

Kyiv, , Ukraine

Site Status

Countries

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United States Poland Russia Ukraine

References

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Donnez J, Taylor HS, Taylor RN, Akin MD, Tatarchuk TF, Wilk K, Gotteland JP, Lecomte V, Bestel E. Treatment of endometriosis-associated pain with linzagolix, an oral gonadotropin-releasing hormone-antagonist: a randomized clinical trial. Fertil Steril. 2020 Jul;114(1):44-55. doi: 10.1016/j.fertnstert.2020.02.114. Epub 2020 Jun 4.

Reference Type DERIVED
PMID: 32505383 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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15-OBE2109-001

Identifier Type: -

Identifier Source: org_study_id

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